EUT Congress News Saturday 21 March 2015

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30th Anniversary Congress of the European Association of Urology

Saturday, 21 March 2015

Madrid, 20-24 March 2015

Urology should pursue relevance to stay ahead Abrahamsson bids adieu in upbeat opening ceremony

By Alba Leon With the upbeat tune from a brass band ushering participants to the main hall and the fiery staccato number from a flamenco dance troupe, the 30th Anniversary Congress opened yesterday, another landmark in the annual congress history.

“I have served this wonderful organisation for 11 years and it has been the best journey of my life,” said EAU Secretary General Per-Anders Abrahamsson in an emotional moment, which was interrupted by applause.

About the congress, he remarked in jest: “The weather could have been better, but for a meeting it is good to have rain, so we can enjoy the scientific programme- inside.”

Laurent Boccon-Gibod (FR), recipient of the Willy Gregoir Medal. Boccon-Gibod is very aware of the rapid advances in urology and reminded young urologists that “…several different pathologic conditions that used to be the ‘core business’ of urology disappeared due to therapeutic breakthroughs. Young urologists should be prepared for the consequences of technological progress and redefine the core business of urology in the next 10 to 15 years.”

Prof. Humberto Villavicencio (ES), who won the Frans Debruyne Life Time Award, echoed Boccon-Gibod’s sentiments: “Urology is possibly the specialisation with the most technological advances booked to date. The hospitals without enough vision to invest in technology can become obsolete.”

Flamenco music, courtesy of Ballet Carmen Cantero, filled the main auditorium hall with energy, and the Chattanooga Big Band, with its funky, pop band music, welcomed the audience in style.

He urges young urologists to “study and publish in high- impact journals, to gain more knowledge and provide added-value to the specialty.”

“The main challenge for urology in the future is to stay as a ‘comprehensive’ specialty, ” said Prof.

Dr. Morgan Rouprêt (FR) received the 18th Crystal Matula Award, a prestigious honour granted by the

A fiery, energetic flamenco number by the Ballet Carmen Cantero

Personalised medicine Challenges remain despite progress in research

By Joel Vega

‘This roundtable meeting recognises the need for personalized medicine as we move away from old diagnoses and therapies to those which specifically identifies high-risk from low-risk diseases,” said session chairman Arnulf Stenzl (DE).

Personalised Medicine roundtable session

Despite the apparent need for personalised medicine, the panel experts underscored that current conditions are still fraught with challenges as they urged more support for clinical trials and the development and optimal use of medical therapies.

“There are many agents that work but we don’t see the effect because the tumour volume is too high.

The crucial task is to identify patients with high-risk disease and act within the (limited) window of opportunity,” noted Hamdy.

Hamdy said precision cancer therapy is basically physically, physiologically and molecularly targeted, which implies that diagnosis tests would involve, among others, deep genome sequencing, and tests Saturday, 21 March 2015

Simon Horenblas (NL) received the EAU Innovators in Urology Award, while Martin Spahn (DE) won the EAU Prostate Cancer Research Award. The new EAU honorary members are Professors Gopal Badlani (USA), Keong Tatt Foo (SG), and Ladislav Jarolim (CZ).

Oncology, functional urology dominate first day sessions Issues in onco-urology such as prostate, renal and bladder cancers to controversies in urological strategies and treatment were discussed yesterday in various sessions during the Urology Beyond Europe joint discussions with the EAU.

The need for personalized medicine will further expand as patient demand for efficient therapy with less side effects increases, on the one hand, and medicine develops gene-based diagnostics and sophisticated imaging techniques, on the other.

The panel included Didier Jacqmin (FR) who defined the current understanding of personalised medicine and also spoke on the impact of economic costs; Freddie Hamdy (GB) who gave an update on clinical trial design adapted to personalised medicine; Thorsten Bach (DE) who provided an overview of the EAU’s Patient Information project and its influence on clinical studies, and clinical pharmacologist Michael Schwab who presented pathways in precision medicine, particularly in lung and kidney cancers.

EAU to a young promising European urologist.

Stavros Tyritzis (GR) received the Hans Marberger award, as lead author of the best European paper published related to minimally-invasive surgery in urology.

organized by the Young Academic Urologists and the European Urological Scholarship Programme (EUSP) which aims to facilitate educational training (See full stories on Page 2).

Delegates from China, Japan, Korea, India, Latin America, Africa, the Mid-East, to name a few, tackled various challenges in prostate cancer treatment.

Special sessions were also held on prostate cancer by the Prostate Cancer Prevention Group and the ESO Prostate Cancer Observatory, which held their second annual meeting yesterday. Other special sessions concerned a roundtable discussion on Personalised Medicine, a first in the congress, and meetings Urology Beyond Europe session

which are biomarker-driven and biologicallytargeted.

According to Hamdy, the future of precision cancer trials will hinged on genomics, targeted agents, functional and molecular imaging, particle therapy and robotic surgery. With regards functional imaging tools, he added there are several options, among them are positron emission tomography (PET), single photon emission computed tomography (SPECT), functional magnetic resonance imaging (fMRI) and functional photoacoustic microscopy (fPAM).

In response, Jacqmin said personalised treatment also entails both cost savings and cost burden, the latter due to longer and expensive clinical trials, fewer patient numbers in these clinical trials and the need for companion diagnostic tools, to name a few.

He enumerated possible solutions to reduce costs, such as new designs for clinical trials (CT) in agreement with the European Medical Association (EMA), the creation of a unique portal for initiation of CT and access to all the results of CT performed to avoid duplication. Another challenge for researchers is to base their clinical trials on molecular target instead of a disease to improve patient recruitment.

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Today’s Industry Sessions

Touijer: “Get our heads together Pasoglou wins and rethink the paradigm” Vision Award

Industry sessions, all starting at 18:00 hrs

Multidisciplinary links at ESO PCa Observatory

Treatment decisions in a new therapeutic landscape: Taking direct action ASTELLAS PHARMA EMEA - eURO Auditorium The truth about TRT (Testosterone Replacement Therapy) for the treatment of hypogonadism BESINS HEALTHCARE - Room Barcelona Workshop: Urological infections and stone disease: Different host reactions need different strategies BIONORICA SE - Room N107-108 A new approach for the patient with ED CASEN RECORDATI ESPANA, LABORATORIES MAJORELLE, SANDOZ INTERNATIONAL GMBH AND TAKEDA UK LIMITED - Room N101-102 How, why, when - risk stratification in newly diagnosed BPH patients with moderate symptoms GLAXOSMITHKLINE - Room Stockholm Chemo and radiotherapy induced urinary side effects: The role of Glycosaminoglycans (GAGs) IBSA INSTITUT BIOCHIMIQUE SA - Room N103 Alternative approaches to individualise care in prostate and bladder cancers IPSEN - Room Paris Managing patients with NMIBC: Therapeutic strategies in times of BCG shortage MEDAC - Room N104 Avanafil: the 4 “S” of a new PDE5-I for ED treatment MENARINI - Room N105-106

European Urology Today

Prof. Karim Touijer

“We have to put our heads together, get out of our comfort zones and rethink the paradigm,” said Touijer.

Speaking as a urologist in a programme that featured a researcher, a medical oncologist, a radiation oncologist, a radiologist and a patient representative, Touijer stressed it is inevitable to work in a multidisciplinary manner.

Prof. Mohamed Eissa (EG), session chairman, explained there still is a shortage of urologists in Africa and that most urological surgeries are performed by general surgeons. “In the Democratic Republic of Congo, for instance, there are only eight certified urologists in a population of more than four million,” Eissa said.

Coordination and Editing J. Vega Onsite Reporting and Editing Team M. van Hout L. Keizer A. Leon J. Vega

One of the ways in which PAUSA tries to improve this is by creating training centres throughout the

The award was handed today at the ESUI Meeting.

Pasoglou and her colleagues won for their study titled “Whole-Body 3D T1-weighted MR Imaging in Patients with Prostate Cancer: Feasibility and Evaluation in Screening for Metastatic Disease,” published in the December 2014 edition of the journal Radiology.

The prospective study used a 3D T1 whole body MRI in addition to a routine MR imaging protocol for node and/or bone metastasis screening in patients at high risk for metastasis. The study showed that 3D T1-weighted imaging improved the diagnostic performance relative to 2D T1 weighted imaging due to a higher signal-to-noise and contrast-tonoise ratio.

“The study implements a new innovative imaging tool into clinical practice,” the ESUI said.

continent, together with large international societies like the EAU, which provide training sessions and offer workshops to encourage young physicians to specialise in urology.

The treatment of complex and recurrent kidney stones was discussed and Prof. Christian Türk (AT) explained that stone treatment can be complex due to their size, location, or quantity. They can be managed by open surgery, laparoscopic surgery, percutaneous nephrolithotomy (PNL), and ureteroscopy (URS).

PNL is the first choice for complex stones, possibly in combination with flexible URS, but actual management depends on many factors including availability of instruments. In the African setting in particular, this can be a complex issue. Prof. Andreas Skolarikos (GR) also examined this problem when he discussed metabolic evaluation in patients with stone

recurrence. Especially in high-risk patients, who need detailed metabolic evaluations, shortage of resources can be problematic.

Prof. Hassan Abolella Abdelkhalek (EG) addressed the major problem of a widespread tradition of female genital mutilation (FGM) in Africa. FGM is deeply rooted in African cultural history and is believed to have been practiced by various ethnic groups. It mostly affects girls up to 15 years of age and over 101 million girls and women suffer from the long-lasting physical and psychological consequences of FGM. “We can end this human tragedy by collaborating with local organisations. Legislation alone is not enough to solve this problem because it requires a huge change of mentality and it needs to come from the people. By talking to families and spreading the message, we can all contribute to end FGM,” said Abdelkhalek.

Decision-making challenges in China and the world

Advertising W. Dennissen I. Moerkerken L. Schreuder

Diagnostic approaches and challenges in LUTS

By Alba Leon

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EUT Editorial Office PO Box 30016 6803 AA Arnhem The Netherlands T +31 (0)26 389 0680 F +31 (0)26 389 0674 EUT@uroweb.org

Continuing with the tradition of cooperation and information exchange, the EAU-World Chinese Urologists session focused on the importance of correct diagnosis to improve the decision-making process regarding treatment for patients suffering from a range of urological diseases ranging from Lower Urinary Tract Symptoms (LUTS), overactive bladder (OAB), prostate cancer to urinary diversion.

With the growing incidence of LUTS in China, especially in younger people, the first part of the session focused on the diagnosis and challenges in LUTS. Chun-Hou Liao (TW) offered insights into the management of male LUTS. In his view, “calculating IPSS-V/S can be a useful tool to differentiate and guide initial treatment.” Moreover, this tool is important as another marker to complement the practical guidance provided by symptom - oriented guidelines such as those of the EAU. Later in the session, Limin Liao (CN) shared data from

EUT Congress News

This year’s Vision Award is the fifth and fulfils ESUI’s goal to highlight the most innovative Dr. V. Pasoglou imaging study published in urology during the last year. The first Vision Award was given in 2011 during the EAU Congress in Vienna, Austria. Pasoglou is a member of the Department of Radiology, Cliniques Universitaires Saint Luc in Brussels, Belgium.

Chronic issues hound urological treatment in Africa

The lack of urologists, insufficient proper training, poverty and complications from female genital mutilation, are among the pressing issues in Africa, which were discussed yesterday during the Joint Session of the EAU and the Pan-African Urological Surgeons’ Association (PAUSA).

Founding Editor Prof. F. Debruyne, Nijmegen (NL)

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but no longer mandatory to define the patient as being castration-resistant. Her comments triggered many questions from the audience.

Radiology This year marked the first time a radiologist took part as a speaker, and Dr. Geert Villeirs (BE) was pleased to “Urologists will play a central role in the managing PCa offer the radiologists’ perspective on PCa treatment. He and they are going to start exploring -in a thoughtful pointed out that last year’s ESO PCa Observatory may and scientific way- the role of surgery in have been a little optimistic with the outlook for 2015. oligometastatic PCa. In other malignancies, we have Better targeting for biopsies, better stratification of seen great value in treating primary cancer through aggressiveness, better N- and M-staging and better surgical excision,” added Touijer. follow-up (more imaging, fewer biopsies) were very much in reach for the coming year. A better The PCa Observatory, chaired by Prof. Valdagni (IT) on quantification of the tumour burden was still behalf of the European School of Ocology and Prof. uncertain, and while dosage may improve, measuring Hein van Poppel (BE), invited speakers to look at the volume remains difficult. innovation and care in the next 12 months.

Dr. Maria De Santis (AT) provided a medical Valdagni welcomed the participation of a radiologist oncologist’s perspective, and forecasted various and told the EUT: “In the future, we will continue to treatment options in the coming year. “The TERRAIN invite a radiologist. Their role is becoming more and study gives indications that suggest that bicalutamide more important. Not only for the general evaluation of will have a diminished role in PCa treatment,” she the patient, but specifically in local evaluation of said. She also cited the 2015 EAU Guidelines, which disease, aggressiveness and targeted biopsy. The state that second hormonal manipulation is an option, radiologist also follows patients in active surveillance.”

By Monique van Hout

Section Editors Prof. T. E. Bjerklund Johansen, Oslo (NO) Mr. Ph. Cornford, Liverpool (GB) Prof. O. Hakenberg, Rostock (DE) Prof. P. Meria, Paris (FR) Dr. G. Patruno, Rome (IT) Dr. G. Ploussard, Paris (FR) Prof. J. Rassweiler, Heilbronn (DE) Prof. O. Reich, Munich (DE) Dr. F. Sanguedolce, London (GB)

No part of European Urology Today (EUT) may be reproduced without written permission from the Communication Office of the European Association of Urology (EAU). The comments of the reviewers are their own and not necessarily endorsed by the EAU or the Editorial Board. The EAU does not accept liability for the consequences of inaccurate statements or data. Despite of utmost care the EAU and their Communication Office cannot accept responsibility for errors or omissions.

The speakers at the 2nd ESO Prostate Cancer Observatory, each representing a different discipline, prompted Prof. Karim Touijer (USA) to say that everyone is quite aware that there is much to gain from collaboration.

PAUSA seeks ways to improve urological treatment despite challenges

Editor-in-Chief Prof. M. Wirth, Dresden (DE)

Disclaimer

By Loek Keizer

Vasiliki Pasoglou won this year the Vision Award annually granted by the EAU Section of Urological Imaging (ESUI).

the LUTS-China I-III survey with the audience. This survey provides much welcome data on preferred medical treatment of male LUTS and on the incidence of lower urinary tract symptoms in the country. It was conducted among more than 12,180 patients across some 150 hospitals throughout China.

remains to be done, particularly in terms of awareness, as “the perception of long-term treatment for BPE and OAB needs to be improved.”

To complement the views on treatment, Marcus Drake (GB) asked how to best adapt the treatment to each patient. He stressed that the assessment of LUTS Most interestingly, “most LUTS patients with moderate should always seek to identify whether the symptoms to severe symptoms visit the hospital or their doctor of the lower urinary tract are caused by more serious relatively late.” The survey further showed around conditions. This is important since drug treatment 90% of LUTS patients chose drug treatment to manage primarily seeks to treat the symptoms, and treatment their symptoms, and that roughly 60% of them choose for other, and serious, underlying causes could be alpha blockers as their first treatment option. Much delayed.

The moderators during the Male LUTS presentations

The rest of the session was dedicated to answering questions on OAB, urinary diversion, and prostate cancer; the latter topic has gained relevance in recent years. Prostate disease is currently the fifth leading malignancy in Taiwan, and its incidence is on the rise.

As with LUTS, the issue of late diagnosis needs to be addressed adequately to ensure appropriate treatment, a challenge for urologists in China, Taiwan, and the rest of the world.

Saturday, 21 March 2015

Structured robotic training curriculum Certified robotic training will be available in host centres across Europe

Congress news. . . . . . . . . . . . . . . . . . . . . . . . 1 Congress highlights . . . . . . . . . . . . . . . . . . 2/3

By Joel Vega

Molecular profiling in bladder cancer. . . . . . . 4 A certified, structured robotic training programme will be offered across Europe following the completion of a pilot study spearheaded by the EAU Robotic Urology Section (ERUS).

Surgery in metastatic kidney cancer. . . . . . . . 5 Managing paediatric stones. . . . . . . . . . . . . . 7 How to solve mesh complications. . . . . . . . . . 8

“There is an absolute need for proper training. The robot is a fantastic tool but a fool with a tool is still a fool, as they say. Thus, what is crucial and needed is to implement proper and structured training,” said ERUS chairman Prof. Alexander Mottrie.

Immunotherapy: Urothelial bladder cancer . . 9 Challenging cases in Live Surgery. . . . . . . . . 10 Prostate cancer in renal transplant recipients. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Mottrie said the ERUS will introduce the ERUS Robotic Curriculum, the first of its kind and an initiative that was fully endorsed by the EAU and the European School of Urology (ESU). “A well-organised educational curriculum, as well as proficiency-based credentialing processes are needed. Patient safety and better surgical outcomes depend on this,” added Mottrie.

The ERUS conducted a six-month pilot study from January to June 2014 to assess and validate the robotic curriculum which basically consists of a baseline assessment, an ORSI intensive training, a fellowship with modular training on the console in a robotic expertcenter and a final evaluation. The first phase requires participants to undergo a basic robotic skills course and also pass the advanced level. The theoretical part of the training includes the eBRUS and da Vinci surgical community online theoretical training.

Practical experience is gained with virtual Skill SimulatorTM, dry and wet labs, including an intensive week of lab training at a selected training centre. A dual console enables mentors to teach the fellows during live procedure trainings. Throughout the curriculum the procedure is taught in a step-bystep manner (modular training). An assessment of the technical skills on simulator and dry lab will be performed on days 1, 28, 35 and 180.

Stone treatment: What do the patients want?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 New topics in compact EAU Guidelines. . . . . 13 Where do we stand with predictive biomarkers in mCRPC?. . . . . . . . . . . . . . . . . 14

Robotic training session during the ERUS meeting in Amsterdam in 2014

Diagnosing PCa: Is MRI needed besides biopsy?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Novel approaches to ureteroscopy . . . . . . . . 17

According to Mottrie, the three pilot studies confirmed that a six-month training scheme proved to be the most effective period for many participants athough there could be a few exceptions in cases where participants already possess advanced skills.

The mentors perform a final evaluation of the technical skills (using GEARS), while non-technical skills are assessed by Non-Technical Skills for Surgeons (NOTSS) System and the Revised Nontechnical skills (NOTECHS) scale.

In the ERUS robotic curriculum, the fellows or participants at the end of the training had to perform a case of radical prostatectomy independently. The full procedure is recorded and assessed blindly by two independent international experts. After effective completion of this

curriculum, surgeons will be certified ERUS Robotic Fellows.

Mottrie added that robotic host centres will be identified across Europe where applicants would undergo training. The host centres have to fulfill requirements such as having at least two robotic surgeons, a solid scientific and practical experience in the robotic field and the commitment to train properly and allow the trainee access to the robot, among other prerequisites.

As lead organiser for a structured robotic training, the ERUS welcomes feedback and inquiries from interested urologists. Details of the robotic curricula will be published in the ERUS website and potential participants can inquire from or direct their queries to Mottrie.

The role of ischemia. . . . . . . . . . . . . . . . . . . 18 Future of biodiversity studies on the male genital tract. . . . . . . . . . . . . . . . . . . . . 19 Treatment strategies for CRPC in 2015 and beyond . . . . . . . . . . . . . . . . . . . . . . . . . 20 Robot-assisted renal surgery . . . . . . . . . . . . 22 Evolving technology in the diagnosis of urothelial cancer . . . . . . . . . . . . . . . . . . . 23 New EAUN guidelines to benefit bladder cancer patients. . . . . . . . . . . . . . . . . . . . . . . 25 +1 Campaign: Optimal links between nurses and doctors. . . . . . . . . . . . . . . . . . . . 31

Day 1 Awards Gallery

Prof. Abrahamsson awards Prof. Boccon-Gibod with the EAU Willy Gregoir Medal

Prof. Villavicencio receives the EAU Frans Debruyne Life Time Achievement Award

Prof. Horenblas receives the Innovators in Urology Award from Prof. Abrahamsson

Prof. Tyritzis accepts the Hans Marberger Award from Prof. Abrahamsson and Mr. Wehrstein from KARL STORZ

Prof. Spahn receives the EAU Prostate Cancer Research Award from Prof. Schröder and Prof. Abrahamsson

Prof. Roupret received the EAU Chrystal Matula Award from Prof. Abrahamsson and Mr. Bulla from LABORIE

Prof. Abrahamsson congratulates Prof. Badlani with his Honorary Membership

Prof. Abrahamsson congratulates Prof. Jarolim with his Honorary Membership

Prof. Abrahamsson congratulates Prof. Foo with his Honorary Membership

Saturday, 21 March 2015

EUT Congress News

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Molecular profiling in bladder cancer The Cancer Genome Atlas (TCGA) project Prof. Seth Lerner Scott Department of Urology Beth and Dave Swalm Chair in Urologic Oncology Baylor College of Medicine Medical Center Houston, Texas (USA) The Cancer Genome Atlas Project (TCGA) began as a three-year pilot project co-funded by the National Cancer Institute and National Human Genome Research Institute to characterize glioblastoma multiforme, lung and ovarian cancer.

The early success led to expanded funding to comprehensively characterize the genome of 25 common cancers and eight additional rare tumors.

Genitourinary malignancies are prominent with completed or ongoing projects in clear cell, papillary and chromophobe renal cell carcinoma, muscle invasive bladder cancer, prostate adenocarcinoma and germ cell testicular cancer. Highly annotated fresh frozen tumor specimens that meet strict clinical and pathologic entry criteria are submitted to a central biospecimen-processing center where additional histology and molecular quality control are performed.

DNA, RNA and protein are then extracted and distributed to genome characterization centers. The molecular findings are then integrated to produce a comprehensive characterization of the genome unique to each tumor type resulting in a ‘human genome project’ for each cancer (Figure 1). After publication of the first “marker paper” for a given cancer, the data are stored in an open access repository creating a rich resource for the research community (https://tcga-data.nci.nih.gov/tcga and https://cghub.ucsc.edu/).

The unique aspects of the TCGA projects are the comprehensive description and integrated analysis of genomic data for each individual tumor. The TCGA project in bladder cancer reported the integrated genomic analysis of the first 131 patients in 20141.

Significantly mutated genes We analyzed chemotherapy-naive, muscle-invasive urothelial cancers for somatic mutations, DNA copy number variants (CNVs), mRNA and microRNA expression, protein and phosphorylated protein expression (RPPA), DNA methylation, integrated with comprehensive clinical and pathologic data. In addition viral integration and translocations were characterized. This muscle invasive cohort has one of the highest somatic mutation rates with a mean and median of 7.7 and 5.5 per megabase (Mb), similar to lung adenocarcinoma and squamous cell carcinoma and melanoma.

Figure 2: TCGA Muscle Invasive Bladder Cancer Pipeline (https://tcga-data.nci.nih.gov/datareports accessed 1/9/2015)

We reported 32 significantly mutated genes (SMGs) involved in multiple pathways include cell cycle regulation (93% of tumors), chromatin remodeling (76%), DNA damage response, transcription factors, and RAS/RTK/PI3K (72%) signaling pathways. Four SMGs are involved in epigenetic regulation: ARID1A, MLL2, KDM6A, and EP300 and were mutated in up to one fourth of the tumors. One-third of the tumors were characterized by cancer–specific DNA hypermethylation.

An additional 281 tumors are in the pipeline and the complete data set will be analyzed beginning early 2015. We have preliminary mutation data on 238 samples (including the first 131) and six additional SMGs have been identified (Table 1). Several of the 38 SMGs have not previously been described in bladder cancer.

Three mutation clusters were identified combining copy number variation and somatic mutations characterized as: 1) “Focally amplified” - enriched in focal copy number alterations (eg. 3p loss/PPARG) and MLL2 mutations; 2) Enriched for TP53 and RB1 mutations, E2F3 amplifications; and 3) Papillary histology, FGFR3 mutant CDKN2A-deficient. This integrated analysis also indicated that the majority of tumors (69%) harbor one or more potentially actionable targets.

There are approved drugs targeting these genes in other tumor types that can be applied in clinical trials today as well as drugs in development. The future may be that therapies are target- specific rather than organ/tissue-specific. One example might be drugs targeting the PI3K/AKT/mTOR pathway which was altered in 42% of the TCGA cohort. These included activating point mutations in PIK3CA (17%), mutation or deletion of TSC1 and TSC2 (9%), and overexpression of AKT3 (10%).

These were largely mutually exclusive with one another suggesting that targeting these specific alterations may be effective. One example is TSC1mutations which may convey unique sensitivity to the mTOR inhibitor Everolimus (approved for

Table 1: Significantly mutated genes in 238 tumors (percent of tumors with mutation). Six additional genes in blue identified since publication of the first 131 tumors TP53 (49%)

RB1 (17%)

NFE2L2 (6%)

FOXA1 (5%)

MLL2 (27%)

ERCC2 (9%)

ERBB2 (8%)

PAIP1 (5%)

ARID1A (25%)

FGFR3 (12%)

TSC1 (7%)

BTG2 (3%)

KDM6A (24%)

STAG2 (14%)

KLF5 (6%)

HRAS (4%)

PIK3CA (19%)

ERBB3 (11%)

TXNIP (7%)

ZFP36L1 (7%)

EP300 (15%)

FBXW7 (8%)

FOXQ1 (5%)

RHOA (5%)

ATM (15%)

RXRA (7%)

CDKN2A (6%)

CCND3 (4%)

CDKN1A (10%)

ELF3 (12%)

RHOB (5%)

CTNNB1 (2%)

HSP90AA1 (7%)

PSIP1 (5%)

ZFP36L2 (5%)

ZNF513 (5%)

PTEN (4%)

CEBPB (2%)

Figure 1: TCGA muscle invasive bladder cancer timeline, data types and project leaders.

DWG – disease working group AWG – analysis working group

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EUT Congress News

metastatic renal cell carcinoma and other tumor types) as suggested by Iyer, et al2. While loss of function mutations in TSC1 occurred in only 6% of bladder cancers, they are also present in several other TCGA tumor types including lung adeno and squamous cancers, ovarian, colorectal and breast cancer suggesting that clinical trials targeting this pathway across these tumor types may be a rational approach.

MATCH The NCI has launched an innovative clinical trial (MATCH - Molecular Analysis for Therapy Choice) using this strategy that will treat patients with advanced solid and hematologic cancers targeting up to 30 specific gene alterations in small phase II trials.

The Alliance cooperative group is planning to test this paradigm in locally advanced and metastatic bladder cancer where frontline therapy has failed. It is proposed that actionable targets for this trial will include alterations in FGFR3, the PI3K/AKT/mTOR pathway, and RB inactivation.

Molecular subtypes Integrated analysis of the 131 tumors in the initial TCGA muscle invasive bladder cancer cohort using unsupervised clustering of mRNA, miRNA and RPPA suggested four expression clusters, three of which were fully characterized as follows. Cluster I comprised 25% of tumors and shows papillary morphology and FGFR3 dysregulation including mutation, amplification and three tumors with translocations involving TACC3, which results in constituitive activation of the kinase domain of FGFR3 and reported previously by Williams, et al3.

Tumors harboring these translocations may be particularly sensitive to FGFR3 targeted therapy.

Clusters I and II express high HER2 (ERBB2) and estrogen receptor beta signaling signature, sharing features with Luminal A breast cancer. Cluster III shows similarities to Basal-like breast and squamous cell head and neck carcinomas. Cluster III has a high cancer stem cell content, similar to the basal phenotype reported earlier by Volkmer and Ho and colleagues4,5. Cluster III is also enriched with tumors with mixed squamous histology similar to the subtype described by Sjodal, et al, which had the worst prognosis compared to three other subtypes which correlate well with the four subtypes described in the TCGA dataset6.

Cluster III also correlates with other TCGA subtypes in including basal-like breast carcinoma, head and neck squamous and lung squamous cell carcinomas1. This has been confirmed with a recent “cluster of cluster” TGCA pan cancer analysis, which stratified the bladder cancer cohort into three subtypes. Two were similar to lung adeno and lung squamous carcinoma as well as head and neck carcinoma while the third, which contained the majority of tumors, was unique to bladder cancer and had the best prognosis compared to the two other subtypes7.

amplification and expression and urothelial differentiation markers (UPK1A, 2, II, KRT 20). Cluster III is enriched with squamous morphology, basal markers (KRT 14, 5, TP63) and expression of several immune response genes. These include programmed cell death-ligand 1 (PD-L1) whose normal function to suppress the immune system during events such as pregnancy, but may be up-regulated in cancers thereby allowing them to evade the host immune system8.

Blockade of the interaction between PD-L1 and its receptor by anti–PD-L1 antibodies have been shown to potentiate immune responses and mediate antitumor activity9. The PD-L1 receptor PD-1 may be blocked by monoclonal antibodies including pembrolizumab, nivolumab and AMP-514, and several clinical trials in bladder cancer are planned or underway. PD-L1 may be targeted by human monoclonal antibodies such as MPDL3280A and MEDI4736.

A recent Phase I trial of MPDL3280A in advanced bladder cancer demonstrated rapid and sometimes sustained responses in tumors with high expression of PD-L110. A Phase II trial in patients who have progressed following cis-platinum-based chemotherapy (NCT02108652) and a Phase III trial comparing MPDL3280A to chemotherapy in a similar group of patients are underway (NCT02302807).

The total muscle invasive TCGA cohort now includes 412 tumors that have met the pre-specified quality controls for pathology and RNA quality and have been distributed to the genome characterization centers (See Figure). This complete data set will increase the power to detect additional low frequency events11, validate the cluster analyses, test hypotheses regarding chemotherapy resistance and provide a host of translational opportunities for functional validation and targeted therapy trials. Outcome analyses were deliberately not included in the analysis of the first 131 tumors as the follow-up data were not mature and will be included in the final analysis.

Unmet need We expect to be able to include this in the final analysis of the full cohort. The analysis working group will reconvene in early 2015 to begin the final analysis with the expectation of publishing an update comprehensive integrated analysis.

There is also a large unmet need for comprehensive genomic characterization of non-muscle invasive bladder cancer (NMIBC). FGFR3 mutations characterize low-grade Ta tumors and high-grade tumors share similar genomic alterations as muscle invasive carcinomas.

The NCI is sponsoring a clinical trials planning meeting to be held in March 2015 with the goals of designing a targeted therapy trial and an immunotherapy-based trial and a more comprehensive understanding of the genomic The fourth cluster (10%) showed similarities to cluster landscape is a critical step in this process.

I with FGFR3 alterations and high expression of miR-99a and 100 as well as similarities to cluster III Editorial Note: Article contributed by Dr. Lerner with low expression of e-cadherin and mi-200a and on behalf of project co-chair John Weinstein b, both associated with epithelial-mesenchymal (MD Anderson Cancer Centre), David Kwaitkowski transition. Gordon Roberston and Andy Mungall have (Broad Institute) and the Analysis Working Group. also performed unsupervised clustering of miRNA in 310 tumors and provide an integrated analysis of Due to space constraints the reference list has been anti-correlations of clusters of miRNA regulating omitted. Interested readers can send a request at many pathways including epithelial-mesenchymal EUT@uroweb.org. transition, DNA methylation, and FGFR3 expression among many others.

Saturday, 21 March 8.30-11.00: Plenary Session 1 Immune responses Controversies in surgical oncology in bladder We have now integrated the mutation subtypes and and kidney the expression clusters for 234 tumors. Expression Hot topic lecture cluster I is enriched with FGFR3 mutations, Saturday, 21 March 2015

Surgery in advanced and metastatic renal cell carcinoma Is there a role for neoadjuvant/adjuvant therapy?

Dr. Axel Bex The Netherlands Cancer Institute Division of Surgical Oncology Department of Urology Amsterdam (NL)

Renal cell carcinoma (RCC) accounts for 3% of adult malignancies and constitutes 95% of renal tumours1.

In the European Union, approximately 85 new cases and 35 deaths per 100,000 were reported in 20122.

For the United States comparable figures exist with approximately 64,000 new cases in 2014 alone3.

Surgical complete resection is the only curative treatment of locally advanced RCC including patients with limited metastatic disease. However, these patients carry a high risk to develop locally recurrent disease and systemic progression. According to the validated Leibovich or UISS risk scores high-risk patients have a two-year local or systemic failure rate of 57.5 % and a three-year metastasis free survival of only 37.1 %4. High-risk patients with no evidence of disease following complete resection may therefore benefit from adjuvant and neoadjuvant systemic treatment strategies which primarily aim to prolong disease-free and, ultimately, overall survival.

Studies performed in the past with adjuvant therapy based on radiotherapy, chemotherapy, immunotherapy and hormonal therapy were without benefit5. Some immunotherapy concepts, including adjuvant autologous vaccines derived from tumour cells6 or heat shock protein-peptide complex-96 (vitespen)7, may have a benefit in a subgroup of patients but the overall data from phase III trials were negative.

After the introduction of VEGF-targeting therapy and inhibitors of the mammalian target of rapamycin (mTOR) several adjuvant phase III randomized controlled trials currently investigate tyrosine kinase inhibitors (TKI) and mTOR inhibitors following nephrectomy in high-risk RCC (Table 1)8. The primary endpoint of these trials is disease-free survival and some studies are expected to report in 2015 and 2016.

However, use of anti-VEGF therapy in the adjuvant setting may have negative effects beyond the standard adverse events associated with this type of drugs.

Small controversial studies in mice and humans suggest that TKI may worsen outcome parameters by potentially promoting tumour invasiveness, metastasis and shedding of tumour cells9-11.

None of these assumptions has been substantiated in controlled trials in humans. Nevertheless, because of the associated toxicity and the potential harm, high-risk patients with no evidence of disease should only receive targeted agents in the context of a clinical trial until more evidence becomes available.

Neoadjuvant therapy While efforts to establish a robust evidence base for or against adjuvant targeted therapy with TKI or mTOR inhibitors are underway, randomized controlled trials have not been initiated for neoadjuvant VEGFtargeting strategies in high-risk RCC. Results from the on-going adjuvant phase III studies are not yet available and this partly explains the reluctance to set

up large neoadjuvant phase III trials with the same class of drugs and disease-free survival as endpoint.

superior in terms of overall survival when compared to complete metastasectomy alone.

Neoadjuvant therapy should be distinguished from presurgical therapeutic concepts currently being investigated in primary metastatic disease in conjunction with cytoreductive nephrectomy.

Unfortunately, both the terminology ‘neoadjuvant’ and ‘presurgical ‘ are often used interchangeably in the literature for patients who receive systemic therapy prior to a surgical intervention in the face of irresectable multiple distant metastases. Contrary to neoadjuvant concepts, complete resection of disease is not the primary aim in presurgical strategies.

Rather, presurgical therapy may have a benefit in selecting non-progressing patients for cytoreductive nephrectomy and this concept is currently investigated in a randomized EORTC trial.

Finally, most pivotal phase III trials of first-line TKI therapy included a subset of advanced or metastatic patients who were enrolled with the primary tumour in situ. It can, therefore, safely be concluded that patients with evidently irresectable locally advanced tumours who have no other local treatment options should be treated according to the available first-line recommendations as published in international guidelines28. In case of dramatic responses the ability and indication for complete surgical resection may be revisited on an individual basis.

Presently, neoadjuvant VEGF-targeting therapy has only been investigated in non-randomized phase II studies and retrospective series in patients with locally advanced or oligometastatic disease2-15. Some of the studies also included primary metastatic patients with distant multiple metastases and were therefore not performed in a truly neoadjuvant setting12,13.

A new class of drugs has recently been introduced, targeting and blocking the inhibitory T-cell receptor Programmed Death-1 (PD-1) or the cytotoxic T-lymphocyte associated antigen 4 (CTLA4)-signaling with monoclonal antibodies to restore tumour specific T cell immunity29. While pembrolizumab and nivolumab target the PD-1 receptor, MPDL3280A blocks its ligand, PD-L1.

A recent randomized dose ranging phase II trial of Renal cell carcinoma, with an 8-centimeter carcinoma of the nivolumab in metastatic RCC patients revealed a high lower pole of the kidney (Photo: Wikipedia) overall response rate with rapid and durable responses in heavily pretreated patients. Effective Additionally, there are several case reports in which T-cell responses against tumour cells can now be TKI were used to downsize caval thrombi and short-term treatment with a potent inhibitor of tumor achieved with immune checkpoint blockade. A phase I retroperitoneal lymph node metastasis followed by a angiogenesis. Cancer Cell. 2009;15:232-9. complete resection of the lesions16-20. From these data neoadjuvant trial in patients with RCC has been 10. Paez-Ribes M, Allen E, Hudock J, Takeda T, Okuyama H, initiated to investigate the lymphocytic infiltration, we learned that surgery after neoadjuvant therapy is Vinals F, et al. Antiangiogenic therapy elicits malignant safe , provided the half-time of the drug and the onset safety and early efficacy of pembrolizumab30. progression of tumors to increased local invasion and of angiogenesis in wound healing are taken into distant metastasis. Cancer Cell. 2009;15:220-31. consideration in calculating the interval of drug Based on the rationale that immunotherapy is more 11. Kats-Ugurlu G, Oosterwijk E, Muselaers S, Oosterwijkwithdrawal and surgery21. TKI with their generally effective in eliminating circulating tumour cells or Wakka J, Hulsbergen-van de Kaa C, de Weijert M, et al. shorter half-time should be preferred over anti-VEGF micrometastases than inhibitors of angiogenesis, it is Neoadjuvant sorafenib treatment of clear cell renal cell monoclonal antibodies. very likely that these drugs will be studied on a larger carcinoma and release of circulating tumor fragments. scale in the adjuvant and neoadjuvant setting in renal Neoplasia. 2014;16:221-8.

Data suggest that while down-staging is rare, cell carcinoma.

12. Cowey CL, Amin C, Pruthi RS, Wallen EM, Nielsen ME, downsizing of primary tumours, local recurrences and Grigson G, et al. Neoadjuvant clinical trial with sorafenib oligometastatic lesions with the aim to achieve References for patients with stage II or higher renal cell carcinoma. J complete resection can be considerable. However, 1. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer Clin Oncol. 2010;28:1502-7. together with an unproven disease-free and overall statistics, 2009. CA Cancer J Clin. 2009;59:225-49.

13. Hellenthal NJ, Underwood W, Penetrante R, Litwin A, survival benefit, the absence of markers to predict a 2. Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Zhang S, Wilding GE, et al. Prospective clinical trial of significant downsizing and the lack of a universally Boyle P. Estimates of the cancer incidence and mortality preoperative sunitinib in patients with renal cell accepted definition of surgical irresectability, the role in Europe in 2006. Ann Oncol. 2007;18:581-92. carcinoma. J Urol. 2010;184:859-64. of a neoadjuvant approach in the management of RCC 3. Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA 14. Kates M, Badalato GM, Pitman M, McKiernan JM. remains poorly defined22.

Cancer J Clin. 2014;64:9-29.

Increased risk of overall and cardiovascular mortality Available data demonstrate a clear dose-response relationship of VEGF-targeting therapy if downsizing is the aim23,24. In one of the largest neoadjuvant phase II studies including patients with non-metastatic locally advanced RCC, axitinib resulted in a 45.8 % RECIST partial response rate of primary tumours15.

Unclear role At present, no recommendations can be made for neoadjuvant treatment with targeted therapy nor any other class of drugs or intervention. Retrospective series suggest that caval vein thrombi should not be treated with neoadjuvant TKI since thrombi have been observed to progress under systemic treatment 25,26.

Primary resection should be the treatment of choice for venous tumour thrombi whenever feasible. The role of neoadjuvant therapy to achieve complete resection of local recurrences or metastases is unclear since the relevant retrospective reports included only patients selected after successful complete resection had been performed27. As a consequence, no data exist on the failure rate of this approach, nor do we know if neoadjuvant TKI and complete metastasectomy is

4. Sun M, Shariat SF, Cheng C, Ficarra V, Murai M, Oudard S, et al. Prognostic factors and predictive models in renal cell carcinoma: a contemporary review. Eur Urol.

2011;60:644-61.

5. Pal SK, Haas NB. Adjuvant therapy for renal cell carcinoma: past, present, and future. Oncologist.

2014;19:851-9.

6. Jocham D, Richter A, Hoffmann L, Iwig K, Fahlenkamp D, Zakrzewski G, et al. Adjuvant autologous renal tumour cell vaccine and risk of tumour progression in patients with renal-cell carcinoma after radical nephrectomy: phase III, randomised controlled trial. Lancet.

2004;363:594-9.

7. Wood C, Srivastava P, Bukowski R, Lacombe L, Gorelov AI, Gorelov S, et al. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet. 2008;372:145-54.

8. Kapoor A, Gharajeh A, Sheikh A, Pinthus J. Adjuvant and neoadjuvant small-molecule targeted therapy in high-risk renal cell carcinoma. Curr Oncol. 2009;16 Suppl 1:S60-6.

9. Ebos JM, Lee CR, Cruz-Munoz W, Bjarnason GA, Christensen JG, Kerbel RS. Accelerated metastasis after

Table 1: Overview of ongoing adjuvant randomized controlled trials with targeted agents in renal cell carcinoma Trial

N

Patient Characteristics

Treatment Arms

Treatment Duration Primary End Point

S-TRAC: Sunitinib Trial in Adjuvant Renal Cancer Treatment

600

High-risk patients according to UISS

Sunitinib Placebo

1 yr

DFS

ASSURE: Adjuvant Sorafenib or Sunitinib for 1,923 Unfavorable RCC

Non-metastatic RCC; disease stage II–IV

Sunitinib Sorafenib Placebo

1 yr (9 treatment cycles)

DFS

SORCE: Sorafenib in Patients with Resected Primary RCC at High/Intermediate Risk of Relapse

1,656

Patients with high- and intermediate-risk resected RCC

Sorafenib Sorafenib/ Placebo Placebo

3 yrs

DFS

EVEREST: Everolimus for Renal Cancer Ensuing Surgical Therapy

1,218

Pathological stage intermediate or very high-risk patients with full or partial nephrectomy

Everolimus Placebo

9 treatment cycles

RFS

PROTECT: Pazopanib as an Adjuvant Treatment for Localized RCC

1,500

Patients with moderately high or high risk of relapse with nephrectomy of localized or locally advanced RCC

Pazopanib Placebo

1 yr

DFS

ATLAS: Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

592

High-risk, non-metastatic RCC with nephrectomy

Axitinib Placebo

Saturday, 21 March 2015

3 yrs

DFS

after radical nephrectomy for renal cell carcinoma 2 cm or less. J Urol. 2011;186:1247-53.

15. Karam JA, Devine CE, Urbauer DL, Lozano M, Maity T, Ahrar K, et al. Phase 2 Trial of Neoadjuvant Axitinib in Patients with Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma. Eur Urol. 2014.

16. Amin C, Wallen E, Pruthi RS, Calvo BF, Godley PA, Rathmell WK. Preoperative tyrosine kinase inhibition as an adjunct to debulking nephrectomy. Urology.

2008;72:864-8.

17. Di Silverio F, Sciarra A, Parente U, Andrea A, Von Heland M, Panebianco V, et al. Neoadjuvant therapy with sorafenib in advanced renal cell carcinoma with vena cava extension submitted to radical nephrectomy. Urol Int. 2008;80:451-3.

18. Harshman LC, Srinivas S, Kamaya A, Chung BI. Laparoscopic radical nephrectomy after shrinkage of a caval tumor thrombus with sunitinib. Nat Rev Urol.

2009;6:338-43.

19. Karakiewicz PI, Suardi N, Jeldres C, Audet P, Ghosn P, Patard JJ, et al. Neoadjuvant sutent induction therapy may effectively down-stage renal cell carcinoma atrial thrombi. Eur Urol. 2008;53:845-8.

20. Patard JJ, Thuret R, Raffi A, Laguerre B, Bensalah K, Culine S. Treatment with sunitinib enabled complete resection of massive lymphadenopathy not previously amenable to excision in a patient with renal cell carcinoma. Eur Urol. 2009;55:237-9; quiz 9.

21. Margulis V, Matin SF, Tannir N, Tamboli P, Swanson DA, Jonasch E, et al. Surgical morbidity associated with administration of targeted molecular therapies before cytoreductive nephrectomy or resection of locally recurrent renal cell carcinoma. J Urol. 2008;180:94-8.

22. Bex A, Jonasch E, Kirkali Z, Mejean A, Mulders P, Oudard S, et al. Integrating Surgery with Targeted Therapies for Renal Cell Carcinoma: Current Evidence and Ongoing Trials. Eur Urol. 2010;58:819-28.

Editorial Note: Due to space constraints the reference list has been shortened. Interested readers can email at EUT@uroweb.org for a complete listing.

Monday, 23 March 10.30 - 10.50 Thematic Session 13 Surgery in advanced and metastatic RCC; State-of-the-art lecture

EUT Congress News

5

XOFIGO® IS INDICATED for the treatment of adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases.1

At the onset of symptoms from bone metastases in prostate cancer,

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Extend life while preserving its quality2 In the phase III pivotal trial • Symptomatic was defined as regular analgesic use, including OTC, or use of EBRT to treat bone pain2 • In the Xofigo arm, 42% of patients were on non-opiate pain medications, 57% were on opiate pain medications, and 2% were not taking any pain medications2 • The effect of Xofigo on overall survival was consistent across patients with opioid use and without opioid use. The addition of Xofigo to best standard of care reduced the risk of death by 30% in the non-opioid subgroup, and by 32% in the opioid subgroup2 • 3.6-month increase in median overall survivalb (14.9 months in the Xofigo armc [n=614] vs 11.3 months in the placebo armc [n=307]; HR=0.695; 95% CI: 0.581-0.832)1

ADT=androgen-deprivation therapy; EBRT=external beam radiation therapy; OTC=over the counter. vs placebo plus best standard of care.1

a

Updated analysis.1

b

Plus best standard of care. In ALSYMPCA, best standard of care was defined as local EBRT or treatment with glucocorticoids, antiandrogens, ketoconazole, or estrogens such as diethylstilbestrol or estramustine.1

c

Essential Information Xofigo 1000 kBq/mL solution for injection (Refer to full Summary of Product Characteristics before prescribing).

• Composition1: Active ingredient: radium Ra 223 dichloride (radium-223 dichloride, 1000 kBq/mL, corresponding to 0.53 ng radium-223 at the reference date). Each vial contains 6 mL of solution (6.0 MBq radium-223 dichloride at the reference date). Excipients1: Water for injections, sodium citrate, sodium chloride, hydrochloric acid, dilute.

• Indication: Treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings.

• Contraindications: There are no known contraindications.

• Warnings and Precautions: Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, has been reported. Haematological evaluation of patients must be performed at baseline and prior to every dose. In case there is no recovery in values for absolute neutrophil count (ANC) and haemoglobin within 6 weeks after the last administration of Xofigo despite receiving standard of care, further treatment with Xofigo should only be continued after careful benefit/risk evaluation. Patients with evidence of compromised bone marrow reserve e.g. following prior cytotoxic chemotherapy and/or radiation treatment (EBRT) or patients with advanced diffuse infiltration of the bone (EOD4; “superscan”), should be treated with caution as an increased incidence of haematological adverse reactions such as neutropenia and thrombocytopenia has been observed. Limited available data indicate that patients receiving chemotherapy after Xofigo had a similar haematological profile compared to patients receiving chemotherapy after placebo. Crohn’s disease and ulcerative colitis: due to the faecal excretion of Xofigo, radiation may lead to aggravation of acute inflammatory bowel disease, therefore Xofigo should only be administered to these patients after a careful benefit-risk assessment. In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting or resuming treatment with Xofigo. In patients with bone fractures, orthopaedic stabilisation of fractures should be performed before starting or resuming treatment with Xofigo. In patients treated with bisphosphonates and Xofigo, an increased risk of development of osteonecrosis of the jaw (ONJ) cannot be excluded. In the phase III study, cases of ONJ have been reported in 0.67% patients (4/600) in the Xofigo arm compared to 0.33% patients (1/301) in the placebo arm. However, all patients with ONJ were also exposed to prior or concomitant bisphosphonates and prior chemotherapy. Xofigo contributes to a patient’s overall long-term cumulative radiation exposure and therefore may be associated with

an increased risk of cancer and hereditary defects. No cases of Xofigo-induced cancer have been reported in clinical trials in follow-up of up to three years. Depending on the volume administered, this medicinal product can contain up to 2.35 mmol (54 mg) sodium per dose.

• Undesirable effects: Very common: thrombocytopenia, diarrhoea, vomiting, nausea; Common: neutropenia, pancytopenia, leukopenia, injection site reactions; Uncommon: lymphopenia.

• Classification for supply: Medicinal product subject to restricted medical prescription.

• Marketing Authorisation Holder: Bayer Pharma AG. 13342 Berlin. Germany.

• Date of revision of the underlying Prescribing Information: November 2013.

References: 1. Xofigo® (radium Ra 223 dichloride) solution for injection Summary of Product Characteristics (SmPC), Bayer Pharma AG, 13342 Berlin, Germany, 2013. 2. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213-223.

This medicinal product is subject to additional monitoring.

Este medicamento está sujeto a seguimiento adicional, es prioritaria la notificación de sospechas de reacciones adversas asociadas a este medicamento.

Xofigo is not currently reimbursed in Spain. Information is correct at time of printing (1 February 2015). En el momento de imprimir este material (1 de Febrero de 2015) Xofigo no está comercializado en España.

To learn more, visit www.xofigo.com.

Please see Summary of Product Characteristics available at the Bayer HealthCare booth (FO2) in Hall 9.

La ficha técnica del producto está disponible en el stand de Bayer HealthCare (FO2) en el pasillo 9.

1

List of excipients should only be included when required according to national legislation.

© 2015 Bayer Pharma AG. February 2015. L.ES.SM.02.2015.0344

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Managing paediatric stones Epidemiology, medical and surgical management Kemal Sarica Professor of Urology Chairman, EULIS Istanbul (TR)

Regarding the proper management of urolithiasis in children the clinicians should make a decision based on metabolic evaluation, stone analysis data, as well as the frequency of stone events.

Medical management Due to the multifactorial causes of stones in children (metabolic, anatomic and/or recurrent UTI ) long-term follow-up treatment can only be successful when combined with additional appropriate prophylactic measures. Despite continous efforts to find an effective treatment regimen to prevent the recurrent formation of calcium stones, no medication has proven itself in terms of adequate prevention of these recurrences.

Fıve to 10 % of the human population suffer from stone disease during their lifetime and of these cases only 1–3 % are children. With a general incidence of around 2-3 %, the pattern of pediatric urolithiasis Like the adult population, children can be treated shows marked variation in developed and developing conservatively by an increased fluid intake with or countries. without dietary manipulations or by administering pharmacological agents. Among the medical While the disease has been reported to be rather rare theraputic options, such as a pharmacological agent, in some countries such as in Scandinavia, it is still an potassium citrate has been used with acceptable endemic problem in developing ones such as Turkey, success rates.

Iran, Pakistan and the Far East. Stones occur in children of all ages and do not disproportionately However, it is really very troublesome to keep the affect any age group. Although stone disease is a child under a certain preventive measure for a long frequent consideration in these cases, its diagnosis is period. Cooperative parents with older children are rarely confirmed. the cases which may demonstrate acceptable successful outcome following these measures.

With respect to the chemical composition and the possible etiology of the stone disease, and although “While earlier reports with PCNL in majority of the calculi in children are infectious in origin with a high incidence of urinary tract anomalies children described the use of adultin European countries, bladder stones (composed of size instruments, advancements in ammonium acid urate and uric acid) predominate in developing countries, strongly implicating dietary instrumentation and availability factors. However, overall evaluation clearly of more efficient energy sources demontates that more than 75 % of all children present with calcium oxalate or calcium phosphate for intracorporeal lithotripsy have stones.

Among the possible underlying causative factors, some well-evaluated causative factors (namely metabolic abnormalities, urinary tract infections, anatomical abnormalities and endemic factors), have been found to be responsible in the etiology of the disease in the vast majority of these cases.

Of the metabolic disorders (with hypercalciuria as the most common abnormality, accounting for up to 34 % of all pediatric stones), as many as 8 % of these casess present with hyperuricosuria. Being usually detected before the age of six years, infection- related stones are more common in boys and more than 50 % of all children with such stones have associated genitourinary anomalies.

Cystinuria accounts for 2% to 7% of children with metabolic urolithiasis in industrialized countries. Last, but not least, calcium oxalate calculi or nephrocalcinosis are commonly diagnosed in children suffering from primary hyperoxaluria (type 1 and 2 ).

Approximately 50 % of children with primary hyperoxaluria have symptoms by the age of five.

Oxalosis is more common in childern with type 1 primary hyperoxaluria (PH1) and approximately 1% of chronic renal failure in childhood originates from this type of hyperoxaluria. Children with PH2, however, usually do not present until their second or third decade of life.

Complete stone clearance The natural history of pediatric stone disease is not as well defined as it is in adulthood. The pathology is associated with considerable morbidity, with recurrence rates of 6.5- 44 %. Without follow-up and medical intervention, stone recurrence rates have been reported to be as high as 50 % within five or six years particularly in children with documented metabolic abnormalities.

The principles of stone management in children should consider complete stone clearance, prevention of stone recurrence and regrowth, preservation of renal functions, control of UTI’s, correction of anatomic abnormalities as well as the underlying metabolic disorders. Long-term post-operative followup is mandatory; especially after using newer technical innovations for urinary calculus management during childhood.

Obstructive pathologies along with the established metabolic abnormalities should be treated on time.

Children with a positive family anamnesis are the candidates for a close and careful follow-up with respect to stone recurrence. Urine volume should be increased with adequate fluid intake evenly distributed the whole day should be encouraged.

Saturday, 21 March 2015

revolutionized this procedure in children.”

Surgical management Technological advancements, miniaturization of endourologic instruments along with the increasing experience of the surgeons have significantly altered the management of pediatric stone disease.

Currently, the majority of stones in children can be managed either with shock-wave lithotripsy (SWL), percutaneous nephrolithotomy (PCNL) or ureterorenoscopy (URS), or a combination of these modalities, while open surgery is currently needed in a limited number of cases. To select the most appropriate treatment modality, important factors to consider are stone location, composition and size, the anatomy of the collecting system, and the presence of obstruction and infection of the urinary tract.

Extracorporeal shock wave lithotripsy ( ESWL) Despite the increasing application of minimally invasive alternatives in recent years, SWL still remains the least invasive , safe and effective treatment alternative. Renal pelvic stones or calyceal stones up to 2 cm. in diameter are ideal indications for SWL and success rates decrease as the size of the stone(s) increase. Currently, and depending on the size, number, location and the chemical composition of the stones, nearly 80 % of all stones in children are being treated successfully with ESWL.

restriction of the number of SW and the energy used in each session will be helpful in protecting the kidneys on this aspect.

In contrast to the effective results of SWL in renal stones, and regarding the management of ureteral stones, as as much as the 98% of the stones with a diameter of < 5 mm are likely to pass spontaneously, with intervention required in large-sized as well as impacted stones. The success rates decrease as the stone passes to the more distal parts of the ureter.

Mini-percutaneous nephrolithotomy (Mini-PNL) procedure in a child

Currently, larger stones ( > 1 cm), impacted stones, Ca-oxalate monohydrate and cystine stones, stones in children with unfavourable anatomy and in whom the localization difficulties exist, are the cases in which the SWL may be unsuccessful. Indwelling ureteral stents are seldom required after ESWL for upper tract stones in these cases.

Ureteroscopy With the advances in endoscopic technology, the principles of ureteral stone treatment is now similiar to that in adults where open surgery is rarely needed in such cases.

Currently, by using fine, smaller calibre instruments along with Ho-YAG laser, this modality has become the treatment of choice in middle and distal ureteric stones in children. Following the use of relatively larger ureteroscopes in the beginning, with the current use of 4.5 and 6.0 Fr semirigid ureteroscopes and a 6.9 Fr flexible ureterorenoscope, the rate of instrumentrelated complications have decreased considerably.

Although studies have shown satisfactory results for mid and lower ureteral stones (ranging from 87.5% to 100%), results obtained in upper ureteral stones are less encouraging (78 %).

Regarding the efficacy of SWL and URS, while the SF rates for calculi sizing > 10 mm were 93% and 50% for URS and SWL respectively, they were 100% and 80 %, respectively, for stones with sizes <10 mm. Overall, ureteroscopy for ureteral calculi is associated with a 90% SF-rate with a single procedure.

However, it should be kept in mind that pediatric ureteroscopy requires greater technical skill and judicious use because of the potential risks of traumatic complications, such as perforation and strictures being encountered in approximately 0 to 7% of the patients.

Regarding the stenting, although no stent may be necessary after a short and uncomplicated URS procedure, it may be indicated if the procedure is more complicated or if there is any question of ureteral injury.

Similar to the adult population, indications for PCNL in children include a large stone burden, evident renal obstruction, failure of SWL and significant volume of residual stones after open surgery.

Again, intraoperative bleeding requiring blood transfusion, injury to the pelvicalyceal system and sepsis are major concerns with this technique. Thus, based on the accumulated data so far, we may say that PCNL for relatively larger calculi in children is a safe and feasible method for maximal clearance of stone burden. Concerning the efficacy, stone- free rates of about 90% (ranging from 67% to100%) with no major complication have been reported in many series.

Retrograde intrarenal surgery (RIRS) With increasing experience of RIRS in adults, a number of studies regarding successful ureterorenoscopic management of inferior calyceal stones in children have been published in recent years. With accumulating experience, RIRS may be used more frequently in these cases to treat residual stones after SWL, inferior calyceal stones and cystine stones .

Prior experience Despite its relatively uncommon incidence, management of stones in children poses a specific technical challenge to the urologist. Like in adult cases, SWL is the first choice in upper tract calculi and other minimally invasive methods have specific indications.

Although SWL is safe and efficient in the treatment of both renal and ureteral stones in expert hands, ureteroscopy and PCNL can be successfully applied in appropriate cases.

However, due to the technically demanding nature of these procedures, prior experience in the adult population is essential before the urologists bring these management alternatives into general urologic practice. Because of small body habitus, fine, growing tissues and likelihood of short-long term complications, proper and detailed planning of the surgical procedure is of utmost importance in the pediatric patient for a successful outcome.

References

Following SWL, stone free (SF) rates ranging from 57 to 97 % during short-term and 57 to 92 % during long-term follow-up have been reported in the literature. Again, while the re-treatment rates range from 13.9 to 53.9 % in different series, auxiliary procedures and/or additional interventions range from 7 to 33%. Although general anesthesia is generally performed, especially with first-generation lithotriptors (except for older cases), sedation is needed to relieve the possible discomfort in younger children during SWL. In addition to the successful management, studies have clearly shown that children pass the disintegrated stone fragments in a quick and easy fashion. However,despite its effective and minimal invasive profile, theoretical concerns have been raised regarding safety and the bioeffects of SWL on the immature, growing kidney and surrounding organs.

But no irreversible serious side effect of high energy shock wave could also be demonstrated during short, as well as long-term follow-up. Long-term evaluation of the treated children did not show any significant morphologic as well as functional changes, and

Percutaneous nephrolithotomy Like in adults PCNL can be performed in larger and complex calculi in this specific population. Despite the gradual acceptance of this technique particularly due to concerns regarding long-term renal damage on small kidneys and use of relatively large instruments, the results of relatively large series including radioisotope scans before and after PCNL demonstrated that there may be minimal scarring and insignificant loss of renal function after PCNL. While earlier reports with PCNL in children described the use of adult-size instruments, advancements in instrumentation and availability of more efficient energy sources for intracorporeal lithotripsy have revolutionized this procedure in children.

In addition to the clinical use of smaller nephroscopes (miniperc and even microperc procedures ), holmium:YAG laser, and smaller pneumatic lithoclast and ultrasound probes can be used during PCNL in this population. Ultrasound-guided puncture is a good alternative to fluoroscopy and has the advantages of avoiding radiation, providing a straight peripheral calyceal puncture and preventing visceral injury.

1. Sarica,K.: Pediatric urolithiasis: etiology, specific pathogenesis and medical treatment.Urol.Res.; Jan. 24: 1-6, 2006.

2. Dogan HS, Tekgül S.: Management of pediatric stone disease.Curr Urol Rep; Mar;8(2):163-73;2007.

3. Schultz-Lampel D. And Lampel A.: The surgical management of stones in children. BJU Int.; 87:732740,2001.

4. Lahme S.: Shockwave lithotripsy and endourological stone treatment in children.Urol Res. Apr;34(2):112-7, 2006.

5. Erdenetsesteg G, Manohar T, Singh H, Desai MR.: Endourologic management of pediatric urolithiasis: proposed clinical guidelines. J.Endourol.;20(10): 737-48;2006.

6. Frick J, Sarica K, Kohle R, et al. Long-term follow-up after to extracorporeal shock wave lithotripsy in children. Eur Urol; 19:225-229,1991.

Sunday, 22 March 11.10-11.30: Thematic Session 7 Paediatric urology, State-of-the-art lecture

EUT Congress News

7

How to solve mesh complications Real rate of open mesh complications remains unknown due to absence of a registry

We will review how to solve most common complications of transvaginal mesh kits reported so far.

First, let’s clarify an important issue. The often quoted FDA notifications of 2008 and 20113,4 clearly focused on transvaginal mesh placement for prolapse repair (POP), and not on open mesh sacrocolpopexy. This means that keeping the vagina intact and placing the mesh from inside the abdominal cavity has its risks (as outlined in several reviews in the literature), but those risks are different and not as frequently observed than since the inception of transvaginal mesh placement with various kits (7,8). Truth should be said: in the absence of a registry, one could argue that we don’t know a lot about the real rate of open mesh complications.

“Removal of posterior mesh compartment should include a consent discussing the risk of rectal tear, and possible temporary colostomy.”

Residual pain is very challenging. Specialized testing (for example MR neurography) can discover nerve entrapment in scar next to where mesh is presumably located since mesh cannot be reliably seen on MRI. Physical medicine rehabilitation, trigger point injections, and other forms of pain management (pain clinic) will require the involvement of other sub-specialties.

“...there is already a sense that these complications are more frequently observed in the US than for any prior procedure historically performed to repair vaginal prolapse...”

Recurrent POP Most series described recurrent POP in the anterior compartment8,3. Rate not known, likely less than 10%.

Management seldom discussed, including native tissue repair, or open/laparoscopy/robotic mesh sacrocolpopexy but not all patients are interested in having more mesh placed around the vagina once they have endured a mesh complication already.

Mesh erosion; Mesh with vesicovaginal fistula Often related to a technical mishap, including bladder perforation (recognized or not) at the time of the original placement. The erosion can be seen on the base of the bladder or unilaterally close to a ureteric orifice. Repairs can be extremely challenging and may involve ureteral reimplantation uni or bilaterally.

When there is communication with the vagina, the repair approach can be transvaginal or open based on extent of the extrusion, relationship with the ureteric orifices, and the surgeon’s experience.

Tissue interposition is suggested to minimize risk of fistula recurrence, as well as prolonged bladder drainage.

Likewise, until a registry process becomes widely available for tracking transvaginal mesh placement placed to support the vaginal vault and any associated Rectal injury compartment prolapses, the true extent of what • Removal of posterior mesh compartment should appears at times “life-altering and potentially include a consent discussing the risk of rectal irreversible complications”1,4, and the need for tear, and possible temporary colostomy. multiple explant procedures, that true extent will not • Intraoperative recognition of rectal tear during be known for sure. mesh removal can be corrected immediately Based on the over 66,000 class action suits filed in once recognized. The tear can be small, and if West Virginia under Judge Goodwin, there is already a overlooked, may result in a recto-vaginal sense that these complications are more frequently fistula. observed in the US than for any prior procedure historically performed to repair vaginal prolapse.

• Rectal packing can be useful to mold the rectum and detect a small rectal injury.

Of note, this staggering number is only for federal suits and does not take into account local jurisdiction • Colostomy should be considered for large injuries courts. So when a complication does occur, what are or when mesh material cannot be extracted the options to treat it? without compromising a large segment of the rectal wall.

The information provided in the following paragraphs is based on a recent review of the literature which Financial disclosure provides, in fact, very limited guidance and no The author has no relevant financial interests related long-term follow-up on how best “to solve” these to this manuscript, including employment, mesh complications. The interested reader should consultancies, honoraria, stock ownership or options, review a recent article on Meshology by Lee, Bacsu expert testimony, grants or patents received or and Zimmern summarizing the available studies on pending, or royalties. mesh excision9.

References 1. Lee D, Dillon B, Lemack G, Gomelsky A, Zimmern P. Mesh extrusion Transvaginal mesh kits--how “serious” are the • Management: local therapy with hormone cream, complications and are they reversible? Urology. 2013 excision in the office, or excision in the operating Jan;81(1):43-8. room.

2. Isom-Batz G, Zimmern PE. Vaginal mesh for incontinence

•

•

and/or prolapse: caution required! Expert Rev Med Complications from removing an exposed Devices. 2007;4(5):675-9. transvaginal mesh depend on the extent of the 3. FDA Public Health Notification: Serious Complications exposure, the extent of the mesh removal, and Associated with Transvaginal Placement of Surgical Mesh the location of the exposure, with concerns for the in Repair of Pelvic Organ Prolapse and Stress Urinary bladder and ureters anteriorly, and for a rectal Incontinence. Issued: October 2, 2008. injury posteriorly (colostomy has been reported)

Other issues can include large vaginal defects, possibly requiring skin grafting.

Chronic pelvic and vaginal pain • Variable outcomes after mesh removal have been reported. Several series, including ours, are encouraging. Rates vary from 10 to 25% or more.

8

EUT Congress News

4. FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. Issued: July 13, 2011.

5. Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW, Deprest J, Dwyer PL et al. An International Urogynecological Association (IUGA) / International Continence Society (ICS) joint terminology and

© Philippe E. Zimmern, M.D., 2015. All rights reserved.

Mesh exposed inside the bladder on both sides and responsible for recurrent urinary tract infections. Photo: P. Zimmern

classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery. Int Urogynecol J. 2011 Jan;22(1):3-15.

6. Hou JC, Alhalabi F1, Lemack GE1, Zimmern PE. Outcome of Transvaginal Mesh and Tape Removed for Pain Only. J Urol. 192:856-860, 2014 7. Jacquetin B, Cosson M. Complications of vaginal mesh: our experience. Int Urogynecol J. 2009;20:893-6.

8. Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Rogers RG; Systematic Review Group of the Society of Gynecologic Surgeons. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials:

a systematic review. Int Urogynecol J. 2011 Jul;22(7):789-98.

9. Lee D, Bacsu C, Zimmern PE: Meshology: a fast growing field involving mesh and/or tape removal procedures and their outcomes. Expert Rev. Med Devices, Early online, 1-16, 2014

Sunday, 22 March 10.30-12.00: Thematic Session 10 Female urology: What you need to know about mesh in 2015 State-of-the-art lecture

An Independent Journal – A Solid Choice

Urologia Internationalis

Editorial Board Editors M.P. Wirth, Dresden O.W. Hakenberg, Rostock D. Castro-Diaz, Santa Cruz de Tenerife B. Wullich, Erlangen

Urol Int 94(1) 1–124 (2015)

94 | 1 | 15

print ISSN 0042–1138

www.karger.com/uin

Urologia Internationalis 0 μg/ml

Editorial Committee A. Briganti, Milan S. Egawa, Tokyo Y. Igawa, Tokyo S. Madersbacher, Wien M.S. Michel, Mannheim V. Mirone, Napoli R. Mundy, London J. Nordling, Herlev M. Porena, Perugia J.J. Rassweiler, Heilbronn H. Rübben, Essen A. Stenzl, Tübingen J. Stolzenburg, Leipzig Y. Sun, Shanghai W. Weidner, Giessen

online e-ISSN 1423–0399

50

100 μg/ml

8h 16 h 24 h

40

* *

30

* * *#

20

10

0

400 μg/ml

*

*#

*# * ‫ڊ‬

*# * ‫ڊ‬

* ‫ڊ‬

* ‫ڊ‬

* ‫ڊ‬ 0

*#

10

50

100

200

400

Concentrations of exosomes (μg/ml)

S. Karger Medical and Scientific Publishers Basel . Freiburg . Paris .

London . New York . Chennai .

New Delhi . Bangkok . Beijing .

Shanghai . Tokyo . Kuala Lumpur .

Singapore . Sydney

Official Scientific Journal Deutsche Gesellschaft für Urologie

Urologia Internationalis (www.karger.com/uin)

2 volumes per year 4 issues per volume Language: English ISSN 0042–1138 (print) e-ISSN 1423–0399 (online)

KI15283

The use of synthetic material has generated novel complications including mesh extrusion, pelvic and/ or vaginal pain, dyspareunia, fistula, mesh erosion1,2.

A new classification of complications has been implemented by the International Continence Society (ICS) and International Urogynecological Association (IUGA) to better categorize each event and allow more thorough reporting5.

•

Apoptotic cells (%)

Dr. Philippe Zimmern Department of Urology University of Texas Southwestern Medical Center Dallas, Texas (USA)

Saturday, 21 March 2015

Immunotherapy: Urothelial bladder cancer Trials on a new group of drugs may lead to survival benefit Prof.Thomas Powles Clinical Professor of Genitourinary Oncology Barts Cancer Institute Barts Health and the Royal Free NHS trust Queen Mary University of London London (GB)

distribution within immune tissue and tumors is distinct. Therefore, their activity as well as their tolerability profile may be different.

The first study to read out with this class of agent in UBC reported on the PD-L1 inhibitor MPDL3280A3. The agent had significant activity in a group of heavily pre-treated UBC patients. This was particularly marked in a subset of patients whose archived tissue over expressed PD-L1 (43% response by RECIST v1.1).

PD-L1 was measured by immuno-histochemisty in the lymphocytic immune infiltrate (also known as the immune component). The correlation between response rates and tumor cell PD-L1 expression was Until recently it seemed that the development of new less clear. Responses also occurred in PD-L1 negative therapies in urothelial bladder cancer (UBC) was a distant prospect. Targeted therapies which have proven patients (11%) supporting further evaluation in this effective in other cancer failed to improve outcomes in population. Archived tissue was used to measure biomarker expression, suggesting biomarker stability UBC and survival remained stubbornly poor. in the immune component occurred with time.

Current treatment pathways for advanced/metastatic Another important property of this agent was the UBC are based around combination chemotherapy attractive toxicity profile. Unlike chemotherapy, the and have not changed for a generation. Immune adverse events were usually mild and uncommon. therapy, in the form of Bacillus Calmette-Guérin This is attractive for the bladder cancer population, (BCG), has been used to successfully prevent many of whom cannot tolerate optimal chemotherapy. recurrence of early aggressive UBC for some time1.

This agent is under evaluation in two large UBC studies open in Europe, including a large randomised However, immune therapy has not been robustly phase III study against chemotherapy (NCT02108652, investigated in the metastatic space, despite the fact NCT02302807). that the tumor has a high frequency of tumor mutations2. Recent data with the immune checkpoint Pembrolizumab (a PD1 inhibitor) also has activity in inhibitors (PD-L1 and PD-1 inhibitors) demonstrate heavily pre-treated UBC PD-L1 positive patients with considerable activity in metastatic chemotherapy response rates of 24%4. Again, the agent was well refractory UBC3,4. tolerated with responses in chemotherapy refractory patients. PD-L1 positivity was defined by expression Immune check point inhibitors on the tumor cells rather than the immune Immune check point inhibitors are a new group of component. This agent is also being evaluated in a immune therapies. They work by reversing PD-1/ randomised phase III study against chemotherapy PD-L1 related immune evasion. A significant (NCT02256436). proportion of UBCs express PD-L1 (both on the tumour cells and in the stroma). Targeting PD-L1 or Key questions PD-1 with engineered monoclonal antibodies results Key questions are how these agents can be further in T cell activation and tumor recognition5. Although developed in the future: PD-1 and PD-L1 are closely interrelated, their Co-Author: Kate Smith, London (GB)

1. Investigation in the first line metastatic setting, or perhaps as maintenance therapy after chemotherapy, is attractive. Immune therapy is thought to be more active earlier in the disease process. A natural progression would be to look in the adjuvant space and in non-muscle invasive disease. As investigation is moved earlier in the disease, the studies become large, patient populations complex and endpoints more difficult to achieve.

2. Work on biomarkers in immune therapy is ongoing and investigation beyond PD-L1 expression looks promising6. This may require methods such as next generation sequencing to identify neoantigens. Personalised therapy with immune checkpoint inhibitors is a realistic goal.

3. A number of different immune therapies are under development. Results from other tumor types with the combination of PD-L1 and CTLA-4 inhibition look impressive and requires evaluation in bladder cancer7. The role of the biomarker in combination therapy is unclear.

Promising activity Overall, there is a new group of drugs with promising activity in UBC. A number of trials are ongoing to evaluate this issue in detail. There is a good chance that the initial findings will be translated into a survival advantage, helping patients.

It is likely that the drugs will be tested earlier in the disease process where the benefits may be larger.

Biomarkers and immune combinations require development to take these results to the next level.

References 1. Wang Y, Yang M, Yu Q, Yu L, Shao S, Wang X.Recombinant bacillus Calmette-Guérin in urothelial bladder cancer immunotherapy: current strategies.

Expert Rev Anticancer Ther. 2015 Jan;15(1):85-93 2. Cancer Genome Atlas Research Network. Comprehensive molecular characterization of urothelial bladder

Recent data with immune checkpoint inhibitors (PD-L1 and PD-1 inhibitors) show some activity in metastatic chemoresistant UBC

carcinoma. Nature 507, 315–322 (2014).

3. Powles T, Eder JP, Fine GD, Braiteh FS, Loriot Y, Cruz C, Bellmunt J, Burris HA, Petrylak DP, Teng SL, Shen X, Boyd Z, Hegde PS, Chen DS, Vogelzang NJ. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer.Nature. 2014 Nov 26;515(7528):558-62.

4. Plimack E er al, Fox Chase Cancer Center, Philadelphia, at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain (ABSTRACT #LBA23).

5. Chen, D. S. & Mellman, I. Oncology meets immunology: the cancer-immunity cycle. Immunity 39, 1–10 (2013).

6. Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon RA, Reed K, Burke MM, Caldwell A, Kronenberg SA, Agunwamba BU, Zhang X, Lowy I, Inzunza HD, Feely W, Horak CE, Hong Q, Korman AJ, Wigginton JM, Gupta A, Sznol M. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013 Jul 11;369(2):122-33.

7. Snyder A, Makarov V, Merghoub T, Yuan J, Zaretsky JM, Desrichard A, Walsh LA, Postow MA, Wong P, Ho TS, Hollmann TJ, Bruggeman C, Kannan K, Li Y, Elipenahli C, Liu C, Harbison CT, Wang L, Ribas A, Wolchok JD, Chan TA. Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med. 2014 Dec 4;371(23):2189-99.

Sunday, 22 March 10.30-12.00: Thematic Session 9 Immunotherapy in urologic oncology State-of-the-art lecture

1st European da Vinci Xi Live Surgery In Urology Please join our parallel live surgeries on

Sunday, 22nd March 14:00 - 17:00 Room Milan Moderators

Walter Artibani • Verona, Italy Ben Challacombe • London, UK

Live da Vinci® Xi Partial Nephrectomy Surgery with Firefly™ Fluorescence Imaging with Live Narration Operating Surgeon Alexandre Mottrie • Aalst, Belgium

Live da Vinci® Si Advanced Prostatectomy with Extended Lymphnode Dissection Operating Surgeon Henk van der Poel • Amsterdam, The Netherlands

All surgery presents risk. While clinical studies support the use of the da Vinci® Surgical System as an effective tool for minimally invasive surgery for specific indications, individual results may vary. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. For complete technical information, including indications for use and full cautions and warnings, please refer to the da Vinci Si, da Vinci Si-e and da Vinci Xi Surgical System instructions for use, Instrument & Accessory, Single-Site and Firefly instructions for use and other product information. © 2015 Intuitive Surgical, Inc. All rights reserved. PN 1016607-EU Rev A 1/15

1016607-EUrA_EAU_2015_Ad_A4_landscape.indd 1

Saturday, 21 March 2015

1/23/15 11:44 AM

EUT Congress News

9

Live Surgery to present challenging cases ESUT to lead presentation of live surgeries on Monday Prof. Dr. Jens Rassweiler Chairman EAU Section of Uro-technlogy SLK-Kliniken Heilbronn GmbH Dept. of Urology Heilbronn (DE)

Following the more than 10-year tradition of live-surgery sessions, the EAU-section of UroTechnology (ESUT) will lead in presenting an ambitious full-day programme this coming Monday, focusing on novel techniques in percutaneous, endourological, laparoscopic, and robotic-assisted procedures.

The organization and presentation of the comprehensive programme has been approved by EAU-Live Surgery Committee (ELSC), with all planned procedures fulfilling the strict criteria and ethical requirements needed for such a complex full-day event.

This year, with “From the prototype to clinical practice - Challenging Uro-Technology” as theme, we want to

focus on novel technologies which improve the performance of video-assisted surgery and diagnostics in all fields of urology.

This session is conducted in collaboration with the EAU Section Robotic Surgery in Urology (ERUS), the EAU Section of Urolithiasis (EULIS), and the EAU Section of Imaging in Urology (ESIU).

“This year, with “From the prototype to clinical practice - Challenging Uro-Technology” as theme, we want to focus on novel technologies which improve the performance of video-assisted surgery...”

In the laparoscopic and robot-assisted cases, we will focus on the developments of imaging (3D-HD), as well as new instruments and devices (laser) improving the ergonomics of laparoscopy and endourology. The latest digital developments for flexible endoscopy of the upper urinary tract for diagnosis and treatment of tumors and calculi will also be demonstrated.

Additionally, the use of different robot-assisted or navigated techniques for prostate biopsies will be shown. These cases were pre-recorded yesterday, so that the pathologist can present the histological results on Monday during the live surgery.

Surgical procedures will be transmitted live to the Plenary Session Hall from Madrid’s Hospital Clinica San Carlos

The ESUT faculty consists of internationally well-known experts serving as surgeons and moderators. Annotation and commentary from the

Participants closely observed the live surgery sessions organised by the ESUT and other sections offices during the EAU annual congress in Stockholm last year

panel regarding the live procedures aim to stimulate discussion and questions coming directly from the audience. A split-screen will allow the audience to follow the procedures.

Traditionally, the format of ESUT Live Surgery will allow participants to directly communicate with the surgeons for questions on every aspect of the procedure. The various surgical procedures will be transmitted from Hospital Clinica San Carlos in Madrid under the supervision of Dr. Jesus Moreno Sierra. All broadcast will be in high-definition and 3D-quality.

Selected procedures from the ESUT session will also be available on-line.

The programmed is supported by unrestricted educational grants from Karl Storz GMBH & Co. KG, Olympus, Intuitive Surgical, American Medical Systems, Cook, Boston Scientific, SurgiQuest, MaunakeaTech, Analogic, ANNA/C-Trus, Koelis, MIM Software and Biobot Surgical.

Monday, 23 March 10.15-17.15: EAU Section Meetings Meeting of the EAU Section of Uro-technology (ESUT) in collaboration with ERUS ESIU and EULIS in the eUro-Auditorium From the prototype to clinical practice challenging Uro-technology

ADVERTORIAL

PRIMERA ST360® – Perfection for diagnosis and therapy The new PRIMERA ST360® urological workstation was presented for the first time ever at the 66th Congress of the German Association of Urology in Düsseldorf in 2014. Now STORZ MEDICAL will also exhibit it at the EAU 2015 Congress in Madrid.

This will be the first time for the Swiss company to present a medical system without an integrated shock wave unit. In doing so STORZ MEDICAL is treading a new path in a field with which it is most familiar already. This workstation is a reaction of the medical device company to market needs and reasonable complements its assortment.

allows all system components required for urological diagnosis and therapy to be interconnected to enhance the safety, reliability and efficiency of complex processes.

This leads to a significant workflow improvement. The integrated SCB interface decisively helps to reduce the system complexity and allows the user to concentrate fully on the patient and the treatment.

In the course of concept development STORZ MEDICAL primarily intensified its cooperation with KARL STORZ Endoskope, thus affording interesting solutions to the customers.

Central control via touch screen Thanks to the central control system all functions and parameters of the patient table, digital X-ray system, endoscopic imaging devices and therapy units are displayed on the touch screen during treatment.

Depending on the situation, these parameters can be controlled quickly and easily by the surgical team or the physician in charge of the treatment.

State-of-the-art digital X-ray technology The PRIMERA ST360® system is equipped with state-of-the-art digital X-ray technology. The 43 x 43 cm flat-panel detector can image the entire urogenital tract in a single shot and delivers pictures of outstanding quality. Continuous and pulsed fluoroscopy offers flexible viewing of dynamic processes.

A high-performance patient database is embedded in this environment. It allows all images generated by the different medical imaging systems to be added to a patient record. Furthermore, treatment parameters such as the applied dosage or the duration of radiation are shown at a glance and can be archived comfortably.

The range of applications of the PRIMERA ST360® covers from urological examinations and diagnostics to endourological procedures. Thanks to the large flat-panel detector it is practically no longer necessary to change the patient’s position during the treatment.

The corresponding DICOM services establish the connection with the hospital network.

Radiation free positioning of the collimator via touch screen and pre-positioning of the patient by means of the integrated light-indicator help to reduce the radiation dosage.

The work monitors and the touch screen can be positioned flexibly, which ensures both an ergonomic treatment position for every urological intervention and an ideal view of the monitors.

The various video sources such as X-ray, PACS, ultrasound or endoscopy can be displayed on the work monitors by means of video routing. One simple Integration of SCB interface push at the multifunctional pedal switch or the touch The STORZ Communication Bus (SCB) is one of the screen is enough to switch from one source to special features of the PRIMERA ST360®. This interface another.

10

EUT Congress News

Low access height and free accessibility of patient table Thanks to the solid and reliable mechanical design of the PRIMERA ST360® a patient table weight capacity of 250 kg is reached. The generous movement range of the table allows almost unrestricted positioning.

The low access height of 64 cm greatly facilitates the daily routine of the surgical team, because mobile patients can ascend on the table on their own.

The great variety of available versions ranges from the basic configuration with a monitor arm to complex solutions with ceiling mounts that include an operating room lamp and radiation shielding.

The free accessibility of the table from all four sides makes it possible to carry out among others the PCNL both on the right and on the left.

In close cooperation with leading urologists, STORZ MEDICAL is already developing new ideas in order to increase the functionality of the PRIMERA ST360®.

As with lithotripsy systems, planning and implementation of sophisticated projects is also coordinated and performed by experienced STORZ MEDICAL experts with the usual professionalism.

Saturday, 21 March 2015

Prostate cancer in renal transplant recipients Radical prostatectomy may offer optimal cancer control with low morbidity Prof. Axel Heidenreich Department of Urology Uniklinik RWTH Aachen (DE)

With the extension of the upper age limit, an increasing number of patients 50 years and older are candidates for renal transplantation. Currently, about 40% of all renal transplant recipients (RTR) in the United States are > 50 years and they experience a mean graft survival of 21.6 years [4].

Both the increasing age of RTR and the long-term survival with functional renal grafts might result in an increasing number of RTR with prostate cancer. With the routine use of prostate specific antigen (PSA) and increased public awareness, prostate cancer (PCA) incidence as a sign of early diagnosis has significantly increased during the last decade.

There is some controversy, however, about the true incidence of PCA in RTR since only very few data of transplant registries routinely using serial PSA measurements for early PCA detection are available.

When screened for PCA, the prevalence of PCA in RTR appears to be identical or lower than in the general population.

Early detection of PCA appears to be even more crucial in RTR since it is suggested that immunosuppression might have a negative impact on the biological aggressiveness of malignancies. Due to the low number of patients the natural history of PCA in RTR remains unknown, but there is some evidence

indicating that immunosuppression might depress T-cell responsiveness thereby enhancing disease progression.

The type of immunosuppresion is thought to exert a profound effect on the development of posttransplantation cancer. Cyclosporin might be associated with an increased risk of malignancies, whereas other agents such as mycophenolic-acid base agents and sirolimus are associated with a lower risk of cancer. The prognosis of early detected and adequately treated cancers of the genitourinary tract, however, does not differ significantly from nontransplanted patients.

Retrospective study Recently, our group has retrospectively analysed one of the largest series of open radical prostatectomy (RP) for clinically localized PCA in a cohort of 23 consecutive RTR. The PSA serum concentration was ≤ 10 ng/ml in 20 (86.9%) patients and 10.1 – 20 ng/ml in 3 (13.1%) patients. RRP was performed according to standardized surgical techniques used in non-RTR. The mean patient age at time of surgery was 64 (59 – 67) years. The mean interval between renal transplantation and diagnosis of PCA was 95 (24 206) months. None of the patients developed Clavien grade III – V complications, postoperatively.

Pathohistological evaluation of the radical prostatectomy specimens revealed stage pT2acpN0 in 16 patients and stage pT3a-bpN0 in 7 patients. The Gleason score of the radical prostatectomy specimen was 6 (3+3) in 13 patients, 7a and 7b in 6 and 3 patients, respectively. In one patient a unifocal positive urethral margin associated with a pT2cpN0 PCA and a Gleason score of 6 (3+3) was identified; currently, this patient is monitored by active surveillance; there is no evidence of biochemical recurrence 18 months postoperatively.

Table 1: Radical prostatectomy in renal transplant recipients – literature review Author

n

Prostatectomy

PLND

bNED

Manson et al.

1

retropubic

1

1

0

Kinahan et al.

3

retropubic

3

3

0

Morton et al.

2

retropubic

?

No data

0

Multanen et al.

1

retropubic

1

1

0

Konety et al

9

retropubic

8

0

2

retropubic

0

No data

0

Cormier et al.

9

retropubic

6

6

0

Hoda et al.

16

retropubic

0

16

25 mon

9

13 mon

Antonopoulos et al.

9

retropubic

0

20

retropubic

0

Thompson et al.

9

retropubic

0

8

58 mon

0

Heidenreich et al.

16

retropubic

16

16

48 mon

0

7

perineal

0

7

39 mon

0

Yiou et al.

2

perineal

1

No data

Hafron et al.

7

perineal

0

6

Robert et al.

9

laparoscopic

0

9

Maestro et al.

2

laparoscopic

0

2

Thomas et al.

3

laparoscopic

0

3

Doerfler et al.

1

laparoscopic

0

1

0

Shah et al.

1

laparoscopic

0

1

0

Smith et al.

3

RALRP***

0

3

13 mon

0

Jhaveri et al.

1

RALRP

0

1

11 mon

0

27 (20.3%)

94.1%

TOTAL

133

For further information contact chminfo@rcsed.ac.uk

www.essqchm.rcsed.ac.uk Saturday, 21 March 2015

0 2**

0 22 mon

0 0*

24 & 36 mon

0

2 (1.5%)

* **

significantly increased frequency of rectal injury as compared to non-RTR (22.2% vs 1.8%, p = 0.022) 2 ureteral injuries, significantly increased rate of systemic bacterial infections as compared to non-RTR (15% vs 2.5%, p = 0.01) *** RALP = robot-assisted laparoscopic radical prostatectomy

Kleinclauss et al. [9] have evaluated 62 RTR with prostate cancer who were treated at different French transplant centres. The authors concluded that the type of the immunosuppressive maintenance regime was the only independent risk factor associated with the presence of locally advanced and metastatic PCA.

This two year part-time Master of Surgery programme in Urology, taught entirely online, supports learning for professional urology examinations [FRCS(Urol) and FEBU] and develops skills in academic urology.

0

Kleinclauss et al.

The mean follow-up is 48 (45-141) months and currently all patients are without evidence of disease as demonstrated by undetectable PSA serum levels.

Renal transplant function was well-maintained in all cases as documented by stable postoperative creatinine and urea serum levels [1.4 (0.9-2.0) mg/dl and 45 (40 – 54) mg/dl] which did not differ significantly from the preoperative serum values [1.3 (0.8 – 2.0) mg/dl and 48 (40 – 58) mg/dl].

ChM in Urology

graft injury

Brendler

Urinary continence was evaluated every three months postoperatively by mailed questionnaires asking for the need and the number of pads per day. Continence is excellent with the majority of the patients being continent and requiring no pads, 2 patients need 1 safety pad/day. Potency with and without 5-phosphodiesterase inhibitors was preserved in 6 out of 10 patients in whom a nerve-sparing approach was performed.

Radical prostatectomy offers optimal cancer control with low morbidity, extremely low-risk for renal graft injury and long-term cure of prostate cancer (Photo by Prof. Gunner Aus)

F-up

Patients with a combined protocol of calcineurine inhibitors and azathioprine had a 9-fold higher risk to develop locally advanced PCA (OR: 8.7, 95% CI, 1.8 – 42, p = 0.007) as compared to those only receiving azathioprine.

The risk to harbour locally advance disease and/or metastasis was 44% and the risk to die from PCA was 24% after a mean follow-up of only 25 months which is significantly higher as compared to the group of non-RTR. In our group of 23 RTR, none of the patients developed biochemical recurrence or died from PCA after a mean follow-up of 39 months.

Active treatment Based on these data, active treatment instead of active surveillance might be the most appropriate treatment to be offered to RTR with biopsy proven PCA dependent on stage, grade and age of the patient.

With regard to treatment of PCA, there is a general consensus that the same therapeutic interventions should be pursued as in the general population and that aggressive approaches should not be withheld from RTR [1, 7]. This recommendation is based on data of recent retrospective studies which compared the long-term outcome of the renal graft among

recipients aged > 60 years with those in younger patients [1-5]. None of the studies demonstrated significant differences with regard to patient and graft survival at 1, 5 and 10 years.

Concerning the treatment modality, radical prostatectomy (RP) via the retropubic or the perineal approach, three-dimensional conformal radiotherapy and interstitial brachytherapy are available options for the management of clinically localized PCA [6]. In our cohort, radiation therapy was not considered as the most appropriate therapy due to the poor experiences of oncological and functional outcome [38]. Clinical experiences with radiation therapy are limited to EBRT in 8 RTR and brachytherapy in 3 [37, 38].

After a mean follow-up of 28 months, 25% experienced biochemical relapse, 25% developed significant obstruction of the terminal ureter resulting in the need for surgical reimplantation and 1 patient experienced a significantly decreased function of the renal graft.

Including the results of our retrospective series, data on a total of 110 and 23 RTR with PCA who underwent retropubic or perineal RP, respectively, (Table 1) have been reported. In all cases, RP was performed safely without significant complications and the maintenance of a well – functioning graft. Bladder descent was never impaired due to a fixed allograft or the transplant ureter and in all cases a tension-free vesicourethral anastomosis was achieved.

Optimal cancer control Especially for patients with intermediate and high-risk PCA, the retropubic approach offers the possibility to perform staging pelvic lymphadenectomy. In men with low-risk PCA and ≤ 50% of prostate biopsies involved, PLND is not mandatory. Quite recently, the very first reports on laparoscopic and robot – assisted RRP in RTR have been described in 16 and 4 patients, respectively, with apparently equal functional results as compared to open RRP or RPP [12, 23-28].

Therefore, a minimally invasive approach might be discussed in experienced centres.

In conclusion RP offers optimal cancer control with low morbidity, extremely low-risk for renal graft injury and long-term cure of PCA. Sunday, 22 March 10.30-12.00: Thematic Session 8 Urological malignancies in the transplant recipient State-of-the-art lecture

EUT Congress News

11

Stone treatment: What do the patients want?

Perceptions on preferred stone treatment differ among patients and doctors Prof. Dr. Thomas Knoll Department of Urology Klinikum SindelfingenBöblingen University of Tuebingen Sindelfingen (DE) Interventional stone treatment patterns have dramatically changed within the last 35 years. Open stone surgery, standard until the late 70ies was replaced by minimal-invasive technique starting with percutaneous nephrolithotomy (PNL), followed and soon replaced as well for a decade by extracorporal shock wave lithotripsy (SWL), and since 20 years by ureterorenoscopy (URS).

These changes were driven by technological progress and wider availability of those technologies on one hand, and on the other hand by patient expectations, as well as the urologists’ preferences which play an important role for treatment selection. Current treatment patterns in most industrialized countries demonstrate a significant decrease in SWL, which has been replaced by URS in many places.

What do the patients want? There is not much data published on this important issue. While there are thousands of papers on treatment modalities and options, there are only few papers evaluating patients’ preferences, satisfactions and expectations.

Chandrasekar recently performed an internet-based survey on urolithiasis and patient satisfaction. Four hundred forty-three respondents completed the survey. The majority (46%) were treated ureteroscopically, followed by extracorporeal shock wave lithotripsy (SWL, 25%) and percutaneous nephrolithotomy (7%). Other treatments included spontaneous passage (13%), medical expulsive therapy (7%), and home remedies (2%). Sixty-four percent of respondents deemed their treatment ‘‘successful,’’ while 36% reported their treatment as either ‘‘partially successful’’ or ‘‘unsuccessful.’’

Unsuccessful treatment was more likely for SWL (17%) and home remedies (14%) ( p = 0.002). Most respondents (52%) reported being either satisfied or very satisfied with their treatment choice; however, a certain fraction of patients was unsatisfied with their treatment (Figure 1). Satisfaction did not vary significantly by treatment type, but was significantly associated with treatment success.

they participated in clinical decision-making.

Anxiety also declined among patients with a passive coping style who perceived that they had received information or had participated in the decision-making process.

The results emphasize the need to tailor the therapeutic approach to patient characteristics.

Another dilemma has been the lack of disease-specific questionnaires for life quality of urolithiasis patients.

Figure 2: Reason for treatment selection (www.kidneystoners.org)

In 2014, Penniston and Nakada developed, therefore, the Wisconsin Stone QOL, to assess the quality of life of patients with stones. Included Thummar et al. (2014) sent a questionnaire on patients for evaluation ureteral stones to patients with urolithiasis history . and validation were The replies were scored using a 5-point Likert Scale.

Although URS seems to be the winner of the race, recurrent stone formers Overall, more patients chose URS vs. SWL (62% vs. there is a clear shift towards endoscopy and PNL including those with and 38%, P = 0.03). Ninety-five percent of patients cited frequency is also increasing. It is noteworthy that even stone-free success as extremely or largely important, those without current in Germany, the so-called ‘motherland of shock wave,’ followed by risk of complications (85%), need for stones. A preliminary some larger hospitals have already decided against instrument was created, second surgery (66%), and the need for a stent acquiring a new machine. However, while more and followed by patient (47%). For patients who chose URS, stone-free more urologists recommend primary URS (and not feedback and item success rate and need for a second surgery were of SWL) to their patients, they may vote for SWL if they reduction. A 28-question greater importance compared to those who chose would require a treatment of their own urinary calculi. SWL. Conversely, for those who chose SWL the need instrument was ultimately developed which was for a stent after surgery was of greater importance All minimal-invasive treatment modalities can be tested for reliability as compared to the URS group.

Figure 3: Would the patient opt for the same treatment again (www.kidneystoners.org)? considered for stone intervention, according to the well as internal face, construct and EAU Guidelines on Urolithiasis, especially for stones Is it helpful to involve patients in clinical decision from 10-20 mm. The advantage of PNL and URS is the making? This question was evaluated by Margalith et discriminant validity in faster stone-free status, usually in a single session, al. in 1997. Forty-two of the subjects (the experimental 248 stone formers. while the advantage of SWL is the lower morbidity group) were given information about two alternative and the application without general anesthesia. The treatments, ESWL and URS, and were asked to choose The Wisconsin StoneQOL main argument against SWL is therefore the longer seems to be capable of which therapy they preferred. Fifty-four subjects (the time until stone fragment pass and the need of assessing the health control group) were not given information, not repeated treatments in some patients. allowed to choose, and were treated according to the related quality of life of stone formers at various physician’s decision. Subjects’ level of anxiety was However, as for all medical treatments, we focus on points along the disease compared within each group on three occasions: the aims and expectations of our patients. All three continuum. Future before meeting with the physician, immediately modalities should be offered to the patient, and to assessment will establish afterwards and upon hospitalization for treatment of remain unbiased an endourologist should have access the stone. minimal clinically to all of these modalities. What our patients want is important differences for the result of a good explanation of the techniques by use in individual patients.

Patients’ perception of receipt of information and the doctor and – many have stone recurrences – participation in clinical decision-making, coping style, experiences with prior treatments. We should perform educational level, and knowledge about treatment Only few patient the treatment they choose, and not what we expect initiatives exist for alternatives were also measured. A statistically them to like most. This article gives an overview on significant decrease in anxiety after meeting with the urolithiasis in contrast to papers evaluating patients’ desires and expectations, urologist was found among patients who were not oncological diseases. This Figure 4: What did patients like most about their treatement (www.kidneystoners.org) including intervention and prevention. might explain why we asked to participate in the decision-making process know so little about their and among patients who perceived that they had Stone intervention expectations and fears. received information. A decrease in anxiety after Skenazy et al. evaluated in 2005 treatment An interesting concept, driven by patients and meeting with the physician was also found among and 88% of patients responded that they would preferences of urologists in Minnesota. The wide urologists in the US, is the webpage www. patients who, according to their own perception, did rather take medication than tolerate a single stone range of answers, including all modalities, underlined not participate in decision-making. stoneformers.org. This page gives excellent event at home or in the emergency room, the broad treatment options and the factors that have information on the whole disease, as the EAU Patient respectively. an impact on doctors’ choice. These factors do not Information page (patients.uroweb.org) does. But Patient anxiety necessarily reflect medical aspects, but others such as Patients’ educational level and coping style were what makes this group interesting is the voting they Likewise 92% of patients stated that they would doctor’s age, urban environment or training. The related to their anxiety. A decline in anxiety was found usually do on several topics as satisfaction after prefer daily medication compared to any surgical treatment or stent morbidity (some results are given availability of first-line treatments with equal efficacy among those with a lower educational level who procedure. Among 61 urologists 26%, 38% and 18% in Figures 2-4). makes both recommendation and choice of a perceived that they had received information and responded that patients would likely tolerate one, two procedure difficult among higher educated patients who perceived that or an unlimited number of stone passages at home, Stone prevention respectively, before agreeing to take medication. Of The EAU Guidelines on Urolithiasis recommends the urologists 66% estimated that patients would metabolic evaluation and preventive measures in tolerate up to two acute stone events requiring an high-risk stone formers. However, most patients do emergency room visit before starting medication. In not receive such recommendations by their urologists. addition, 20%, 31% and 33% of urologists presumed On the other hand, long-term compliance to medical that patients would accept the need for surgery treatment is often frustrating. annually, every other year or every third year rather than take medication.

Bensalah et al evaluated how physician and patient perceptions differ regarding medical management of Preventive medical treatment urinary stone disease. A total of 159 patients were Most patients with stones will consider preventive prospectively interviewed. Patients were asked three medical therapy to avoid recurrent pain or a surgical questions concerning subjective tolerance of stone procedure. In contrast, most urologists perceive that passage and surgical intervention weighed against patients prefer to avoid medication even if it means the use of daily preventive medication. tolerating several acute stone events and/or surgical procedures.

The same questions were sent to members of the Endourological Society. The results were: Mean +/SD patient age was 51 +/- 14 years. Recurrent stone Saturday, 21 March formers comprised 72% of patients and 76% had 10.15-14.00: Meeting of the EAU Section of undergone a prior surgical procedure while 43% Urolithiasis (EULIS) Figure 1: Patient satisfaction after stone intervention (Chandrasekar et al., J Endourology 2015) were taking prophylactic medication. Overall, 81% 12

EUT Congress News

Saturday, 21 March 2015

EAU Guidelines: Raising the standards of clinical practice Newly formatted guidelines include results of recent studies Prof. James N ‘Dow Chairman EAU Guidelines Office

clinical guidelines production is a priority activity within the organisation. With the systematic introduction of Cochrane review methodology, we believe that a solid foundation is put in place for years to come. Over this past year, the EAU Guidelines Office has engaged their panel experts in training courses to facilitate this process. Additionally, also young clinicians have been identified who will be assisting with review activities.

Guidelines Office recognises that they claim considerable time from busy clinicians, many of whom are key opinion leaders in their fields. These are your colleagues, fellow EAU members, who feel passionate about patient care and the role guidelines play in improving clinical practice. We cannot thank them enough for their patience and enthusiasm in helping us in bringing this challenging project forward.

EAU PO Box 3001 6 6803 AA Arnh The Netherla em nds

Eu ro pea n A ssociatio n Eu ro pea n of U ro l og y A ssociation Gu i d e l i n e of U ro l ogy s European

T +31 (0)26 389 0680 F +31 (0)26 389 0674 guidelines@ uroweb.org www.uroweb #eauguidelin .org es

uroweb.org guidelines@ .org www.uroweb es #eauguidelin

2015 editio

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A ssocia tio

EAU 6 PO Box 3001 em 6803 AA Arnh nds The Netherla 389 0680 T +31 (0)26 389 0674 F +31 (0)26

Gu i d e l i n e 2015 editio

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Guideline

Guideline 2015 edition

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Clinical guidelines are one of the key drivers of continuous improvement of patient care and as such

Europ e a n A s s ocia tion o f U rology

In order to make such changes possible a number of committees were set up, each tasked with a specific As in previous years, the EAU Annual Congress marks aspect of guidelines production and dissemination.

The Guidelines Office now includes a Methods the publication of the EAU guidelines compilations.

Also for this year, a substantial number of topics have Committee, headed by Prof. Richard Sylvester, responsible for the development of methodological been revised. standards and their implementation. Prof. Carlos Not only were the results of recent studies taken into Llorente chairs the Dissemination Committee which consideration but considerable effort has been invested includes a New Media group. Both chairmen have assembled teams of enthusiastic experts to assist to present a fresh and improved format from previous years. Almost all texts have been reduced in size as them with their activities. well as restructured, aiming to make consultation Development of clinical guidelines, as important as it easier for the reader. Background information, including systematic review protocols, will be made may be, will need to be supported by an effective available online. Some of this information can already dissemination strategy. A number of different options be found in the guidelines section of the EAU website are being explored at the moment, and the Guidelines – Uroweb – but the expectation is that these sections Office intend to report on their progress in due time. will grow exponentially in the months to come, so do Through its membership, the EAU are able to reach take a look. an ever growing number of clinicians; not just in Europe but worldwide. Ambition of the EAU All of these documents were subjected to blinded Guidelines Office is, however, to have a copy of their peer review prior to publication and the EAU guidelines on every urologist’s desk, computer or on Guidelines Office intends to revisit formal review any other electronic storage device. whenever new updates are achieved. Reviewers were identified based on their expert knowledge within the However, as our EAU members are highly valued by urological field and we are most grateful for their the association, EAU membership should translate time and diligence in providing complete and into benefits that are not available to non-members.

The EAU Guidelines have always been freely extensive reviews of the individual Guidelines.

Whenever possible, feedback from patient advocacy accessible to all, but this will change in the year to come with restricted access to guidelines material for groups or lay reviewers has been sought, and this activity will also be further expanded. those that are not members of the EAU.

We hope that you will join us in our endeavours to further improve. The support of all EAU member and friends as the key stakeholders in our guidelines project will be crucial to their success. Please remember, these are YOUR guidelines, first of all. You will find the EAU Guidelines Office on Facebook and Twitter (#eauguidelines). Your feedback and active engagement are not only encouraged, but very welcome.

2015 edition

As we discuss guidelines, it is important to recognise those who are tasked with their production. The EAU

Back and front covers of the new EAU Guidelines

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As a pioneer and market leader in extracorporeal shockwave technology Dornier MedTech offers with ARIES for ED a solution that is beneficial for you and your patients.

Learn more about ARIES for ED and visit our booth at EAU 2015, No. G52.

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Saturday: 10.00 h and 16.00 h Sunday: 10.30 h and 14.00 h Monday: 10.30 h and 14.00 h

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Saturday, 21 March 2015

At Booth No. G52

YEARS

W E ' R E

A L L

A B O U T

P E O P L E.

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Where do we stand with predictive biomarkers in mCRPC? Biomarker-driven studies are crucial in identifying mechanisms of resistance to new drugs Dr. Robert J. van Soest Department of Urology Erasmus University Medical Center and Cancer Institute Rotterdam (NL)

docetaxel was most pronounced in men with high Gleason score tumors, with an OS benefit of 4.4 months in this patient subgroup10.

At the same time, a high Gleason score (8–10) at the time of diagnosis had been reported to be an independent risk factor for poor response to abiraterone11.

These findings suggested a potential predictive role of Gleason score. However, although the OS benefit in the COU-AA-302 study of abiraterone preCo-Author: Dr. Ronald de Wit, Medical Oncology, chemotherapy was less pronounced in patients with Erasmus University Medical Center and Cancer high Gleason score tumors (7-10), the clinical benefit Institute, Rotterdam (NL) as assessed by radiographic PFS demonstrated to be irrespective of Gleason score12. Similarly, a post-hoc Treatment options for men with metastatic castration- analysis of the TROPIC trial has shown that cabazitaxel resistant prostate cancer (mCRPC) have expanded also provided clinical benefit regardless of the tumor with the introduction of several new approved agents grading at initial diagnosis9. including abiraterone, enzalutamide, cabazitaxel and radium-2231-6.

Thus, Gleason score could be useful in identifying patients who derive the most benefit from docetaxel With evidence that both abiraterone acetate and chemotherapy, but might be of less value to predict enzalutamide are effective agents when administered benefit from other treatments. to men with mCRPC either before or after chemotherapy2-4,6, treatment selection and sequencing Neutrophil-to-lymphocyte ratio for an individual patient has become more challenging. An emerging biomarker across different tumor types and disease settings is the neutrophil to lymphocyte Therefore, predictive biomarkers for response to the ratio (NLR). An elevated NLR, a marker for host various drugs approved for treatment of mCRPC are inflammation, was found to be an independent marker of adverse outcomes for several solid tumors needed to guide clinical practice and trial design.

Since prospective studies of established predictive including mCRPC13. In men with mCRPC treated with abiraterone, NLR ≥5 was associated with lower PSA biomarkers facilitating treatment decisions are still lacking, we herewith provide an overview of potential response rates and shorter survival14. predictive factors to the currently available treatment options in mCRPC. Although associated with worse prognosis, docetaxel provided a robust OS benefit of 4.3 months and ≥50% ARv7 expression PSA declines in 53-67% in two randomized phase III The androgen receptor (AR) is a key driver of mCRPC, trials including patients receiving first-line which is targeted by the novel hormonal agents chemotherapy8. Unfortunately, there is no data to confirm whether NLR is a marker of better response abiraterone and enzalutamide. The AR-isoform encoded by splice variant 7 lacks the ligand-binding to AR-targeted agents or chemotherapy. domain, and remains constitutively active in the absence of ligand. ARv7 expression develops in the Taken together, with a rapid evolvement of the course of disease progression, and is more likely to treatment landscape for mCRPC, predictive occur in patients with more advance disease, and after biomarkers for the current treatment options are previous treatment with abiraterone or enzalutamide. urgently needed. Biomarker-driven studies are key in identifying mechanisms of resistance to new drugs, A well-designed, prospective study by Antonarakis et and developing strategies to overcome resistance. al. showed that men expressing ARv7 in circulatingSuch translational efforts are necessary to change the current one-size-fits-all approach into a more tumor cells did not respond to treatment with either personalized treatment strategy for mCRPC. abiraterone or enzalutamide. Also, clinical/ radiographic progression-free survival (PFS) and overall survival (OS) were inferior in men expressing At this time, ARv7 expression in circulating-tumor ARv7. Although these findings require large-scale cells is the most promising biomarker for future validation, it is a promising first step towards a more treatment selection. Other potential patient factors that might facilitate treatment decisions are derived personalized treatment approach in mCRPC, where from retrospective analyses and should therefore be ARv7 expression in circulating-tumor cells might be interpreted with care. However, in the absence of used to facilitate treatment decisions. prospectively derived biomarkers, duration of response to previous hormonal therapy and NLR are In the absence of other predictive biomarkers, clinical parameters that are readily available, and another challenge is to define subgroups of patients might have potential to guide future treatment who potentially derive more benefit from novel selection.

AR-targeted therapy, or chemotherapy. In this light, several retrospective, hypothesis-generating efforts have been conducted.

References Duration of response to prior ADT An interesting retrospective study of 108 mCRPC patients enrolled in clinical trials demonstrated that patients with a short response to prior androgen deprivation therapy (ADT) (<16 months) had poor PSA responses and PFS when treated with subsequent hormonal agents including abiraterone7.

These findings suggest that patients, who progress rapidly to castration-resistant disease, with short responses to prior ADT, might do worse on consecutive hormonal treatments. In contrast, post-hoc analyses of two large phase III trials of patients with mCRPC receiving docetaxel showed the treatment benefit was irrespective of duration of initial ADT8.

Likewise, a post-hoc analysis of the TROPIC trial of cabazitaxel versus mitoxantrone demonstrated that cabazitaxel improved OS as compared with mitoxantrone regardless of the duration of prior ADT9.

Prospective validation of these findings for the various drugs approved for the treatment of mCRPC should define whether duration of response to prior ADT could be a good parameter for further personalizing treatment.

Gleason score Another patient factor of interest is the Gleason score at initial diagnosis. A post-hoc analysis of the TAX327 study showed that the OS benefit obtained by 14

EUT Congress News

1. de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

Lancet. 2010;376:1147-54.

2. Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368:138-48.

3. Scher HI, Fizazi K, Saad F, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy. N Engl J Med. 2012;367:1187-97.

4. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364:1995-2005.

5. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369:213-23.

6. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in Metastatic Prostate Cancer before Chemotherapy. N Engl J Med. 2014;371:424-33.

7. Loriot Y, Massard C, Albiges L, et al. Personalizing treatment in patients with castrate-resistant prostate cancer: A study of predictive factors for secondary endocrine therapies activity. J Clin Oncol 30, 2012 (suppl 5; abstr 213).

8. van Soest RJ, Templeton AJ, Vera-Badillo FE, et al.

Neutrophil to lymphocyte ratio as a prognostic biomarker for men with metastatic castration-resistant prostate cancer receiving first-line chemotherapy: data from two randomized phase III trials. Ann Oncol 2014. In press. doi: 10.1093/annonc/mdu569.

Predictive biomarkers for response to the various drugs approved for mCRPC treatment are needed to guide clinical practice

9. Oudard S, de Bono JS, Ozguroglu M, et al. Impact of cabazitaxel + prednisone on overall survival at 2 years and in patients with aggressive disease: post-hoc analyses of TROPIC trial. Ann Oncol. 2012;23 Suppl 9; abstr 933.

10. van Soest RJ, de Morree ES, Shen L, et al. Initial Biopsy Gleason Score as a Predictive Marker for Survival Benefit in Patients with Castration-resistant Prostate Cancer Treated with Docetaxel: Data from the TAX327 Study. Eur Urol. 2014;66:330-6.

11. Azria D, Massard C, Tosi D, et al. An ambispective observational study in the safety and efficacy of abiraterone acetate in the French temporary authorizations for use (ATU): Predictive parameters of response. J Clin Oncol 2012;30 (suppl 5; abstr 149).

12. Fizazi K, Flaig TW, Ohlmann CH, et al. Does Gleason score (GS) predict efficacy of abiraterone acetate (AA)

therapy in patients (pts) with metastatic castrationresistant prostate cancer (mCRPC)? An analysis of AA phase 3 trials. J Clin Oncol 32, 2014 (suppl 4; abstr 20).

13. Templeton AJ, McNamara MG, Seruga B, et al. Prognostic Role of Neutrophil-to-Lymphocyte Ratio in Solid Tumors: A Systematic Review and Meta-Analysis. J Natl Cancer Inst. 2014;106:dju124.

14. Leibowitz-Amit R, Templeton AJ, Omlin A, et al. Clinical variables associated with PSA response to abiraterone acetate in patients with metastatic castration-resistant prostate cancer. Ann Oncol. 2014;25:657-62.

Sunday, 22 March 11.00-12.00: Thematic Session 1 Managing the early metastatic CRPC patient State-of-the-art lecture

S a t e l l i t e S y m p o s i u m Saturday March 21st 2015 18:00-19:30 Room: Paris

Alternative approaches to individualised care

in prostate and bladder cancers Chairman: N. Clarke (United Kingdom)

Do we have new markers beyond PSA for diagnosing primary prostate cancer?

M. Ribal (Spain) Beyond the androgen receptor – future therapeutic approaches in complex metastatic castration-resistant prostate cancer Y. Loriot (France) Can the combination of better tumour visualisation and en-bloc resection lower recurrence rates in NMIBC? J.A. Witjes (The Netherlands)* *"Bladder Cancer Topic of the Year" will be voted on, and results announced, at the end of this presentation.

TOPIC OF THE YEAR 2015

Recent developments in caring for patients with urological cancers have focussed on the individualised nature of therapy. This symposium will discuss novel advances in diagnostic and therapeutic approaches for both prostate and bladder cancers.

Recently, there has been a renewed focus on innovative diagnostic biomarkers in prostate cancer. These have the potential to help clinicians determine whom to biopsy, when to re-biopsy, whether to treat or observe, and how to assess therapeutic response. New developments in this area could improve the clinical management of prostate cancer and inform treatment guidelines.

Our understanding of disease biomarkers is evolving in parallel with changes in the treatment landscape for metastatic castration resistant prostate cancer. Recent therapeutic advancements have brought new clinical benefits to patients but there is still room for improvement; better therapies are needed. Alternative therapeutic approaches of interest in prostate cancer include tubulin-targeting agents in early-stage disease, disruption of cell survival, MET/Src pathways and blocking the interaction between cancer and its microenvironment.

In superficial bladder cancer better therapies are imperative. Improved visualisation techniques such as HAL-guided TURBT have the potential to reduce tumour recurrence and improve outcomes. Other techniques including blue light guided en-bloc resection and new non-touch techniques may also show additional benefits.

Saturday, 21 March 2015

Is MRI needed besides biopsy to diagnose prostate cancer?

Adding mpMRI to biopsy: an important forward step in developing an ideal diagnostic test Prof. Dr. Geert Villeirs Ghent University Hospital Ghent (BE)

Traditionally, prostate cancer has been diagnosed on the basis of an elevated serum PSA, abnormal digital rectal examination and transrectal ultrasound-guided biopsy. This diagnostic gold standard has succeeded in finding a number of significant cancers, but also in detecting a number of insignificant cancers that may not need treatment.

Furthermore, not all cancers are detected, among which both significant and insignificant ones. The current gold standard hence only partially approaches the ideal diagnostic test, which would detect all significant cancers and would leave untouched all insignificant cancers.

In recent years, multiparametric magnetic resonance imaging (mpMRI) has become an appealing tool to facilitate reaching this ideal. It consists of morphologic T2-weighted MRI, supplemented by one or more functional techniques such as diffusion-weighted MRI, dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging.

T2-weighted MRI (T2w) typically shows a prostate cancer as a low signal-intensity area among the high signal-intensity normal peripheral zone tissue background. In the transition zone, prostate cancer has an equally low signal-intensity, although contrasting less well with the surrounding heterogeneous signal-intensity of glandular and stromal hypertrophy.

“More recent papers meanwhile suggest superiority of MRI-guided biopsy over non-targeted TRUS biopsy in the detection of clinically significant disease.”

It has been shown that the observed signal intensity inversely correlates to some extent with the aggressiveness of the cancer (lowest signal intensities in higher grade cancers). The sensitivity of T2w imaging for prostate cancer (of any Gleason grade) is quite high (up to 85%), but with a low specificity (about 55%) due to many false positive calls1.

Therefore, functional imaging tools are required to improve the overall diagnostic accuracy.

Diffusion-weighted MRI Diffusion-weighted MRI (DWI) is currently the most important functional technique in addition to T2w MRI. Its mechanism is based on the inhibition of spontaneous water diffusion in tumor areas, due to both increased cellularity (more hydrophobic cell membranes inhibiting water diffusion) and destruction of fluid-rich acini and ductules.

Morphologic T2-weighted image of Gleason 4+3 prostate cancer in right anterior horn of the peripheral zone (PZ)

Prostate cancers can hence be detected as areas of decreased signal-intensity on apparent diffusion coefficient (ADC) maps or as increased signal-intensity on high b-value images. It is more than noteworthy that a quite robust inverse correlation exists between ADC-values and tumor aggressiveness (lowest ADC-value in higher grade cancers).

Dynamic contrast-enhanced MRI (DCE) measures the amount and characteristics of tumoral neoangiogenesis. After an intravenous bolus injection of gadolinium-containing contrast media, prostate cancers tend to enhance earlier, more rapidly and with a more pronounced de-enhancement (wash-out) than benign or normal tissue.

DCE greatly helps detecting cancers in the peripheral zone, but suffers from false positive calls in the transition zone due to similar enhancement characteristics in glandular hypertrophy.

Magnetic resonance spectroscopic imaging (MRSI) is a more advanced tool that currently is mainly performed in expert centers and in clinical trials. It is based on measurement of the relative concentrations of citrate and choline, markers of benign and malignant tissue, respectively. MRSI adds specificity to T2w MRI (reduction of false-positive findings), but its main value lies in its direct correlation between the choline-to-citrate ratio and tumor aggressiveness.

and the recently revised Prostate Imaging Reporting and Data System (PI-RADS).

The latter consists of a diagnostic probability scale, in which PI-RADS 1 and 2 signify “clinically significant disease (highly) unlikely,” PI-RADS 3 “clinically significant disease is equivocal,” and PI-RADS 4 and 5 signify “clinically significant disease (highly) likely.”

These scales are largely based on the unique ability of mpMRI to more easily detect high-grade and larger (i.e. clinically significant) tumors than small lower-grade lesions. This holds promise in the assessment of patients suspected of having prostate cancer.

“Diffusion-weighted MRI (DWI) is currently the most important functional technique in addition to T2w MRI.”

mpMRI currently more and more consists of T2w MRI combined with DWI. DCE is additionally performed in all cases by some institutions, or only in doubtful cases by others.

Targeted biopsy While PI-RADS 1 or 2 patients can be considered as not requiring (immediate) biopsy owing to a negative predictive value for excluding high-grade disease up to 98% (hence significantly decreasing the number of unnecessary biopsies), patients with a PI-RADS 4 or 5 would benefit from a targeted biopsy to the suspicious area (hence increasing the positive biopsy yield and the significant cancer detection rate).

Meanwhile, it remains very important that all mpMRI studies are performed according to uniform quality and reporting standards, as pointed out by the European Society of Urogenital Radiology Guidelines2

PI-RADS 3, on the other hand, would require biopsy only in selected cases, taking into account clinical parameters such as PSA-density, PSA-kinetics, patient age and potential comorbidity.

ADC-map showing low signal-intensity prostate cancer in the right PZ

Saturday, 21 March 2015

Dynamic contrast-enhanced MRI (DCE) measures the characteristics of tumoral neoangiogenesis.

Note slightly increased enhancement in the right PZ

A 2013 systematic review comparing the accuracy of MRI-targeted biopsy with standard transrectal biopsy in the detection of clinically significant prostate cancer concluded that “both methods detect clinically significant prostate cancer equally well, but with the addition of MRI this was achieved using fewer biopsies in fewer men and with a reduction in the diagnosis of clinically insignificant cancer”3.

More recent papers meanwhile suggest superiority of MRI-guided biopsy over non-targeted TRUS biopsy in the detection of clinically significant disease.

Therefore, the addition of mpMRI to biopsy seems to be an important step forward in the quest for an ideal diagnostic test, with detection of more significant and less insignificant cancers, and on the basis of fewer biopsies overall.

References 1. Mowatt G, Scotland G, Boachie C, Cruickshank M, Ford JA, Fraser C, et al. The diagnostic accuracy and cost-effectiveness of magnetic resonance spectroscopy and enhanced magnetic resonance imaging techniques in aiding the localisation of prostate abnormalities for biopsy: a systematic review and economic evaluation.

Health technology assessment. 2013;17(20):vii-xix, 1-281.

2. Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, et al. ESUR prostate MR guidelines 2012.

European radiology. 2012;22(4):746-57.

3. Moore CM, Robertson NL, Arsanious N, Middleton T, Villers A, Klotz L, et al. Image-Guided Prostate Biopsy Using Magnetic Resonance Imaging-Derived Targets: A Systematic Review. European urology. 2013;63:125-40.

Sunday, 22 March 07.30-10.00: Plenary Session 2 Prostate Cancer

High b-value image showing high signal-intensity prostate cancer in the right PZ

EUT Congress News

15

Z I M M E R / M A D I C H AMS EAU StoneLight 30 Ad | EAU

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EUT Congress News

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™ The denoted marks are trademarks or registered trademarks of American Medical Systems, LLC. © 2015 American Medical Systems, LLC. All Rights Reserved. Minnetonka, MN 55343 AMSUS/STL-01549/March 2015 www.AmericanMedicalSystems.com 1-800-328-3881 U.S. and International Use Saturday, 21 March 2015

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Exhibition Guide 30th Anniversary Congress of the European Association of Urology Madrid, 21-23 March 2015

FLOORPLAN EXHIBITION HALL 9 PASSAGE TO NORTH BUILDING

I42

EDUCATION & INNOVATION

OPTIMUM

I40

I38

I36 I34 NOVA-I32 RSU MEDICA MEDTEK/ INVIDIA

WYAAU MEDICAL

I43

I39

I45

I41

G74

WFIP EUROPA UOMO G102

VISION SCIENCES

UAT

MEDI- NANOTATE VIBRONIX

EPONA

I37

H66

I28

I24

I22

SMU

I33

I35

OCEANA

INTERMEDIC

R-ACTION DISTRIBUTION

I18

I20

I16

I14

I19

I29

MAVIG

H28

CHARGE & CONNECT AREA

G98

SIMBIONIX PRODUCTS, 3D SYSTEMS G96

ANGIODYNAMICS G94

MIMIC

I06

MCUBE

SONACARE

I02

I03

IBSA

H24

I11

GRUPO MEDISURG TAPER

BARD

I07

UPCOMING MEETINGS AREA

VITA GREEN ANDROMEDA

H22

BOWA ERASMUS

H64

G100

ERASMUS MC

I08

CUA BIOBOT CUA LENUS PHARMA CANADA CHINA

CAU

H20

H26

GE CAREHEALTHSONO CARE

H52

H40

H08

KITALDIREX PHA

ERBE

ROCAMED

H04

SPECIALITY EUROPEAN PHARMA

ELMED

H03

XODUS MEDICAL H01

SONY

H51

EUROMEDICAL

G66

G62

UROTECH & UROVISION

G90

MMS

WILEY

G34

G44

G52

QUANTA SYSTEM

DORNIER

WISEPRESS

G30

G06

G12

G20

G28

MTS MIANYANG MEIKE

G56

KLS MARTIN BK ULTRASOUND

COMBAT

G10

INVIVO

PAJUNK

G04

G02

EXACT IMAGING G01

ENDOCARE

APOGEPHA

ESU HANDS-ON TRAINING ROOMS

F86

F94

F66

F78

F54

F30

F42

F14

F02

B. BRAUN AESCULAP

F96

WELLSPECT HEALTHCARE

EMS

LUT

RICHARD WOLF

SIEMENS

COOK

MENARINI

BAYER HEALTHCARE

RECORDATI

F93

ACCORDION F91

F01

OPKO DIAGNOSTICS

F63

F75

TAU

F03

LISA LASER

G79

GRENA

COLOPLAST PORGÈS

TAKEDA

E46

PIERRE FABRE MÉDICAMENT

KARL STORZ STORZ MEDICAL

E08

E20

E36

GSK

IPSEN

MAIN ENTRANCE

RESTAURANTS D88

D72

D60

D20

D40

D02

TRISTEL INTUITIVE SURGICAL

JANSSEN PHARMACEUTICAL COMPANIES

D86

ALLERGAN

OLYMPUS

SIU D73

ASTELLAS

AEU D69

C46

CURAN

D63

D65

TAEWOONG

C68

C72

BIONORICA

M.A.S.

MEDA

D61

D59

ENDO- ALLIUM CONTROL

C66

C64

D57

AUA

C62

C56

MED- SYSMEX UEG MEDICAL KONSULT

C44

C38

C34

BESINS EDAP TMS HEALTHCARE

HITACHI

SURGIQUEST

C22

D01

C10

UROMED

AMERICAN MEDICAL SYSTEMS

AMGEN

C02

URACYST® / UROPOL®

AMI

C03

APPLIED MEDICAL ELVATION

C69

ISTEM

B78

TELEFLEX

B80

UROMEDICA

C63

C57

C61

GENOMIC HEALTH

B52

B60

B32

B44

B20

KOELIS

B76

B74

ALBYN ELMEDICAL MEDICAL

ACCU-TECH

PROMEDON

LUMENIS

SANDOZ

FERRING

B82

EAU MEMBERSHIP HISTORICAL EXHIBITION RESEARCH FOUNDATION EBU EU-ACME EAU 2016 MUNICH YOUNG UROLOGISTS/RESIDENTS CORNER

A54

A52

SIGNOSTICS A50

MEDPRO MEDICAL

A41

MIM

A39

A37

A35

B08

A42

EAU BOOTH:

BIOLITEC

BOSTON SCIENTIFIC

JENA SURGICAL

MEDAC

PHYSION

B12

MEDICAL ENTERPRISES

LABORIE

B70

B28

A56

B16

A31

BACTIREALTON POLY- DYNAMESH GUARD DIAGNOST

BY FEG

C01

MEDCOM B04

GALIL B02

PROFOUND MEDICAL A36

A30

EAU VIDEO LIBRARY

MEDNEOTRACT TRONIC A34

CONCILE

A28

MYRIAD

A27

A25

MEDISPEC ETSCA

A23

A21

SIU ESSM ITALIA

A19

A17

A14

A20

NEOMEDIC A12

A08

A02

ZSI A06

ANGIOTIME RESEARCH DYNAMICS

A15

VERA- WCE 2015 LASER THON BAUS PERI-

A13

ELSEVIER

A11

EMED

A09

MONTAVIT

EUROPEAN UROLOGY

A01

CATERING

C65

Company and Product Description A.M.I. GMBH Im Letten 1, 6800 Feldkirch, Austria T : +43 5522 90505-0 F : +43 5522 90505-4006 W : www.ami.at E : marketing@ami.at Booth nr. : C56 A.M.I. is dedicated to designing ingenious surgical instruments, as well as developing innovative solutions for treating a variety of common afflictions including haemorrhoids, obesity and incontinence. In addition to the adjustable TVA/TOA Slings for female stress urinary incontinence and ATOMS System for male stress urinary incontinence, we also offer a advanced pelvic floor repair system comprising a range of slings and meshes to cover a variety of pelvic floor disorders.

AAU (ARAB ASSOCIATION OF UROLOGY) P.O. Box 11-0236, Riad Solh 1107-2020 Beirut, Lebanon T : +961 1 350 000 ext. 5279 F : +961 1 363 291 E : aaucongress@mci-group.com Booth nr. : I38 Arab Association of Urology (AAU) AAU conference always is rich in interactive discussions and experience exchange, ensuring that our delegate’s needs are met. The diversity of AAU member profiles and interest levels shown by several Arab societies and government organizations from the region in participating are indeed a further emphasis of the importance of such development. In addition, as the AAU is representing all Arab countries, it is therefore determined to work towards collaboration with other international bodies namely, the SIU and EAU.

ACCORDION MEDICAL 9465 Counselors Way Suite 200, 46240 Indianapolis, United States of America T : +1 317 759-2869 F : +1 317 663-1115 W : www.accordionmedical.com E : sales@AccordionMedical.com Booth nr. : F93 Accordion Medical designs and manufactures anti retropulsion devices for improved kidney stone treatment and control during URS lithotripsy and PCNL treatments.

ACCU-TECH CO., LTD. Room 503, Building No.8, Block 1, East Jiuxianqiao Road, Chao Yang District, 100015 Beijing, China T : +86 010-64392084 F : +86 010-64390200 W : http://www.accu-tech.com.cn/ E : hudehua_at@163.com Booth nr. : B70 Accu-Tech Co.Ltd established in 2003, is a national recognized high-tech enterprise located in ZGC Park. Since its foundation the company commits to the total solution of minimally invasive surgery through innovation and the state of the art technology. The company integrates R&D, production, sales and technical services. It is publicly listed in National Equities Exchange and Quotations (Stock Name: Accu-Tech, stock code: 430351). The company currently business covers the field of urology for urinary stones, benign prostatic hyperplasia and urological tumors therapies, of spine for disc herniation therapies, of gastroenterology of liver and gallstones,serve our clients through the professional clinical academic alliances to promote and popularize the modern and advanced clinical skills and innovative technologies of the world, to bring the benefits to the majority of patients of high-tech development through skilled surgeons,moreover to reduce the labor intensity of high load majority.

AEU ASOCIACIÓN ESPAÑOLA DE UROLOGÍA C/ Valenzuela, 6, 2º Dcha, 28014 Madrid, Spain T : +34 915 319 823 F : +34 915 326 456 W : http://www.aeu.es E : aeu@aeu.es Booth nr. : D73 The Asociación Española de Urología (Spanish Association of Urology, AEU), established in 1911, is a non-profit scientific society, which has the following purposes: encourage research and study of the conditions, both medical and surgical, urinary and excretory secretory apparatus of both sexes and male, adrenals, etc. genital Exhibition Guide

tract, and all changes resulting from the pathology thereof; and promote and defend the rights and range that correspond to Urology and the practice of its members.

Actas Urológicas Españolas is the official Journal of the Spanish Urology Association (Asociación Española de Urología, AEU) and the American Urology Confederation (Confederación Americana de Urología, CAU) and is the reference urology journal in the Spanish language: http:// www.journals.elsevier.com/actas-urologicas-espanolas/

ALBYN MEDICAL Polígono Industrial Cordovilla, 31191 Cordovilla - Navarra, Spain T : +34 948 29 33 24 F : +34 948 29 34 18 W : www.albynmedical.com E : sales@albynmedical.com Booth nr. : B74

therapies provide new options for patients, providers and payers, and are often inspired by the urologists, gynecologists and urogynecologists who choose AMS as their solutions partner.

AMERICAN UROLOGICAL ASSOCIATION (AUA) 1000 Corporate Blvd., 21090 Linthicum, Maryland, United States of America T : +1 410 689 3933 F : +1 410 689 3939 W : www.auanet.org E : membership@auanet.org Booth nr. : D57

The American Urological Association (AUA) is a globally engaged organization with more than 21,000 members, one-quarter of who practice in more than 120 countries, representing the world’s largest collection of expertise Established in 1985, Albyn Medical has extensive experience in and insight into the treatment of urologic disease. Since the design and manufacture of innovative Urology equipment its inception in 1902, the AUA has worked to advance and consumables. With facilities in Spain, Germany, France urologic education and the highest standards of urologic and the U.K. and with a network of international distributors, care worldwide through its exceptional educational we offer excellent world-wide support. offerings, publications, research and policy initiatives, and At the EAU Madrid we will present: philanthropic activities. AUA’s 2015 Annual Meeting will Hermes Integrated Urodynamics System be held May 15-19 in New Orleans, Louisiana. For more SmartDyn Wireless Urodynamics System information visit www.aua2015.org SmartFlow Wireless Urine Flowmeter Urodynamics catheters and consumables BioSmart Biofeedback System AMGEN (EUROPE) GMBH Incontinence products & accessories Dammstrasse 23, 6301 Zug, Switzerland Please visit our booth to discuss your requirements with a T : +41 413 690 300 product specialist.

F : +41 41 3690 400

ALLERGAN Marlow International, The Parkway, Marlow, Buckinghamshire, SL7 1YL Marlow, United Kingdom T : +44 162 849 44 44 F : +44 162 849 44 49 W : www.allergan.co.uk E : uk_medinfo@allergan.com Booth nr. : D72 Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to develop and deliver innovative and meaningful treatments. Today, we have a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. With our focus on several medical specialties, including neurosciences and urologics, Allergan is proud to support today the patients and physicians who rely on our products in more than 100 countries.

ALLIUM LTD. 2 Ha-Eshel Str. P.O. Box 3081, 38900 Caesarea Industrial Park (South), Israel T : +972 462 77 166 F : +972 462 77 266 W : www.allium-medical.com E : info@allium-medical.com Booth nr. : D59 Allium Medical offers unique anatomically designed long term, fully covered, expandable and retrievable metal stents. The Allium stents are anatomically and functionally compatible to specific organs for the treatment of obstructions in the urinary and GI tract.

The guiding concept of the stent design is that every stent will adapt to the individual characteristics of the anatomy at the treated site. Based on this unique concept, Allium offers physicians and patients more effective stenting solutions, significantly enhancing clinical results and patients’ quality of life.

AMERICAN MEDICAL SYSTEMS (AMS) 10700 Bren Road West, 55343 Minnetonka, United States of America T : +1 952 930 60 00 F : +1 952 930 64 62 W : www.VisitAMS.com E : info@AmericanMedicalSystems.com Booth nr. : C10 American Medical Systems (AMS), headquartered in Minnetonka, Minn., is a diversified supplier of medical devices and procedures to treat benign prostatic hyperplasia (BPH), incontinence, sexual dysfunction, and other pelvic disorders in men and women. AMS continues to develop new therapies to restore bodily functions enabling people to regain control of their lives. These

W E Booth nr.

: www.amgen.com : kszczepa@amgen.com : C22

Amgen, a biotechnology pioneer, discovers, develops, and delivers innovative human therapeutics. Our therapeutics have changed the practice of medicine, helping people around the world in the fight against serious illnesses.

With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.

ANDROMEDA MEDIZINISCHE SYSTEME GMBH Wallbergstraße 5, 82024 Taufkirchen, Germany T : +49 89 614156-0 F : +49 89 614156-11 W : www.andromeda-ms.de E : info@andromeda-ms.de Booth nr. : I07 Andromeda is a German based medical service company which develops and produces urodynamic measurement systems and disposables. We are market leader for urodynamics in German speaking countries and market these products in 50 countries around the world.

We offer urodynamic equipment from our computerized Conus PC Flowmeter up to complete solutions for video urodynamics with our Ellipse system. The new Ellipse colour offers wireless communication with a coloured screen.

With our Ellipse Chair we set a new benchmark for integrated urodynamic measurement systems. The concept behind this fully integrated system: all analysis functions are permanently installed in the urogynaecological chair, including the flow system, catheter puller and pressure transducers.

The Helix can manage the entire spectrum of urodynamic measurements combined with simple, quick and effective operation. Clinicians can now delegate most of the work involved in preparing the urodynamic procedure.

ANGIODYNAMICS Haaksbergweg 75, 1101 BR Amsterdam, The Netherlands T : +31 207 532 949 F : +31 207 532 939 W : www.angiodynamics.com E : amsterdam@angiodynamics.com Booth nr. : A06 + G96 AngioDynamics is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for Urology and Oncology.

Within Uro-Oncology, our diverse product lines include the NanoKnife System - the first in class device for irreversible electroporation (IRE), a promising and innovative technology for urologists. For thermal ablation we offer both Microwave technology - Acculis System and Temperature controlled Radio-frequency ablation StarBurst System.

Visit AngioDynamics booth A06 and find out more about IRE and the application of NanoKnife IRE System in urology.

APOGEPHA ARZNEIMITTEL GMBH Kyffhäuserstraße 27, 01309 Dresden, Germany T : +49 351 33 63 3 F : +49 351 33 63 440 W : www.apogepha.de E : info@apogepha.de Booth nr. : G01 APOGEPHA is an independent German medium-sized pharmaceutical company specialised in the field of Urology with own production. We developed Propiverine hydrochloride one of the top active ingredients for the treatment of Overactive Bladder, Urinary Incontinence and Neurogenic Detrusor Overactivity in adults and children.

Different dosages and formulations are available under the trademarks Mictonorm® and Detrunorm®. The patent of our unique once daily formulation is approved in most countries. Currently we have marketing and distribution partners in more than twenty countries with a focus in Central Europe, Middle East and South-East Asia. We are looking for out-licensing partners with strong sales force expertise in the Urology sector in all promising markets.

APPLIED MEDICAL EUROPE Wiekenweg 21, 3815 KL Amersfoort, The Netherlands T : +31 800 0200 144 F : +31 800 0200 145 W : http://www.appliedmed.com/ E : info-ne@appliedmedical.com Booth nr. : C03 Applied Medical is dedicated to providing innovative products that improve patient outcomes and enable the advancement of minimally invasive surgery. As a new generation medical device company, Applied Medical is equally committed to improving the affordability and accessibility of high-quality healthcare.

Applied Medical offers a wide range of innovative solutions, including the Kii® access systems, Voyant® intelligent energy system, GelPOINT® advanced access platforms, Alexis® wound protectors/retractors, Epix® instrumentation, and the Inzii® retrieval systems. Applied Medical is pleased to provide solutions for urologic, general, colorectal, bariatric, gynecologic, obstetric, and cardiovascular surgery.

ASTELLAS PHARMA EUROPE LTD. 2000 Hillswood Drive, KT16 0RS Chertsey, United Kingdom T : +44 203 379 8700 F : +44 203 379 8260 W : www.astellas.eu E : astellas.european.communications@

astellas.com Booth nr. : D02 Astellas is a progressive pharmaceutical company with a rich heritage that harnesses cutting-edge medical science to develop innovative and reliable medicines, creating a brighter future for patients in disease areas where there is a high unmet need for better treatments. These therapy areas include Urology & Oncology.

Astellas has a proven track record in urology and a portfolio of medicines. As a global leader in urology, we have a rich pipeline of new medicines, considered by some to be among the strongest in the industry. These include treatment for OAB and BPH induced lower urinary tract syndrome.

In 2006, Astellas made a commitment to join the fight against cancer, by developing treatments to help meet the challenges faced by patients and oncologists. Since then, we have developed strong, specialist research capabilities and established collaborations with key organisations at the forefront of cancer research resulting in a blossoming oncology drugs portfolio.

B. BRAUN AESCULAP Am Aesculap-Platz, 78532 Tuttlingen, Germany T : +49 7461 95-0 F : +49 7461 95-2600 W : www.bbraun.com E : information@aesculap.de Booth nr. : F94 B. Braun Sharing Expertise Through exchanging knowledge with its customers, B. Braun helps to improve treatments and working procedures in hospitals and medical practices and to increase the safety of patients, doctors and nursing staff.

B. Braun offers a wide range of products in the field of continence care, urological specialties, wound closure and sutures and process-oriented advice Aesculap – a B. Braun company is pursuing a goal: to improve therapies and make processes more efficient.

21-23 March 2015

Company and Product Description BACTIGUARD AB

BIOBOT SURGICAL PTE LTD

Box 15, 14621 Tullinge, Sweden T : +46 702148749 F : +46 84405878 W : www.bactiguard.com E : nina.nilsson@bactiguard.com Booth nr. : A39

2 Woodlands Spectrum, #03-10 Woodlands Sector 1, Singapore 738068, Singapore T : + 65 65070366 E : sales@biobotsurgical.com W : www.biobotsurgical.com Booth nr. : I18

Bactiguard provides world-leading solutions, preventing healthcare associated infections – the third largest cause of death in the western world. By using Bactiguard unique technology governments can reduce healthcare cost, lower the use of antibiotics and save lives. The Bactiguard technology consists of an extremely thin noble metal coating that reduces bacterial adhesion. It is biocompatible and applicable on all sorts of medical devices.

More than 130 million Bactiguard® coated urinary catheters have been used since 1995 and over 40 clinical studies with more than 100.000 patients have been conducted.

Today Bactiguard offers a full range portfolio within infection prevention in the urinary tract, respiratory tract and blood stream.

BARD LTD Tilgate Forest Business Park, Brighton Road, RH11 9BP Crawley, United Kingdom T : +44 129 360 67 80 F : +44 129 360 65 26 W : www.crbard.com E : kerrin.waters@crbard.com Booth nr. : I19 Bard Urology is a global leader in urology and continence care offering a comprehensive product range for patient care. In addition to industry-leading products, our Didact educational and resources offer both the clinician and patient valuable sources of information, support and education Urology was at the heart of Bard’s foundation over 100 yrs ago and remains a core business today.

Bard is committed to advancing the technology of diagnosis and intervention to help reduce healthcare costs and improve patient outcomes.

We invite you to come and visit us on booth I19 and see the latest developments in the fields of Homecare Urology and Interventional Urology (including Endourology, Brachytherapy and Women’s Urology).

BAYER HEALTHCARE Bayer Pharma AG, 13342 Berlin, Germany T : +49 304681111 F : +49 304681111 W : www.healthcare.bayer.com E : https://twitter.com/BayerHealthCare Booth nr. : F02 The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world¹s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare¹s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries.

More information at www.healthcare.bayer.com.

BESINS HEALTHCARE 283/92 Sukhumvit 55 Road, 10110 Bangkok, Thailand T : +662 1057888 F : +662 1057889 W : www.besins-healthcare.com E : info@besins-healthcare.com Booth nr. : C44 Besins Healthcare is a global pharmaceutical company specializing in innovative healthcare solutions that restore, restart and regulate fundamental female and male body processes so the body can perform at its optimal level. A privately held, fourth-generation French-based company with central operations in Bangkok, Thailand, Besins has discovered ground-breaking technologies to improve patient well-being throughout its history. A world leader in novel therapies for gynecology and andrology, Besins developed AndroGel® (testosterone gel) – the original and world’s leading testosterone replacement therapy. We also are a market leader in estrogen replacement therapy.

Besins products are trusted and prescribed by healthcare professionals in more than 90 countries throughout the world.

21-23 March 2015

About Boston Scientific Boston Scientific (NYSE: BSX) is a worldwide developer, manufacturer and marketer of medical devices with approximately 23,000 employees and revenue of $7.143 billion in 2013.

Mission Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology Biobot Surgical researches, manufactures, and markets leader for more than 30 years, we advance science for innovative surgical robotic systems for minimally invasive life by providing a broad range of high performance surgery. Our first product, the iSR’obot Mona Lisa, is capable of Ultrasound Imaging and MRI/Ultrasound Fusion. solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.

These capabilities aid the planning and execution of bostonscientific.com and connect on Twitter (@bostonsci) transperineal prostate biopsy and therapy utilising an and Facebook. intelligent targeting software.

Website: http://www.biobotsurgical.com

BIOLITEC BIOMEDICAL TECHNOLOGY GMBH Otto-Schott-Str. 15, 07745 Jena, Germany T : +49 3641 519530 F : +49 3641 5195333 W : www.biolitec.com E : info@biolitec.de Booth nr. : A54 The biolitec group has long-standing experience in the development and production of medical laser systems, optical fibers and minimal invasive devices.

The revolutionary XCAVATOR and TWISTER fibers for treatment of BPH, work in contact mode and enable unmatched performance in speed, safety and effectiveness. In combination with the Ceralas® HPD Laser, procedures can be done with minimal bleeding, achieving optimal results for the patient.

New applications in urology involve partial nephrectomy and the removal of bladder tumors.

BIONORICA SE Kerschensteinerstrasse 11-15, 92318 Neumarkt, Germany T : +49 9181 231-90 F : +49 9181 231-265 W : http://www.bionorica.de/ E : info@bionorica.de Booth nr. : C68 Bionorica SE is one of the leading companies in the area of phytopharmaceuticals and is marketing products with proven efficacy, safety and quality in 50 countries worldwide.

The product range focuses mainly on diseases of the respiratory tract, urinary tract, gynaecological disorders and on medications for the treatment of pain. Bionorica’s know-how in phytotherapy has grown in 80 years and the company’s development of rational herbal medicinal drugs can be compared to the standards of chemically synthesised drugs.

BK ULTRASOUND Mileparken 34, 2730 Herlev, Denmark T : +45 445 281 00 F : +45 445 281 99 W : www.bkultrasound.com E : info@bkmed.dk Booth nr. : G20 BK Ultrasound’s new ultrasound system, bk3000, is powered by Analogic’s unique TriCore Architecture that gives a new level of speed and performance for urologists.

The system gives Ultra High Resolution imaging and Doppler which allows more accurate and consistent visualization of subtle tissue contrast differences. The bk3000 offers advanced modalities like elastography to help identify regions of interest, and MRI/fusion capabilities to enable more precise, targeted biopsies.

The bk3000 supports a wide range of new advanced specialized transducers for urology include the unique triplane prostate transducer, which allows simultaneous biplane imaging and endfire imaging in one transducer, and a portfolio of transducers for kidney, bladder, testis and penile imaging.

BOSTON SCIENTIFIC INTERNATIONAL 2 Rue René Caudron, 78961 St Quentin en Yvelines cedex, France T : +33 139309700 F : +33 139309799 W : www.bostonscientific.com E : isabelle.leix-lebris@bsci.com Booth nr. : B16

BOWA-ELECTRONIC GMBH & CO. KG Heinrich-Hertz-Str. 4-10, 72810 Gomaringen, Germany T : +49 70726002-0 F : +49 70726002-33 W : www.bowa-medical.com/ E : informacion@taper.es Booth nr. : H28 BOWA – SIMPLY SAFE Surgical teams around the globe rely on the BOWA Electrosurgical System, made in Germany. The ARC series offers all of the functions required for electrosurgery today.

Special emphasis has been placed on delivering solutions for demanding applications in urology, such as the sealing technology LIGATION, particularly effective bipolar resection and instrument recognition.

BOWA sets very high standards in terms of quality, and its award-winning ergonomic designs make it one of the global leaders in its field. www.bowa-medical.com

CANADIAN UROLOGICAL ASSOCIATION CUA Corporate Office 185 Dorval Suite 104, H9S 5J9 Dorval, QC, Canada T : +1 514 395 0376 F : +1 514 395 1664 W : www.cua.org E : corporate.office@cua.org Booth nr. : I16 The Canadian Urological Association exists to promote the highest standard of urologic care for Canadians and to advance the science of urology. The CUA is a national member-based organization dedicated to enabling the profession to provide the highest possible standards of urologic care by collaboratively: • Fostering excellence in urologic practice through advocacy, education, research and practice support tools • Leading evidence-based clinical practice through the development of practice standards and guidelines • Providing continuous professional development for Canadian urologists along the career-path continuum • Providing leadership in public education for urologic conditions • Representing the Canadian urologic community in relationships with governments as well as national and international medical societies.

CARESONO TECHNOLOGY CO., LTD. 4th Floor, No11 Buiding, Initiatng Zone, Instruments and Meters Industry Base, Dandong, Liaoning 118009,P, 118009 Dandong, China T : +86 755-26829212 F : +86 755 86365909 W : www.caresono.com.cn E : info@caresono.com.cn Booth nr. : H64 Caresono is an innovator in medical industry for bladder scan total solutions. We develop, manufacture and market innovative hand-carried bladder scan systems to the medical practitioners around the world.

With Caresono Bladder Scan Total Solution, We Create Comfort and Value. Making sure there would be ‘Less Pain for Patients, Easier Work For Nurses’.

In CARESONO, we are dedicated to improve the medical care in urinary catheterization. To make the world a better place.

CAU (CONFEDERACIÓN AMERICANA DE UROLOGÍA) Pasaje De La Cárcova 3526 - Buenos Aires, Argentina T : +54 11 4 963 7941 F : +54 11 4 963 7941 E : sedecentral@caunet.org Booth nr. : I22

Confederación Americana de Urología- CAU, is a nonprofit institution with scientific purposes. Composed of the Spanish Urology Society, Portuguese Urology Society and 24 Latin American Urology societies, CAU promotes the development of urology by organizing annual meetings and courses. CAU also publishes a scientific digital journal that is distributed to its members. CAU also focuses support for its members in areas as Fellowships based on agreements with AUA, (AUA South American Visiting Scholar Program) and with very important Spanish Urological institutions such as AEU (Asociación Española De Urología) And Fundació Puigvert from Barcelona.

CHINESE UROLOGICAL ASSOCIATION (CUA) NO.168 Changhai Rd., Shanghai, 200433, China T : +86 21- 3503 0006 F : +86 21- 3503 0006 W : www.cmacua.org E : sunyh@medmail.com.cn Booth nr. : I20 The Chinese Urological Association (CUA) was established in 1981 by Prof. Jieping Wu, academician of Chinese Academy of Sciences and founder of new China’s urology.

With 30 years’ development, the CUA has grown into a professional organization and the main power to promote the development of China’s urology. The 10th Committee led by prof. Yinghao Sun formed in January of 2014. In order to better sever for Chinese urologists and patients, the new committee has made two plans of Ding Tian and Li Di to continue CUA’s effort of enhancing the overall academic level and international visibility of China’s urology.

COLOPLAST - PORGÈS C.A. La Boursidière, 92350 Le Plessis Robinson, France T : +33 140 836 868 F : +33 140 836 855 W : www.coloplast.com E : frpbe@coloplast.com Booth nr. : F75 For over 120 years, Porgès has supported the medical progress through the development of the latest techniques and devices in cooperation with our surgeon partners in the field of: • Endourology: a wide range of stone extractors, ureteral stents, access sheaths, balloon dilation catheters and percutaneous nephrostomy sets • Women’s Pelvic Health: slings and meshes to treat stress urinary incontinence and pelvic organ prolapses • Men’s Health: male sling, penile implants for treating erectile dysfunction, testicular implants • General Surgery: a wide range of drains and a high quality suction/irrigation device for laparoscopy • Lower Urology: all disposable surgical devices required for handling Prostate disorders and also addressing bladder and suprapubic drainage, urethral strictures voiding dysfunctions and other urological conditions Porgès is proud to provide you the best services, products and guarantees.

Together to care, Innovative surgical solutions

COMBAT MEDICAL LTD Lamer House Office, Lamer Lane, Herts AL4 8RL Wheathamstead, United Kingdom T : +44 1582834466 F : +44 1582834466 W : www.combat-medical.com E : contact@combat-medical.com Booth nr. : G06 Combat Medical is a specialist thermotherapy medical device company. We have developed the COMBAT BRS system, an innovative and patented recirculation system for the delivery of Hyperthermic Intra-Vesical Chemotherapy (HIVEC) in the treatment of non muscle invasive bladder cancer (NMIBC). In clinical use since 2011 the COMBAT BRS system maximises the efficacy of the chemotherapy treatment, is a safe and effective technology. It harnesses the proven synergistic effects of chemo-hyperthermia to target NMIBC whilst remaining simple to integrate into current practice. It requires minimal additional resources for the healthcare provider whilst maximising outcomes for patients with this type of bladder cancer. Chemo-hyperthermia has recently been recommended in UK and Spanish guidelines for treatment options in the fight against bladder cancer.

Exhibition Guide

Company and Product Description CONCILE GMBH

DIREX

EAU HISTORICAL EXHIBITION

Kronenmattenstr. 6, D-79100 Freiburg, Germany T : +49 761 151474-0 F : +49 761 151474-19 W : www.concile.de E : info@concile.de Booth nr. : A34

Blumenstrasse 10, D-65189 Wiesbaden, Germany T : +49 180 215 2152 F : +49 180 215 1151 W : www.direxgroup.com E : wbmaster@direxgroup.com Booth nr. : H20

Booth nr.

UBC® Rapid is a rapid test for primary diagnosis and follow-up of bladder cancer patients. The POC test is manufactured by IDL Biotech AB, Sweden and can be used for qualitative and quantitative measurement in urine. In combination with the POC-reader concile® Ω100 it also facilitates risk prediction compared to conventional nonquantitative dichotomized POC-testing. The reader is being manufactured by concile GmbH from Germany. In addition, concile develops and distributes POC tests for quantitative measurements of PSA, fPSA, Testosterone, LH, FSH and other analytes.

IDL Biotech AB, develops, produces and internationally markets In Vitro Diagnostic (IVD) tests. Within the area of urologic oncology, IDL Biotech AB offers tumor activity markers for detection, prognosis and monitoring of urinary bladder (UBC® ELISA, UBC® IRMA and UBC® Rapid) and prostate cancer (TPS®).

Take a moment and visit both of us, concile GmbH and IDL Biotech AB, during the meeting to learn more about the first quantitative POC system for diagnosing and monitoring urinary bladder cancer (Booth A34 in Hall 9).

COOK MEDICAL O’Halloran Road, National Technology Park, 0000 Limerick, Ireland T : +353 61239344 F : +353 61250599 W : www.cookmedical.com E : sabrina.begoin@cookmedical.com Booth nr. : F66 At Cook Medical, patients come first. For over 35 years, we’ve been working to advance urology procedures and improve outcomes, and we’re leading the way with our stone management solutions. We value our quality and won’t compromise it even if it means taking the extra time to make products you and your patients can trust.

At our core, we believe industry-physician collaboration is vital to providing better healthcare. Our VistaSM Collaboration and Learning programs encourage sharing best practices and learning new techniques.

CURAN MEDICAL BV Barlhammerweg 26, 7006 GE Doetinchem, The Netherlands T : +31 314 392 725 F : +31 314 620 580 W : www.curan.eu E : info@curan.eu Booth nr. : D69

DirexGroup has pioneered usage of Linear Shockwaves Therapy (LSWT), the only technology specifically designed for ED treatment.

Renova applies shockwaves unto 4 linear segments of penis and crura for improved corpus cavernosum coverage.

Renova is the first device in a line of devices applying geometrically shaped shockwaves for various applications.

DORNIER MEDTECH EUROPE GMBH

EAU MUNICH 2016 W Booth nr.

: http://eaumunich2016.uroweb.org/ : A42

The 31st Annual EAU Congress will take place on 11-15 March 2016 in Munich, Germany. Visit this booth to be the first to know all about next year’s congress!

EAU RESEARCH FOUNDATION

Dornier MedTech is an innovative market leader in both the urology and medical laser markets. As the pioneer of extracorporeal shock wave lithotripsy and a variety of medical lasers, Dornier continues to develop advanced medical solutions.

Through the years Dornier has diversified its product offerings to include multifunctional urological workstations, imaging tables and orthopedic shockwave devices.

As a global company, Dornier MedTech has operating units and service partners throughout the world. Dornier MedTech (www.dornier.com) is a privately held company headquartered near Munich, Germany.

The EAU Research Foundation (EAU-RF), an independent non-commercial organization affiliated to the EAU, was set up for recognizing research initiatives and outcomes beneficial for urological patients and the international community. The EAU-RF stimulates, coordinates and supervises basic, translational and clinical research by acting as a bridge between urological centers, patient,and research organizations and the EAU.

DYNAMESH BY FEG TEXTILTECHNIK MBH Prager Ring 70, 52070 Aachen, Germany T : +49 241 189 237 40 F : +49 241 189 237 459 W : www.dyna-mesh.com E : s.roos@dyna-mesh.com Booth nr. : A31

With installations at many clinics & hospitals worldwide, ELMED has proven record for its ability to deliver high performance products and develop solutions that meet specific user requirements.

The product range complies with international standards; CE mark in accordance with MDD 93/42/EEC, ISO 9001, ISO 13485, for Intracorporeal Lithotripters FDA clearance.

ELMEDICAL LTD.

Mr. E.N. van Kleffensstraat 5, 6842 CV Arnhem, The Netherlands T : +31 26 389 0677 F : +31 26 389 0679 W : http://www.uroweb.org/research E : researchfoundation@uroweb.org Booth nr. : A42

Whether you are a member of the EAU or not, we 7100 Euclid Avenue, Suite 180, 44103 Cleveland, Ohio, welcome you to visit our booth on the exhibition floor.

United States of America Here you can meet the staff of the European Association of T : +1 216 229 2040 Urology, who will answer any questions you might have F : +1 216 220 2070 W : www.simbionix.com about the activities of our association. You will also be E : simbionix@3dsystems.com able to pick up informational flyers, newsletters, and other Booth nr. : G98 must-have materials about the EAU. Here you can also purchase various EAU publications. If you wish to become 3D Systems-Simbionix Products is a leader in 3D modeling, an EAU member, you can directly apply at our booth. simulation training and 3D printing of personalized If you are already a member of the EAU, you can medicine. Our comprehensive hands-on training solutions conveniently pay your dues, inquire about your for urology surgeons include Laparoscopy skills and membership status, and update your information in suturing training followed by full procedures practice the database. As a member you will also receive the on the LAP Mentor; Robotic tasks and skills followed by EAU Extended Guidelines 2015, the 22nd volume of prostatectomy full procedure practice on the RobotiX Historia Urologiae Europaeae series, the congress gift 30 Mentor; Endourology including essential skills, and diagnostic and therapeutic procedures on the URO Mentor; Milestones in Urology and the digital version of the ICUD TURP basic skills and procedures on the TURP Mentor. book.

Exhibition Guide

Visit the historical exhibition, which is a special part of the EAU booth and is traditionally organised by the EAU History Office. This year’s exhibition presents the instruments which paved the way for modern urology.

Come and have a look at the world’s first endoscope built in 1804 by Philipp Bozzini.

Argelsrieder Feld 7, 82234 Wessling, Germany T : +49 8153-888-625 F : +49 8153-888-444 W : www.dornier.com E : infoeurope@dornier.com Booth nr. : G52

FEG Textiltechnik mbH in Aachen, Germany, is the world’s leading company in research and development of textile human implants made of PVDF (Polyvinylidene fluoride).

The implants are distributed worldwide under the brand name DynaMesh®.

The product range includes specific textile implants Curan Medical stands for great ambition and experience and instruments for various applications in the fields of within the continence care market. We focus on the needs hernia surgery, stoma surgery and pelvic floor surgery. of our customers and users. ® ® Specializing solely on innovative intermittent catheterization With DynaMesh -CESA and DynaMesh -VASA , FEG have solutions, we have managed to closely develop our range of developed the worldwide first Implants for the Surgical Treatment of Urge Urinary Incontinence. catheters alongside users and prescribers.

The Curan Lady compact female device is a great example All products are fully engineered and manufactured in of what we are capable of and we have several successful certified facilities at the head office in Germany.

R&D projects in the final stages of trials ready to be rolled www.dyna-mesh.com out throughout 2015.

Asides from offering what we believe to be avant-garde product solutions, we also fondly believe in providing EAU exclusive sales, marketing tools, post market surveillance, P.O. Box 30016, 6803 AA Arnhem, The Netherlands solid deliveries and competitive prices.

T : +31 26 389 06 80 Curan meets your needs!

F : +31 26 389 06 74 W : www.uroweb.org Booth nr. : A42

3D SYSTEMS-SIMBIONIX PRODUCTS

: A42

EAU VIDEO LIBRARY Booth nr.

: A20

The EAU has an extensive library of digital videos dedicated to surgical procedures and techniques. The Digital Video Library offers you an opportunity to browse and view these videos, as well as select those of interest and have them copied onto a DVD for you free of charge.

The Video Library is supported by an unrestricted educational grant from ASTELLAS.

EDAP TMS 4, Rue du Dauphiné, 69120 Vaulx-en-Velin, France T : +33 472 153 150 F : +33 472 153 151 W : www.edap-tms.com E : contact@edap-tms.com Booth nr. : C46 Global leader in therapeutic ultrasound and present in the market for 35 years, EDAP TMS (NASDAQ: EDAP) develops, manufactures, promotes and distributes worldwide minimally-invasive medical devices for urology using ultrasound technology.

By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® as the answer to all requirements for ideal focal therapy of prostate cancer as a complement to the existing Ablatherm® HIFU. As a pioneer and key player in the field of extracorporeal lithotripsy (ESWL), EDAP TMS exclusively utilized the latest generation of shock wave source in its Sonolith® range of ESWL systems.

29 Haharash St. Hod-Hasharon, Israel 4501303 T : +972.9.7413211 F : +972.9.7423212 W : www.elmedical-group.com E : Jacob@elmedical-group.com Booth nr. : B76 Elmedical treats non-muscle invasive bladder cancer (NMIBC) by its unique BWT - Bladder Wall Thermochemotherapy. BWT is a powerful combination of exact & uniform hyperthermia over the entire bladder lumen and mitomycin-C (MMC) instillation. Treatment efficacy, drug stability and patients’ tolerance provided by low-pressure, high-flow circulation of a carefully heated MMC thru the bladder.

The CE approved technology is better controlled and tolerated, easier to perform and more cost effective than other device-assisted bladder instillations and has excellent outcomes. With 6 years median follow-up in a difficult group of highly recurrent NMIBC patients (median disease-free interval 5month) where 100% of patients failed BCG, 32% failed also MMC and 19% also microwave thermo-chemotherapy, BWT resulted in around a 6X extended disease-free interval compared to each patient baseline. Due to its extended disease-free interval, BWT is even more cost effective than stand-alone bladder instillations and is a clear solution for the BCG shortage.

Today, more than 7000 BWT procedures performed successfully, practically with no adverse events.

Elmedical is looking for international distributors.

Contact person: Uzi Eshel Email: uzi@elmedical-group.com Cell. +972.544.588.211

ELSEVIER Radarweg 29, 1043 NX Amsterdam, The Netherlands T : +31 204852825 F : +31 204852521 W : www.elsevier.com E : f.foroni@elsevier.com Booth nr. : A13 Elsevier is a world-leading provider of scientific, technical and medical information products and services, working in partnership with the global science and health communities to enhance the productivity of science and health professionals.

We proudly publish the European Association of Urology journal, European Urology, as well as The Journal of Urology and Urology Practice on behalf of the American Urological Association. Additional journals published by Elsevier include: Urologic Oncology, Urology, Journal of Pediatric Urology and the open access journal, Urology Case Reports.

With an extensive media spectrum – print, online and mobile – Elsevier is able to supply the information you need in the most convenient format.

Visit the Elsevier booth A13 to browse and collect free sample copies (while stocks last) of our journals and learn more about our new products!

ELMED MEDICAL SYSTEMS Bati Sitesi Mah. Gersan San. Sitesi, 2307 Sokak, No:46 Yenimahalle, 06370 Ankara, Turkey T : +90 312 256 92 22 F : +90 312 257 06 08 W : www.elmed-as.com E : sales@elmed-as.com Booth nr. : H08 ELMED is involved in developing, manufacturing, servicing and exporting of advanced medical equipment in the field of urology since 1991 in Turkey. The company’s leading product range consists of World’s First Flexible Ureteroscopy Robot, Extracorporeal Shock Wave Lithotripsy (ESWL) Systems and Pneumatic and Ultrasonic & Pneumatic Combined Intracorporeal Lithotripters for the treatment of urinary tract calculi.

With its own R&D department, ELMED continually innovate its existing product range. Additionally follows up the new technology and market demands in order to design and produce new devices in the other fields of medicine.

ELVATION MEDICAL GMBH Ludwig - Wolf - Str. 6, 75249 Kieselbronn, Germany T : +49 07231-563656 F : +49 07231-563646 W : www.elvation.de E : info@elvation.de Booth nr. : C65 Piezo Shockwave Piezo-electric shockwave systems. Precise, focused and economic Richard Wolf and Elvation Medical – two names which are almost synonymous with piezo-ceramic shockwave technology. Since more than 30 years, shockwave generation using piezo technology has been one of the most precise, effective and economic ways of generating shockwaves to treat urological stones (Lithotripsy, ESWL) and offer shockwave therapy (Erectile Dysfunction, ESWT).

21-23 March 2015

Company and Product Description EMED SP. Z O. O. SP. K.

EPONA MEDICAL

Ryzowa 69A, 05-816 Opacz, Poland T : +48 22 723 08 00 F : +48 22 723 00 81 W : www.emed.pl E : export@emed.pl Booth nr. : A11

Beursplein 37 suite 517, 3011 AA Rotterdam, The Netherlands T : +31 102066370 F : +31 102066379 W : www.lap-x.com E : info@epona.com Booth nr. : G102

Confidence in performance.

EMED offers ATOM electrosurgical unit – a compact, easy to operate and fully customizable electrosurgical system.

ATOM provides high performance of specialized cutting, coagulation and vaporization bipolar modes for resection in saline.

Automatic power regulation guarantees easy start and continues control of electric arc. Real-time monitoring of all parameters ensures the best results regardless of the working conditions.

Along with an universal resectoscope, ATOM allows versatile use in monopolar and bipolar urology.

Our aim is to deliver maximum surgical efficiency and patient safety through our innovations in electrosurgery.

EMS ELECTRO MEDICAL SYSTEMS S.A. Ch. De La Vuarpillière 31, 1260 Nyon, Switzerland T : +41 229 944 700 F : +41 229 944 701 W : www.ems-medical.com E : welcome@ems-ch.com Booth nr. : F86 EMS Electro Medical Systems SA is the inventor of the Swiss LithoClast®. The Swiss LithoClast Master®, a combined pneumatic and ultrasound lithotriptor, is now the gold standard for fragmentation and clearance of large stones. By combining the Swiss LithoClast Master® with the Swiss LaserClast®, the latest generation holmium laser with long pulse mode, EMS offers the best solution for all stones.

ENDOCARE, INC. 9825 Spectrum Drive, Bldg. 3, 78717 Austin, Texas, United States of America T : +1 512.314.4391 F : +1 512.201.6789 W : www.endocare.com &

www.healthtronics.com E : international@healthtronics.com Booth nr. : G04 Endocare, Inc., a wholly-owned subsidiary of Healthronics, is a medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation. Endocare has initially concentrated on developing cryoablation (freezing) technologies for the treatment of prostate cancer and believes that its proprietary technologies have broad applications across a number of markets. With over 10-years of clinical experience in percutaneous, laparoscopic, and open cryoablation for prostate, kidney, and other tissues, we remain committed to innovative technology that improves and extends patients’ lives.

ENDOCONTROL 2 avenue de l’OBIOU, 38700 LA TRONCHE, France T : +33 428380804 F : +33 428380802 W : www.endocontrol-medical.com E : communication@endocontrol medical.com Booth nr. : D61 EndoControl is a leading innovator of robot-assisted systems for endoscopic surgery. Its mission is to enhance clinical progress by designing state-of-the-art solutions for surgeons. The company markets a range of products including ViKY® EP, a laparoscopic motorized endoscope holder, ViKY® UP , a motorized uterus positioner, and JAiMYTM, the first 5 mm motorized articulated laparoscopic instrument.

Over 10,000 surgical interventions have been carried out using ViKY around the world. EndoControl markets its products in Europe, the Middle East, Africa and SouthEast Asia by means of a distribution agreement with Trumpf Medical System (Germany). EndoControl is also represented in the USA, Canada and Japan by a network of independent distributors.

There are 150 EndoControl robots currently in use in medical establishments across the world.

21-23 March 2015

Epona Medical is a Dutch company located in Rotterdam, the Netherlands, manufacturing and marketing cuttingedge medical training simulators and health care learning material. Epona Medical’s simulation products (for laparoscopy, arthroscopy, endovascular interventions and human patient critical care) are created with the commitment to provide medical professionals worldwide with affordable high tech training tools.

ERASMUS CONFERENCES TOURS & TRAVEL 1 Kolofontos & Evridikis str., 16121Athens, Greece T : + 30 210-7414700 F : + 30 210- 7257532 W : www.erasmus.gr E : info@erasmus.gr Booth nr. : H22 ERASMUS S.A. is a Company with 22 Years of experience in Organizing Congresses globally. Especially in the field of Urology, we are the proud Professional Congress Organizers of the following Events: 8th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer (Amsterdam, 21-23 June 2015), 5th International Meeting Challenges in Endourology and Functional Urology (Paris, 28-30 June 2015) and 3rd Experts in Stone Disease Conference (India, December 2016)

ERASMUS MC Dr. Molewaterplein 50, 3015 GE Rotterdam, The Netherlands T : +31 10 7043690 W : www.erasmusmc.nl E : d.kok@erasmusmc.nl Booth nr. : G100 The ErasmusMC department of urology develops m-health applications for patient care. Current products are an app for prostate cancer risk calculation (co-developer SWOP) and a platform of interactive lifestyle coaching apps for healthy people and patient groups where lifestyle effects disease development (co-developers GGD Rotterdam, Sint Franciscus Gasthuis Rotterdam, Sint Lucas Hospital Gent, Department of Nephrology; co-sponsors SPA Belgium and Shire). Hospitals and companies that are interested in co-developing and co-sponsoring these lifestyle apps are invited to take contact.

ERBE ELEKTROMEDIZIN GMBH Waldhörnlestr. 17, 72072 Tübingen, Germany T : +49 7071 7550 F : +49 7071 755 179 W : www.erbe-med.com E : info@erbe-med.com Booth nr. : H40 ERBE Elektromedizin GmbH Medical technology since 1851 – made in Germany The product range of ERBE Elektromedizin GmbH comprises OR systems for electrosurgery, vessel sealing, argon plasma coagulation (APC), cryosurgery and waterjet surgery.

The systems are configured as workstations for general surgery, gastroenterology, gynecology, pneumology and urology. The equipment and indication-specific instruments are adapted to the requirements of the surgeons.

About 550 of our more than 800 employees world-wide work in Germany, either at the headquarters in Tübingen or at a second manufacturing site in Rangendingen.

A large proportion works in manufacturing and administration and more than 100 employees in research and development.

The world-wide sales and service network consists of subsidiaries and export dealers in more than 110 countries.

ESSM Via G. Ripamonti 129, 20141 Milan, Italy T : +39 02 56601 625 F : +39 02 70048 577 W : www.essm.org E : admin@essm.org Booth nr. : A21

The European Society for Sexual Medicine (ESSM) with more than 1.700 members is a not-for-profit, multidisciplinary,academic and scientific organization dedicated to male and female sexual function and dysfunction. The main purposes of the ESSM are: 1. To promote research and exchange of knowledge about the clinical entity of sexual dysfunction 2. To establish and support the highest standards of ethics in clinical practice, education, and research in the field of sexual dysfunction.

3. To promote the cooperation and improve interaction between researchers and clinicians in sexual dysfunction.

4. To provide education to clinicians who had limited or no experience in the field, as well as continuing education to those involved in the management of sexual dysfunction.

5. To provide patients, the public and the media with accurate and updated information about male and female sexual function and dysfunction.

6. To develop programs, promoting public and health authorities’ awareness

The European Tuberous Sclerosis Complex Association (ETSC) was established in 2012 after demand from National TSC Associations to share knowledge and information concerning tuberous sclerosis complex, understand more about the development of clinical trials and empower patients and families across Europe and raise awareness.

ETSC boasts 19 member countries, each representative is a parent who as well as dealing daily with the devastating effects that this rare disease has, also contributes actively to initiatives related to raising awareness on TSC for their local organisations.

EUROMEDICAL GMBH

European Urology, the official journal of the EAU, has been a respected urological forum for over 35 years, and is currently read by more than 20,000 urologists across the globe. With an impact factor of 12.480, the journal has become the leading scientific publication in the field of urology.

European Urology is constantly updating and innovating its electronic and published features and layout in order to provide the best clinical guidance, research and education for urologists across Europe and the world.

Come see European Urology for yourself - visit either the European Urology or EAU booth (A01) at the exhibition.

Ligusterweg 2, D-83313 Siegsdorf, Germany T : +49 17 28 13 15 74 F : +49 86 62 66 85 49 W : www.euromedical-gmbh.de E : info@euromedical-gmbh.de Booth nr. : H51 Products for: - Endo-urology - Urology - rehab - Uro-surgery - General surgery Activities: EuroMedical, created in 1994, is continuously improving existing products and creating new ones to EuroMedical’s high level of standard.

Distribution network is in full development as EuroMedical is seeking partners who share EuroMedical’s ambition to succeed.

Products, Solutions and Services: for URS, stone retrieval baskets, vacuum therapy system, vascular clips, No-scalpel-vasectomy set, custommade scissors/instruments, Enuresis (device for child incontinence), XXL instruments

EUROPA UOMO Lange Gasthuisstraat 35-37, 2000 Antwerpen, Belgium T : +32 33389151 F : +32 33389152 W : www.europa-uomo.org E : europauomo@skynet.be Booth nr. : I39 Europa Uomo, the European Prostate Cancer Coalition, represents and supports patient groups with prostate diseases in general and cancer in particular. Our aims include increasing awareness of prostate diseases, the support of individualized treatment based on optimal medical treatment with personalized patient care and patients’ advocacy as a priority focused on quality of life based on solidarity and mutual respect. Our expansion is based on collaboration with the professional organizations to provide information on evidence based treatment, to educate men on holistic patient care and on solidarity in advocacy with other patient support groups.

EUROPEAN BOARD OF UROLOGY W Booth nr.

: www.ebu.com : A42

The European Board of Urology (EBU) is a section of the European Union of Medical Specialists (UEMS). The EBU’s objective is to promote the highest level of urological training in Europe, both on the basic and postgraduate level. The EBU is a non-profit organisation that is charged with regulatory matters. It has independent evaluation tools and authority, as well as broad expertise in urology training standards and requirements. The key to ensuring unbiased and high-quality assessment of all EAU and other European urology-related training activities is the fact that the European Board of Urology works as an entirely independent regulatory organisation.

EUROPEAN TUBEROUS SCLEROSIS ASSOCIATION In den Birken 30, 45711 Dattein, Germany T : +351 933836990 W : www.e-tsc.eu E : micaelarozenberg@gmail.com Booth nr. : A25

EUROPEAN UROLOGY Radarweg 29, 1043 NX Amsterdam, The Netherlands T : +31 20 4853346 F : +31 20 4853260 W : www.europeanurology.com E : c.zanden@elsevier.com Booth nr. : A01

EXACT IMAGING (FORMERLY IMAGISTX) 550 Alden Road Unit 210-a, Markham L3R6A8, Canada T : +1 416.274.8166 W : www.exactimaging.com E : info@exactimaging.com Booth nr. : G02 Exact Imaging (formerly Imagistx) introduces the world’s first ultra high-resolution ultrasound system for urological applications enabling a whole new level of resolution.

Urologists can now visualize suspicious areas in the prostate and specifically target biopsies, in addition to performing standard TRUS protocols. Due to its unmatched resolution, this new ultrasound system clearly visualizes ducts and glands and the prostate’s peripheral zone. This system has not yet received FDA or CE approval, and so is not yet available for commercial release.

FERRING INTERNATIONAL CENTER S.A. Ch. De La Vergognausaz, 50, 1162 Saint-prex, Switzerland T : +41 583 010 000 F : +41 583 010 010 W : www.ferring.com Booth nr. : B20 Headquartered in Switzerland, Ferring is a research driven, speciality biopharmaceutical group. The company identifies, develops and markets innovative products in the areas of urology, reproductive health, gastroenterology, endocrinology and Orthopaedics. At ICS 2015, Ferring will highlight FIRMAGON® (degarelix), MINIRIN® (desmopressin) and TESTIM®* (testosterone).

Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in more than 110 countries. To learn more about Ferring or our products please visit www.ferring.com. *TESTIM is a registered trademark of Auxilium Pharmaceuticals, Inc. Ferring markets TESTIM in Europe under license from Auxilium Pharmaceuticals, Inc.

GALIL MEDICAL 4364 Round Lake Road West, 55112 Arden Hills, United States of America T : +1 8776392796 F : +1 6512875177 W : www.galilmedical.com E : siew.neo@galilmedical.com Booth nr. : B04 Galil Medical develops, manufactures and distributes cryotherapy systems and disposable products for minimally invasive tissue ablation. Galil Medical is the only company solely committed to advancing cryotherapy over a broad range of applications. Galil recently added three new products: the IceRod® 1.5 CX Cryoablation Needle, the IceRod® 1.5 i-Thaw Cryoablation Needle and the IceSphere® 1.5 Cryoablation Needle. The narrow profile of all Galil Medical needles facilitates needle placement for Exhibition Guide

Company and Product Description optimum tumor coverage. Please stop by the Galil Medical gives us the purpose to develop innovative medicines and booth B04 to share insight on ablative applications and for products that help millions of people around the world. more information on the new needles and the Visual-ICE For further information please visit www.gsk.com system, the platform technology for the company’s next generation needle products. Galil Medical is based in Arden Hills, Minnesota, with offices in Yokneam, Israel.

HITACHI MEDICAL SYSTEMS

EUROPE

GE HEALTHCARE Beethovenstrasse 239, 42655 Solingen, Germany T : +49 212 28020 F : +49 212 2802 28 W : www.gehealthcare.com E : martina.emde@med.ge.com Booth nr. : H66 GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

GENOMIC HEALTH, INC. 301 Penobscot Drive, 94063-4700 Redwood City, California, United States of America T : +1 650-569-2080 F : +1 650-569-2081 W : www.genomichealth.com E : international@genomichealth.com Booth nr. : C63 Genomic Health The Oncotype DX® Prostate Cancer Assay is a biopsy-based test that predicts the biologic aggressiveness of prostate cancer for men with low risk clinical features. Oncotype DX GPS provides more accurate risk stratification to confidently guide treatment decisions.

GRENA LTD 1000 Great West Road,, TW8 9HH Brentford London, United Kingdom T : +44 203 287 39 55 F : +44 208 587 17 60 W : www.grena.co.uk E : marc@grena.co.uk Booth nr. : G79 Grena Ltd is the manufacturer of disposable medical devices. With the central focus on patient’s safety and users’confort we offer cost-effective quality products. We offer endoscopic instruments, Ligating clips, Stapling, Surgical meshes and consumable medical products.

GRUPO TAPER S.A. Avda. De la Industria No. 49, Edif. Fresno, 2a planta, Poligono Industrail Aclobendas, 28108 Aclobendas / Madrid, Spain T : +34 916 596 520 F : +34 916 619 350 W : www.taper.es E : informacion@taper.es Booth nr. : H28 Taper is a leading distribution company of health and research technology in Iberia, carrying top of the line brands for hospitals, labs and private practitioners.

We cover several fields of expertise, among others: - Anatomical pathology - Cardiology - Surgery - Diagnostics - Endoscopy - Biotechnology - Food industry - Ophthalmology

GSK Calle Severo Ochoa, 2, 28760 Madrid, Spain T : +34 606591605 F : +34 918 070 310 W : http://www.gsk.com/ E : marjana.s.erminio@gsk.com Booth nr. : E20

Sumpfstrasse 13, 6300 Zug, Switzerland T : +41 41 748 63 33 F : +41 41 748 63 32 W : www.hitachi-medical-systems.com E : welcome@hitachi-medical-systems.com Booth nr. : C38 Hitachi Medical Systems Europe with its Hitachi Aloka ultrasound platform range offers an extensive experience in ultrasound imaging. The company provides a comprehensive range of specialized urological probes for standard urological imaging and transrectal examinations as well as specialty probes for brachytherapy, cryotherapy and microsurgery such as robotically controlled ultrasound interventions.

Real-time Virtual Sonography and Real-time Tissue Elastography further offer great clinical potential.

Elastography for the real-time colour visualization of tissue lesions and the Real-time Virtual Sonography, an innovative image fusion technology for optimal detection of prostate lesions and targeted biopsies.

Visit us at Booth C38 www.hitachi-medical-systems.eu

ISTEM MEDIKAL

INVIDIA MEDICAL GMBH & CO.KG

Istem Medical is a progressive and innovative company dedicated to the design and manufacture of hydrophilic urinary catheters, catheter lubricant gel, various urology disposables and HYACYST (Interstitial Cystitis,Painful Bladder Sydrome & Recurrent Bacterial Cystitis) DEXELL VUR (Vesico Ureteral Reflux Treatment) DEXELL SUI (Stress Urinary Incontinance Treatment) and different types of disposable biopsy needles.

Our goal is to provide worldwide high quality products for the medical sector. Thanks to the cooperation with leading medical doctors and technology partners in Turkish universities, our products meet the requirements to be successful in the medical field.

We have also invested a considerable amount of time with patients and physicians to develop our own hydrophilic coating solution.

Quality Policy/Mission Statement Our aim is to be one of the prime suppliers of medical devices to the international areas. We are committed to give quality product at competitive prices.

Carl-Benz-Str. 28, 78576 Emmingen-Liptingen, Germany T : +49 746 592 983 00 F : +49 746 592 983 010 W : www.invidia-medical.de E : info@invidia-medical.de Booth nr. : I32 INVIDIA is a German manufacturer of surgical and endoscopic products and provides complete solutions for the OR. We are located in the Tuttlingen district, the world center of medical technology and possess more than 25 years of quality experience.

• Surgical instruments • Dental instruments • Surgical Retractor Systems • sterile container system • HF-Units and accessories • Operation lamps • Endoscopic Units and accessories • Endoscopes • Laparoscopy • Urology • Gynaecology • Arthroscopy • Sinuscopy

IBSA INSTITUT BIOCHIMIQUE SA Via del Piano 29, 6915 Pambio Noranco, Switzerland T : +41 583 601 000 F : +41 583 601 644 W : www.ibsa-international.com E : paola.quagliucci@ibsa.ch Booth nr. : I02 IBSA Institut Biochimque SA is a pharmaceutical company headquartered in Lugano, Switzerland. The company has developed a series of proprietary technologies allowing a qualitative upgrading of already available and widely-used molecules and therapeutic solutions. With a focus on a high quality manufacturing, IBSA remains fine-tuned on the clinical needs and fully committed to improve compliance, safety and efficacy of its proprietary medicines.

IBSA’s portfolio includes a full range of presentations in the fields of osteoarthritis and pain/inflammation management (Condrosulf®, Sinovial®, Flector® and Akis®/ Dicloin®), dermatology (Betesil®, Ialuset®), endocrinology (Tirosint®), gynaecology (Fostimon®, Merional®/Merional HG®, Choriomon®, Prolutex®) and urology (Ialuril®).

INVIVO 3545 SW 47th Avenue, 32608 Gainesville, FL, United States of America T : +1 877-INVIVO1 W : www.invivocorp.com E : info@invivocorp.com Booth nr. : G30

Invivo, a leader in disease-oriented, multi-modality clinical solutions, is pleased to introduce the next generation of prostate care with the UroNav Fusion Biopsy System.

Advances in multiparametric magnetic resonance imaging of the prostate now enhance the ability to visualize and evaluate clinically significant prostate cancer. Invivo now brings this important diagnostic information to the urology suite in a simple and intuitive workflow. DynaCAD for Prostate provides the diagnostic MR information needed for the fusion biopsy by automatically transferring the relevant prostate images and lesion location data over your computer network for lesion identification and guidance during the TRUS biopsy procedure.

INTERMEDIC ARFRAN SA UroNav automatically recognizes the required prostate Vallès Technology Park, Boters 8 -10, 08290 Cerdanyola del information and loads the images and reference data at Vallès (Barcelona), Spain point of care. It’s powerful, fast and simple.

T : +34 932 656 661 Welcome to a better way for YOU and YOUR patient. For F : +34 932 454 806 more information, please visit www.invivocorp.com or W : www.inter-medic.net 1-877-INVIVO1 E : intermedic@inter-medic.net Booth nr. : I35 INTERmedic’s activity is focused to develop, manufacture and distribute high technology projects for the medical sector to satisfy the needs of the global market.

INTERmedic consolidates its position as a developer of advanced and innovative laser solutions for different medical fields: Urology with the Surgical Urology SST200™ system for vaporization and enucleation of BHP, Opthalmology, with the dacryocystorrhinostomy laser Multidiode S15 OFT™ or Traumatology and Neurosurgery with PL3D platform for percutaneous disc decompression.

INTERmedic also offers unique and versatile platforms for Plastic Surgery, Dermatology and Aesthetic Medicine, leading the path in the most revolutionary minimally invasive anti-aging treatments.

INTUITIVE SURGICAL

Chemin des Mûriers 1, CH-1170 Aubonne, Switzerland T : +41 218212000 F : +41 218212001 GSK is one of the world´s leading science-led global W : www.intuitivesurgical.com healthcare company with a challenging and inspiring : aurelie.gildemyn@intusurg.com mission: to improve the quality of human life by enabling E : D20 people to do more, feel better and live longer. This mission Booth nr.

Exhibition Guide

Intuitive Surgical, Inc. (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is the global leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci Surgical System.

Intuitive Surgical’s mission is to extend the benefits of minimally invasive surgery to those patients who can and should benefit from it.

IPSEN PHARMA 65 Quai Georges Gorse, 92650 Boulogne Billancourt Cedex, France T : +33 158 335 000 F : +33 158 335 001 W : www.ipsen.com E : contact.web@ipsen.com Booth nr. : E08 Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2013.

Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases.

Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen’s R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2013, R&D expenditure totaled close to €260 million, representing more than 21% of Group sales. Ipsen also has a significant presence in primary care. The Group has close to 4,600 employees worldwide.

Ivedik Osb Altinari Yapi Koop.661.Sokak No:4 Ostim/ Ankara/Turkey, 06378 Ankara, Turkey T : +903122195; +903122195385 F : +90 312 219 5613 W : www.istemmedikal.com E : istem@istemmedikal.com Booth nr. : C69

JANSSEN PHARMACEUTICAL COMPANIES Postbus 90240, 5000 LT Tilburg, The Netherlands T : +31 13 583 7373 F : +31 13 583 7300 W : http://www.janssen-emea.com E : https://www.janssen-emea.com/

contactus Booth nr. : D40 Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology.

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.

JENA SURGICAL Brüsseler Str. 10, 07747 Jena, Germany T : +49 3641 77 00 100 F : +49 3641 77 00 302 W : www.jenasurgical.com E : info@jenasurgical.com Booth nr. : B08 Jena Surgical, based at the heart of the optical industry in the German city of Jena, designs and sells laser devices for general surgery and precision microsurgery. Jena Surgical is a spin-off from the partnership between DEKA and Asclepion Laser Technologies GmbH, two leading manufacturers and distributors of laser systems for medicine and surgery.

Jena Surgical sells flexible and microscope-assisted systems for surgical teams around the world that are mostly used in cutting edge gynecology, urology, oncology, otolaryngology and general surgery.

These are solutions created from proprietary technologies by international teams with multidisciplinary expertise that aim to: make work in the operating room faster, safer and more accurate, be less invasive and less prone to unexpected surgery, make the post period shorter and more comfortable for the patient.

KARL STORZ GMBH & CO.KG Mittelstrasse 8, 78532 Tuttlingen, Germany T : +49 746 170 80 F : +49 7461708105 W : www.karlstorz.com E : info@karlstorz.com Booth nr. : E46 KARL STORZ is one of the world’s leading suppliers of endoscopes for all fields of application. The family-owned company with its headquarters in Tuttlingen, Germany has 6700 employees worldwide. With a history that stretches back over 60 years, KARL STORZ is well-known for its innovative and high-quality products. Its range of products has been rounded off with the development of the integrated operating room OR1TM and by integrating the field of flexible endoscopy into the various specialties.

21-23 March 2015

Company and Product Description KITALPHA MED LTD Xaver-Weismor-str. 22A, 81829 Munich, Germany T : +49 89-33036974 F : +49 89-346894 W : www.neocontrol.de E : info@kitalpha-med.de Booth nr. : H26 Kitalpha Med LTD is the exclusive distributor of Magic Race LLC products globally. The technology of the EXMI-therapy ( Extracorporeal magnetic innervation) is based on pulsed and focused magnetic fields (Neuromodulation). Neocontrol (the magnetic chair) is a system for the treatment of many pelvic floor diseases such as: urine and feces incontinence, incontinence after radical prostatectomie, pelvic pain, haemorrhoids, cystitis interstitialis, erectile disfunction and other sexual disturbances. It is a noninvasive, painless and very effective therapy. All great ideas are simple

KLS MARTIN GROUP KLS Martin Platz 1, 78532 Tuttlingen, Germany T : +49 746 170 60 F : +49 746 170 61 93 W : www.klsmartin.com E : info@klsmartin.com Booth nr. : G12 KLS Martin – Surgical Innovation is our Passion The name KLS Martin stands for highly innovative solutions in High-Frequency surgery. In the field of Urology KLS Martin offers dedicated HF equipment for fast and gentle bipolar resection as well as for sophisticated bipolar vessel sealing. We kindly invite you to visit us at our booth Hall 9 G 12 at the EAU conference.

KOELIS 5 Avenue de Grand Sablon, 38700 La Tronche, France T : +33 476 6375 87 F : +33 476 549 561 W : www.koelis.com E : info@koelis.com Booth nr. : C57 KOELIS is a world expert in urological imaging and imageguided surgery systems.

Our mission: to design state-of-the-art technologies in image-guided urology comprising full 3D ultrasound, elastic image fusion, Organ Based Tracking.

Focused on prostate cancer, our challenge is to bring 3d mapping, targeting, and revisiting capabilities in ultrasound-guided interventions, for an innovative and personalized patient management.

More than 30000 patients have benefited from the Koelis technology.

LABORIE Lumonics House, Valley Drive, Swift Valley Industrial Estate, CV21 1TQ Rugby, Warwickshire, United Kingdom T : +44 1788 547888 F : +44 1788 536434 W : www.laborie.com E : marketinginc@laborie.com Booth nr. : B32 LABORIE, the worldwide industry leader in Urodynamics, is pleased to provide you with the most advanced solutions in Pelvic Floor Dysfunction Management.

LABORIE is committed to bringing you the most innovative products: from private offices to world class research institutions, our solutions are designed to expand with your practice.

As specific as your requirements may be; streamlined data transfer, educational courses, a full range of disposables or unparalleled customer service, LABORIE’s expertise will exceed your level of satisfaction.

We welcome you to booth B32 to discuss your goals and show you the benefit of partnering with LABORIE.

ejaculation volume, progressive and total motility.

PROfertil® acts as a fitness center for your sperm cells.

A mixture of eight substances addresses and eliminates all those issues that disrupt sperm cell quality. Product developed by Lenus Pharma, an innovative Austrian company specialized on the research, development and marketing of evidence-based nutraceuticals. NEW PROfertil® female a specially developed preparation to cover the specific nutritional requirements of women before and at the beginning of a pregnancy, with a special combination of substances based on the results of scientific research. For further information please visit our booth I14 and www.profertil.eu or www.endlichvater.eu/en/

LISA LASER PRODUCTS OHG Max-Planck-Str. 1, 37191 Katlenburg-Lindau, Germany T : +49 55 56 99 38 16 F : +49 5556-9938-10 W : www.lisalaser.de E : info@lisalaser.de Booth nr. : F03 LISA laser products presents the latest laser developments and complementary product lines: • RevoLix and RevoLix Duo – the leading thulium laser product line which covers BPH, tumours, other soft tissue applications and lithotripsy.

• Sphinx – the holmium laser product family including low and high power lasers for lithotripsy and HoLEP procedures.

• ScopeLine – uretherorenoscopes, nephroscopes and complementary instruments.

• Training Devices by Samed – provide skilfulness with surgical endoscopes and instruments for URS, T-URP, PCNL and laparoscopy before working with patients.

LP SURGICAL FIBERS/LASER PERIPHERALS 13355 10th Ave. No. #110, MN 55441 Plymouth, United States of America T : +1 763-525-8460 F : +1 763 525 84 61 W : www.laserperipherals.com E : info@laserperipherals.com Booth nr. : A15 Laser Peripherals designs, manufactures, distributes and OEM’s medical laser fibers for use in both hard and soft tissue surgical laser applications. We manufacture and market at least thirty different certification and we are now actively looking for surgical fiber options for use with Diode, Holmium, KTP and Nd:YAG lasers. Fiber designs include freebeam, contact and lateral emitting. Laser Peripherals has recently completed our ISO/CE distribution partners in a variety of International markets.

LUMENIS (GERMANY) GMBH Heinrich-Hertz-Str. 3, 63303 Dreieich, Germany T : +49 6103-8335-0 F : +49 6103-8335-300 W : www.lumenis.com E : evelyn.schmidt@lumenis.com Booth nr. : B60 Lumenis, a global leader in the field of minimally-invasive clinical solutions, is a world-renowned expert in the design and manufacturing of laser and light-based devices for surgical, ophthalmic and aesthetic applications.

Lumenis’ ground-breaking products have redefined medical treatments, empowering surgeons with ultimate accuracy and superior clinical outcomes.

LENUS PHARMA

LUT GMBH

Seeböckgasse 59, 1160 Vienna, Austria T : +43 1 40514 19-12 F : +43 1 40514 19-20 W : www.lenuspharma.com

www.profertil.eu

www.endlichvater.eu/en/ E : office@lenuspharma.com Booth nr. : I14

Robert-Bosch-Strasse 3, 79211 Denzlingen, Germany T : +49 7666900690 F : +49 766690069480 W : www.lut-endoscopy.com E : info@lut-endoscopy.com Booth nr. : F96

PROfertil , a patented and study-proven dietary food for special medical purposes for the dietary treatment of limited fertility of men who want a baby. Due to its specific and unique composition PROfertil® improves all parameters of sperm health: sperm cell density, ®

21-23 March 2015

LUT has specialized in selling solutions for endoscopic applications in urology, gynecology and laparoscopy and sets high value on the dialog with customers and a careful advancement and innovation of its products and services.

As a partner in minimally-invasive surgery LUT looks back on more than 20 years of experience.

M.A.S. MEDICAL S.R.L. Corso Siracusa 57, 10136 Torino, Italy T : +39 3485156796 F : +39 0119723007 W : drainstar.it E : info@drainstar.it Booth nr. : C72 Organic Liquids Management

MAVIG Stahlgruberring 5, 81829 Munich, Germany T : +49 89 42096 0 F : +49 89 42096 200 W : http://www.mavig.com E : info@mavig.com Booth nr. : I29

ultrasound. The system is available for transpierineal (TP) and transrectal (TRUS) procedures and can be offered for any existing urological ultrasound device.

Thousands of published patients demonstrate the superiority of our approach with a target accuracy & reproducibility of ca 1 mm.

Together with BiopSee(R) we present Watson Elementary (R), a must-have system assisting the diagnosis of mpMRI scans.

Thousands of individual slices can be processed within seconds and suspicious areas (together wit their CA-probability) are displayed as overlay over the MRI scans. Diagnosis has never been so easy, intuitive, and reproducible.

MEDICA S.P.A.

Via degli Artigiani 7, 41036 Medolla, Italy T : +39 051 6351074 MAVIG designs and manufactures personal protection F : +39 051635081 devices and X-Ray accessories, as well as ceiling- and W : www.menfis.it table-mounted equipment. Our patented ceiling tracks and E : sales@menfis.it suspension systems, comply with the latest requirements Booth nr. : I34 of the industry. All products are certified bearing the CE Symbol. MAVIG is market leader in its business fields.

MEDICA S.p.A with his division Menfis, is an Italian group Product quality ‘’Made in Germany’’ and service is of companies involved in the production of medical acknowledged worldwide. In March 2013 the company equipment and medical devices for many applications.

Pausch Medical GmbH became a 100% subsidiary of MAVIG. We proudly present together the newly developed In particular Menfis division is dedicated to the urological table from Pausch, combined with the 90 years development and sales of state of the art Urodynamic systems, High Resolution Manometry systems, pH/ of experience of X-Ray protection from MAVIG. Impedance recorders and Chemohyperthermic systems.

Since 1985 we have been developing urodynamic systems MCUBE TECHNOLOGY CO., LTD. and uroflowmeters. Now we offer a wide range of device #803, 123, Bonghwasan-ro, Jungnang-gu, 131-863 Seoul, that includes: South Korea FLOWZIG wireless Uroflowmeter T : +82 2 3421 7780 PICO FLOW2 , two-channel stand- alone Uroflowmeter and F : +82 2 3421 7076 Electromyographic device with a built-in thermal printer W : www.mcubetech.co.kr and an extractable SD memory card for prolonged storage.

E : mcube@mcubetech.co.kr PICO BRIGHT a standard urodynamic system, sleek and Booth nr. : I06 space saving. It works with a touch screen colour display 15 inch console. All the urodynamic test are carried out Mcube Technology is a Korea manufacturer specialized in with a finger touch. PICO SMART, advanced urodynamic 3D ultrasound imaging system and therapeutic medical system expandable with video-urodynamic, GI manometry devices. We were established in 1999 and have been and neurophysiology exported to over 20 countries as a leading company of bladder scanner and magnetic stimulator. If you need more detailed information, please visit our website, MEDICAL MEASUREMENT www.mcubetech.co.kr.

SYSTEMS B.V.

MEDA CO., LTD. C2-F3-D,Xinmao Science Skill Park, Huayuan Industry Development Area, 300384 Tianjin, China T : +86 228 371 38 08 ext. 8032 F : +86 228 371 38 80 W : www.MEDA.com.cn E : export@meda.com.cn Booth nr. : D63

Colosseum 25, 7521 PV Enschede, The Netherlands T : +31 534 803 700 F : +31 534 803 701 W : www.mmsinternational.com E : info@mmsinternational.com Booth nr. : G90

MMS B.V. seated in the Netherlands is one of the world’s leading companies providing practical diagnostic equipment and accessories for both simple and advanced urodynamic studies. At EAU, we will introduce our Nexam MEDA Co., Ltd. is committed to delivering highest quality urodynamic product line with wireless functionalities for ophthalmic devices and medical equipment to the world.

With its world-class quality commitment and professional pressure/EMG recording, flowmeter, puller and remote R&D facility, MEDA has become No.1 Ophthalmic Ultrasonic control. Furthermore MMS offers Homeflowmetry, wireless office based Urodynamics, wireless Uroflowmetry and Devices Manufacturer in China and established its worldwide presence in more than 70 countries.

Natural Filling Urodynamics. Please feel free to have a look at our booth G90.

MEDAC GMBH Theaterstraße 6, 22880 Wedel, Germany T : +49 410 380 06 0 F : +49 410 380 061 00 W : www.medac.de E : contact@medac.de Booth nr. : B28 medac is specialised in the treatment of malignant diseases since its foundation in 1970. Now, medac is one of the leading manufacturers of oncology products not only in Germany, but in many international markets. medac offers both, innovative and well proven, therapeutic options in the fields of Oncology, Hematology, Urology, Autoimmune diseases and Fibrinolysis and is one of a handful of companies which is also specialised in the field of diagnostics.

MEDCOM GMBH AND WATSON MEDICAL Rundeturmstrasse 12, 64283 Darmstadt, Germany T : +49 615 195 14 70 F : +49 615 195 147 20 W : www.medcom-online.de E : hschneider@medcom-online.de Booth nr. : C01 MedCom offers a stereotactic, navigated prostate biopsy system with image fusion of mpMRI scans and

MEDISPEC LTD 203 Perry Pkwy, Suite # 6, 20877-2169 Gaithersburg, MD, United States of America T : +1 301 944 15 75 F : +1 301 972 6098 W : www.medispec.com E : marketing@medispec.com Booth nr. : A27 With over 20 years of experience and expertise in shockwave therapy solutions, Medispec continuously introduces competitive systems and technological breakthroughs to the market.The company specializes in shockwave-based systems for urology, cardiovascular and orthopedics applications.

ED1000 is a non-invasive painless treatment designed to treat the cause of ED as opposed to merely treating the symptoms.Using low-intensity acoustic shock waves, the EDSWT treatment triggers the body’s natural repair mechanism and stimulates the creation of new micro vascular blood vessel networks that increase the blood supply to erectile tissue. ED1000 is now available also as desktop system,enabling physicians to extend treatment availability(small facilities,and at home treatments).

Medispec’s lithotripsy systems offer robust performance and competitive technology,backed by successful clinical results: EM1000 (electro-magnetic based system) and (E3000 and E2000, an Electro-Hydraulic based systems).

Exhibition Guide

Company and Product Description MEDI SURG GMBH Lyoner Strasse 14, 60528 Frankfurt, Germany T : +49 69 66554172 F : +49 69 66554173 W : www.medi-surg.com E : info@medi-surg.com Booth nr. : H24 Medi Surg GmbH is ISO 9001 &ISO 13485 CE certified German company which provides products in Urology, Gastroenterology , Women’s Health & Interventional Radiology. Visit our website www.medi-surg.com to view our product range.

MEDI-TATE LTD 9 HaHadas Street, 30 60000 Or Akiva, Israel T : +972 77-700-6745 F : +972 4-770-1838 W : www.Medi-Tate.com E : iTIND@Medi-Tate.com Booth nr. : I45 Medi-Tate is committed to improve the quality of life in the male population by commercializing office based solution for BPH. The Temporary Implantable Nitinol Device, iTIND 555™, BPH reshaping system, is a novel, office based solution, resulting in long term relief from BPH symptoms. There is no cutting, heating or removal of any prostate tissue.

The iTIND 555™ procedure is bloodless, painless and does not require a catheter to be placed post-operatively.

The iTIND 555™ implant is deployed in 5 minutes, remains in the prostatic urethra for 5 days and is then removed in 5 minutes, leaving no foreign body behind and forms a new long lasting pathway in the prostatic urethra.

MEDKONSULT Balcárkova 8, 779 00 Olomouc, Czech Republic T : +420 585 414 511 F : +420 585 416 045 W : www.uromic.eu E : info@uromic.eu Booth nr. : C66 Medkonsult offers a wide range of urodynamic solutions with ease of use and clinical excellence in focus. From compact wireless uroflowmeters and ambulatory urodynamics, to advanced high-end urodynamic systems with up to 16 true measurement channels, several of them with the unique option of integrated inbuilt diagnostic ultrasound module for M mode and CFM mode.

The product line offers very userfriendly and complete measurement packages for filling & voiding Cystometry, Urethral Pressure Profile, Valsalva Leak Point Pressure (VLPP), Videourodynamics, Electromyography as well & anorectal pressure measurements (Manometry).

MEDPRO MEDICAL Landjuweel 11, 3905 PE Veenendaal, The Netherlands T : +31 318769080 F : +31 318769107 W : www.medpromedical.nl E : sales@medpromedical.nl Booth nr. : A50 World class manufacturer of a wide range of urology disposables and unique solutions

MEDTRONIC INTERNATIONAL TRADING SÀRL Route du Molliau 31, 1131 Tolochenaz, Switzerland T : +41 218 027 718 F : +41 218 027 915 W : www.medtronic.com E : nathalie.robert@medtronic.com Booth nr. : A30 At Medtronic, we’re committed to Innovating for Life by pushing the boundaries of medical technology and actually changing the way the world treats chronic disease. Driven by our deep understanding of the human body and our close partnerships with physicians, we’re transforming technology to treat patients across the entire care continuum. Our innovations help physicians diagnose diseases early, treat patients with the least amount of disruption possible, and minimize symptoms throughout the patient’s life. Today, we’re improving the lives of millions of people worldwide each year across numerous conditions—including heart disease, diabetes, neurological disorders, spinal conditions, and vascular diseases. But it isn’t enough. So we’re innovating beyond products. We’re breaking down barriers, challenging assumptions, and looking beyond the status quo—to continually find more ways to help people live better, longer.

Exhibition Guide

MENARINI - THE MENARINI GROUP 1, Avenue de la Gare, 1611 Luxembourg, Luxembourg T : +39 055 568 01 F : +39 055 568 04 84 W : www.menarini.com Booth nr. : F30 A.Menarini is the largest Italian pharmaceutical group and it ranks the world’s number 37 and the Europe’s number 17.

Menarini is present in more than 100 countries worldwide.

Menarini Group is investing 9.1% of its revenues in R&D. Recently A.Menarini expanded its portfolio by adding Urology therapeutic area with the commercialization of Priligy (dapoxetine) a fast acting SSRI that is the first approved oral treatment for premature ejaculation and Spedra (avanafil)a new PDE-5 inhibitor for the treatment of erectile dysfunction.

MIANYANG MEIKE No.238, Middle Section of Chuangye Road, Kechuangyuan Zone，Mianyang. Sichuan, China, 621000 Mianyang, China T : +86 816-6355073 F : +86 816-6355070 W : www.bladder-scanner.com E : amyzhao@bladder-scanner.com Booth nr. : G28 Mianyang Meike Electronic Equipment Co., ltd is located in Mianyang, Sichuan Province, in Western China, Which named as Silicon Valley of Western China.

Meike was estabulished in 1998 split off from former state-owned No.730 factory subordinate to Chinese Ministry of Information Industry. While its innovation date back to 1958 and it developed the first Chinese produced B-mode ultrasound scanners in 1972.

After optimizing its structure, Meike focus on research and marketing Medical device . Today nearly 40% people in 62 staff are engineers in a factory covering 23000 sq.meters.

Some of them have more than 20 years of innovation experience and dozens of patents.

MIM SOFTWARE INC. 25800 Science Park Drive - Suite 180, 44122 Cleveland, United States of America T : +1 216-455-0600 F : +1 216-455-0601 W : www.mimsoftware.com E : mduchateau@mimsoftware.com Booth nr. : A41 MIM Software offers MIM Symphony, a collaborative suite for MR fusion prostate biopsy and therapy guidance.

With MIM Symphony, MR Guided biopsies can now be conducted without an MR Suite. The new standard in prostate imaging for cancer detection is multi-parametric MR (T2W, DCE, DWI). Until now, urologists have not been able to effectively use this targeted information to guide their biopsy sampling. MIM Symphony Bx is changing this with powerful yet easy-to-use tools for everyone on the MR guided biopsy team.

MIMIC TECHNOLOGIES, INC 811 First Avenue, Suite 408, Seattle, WA 98117, United States of America T : + 1.800.918.1670 E : info@MimicSimulation.com Booth nr. : G94 Visit Mimic, the leading innovator in robotic surgery simulation training to test drive the dV-Trainer, the most advanced, cost-effective simulator available! Also, don’t miss our new Maestro AR (augmented reality) procedurespecific modules and the Xperience Team Trainer, the first simulator allowing the first assistant to train in tandem with the console-side surgeon!

MONTAVIT GMBH Salzbergstraße 96, 6067 Absam, Austria T : +43 522 357 926 F : +43 522 352 294 W : www.montavit.com E : pharma@montavit.com Booth nr. : A09 Since 1945, Montavit’s international business is focused on the production and distribution of pharmaceuticals and associated health related products. We are one of the leading companies in the production of steam sterilized lubricants designed for the needs in modern urology.

CATHEJELL is already at home in 60 countries and we are proud to have our product contribute to the safety, efficiency and comfort also in your urological ward. Please visit us at our homepage: http://www.montavit.com/en

MTS MEDICAL UG Robert-Bosch-Str. 18, 78467 Konstanz, Germany T : +49 7531 36185-0 F : +49 7531 36185-72 W : www.mts-medical.com E : sales@mts-medical.com Booth nr. : G34 MTS, located in Konstanz, Germany, is specialized in development and manufacture of a new generation of Spark Wave® therapy systems that are successfully applied in urology, orthopedics and wound care worldwide.

Our urologic product range comprises lithotripter and tabletop devices that ensure a long-term effective, safe and tissue-friendly treatment for renal stones as well as other urogential indications, such as erectile dysfunction.

Visit us on booth G34 and find out more about our new generation Spark Wave® therapy devices.

MYRIAD GENETICS GMBH Leutschenbachstrasse 95, 8050 Zurich, Switzerland T : +41 44 939 91 44 F : +41 44 939 91 31 W : www.myriadgenetics.eu E : fgarnier@myriad.com Booth nr. : A28 Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients’ lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence.

NANOVIBRONIX LTD. 9 Derech Hashalom St., 36603 Nesher, Israel T : +972 48200581 F : +972 48202794 W : www.nanovibronix.com E : amir@nanovibronix.com Booth nr. : I41 NanoVibronix produces innovative medical devices based on its proprietary therapeutic acoustic technology.

UroShield® - clip-on device, produces ultrasound signal that propagates through the Foley catheter and prevents biofilm formation leading to reduced risk for Urinary Tract Infection.

The acoustic lubrication produced on its surface, helps reduce catheter related trauma, pain and discomfort. These positive effects improve patient’s well-being, decrease complaints, staff overload and will allow outpatients to take control of their catheter.

Product is wearable, easy to use and allows application both in the clinical setting and at home.

NEOMEDIC INTERNATIONAL C/Maestrat, 41-43. 1° 1ª, 08225 Terrassa, Spain T : +34 937 804 505 F : +34 903 780 61 05 W : www.neomedic.com E : elisenda@neomedic.com Booth nr. : A14 Neomedic International “The Continence Company” provides you with the right product for every case.

FEMALE REMEEX. Readjustable system for Female Urinary Incontinence, for your ISD and Recurrent patients.

MALE REMEEX. Unique lifetime re-adjustable system for Male Urinary Incontinence. Excel.lent results, low complications and physiological urination.

NEEDLELESS: Single incision TOT, proven 3 years same results as a TOT w/o groin pain.

KIM: Knottless Incontinence Mesh. The tissue friendly mesh for urethral support.

SURELIFT: Fully adjustable universal prolapse mesh, for anterior, posterior and vault prolapse, with sacrospinose fixation system UPLIFT: The laparoscopic sacrocolpopexy mesh with promontory fixation system ANCHORSURE: Reliable least invasive anchoring system Neomedic Int, “The continence Company”

NEOTRACT, INC. 4473 Willow Rd, Ste 100, 94588 Pleasanton, United States of America T : +1 877 408 9628 F : +1 925 401 0699 W : www.urolift.com E : info@neotract.com Booth nr. : A36 NeoTract, Inc. is a medical device company dedicated to developing innovative, minimally invasive, and clinically effective devices to meet the needs of urologists and their patients. Our current focus is the UroLift® System, a minimally invasive device designed to treat lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).

This unique technology directly opens the urethra without prostate tissue injury and offers a quality of life solution for patients. Visit us at booth A36 to learn more.

NOVAMEDTEK Uzaycagi cad. 1253 sok. No:5, Ostim, 06374 Ankara, Turkey T : +90 312 3950355 F : +90 312 3946198 W : www.novamedtek.com E : sales@novamedtek.com Booth nr. : I32 NOVAMEDTEK, has the distinction of being one of the luminous medical equipment manufacturers in Turkey. Our long experience in the field of shockwave Lithotripsy and imaging systems was behind our success in the medical community.

The customer satisfaction is always our main target, from which we inspired our mission and power to provide all our current and future clients with high-tech-quality products at affordable prices. Our success has proven by the tremendous increase in the national- international sales & new customers. All our products are CE certified.

Our Products are: 1. NOVALITH NT-10M: Electromagnetic shockwave Lithotripsy system.

2. NOVALITH NT-10: Electrohydraulic shockwave Lithotripsy system (with the longest-Life electrodes) 3. NOVAREX NT-20: Mobile C-Arm x-ray imaging system 4. NOVALITH NT-10: Pneumatic Lithotripter 5. NOVAMAG NT-60: Magnetic Incontinence Therapy chair 6. NOVAFLOWE NT-40: Uroflowmeter 7. NOVATABE NT-70: C-Arm Operating tables.

OCEANA THERAPEUTICS LTD Suite 602, Q House, 76 Furze Road,sandyford, Dublin 18 Dublin, Ireland T : +353 12930153 F : +353 129 301 66 W : www.salix.com E : Oceana.international@salix.com Booth nr. : I33 Oceana Therapeutics Ltd is a specialty company with a core technology of injectable co-polymer gels which provide durable tissue enhancement. Deflux™ is the only FDA approved bulking agent for the treatment of Vesicoureteral Reflux and is also indicated for the treatment of Stress Urinary Incontinence. Deflux™ gel is composed of dextranomer microspheres and stabilized hyaluronic acid of non-animal origin (NASHA™).

OLYMPUS EUROPA SE & CO. KG Wendenstrasse 14-18, 20097 Hamburg, Germany T : +49 40237730 F : +49 237730 W : olympus-europa.com E : info@olympus-europa.com Booth nr. : D60 Olympus has become the leading endoscopic equipment provider for clinical Urology. Olympus has set the standard for modern BPH and NMIBC treatment with its bipolar resection system, now being available in the second generation called “TURis 2.0”. Olympus imaging technology enables for better tumor detection in NMIBC with the proprietary “HD NBI” technology. For upper tract procedures, Olympus offers the thinnest digital and fiber based flexible uretheroscopes as well as a brand new line-up of stone removal devices, access sheath and as a world’s first on this EAU congress: The new combined Lithotriptor “Shockpulse”. For laparoscopy, we pioneered flexible 3D laparoscopy in HDTV and offer the unique, combined ultrasonic & advanced bipolar surgical tissue management system “Thunderbeat”. Olympus, offering the best for “See & treat”.

21-23 March 2015

Company and Product Description OPKO DIAGNOSTICS

PHYSION SRL

4 Constitution Way, MA 01801 Woburn, United States of America T : +1 781 933 8012 F : +1 781 933 8011 W : www.opko.com E : jjohnson@opko.com Booth nr. : F01

Via Fogazzaro 4B, 41037 Mirandola, Italy T : +39 0535 611 082 F : +39 0535 610 420 W : www.physion.co E : info@physion.it Booth nr. : B82

OPKO Health, Inc., is a pharmaceutical and diagnostics company engaged in the development and commercialization of products solving large unmet medical needs. In diagnostics, OPKO has developed the point of care Claros®1 analyzer for in-office quantitative immunoassays based on SANGIA™ microfluidic technology. The initial assays are targeted for use in the Urology office and include Total Testosterone and Total PSA. In addition, OPKO Diagnostics is introducing the 4Kscore™ test, a personalized risk score for predicting the presence of high-grade prostate cancer prior to biopsy. For more information, please visit www.opko.com.

OPTIMUM MEDICAL Unit 5, Armley Court, Armley Road, LS12 2LB Leeds, United Kingdom T : +44 08456435479 F : +44 01142383826 W : www.optimummedical.co.uk E : vicki@optimummedical.co.uk Booth nr. : I42 Optimum Medical specialise in creating healthcare lubricant gels and urology products.

Present in over 60 countries around the world, including every single UK NHS hospital, some of Optimum Medical’s brands are: OptiLube sterile lubricating jelly, OptiLube Active catheterisation jelly and Ugo Urology Accessories, including Ugo Catheter Valves and Ugo Fix Catheter Straps.

To ensure everyone who uses their products benefits fully from them, they offer Optimum Medical Support - a flexible educational resource.

Optimum Medical always listen to their customers to understand how they can work together to create better healthcare. They call this ‘constantly creating better.’

OVERTOOM LTD. A DIVISION OF OMS Hessenweg 190 e, 3731 JN De Bilt, The Netherlands T : +31 30 225 28 50 W : www.overtoommedical.com E : info@overtoomltd.com Booth nr. : A50 Products: Solution for Obstructive Uropathy: Overtoom Balloon Catheter System® Ureteral stents Ureteric stents Device Description OBS: The Overtoom Balloon Catheter System® is a pyelum catheter intended for treating strictures of the ureter and, in particular, strictures of the ureteropelvic junction in a less invasive way. It comprises a catheter with a balloon and a non-return valve device, and a delivery device with a stylet and two ports.

The balloon (18 French) keeps ureter strictures dilated while they heal, in a similar way to the use of an indwelling large-diameter bladder catheter for urethral strictures, while urine flows through the shaft.

To see the results of the treatment of UPJ obstruction patients with the Overtoom balloon, go to our link: https://lnkd.in/bDKd3i6 To see the possibility to treat ureteric strictures in Bricker bladder patients with the Overtoom balloon go to our link: https://lnkd.in/bEpQuGZ

PAJUNK GMBH Karl-Hall-Str. 1, 78187 Geisingen, Germany T : +49 77 04 9291 549 F : +49 77 04 9221 600 W : www.pajunk.com E : juergen.hintz@pajunk.com Booth nr. : G10 Pajunk offers a homogenous range of products, supplying just the right medical products to fully cover the particular methods of application concerned. The Pajunk ranges of products are: Regional Anesthesia, Interventional Pain, Laparoscopy, Organbiopsy and Dental.

Pajunk is offering needles, instruments and complete kits for Regional Anesthesia and Interventional Pain in particular for: Spinal, Epidural, CSE and Plexus.

For Laparoscopy we offer besides others modular hand instruments, dilation and ring anchor balloons, trocar systems, modular suction- and irrigation system.

21-23 March 2015

EMDA by Physion provides accelerated localized drug administration into the bladder wall and prostatic urethra.

Chemotherapy for high risk bladder tumors, Interstitial Cystitis. and IPP are treated on an ambulatory basis, cost-effectively. N-DO injector catheter needle provides Localized Anesthesia for TURB and biopsies for Day Surgery management.

PIERRE FABRE MÉDICAMENT Parc Industriel La Chartreuse, 81106 Castres Cedex, France T : +33 563 714 500 F : +33 563 714 559 W : www.pierre-fabre.com E : webmaster.pfm@pierre-fabre.com Booth nr. : E36 Pierre Fabre, Gold sponsor of the EAU, is the second largest independent French pharmaceutical laboratory.

The Pierre Fabre Group is present with dermo-cosmetic, OTC and medical activities.

Thanks to sustained R&D investments, the group discovered new compounds to reinforce its world-wide development.

Pierre Fabre Medicament is a successful partner in Urology with: • Permixon® (Serenoa repens hexanic extract), a recognized treatment for B.P.H., marketed in 57 countries • Ormandyl® (bicalutamide) for prostate cancer, • Javlor® (vinflunine) for 2nd line metastatic urothelial carcinoma.

Pierre Fabre Médicament

POLYDIAGNOST GMBH Am Söldnermoos 17, 85399 Hallbergmoos, Germany T : +49 811 99 87 33 8-0 F : +49 811 99 87 33 89 W : www.polydiagnost.com E : info@polydiagnost.com Booth nr. : A35 POLYDIAGNOST GmbH The Art of Endoscopy® Medizintechnik innovativ und Global Made in Germany

PROFOUND MEDICAL INC. 3080 Yonge Street, Ste 4040, M4N 3N1 Toronto, Canada T : +1 6474761350 F : +1 647 847-3739 W : profoundmedical.com E : info@profoundmedical.com Booth nr. : B02

polypropylene slings; Safyre VS - T & T Plus, Adjustable Slings for Female SUI. The company is also focused on providing innovative solutions for male SUI treatment: Argus, Adjustable System and Phorbas, Adjustable System, an hydraulic sphincter-reinforcement system.

Promedon has also developed a bulking agent for treating Vesicoureteral Reflux in Children: Vantris.

QUANTA SYSTEM SPA Via IV Novembre 116, 21058 Solbiate Olona (VA), Italy T : +39 331 376 797 F : +39 331 367 815 W : www.quantasystem.com E : quanta@quantasystem.com Booth nr. : G44 Quanta System S.p.A. was founded in 1985 and belongs to EI. En. Group (a public company listed in the Star segment of the Italian Stock Exchange) since January 2004. The company is divided into three business units medical, scientific and industrial.

Quanta System urological laser systems include applications from BPH to lithotripsy. The state-of-the art Thulium laser(Cyber TM) and contemporary holmium lasers (Litho) represent the real excellence in urology, providing indispensable advantages both to patients and physicians. Besides, a powerful BPH simulator trains urologists to excel the learning curve needed to reach routine and safe procedures.

R-ACTION DISTRIBTION SÀRL Rue Nicole 1, CH-1260 Nyon, Switzerland T : +41 22 362 7682 W : www.radistribution.com E : info@radistribution.com Booth nr. : I33 R-Action Distribution Sàrl specialises in state-of-the-art medical devices in the fields of urology, coloproctology, OB/GYN and paediatric surgery.

Through its solid network of medical professionals & opinion leaders and a hands-on approach to establishing or building presence in its areas of expertise, R-Action Distribution has won the confidence of world-class manufacturers from USA, Europe and Asia.

More than just a distributor, R-Action Distribution has its own proprietary technologies, such as HistoScanning for prostate cancer detection, that are distributed through a combination of its internal sales force and a global network of distributors.

Based in Nyon, Switzerland, R-Action Distribution currently has direct operations in Switzerland, France, Germany, Austria, the Netherlands, Belgium and Luxemburg, as well as a full dealer network in the Russian Federation.

R-Action Distribution offers sales & marketing, regulatory approval, reimbursement and after-sales service.

REALTON

7 Shangdi 5th St. Haohai Bldg.#305, Haidian District, Beijing 100085, China, 100085 Beijing, China T : +86 13801216062 Profound Medical Inc., is a Canadian medical device F : +86 010-82899007 company that has developed a unique and minimally W : www.realton.com.cn invasive treatment to ablate the prostate gland. Profound’s E : lihua.zhu@realton.com.cn novel technology combines Magnetic Resonance Imaging Booth nr. : A37 (MRI) technology with ultrasound thermal energy that is delivered via a trans-urethral approach. This method Realton Corporation is a high-tech medical device of prostate cancer therapy provides highly accurate and company based in Beijing, China. We design and precise treatment within the prostate in a short time span, manufacture high power surgical green lasers and fiber allowing for fast patient recovery. The potential of this optic delivery devices for urological applications. We offer technology is currently being demonstrated in clinical Aurora™ Series of 532nm LBO high power surgical lasers trials. with output power from 120W to 180W, and Flare™ sidefiring surgical fibers. All of these products are CE marked.

Realton products have been clinically proven the safety PROMEDON and efficacy with thousands of successful cases in the Av. Gral. Manuel Savio S/n. Lote 3. Mza. 3. Pque. Ind. treatment of benign prostatic hyperplasia (BPH), bladder Ferreyra, X5925XAD Cordoba, Argentina tumor and other urological diseases. Realton is now the T : +54 351 450 21 00 largest Chinese urological laser company.

F : +54 351 450 21 30 W : www.promedon.com E : ignacio.olmedo@promedon.com RECORDATI S.P.A. Booth nr. : B52 Via Matteo Civitali, 1, 20148 Milan, Italy T : +39 340.1128642 Promedon is a leading international company in the F : +39 024 878 71 26 research, development, production and distribution W : www.recordati.com of innovative medical technology for the urology and E : praolini.m@recordati.it urogynecology market, present in more than 50 countries Booth nr. : F14 around the world. In January 2015, the company opened a new branch office in Germany to boost its presence in the Recordati, established in 1926, is an international group, European market. listed on the Italian Stock Exchange, with a consolidated Among a wide range of solutions, Promedon offers the revenue of € 987.3 million. Headquartered in Milan, it broadest portfolio for female SUI treatment: Ophira, Single has operations in the main EU Countries, in Russia, in incision Mini sling system for female SUI; Opsys, Injectable Central & Eastern Europe, in Turkey, in North Africa & Bulking Agent for female SUI; Unitape VS- T & T Plus, in USA. With a staff of ca. 4,000, it is dedicated to the

research, development, manufacturing & marketing of pharmaceuticals. An efficient field force of medical representatives promotes innovative pharmaceuticals incl. special treatments for rare diseases. Silodosin (UROREC, SILODYX, SILOSIN), the alpha-blocker with the highest uroselectivity to date for the treatment of BPH symptoms, is now marketed in 28 key EU & Middle East countries.

License agreements were entered into with Apricus for marketing & sales of Vitaros (alprostadil), an innovative topical product for the treatment of erectile disfunction and with Plethora for Fortacin, a topical spray formulation for the treatment of premature ejaculation.

RICHARD WOLF GMBH Pforzheimer Str. 32, 75438 Knittlingen, Germany T : +49 704 33 50 F : +49 704 335 12 23 W : www.richard-wolf.com E : info@richard-wolf.com Booth nr. : F42 Being one of the leading manufacturers of medical instruments for minimally invasive surgery, Richard Wolf proudly presents its flexible Sensor URS Cobra & Boa Vision. The Boa Vision stands out with its uniqueness fitting into a 9.5 Fr. access sheath. The Cobra Vision is the only flexible URS with two working channels.

Now Richard Wolf will be able to cover complete procedures by supplying laser-, video-, endoscopeand disposable equipment. With a special portfolio of disposables for URS, PCNL and cystocopies, Richard Wolf is your single source for high quality endoscopy equipment.

ROCAMED 9 Avenue Albert II, 98000 Monaco, Monaco T : +377 97 98 42 43 F : +377 92 05 61 50 W : www.rocamed-urology.com E : info@rocamed.eu Booth nr. : H52 ROCAMED is part of the PROMEPLA group, several decades of existence and experience in medical devices. More than 300 employees and 3 manufacturing sites meet the strictest requirements and the latest European and International standards. The willingness of a group and the strength of our team serving healthcare professionals: ROCAMED. ROCAMED committed to optimize its costs from the design to distribution. Rationalization of scales (reduce the portfolio to the essential product lines), multiply the savings (development, manufacturing and distribution), minimize promotional costs to the minimum necessary (information is only available on www.rocamed.eu) ... while maximizing the quality of products from their conception (premium quality) Quality, Passion, Innovation and Service... Here are the values that define our lives and build the relationships of trust between ROCAMED and healthcare professionals.

RSU (RUSSIAN SOCIETY OF UROLOGY) Bolshaya Pirogovskaya st. 2-1, 119435 Moscow, Russia T : +7 499 248-71-66 W : http://www.ooorou.ru/ E : mail@ooorou.ru Booth nr. : I36 Russian Society of Urologists was founded in 1907 by outstanding surgion-urologist, professor and “father” of Russian urology - Sergey P. Fedorov.

Nowadays ROU is a dynamic, transparent and wellmanaged organization which unites more than 7 000 Russian urologists and seeks to meet their needs in high-quality education, meetings and events, support and integration into world urological trends.

SANDOZ INTERNATIONAL GMBH Industriestr. 25, 83607 Holzkirchen, Germany T : +49 80244764312 F : +49 8024 4762262 W : http://www.sandoz.com/ E : nils.seelbach@sandoz.com Booth nr. : B44 Sandoz International GmbH: Sandoz, a part of the Novartis Group, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees across more than 160 countries, offering a broad range of high-quality, affordable products that are accessible to 90% of the world’s population.

Exhibition Guide

Company and Product Description SIEMENS HEALTHCARE

SONACARE

SURGIQUEST, INC.

TAKEDA

Henkestr. 127, 91052 Erlangen, Germany T : +49 9131840 F : +49 913 184 292 4 W : www.siemens.com/healthcare E : medg.gms@siemens.com Booth nr. : F54

801 E. Morehead St., Ste. 201, 28202 Charlotte, United States of America T : +1 704-332-4308 F : +1 704 332 56 28 W : www.sonacaremedical.com E : alexgonzalez@sonacaremedical.com Booth nr. : I08

333 Quarry Road, Milford CT 06460, United States of America T : +1 203 799 2400 F : +1 203 799 2401 W : www.surgiquest.com Booth nr. : C34

40 Landsdowne Street, Cambridge, MA 02139, United States of America T : +1 617 679 7000 W : www.takeda.com Booth nr. : F63

SonaCare Medical is the leading innovator in non-invasive and minimally invasive ablation technology using high intensity focused ultrasound. The Sonablate 500 ablation system incorporates MRI/US image fusion for focal therapy of the prostate. MRI images are imported into the Sonablate and fused onto real-time ultrasound images in order to facilitate a precise ablation treatment plan. The company’s Sonatherm ablation system allows surgeons to incorporate additional SonaCare treatment probes for the laparoscopic ablation of soft tissue.

Please visit our booth and connect to our live-streaming of HIFU procedures and demonstrations.

SurgiQuest, Inc. is the maker of The AirSeal® System, the world’s first and only integrated access system for Minimally Invasive Surgery that provides stable pneumo, continuous smoke evacuation, and valve-free cavity access to enhance surgeon capabilities, improve anesthesia parameters, protect OR staff, and reduce OR time in both robotic and laparoscopic surgery.

Siemens Healthcare is one of the world’s largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare.

By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 52,000 employees worldwide and operates around the world. In fiscal year 2013 (to September 30), the Sector posted revenue of 13.6 billion euros and profit of 2.0 billion euros.

For further information please visit: www.siemens.com/ healthcare

SIGNOSTICS 1284 South Road, SA 5042 Clovelly Park, Australia T : +61 8 7424 0600 F : +61 8 7424 0601 W : http://www.signostics.com.au/ E : shaken@signostics.com.au Booth nr. : A52 Signostics Limited is an Australian medical technology company with a vision to be a world leader in portable point-of-care devices.The SignosRT Handheld Ultrasound provides clinicians with an easy-to-use, easy-to-carry tool to complement their physical examination.The simple to use SignosRT Bladder Scanner non-invasively images the bladder giving automatic and accurate bladder measurements.

SIU - SOCIETÀ ITALIANA DI UROLOGIA Via G. Amendola, 46, 00185 Rome, Italy T : +39 06 86 20 26 37 F : +39 06 86 32 50 73 W : www.siu.it E : info@siu.it Booth nr. : A23 The Italian Society of Urology , founded in 1908, is the most important Urologist Society in Italy. It has more than 2700 active members and is therefore involved in several scientific research projects, educational courses, clinical studies and awareness campaigns.

SOCIEDAD MEXICANA DE UROLOGIA A.C. Montecito #38 office 25, floor 26, Mexico, Mexico T : +52 55 9000 3385 F : +52 55 9000 3386 W : www.smu.org.mx E : smu@wtcmexico.com.mx Booth nr. : I24 The greatest latin american urological association, with more than 1200 partners. Our national congress will be on November 12-17 in Merida Yucatan, Mexico.

SOCIÉTÉ INTERNATIONALE D’UROLOGIE (SIU)

SONY PROFESSIONAL EUROPE Jays Close, RG22 4SB Basingstoke, United Kingdom T : +44 1256 483 670 F : +49 30 2575 694276 W : http://www.sony.co.uk/pro/products/

medical-home E : kate.moores@eu.sony.com Booth nr. : H01

Amsterdamseweg 147A, 1182GT Amstelveen, The Netherlands T : +31 206 423 719 F : +31 206 421 161 W : www.synergo-medical.com E : miriam001@planet.nl Booth nr. : B12

Medical Enterprises Group develops innovative medical technologies. The company consists of professional staff in the fields of biological science, physics, engineering, For almost 30 years Sony has supported medical medical and product managers. The company’s R&D is environments in capturing the best quality images through focused on less invasive therapies providing benefits for cutting edge technology. In 1985 by way of radiology, both patients and the healthcare system. The lead product, when it connected a video recorder to an X-ray device, Synergo® RITE, offers a clinically proven technology for the through to today, where Sony’s medical products and solutions span across the entire HD spectrum - from image treatment of Non-Muscle-Invasive Bladder Cancer.

Synergo® RITE technology provides radio-frequency acquisition and display to storage and printing.

(915Mhz) – induced thermochemotherapy of the Today Sony’s products are used across a wide range bladder wall combined with instillation of a cooled of applications, such as ultrasound, printing, surgical chemotherapeutic drug. The treatment is safe and effective imaging and recording. Join us at the stand to see our latest technologies and experience our unique 3D surgical with long-term proven safety and efficacy. workflow.

Synergo® is indicated for adjuvant and neoadjuvant use.

Treatments are routinely performed in leading medical centres around the world.

SPECIALITY EUROPEAN PHARMA

14 Tooks Court, EC4A 1LB London, United Kingdom T : +44 2074217400 F : +44 2074217401 W : www.specialityeuropeanpharma.com E : info@spepharma.com Booth nr. : H04 Speciality European Pharma Limited (SEP) is a panEuropean urology/urogynaecology focused speciality company.

SEP’s lead product in the UK is ONCE DAILY REGURIN® XL (prolonged release trospium chloride 60mg) indicated for symptomatic treatment of overactive bladder.

Following the acquisition of Contura, SEP has now added BULKAMID®, which is a class leading bulking agent for patients suffering with stress urinary incontinence.

More than 20,000 people have been treated to date with Bulkamid in a procedure that is performed under endoscopic control using the Bulkamid Urethral Bulking System. For more information, please visit www. specialityeuropeanpharma.com or www.bulkamid.com

STORZ MEDICAL AG Lohstampfestrasse 8, 8274 Tägerwilen, Switzerland T : +41 71 677 4545 F : +41 71 677 4505 W : www.storzmedical.com E : info@storzmedical.com Booth nr. : E46

Established in 1987, STORZ MEDICAL AG is a Swiss member company of the KARL STORZ Group. Our products have proved their efficacy all over the world in SIU Central Office, 1155 University, Suite 1012, H3B 3A7 the medical disciplines of urology, orthopaedics, sports Montreal, Quebec, Canada medicine, rehabilitation, gastroenterology, cardiology and T : +1 514 875 5665 dermatology.

F : +1 514 875 0205 Today, the focus is on personalized stone management, W : http://www.siu-urology.org making it possible to tailor each patient’s treatment to E : central.office@siu-urology.org their own particular situation.

Booth nr. : D86 With the development of the MODULITH®SLX-F2 »connect«, STORZ MEDICAL has introduced a device The Société Internationale d’Urologie (SIU) prides itself that perfectly combines the demands of a urological on fulfilling the educational needs of its members, and workstation with those of a lithotripter. For purely on mobilizing technology to reach the greatest number of endourological workstations without a shock wave therapy urologists worldwide. In October 2014, the SIU launched unit, STORZ MEDICAL has an impressive solution in the its virtual platform enabling the SIU Congress to go hybrid. form of the PRIMERA 360. With both devices, the large Visit Booth # D86 to learn more about our 35th congress in dynamic flat-panel detector allows overview imaging of Melbourne, Australia, Oct. 15 – 18, 2015. Visit us at: www. the entire genitourinary tract in diagnostic quality. siu-urology.org for more information on the different Shock waves can also be effectively used in urological pain facets of the SIU. therapy, such as CPPS and Peyronie’s disease Exhibition Guide

SYNERGO RITE MEDICAL ENTERPRISES EUROPE B.V.

SYSMEX EUROPE GMBH Bornbarch 1, 22848 Norderstedt, Germany T : +49 40 52726-7 F : +49 40 52726-100 W : www.sysmex-europe.com E : info@sysmex-europe.com Booth nr. : C64 Sysmex Europe GmbH is a subsidiary of the Sysmex Corporation based in Japan. For over 40 years, we have set standards and driven innovation in haematology. We have also broken ground in coagulation and urinalysis, life science, bioscience, near patient testing and automation.

We are now among Europe’s top laboratory diagnostics and healthcare companies, and the global leader for haematology diagnostics and service.

As the regional headquarter for the EMEA region, Sysmex Europe is active in co-operation with affiliates and distributors across Europe, The Middle East and Africa. Clear goals combined with targeted research and development result in tailor-made products. Our customers are our guides and, in dialogue with them, we create solutions across the three key areas – in the lab, at the clinician’s and directly with patients. As a result, we are able to offer cutting edge technologies of the highest quality, shaping the advancement of healthcare.

TAEWOONG MEDICAL, CO. LTD Bldg.C 4th Floor, Daebang Triplaon, Jungsan-Dong, Ilsandong-Gu, 400-842 Goyang-Si, South Korea T : +82 319 046 153 F : +82 319 046 157 W : www.stent.net E : airmyth@stent.net Booth nr. : D65 Taewoong Medical We Taewoong Medical was established in 1991 as a metal stent manufacturer and sales. For 10 years of global business, our technology has been conceded. We are World’s Best ”Non-vascular Self-Expandable Stent” leading Company. Over 40 countries, over 30,000 units annual sales are our performance. New year 2012, our innovative concept of ‘Urological Stent’ will be start up.

Our promise is to provide better Quality of Life.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

TAU (TURKISH ASSOCIATION OF UROLOGY) Prof. Nurettin Öktel Street, Lale Palas Apt., no: 18/2, 34382 Sisli – Istanbul, Turkey T : +90 212 232 46 89 F : +90 212 233 98 04 W : http://www.uroturk.com/ E : uroturk@uroturk.org.tr Booth nr. : F91 TAU is a national society of Turkey, recognized by Health Ministry of Turkish Republic

TELEFLEX IDA Business Park, Garrycastle, Dublin Road, Co. Westhmeath, Athlone, Ireland T : +353 9 06 46 08 00 F : +353 14 37 07 73 W : www.teleflex.com E : orders.intl@teleflex.com Booth nr. : B78 TELEFLEX provides comprehensive lines of urological products for customers in the hospital and home care markets. Each product and service we offer is the outcome of more than 100 years of product development, specialisation, experience and collaboration with our customers.

We offer bladder management products (Foleys, intermittent & suprapubic catheters, urine collectors) as well as products for endourology (ureteral stents & catheters, nephrostomy devices, stone extractors, irrigation system for ureterorenoscopy, guidewires).

This portfolio is complemented by surgical products (trocars & closure systems for laparoscopic surgery, metal & polymer ligation systems, retrieval bags, endoscopic instruments, chest drainage systems & other devices for skin closure).

Our irrigation system for ureterorenoscopy or the intermittent catheter systems Liquick Pure & SafetyCat Active, are just a few examples of our high-quality, innovative solutions with a strong focus on patient and provider safety

TIME RESEARCH LIMITED Time House, 56b Crewys Road, NW2 2AD London, United Kingdom T : +44 20 8209 2020 F : +44 20 8209 2021 W : www.timeresearch.co.uk E : lorraine.colley@timeresearch.co.uk Booth nr. : A12 Time Research will be conducting a market research study from our booth. Please come over and share your views.

TRIBUTE PHARMACEUTICALS CANADA INC. 544 Egerton Street, N5W 3Z8 London Ontario, Canada T : +1 226 213 3790 F : +1 519 434 4382 W : www.tributepharma.com E : david.butts@tributepharma.com Booth nr. : C02 Tribute Pharmaceuticals Canada Inc. is an innovative Canadian health care specialty company focused on providing healthcare professionals and their patients with high quality products. Tribute Pharmaceuticals is engaged in the acquisition, licensing and management of prescription pharmaceuticals products and medical devices in Canada. Tribute also develops and markets products for selected therapeutic categories worldwide.

Tribute’s innovative urology product Uracyst®/Uropol®, effective GAG replenishment therapy in the urinary bladder, is available in Canada and through licensing agreements in Europe and parts of Asia.

21-23 March 2015

Company and Product Description Please visit our website www.tributepharma.com for more specific information on Uracyst®/Uropol® and our distribution network.

TRISTEL SOLUTIONS LIMITED Lynx Business Park Fordham Road, Snailwell, CB8 7NY Cambridgeshire, United Kingdom T : +44 163 872 15 00 F : +44 163 872 19 11 W : www.tristel.com E : mail@tristel.com Booth nr. : D88 Tristel Solutions is a UK-based manufacturer of infection prevention and contamination control products. Its lead technology is a proprietary chlorine dioxide formulation, a technology that has been a ground-breaking innovation in the world of infection control.

Tristel products are amongst the highest performing solutions available to hospitals and industry; they destroy a wide variety of organisms, including spores, in short contact times.

Stella Pulse is Tristel’s semi-automated disinfection system for heat-sensitive, lumened medical devices such as cystoscopes, uretheroscopes, and transrectal ultrasound probes. It is an easy-to-use, compact system which fits neatly on a benchtop. With a disinfection cycle of only five minutes using Tristel Fuse for Instruments high-level disinfectant, the Stella Pulse can help you increase patient throughput, cut capital expenditure and improve Health & Safety for patients and staff.

Visit Tristel Solutions on stand D88 for more information.

UEG MEDICAL Room 2202, No.1403, Minsheng Road, Pudong, 200135 Shanghai, China T : +86 21 33927703 F : +86 21 33927715 W : www.uegmedical.com E : info@ueg.cn Booth nr. : C62 Founded in 2008, as a division of Universal Enterprises Group Co., Ltd., UEG Medical Device focuses on R&D and manufacture of medical devices which covers the following categories of medical products: Innovative Disposable Trocar, Innovative Laparoscopes and instruments, Surgical Navigation Systems, Wound Healing Material and Innovative Surgical Instruments etc.

Our GMP certified production workshop is equipped with advanced processing equipment and managed with scientific production mode. Our business philosophy is people-oriented and treasures those with talents, thus attracting a large number of experts at home and abroad.

UROMED KURT DREWS KG Meessen 7/11, 22113 Oststeinbek, Germany T : +49 40 713 007 0 F : +49 40 713 007 99 W : www.uromed.eu E : service@uromed.de Booth nr. : D01 UROMED, a German company, was founded more than 40 years ago. It has been a leading company for urological products and incontinence aids for urinary drainage ever since. The excellent quality and detailed specifications of UROMED products are well-known to doctors in many countries. The comprehensive programme covers nearly all requirements in the urological field and includes a lot of innovative and exceptional items. Over the years, the products have consistently been updated in order to provide safe, high-quality articles.

UROMEDICA INC. 1840 Berkshire Lane North, 55441 Plymouth, MN, United States of America T : +1 076 369 498 80 F : +1 076 369 499 45 W : uromedica-inc.com E : kcook@uromedica-inc.com Booth nr. : B80

UROONCOLOGY ASSOCIATION OF VITA GREEN EUROPA S.A. TURKEY (UAT) Balmes 199, 08006 Barcelona, Spain Hilal Mahallesi, Cezayir Cadolesi No:13, 06550 Ankara, Turkey T : +90 216 594 52 85 F : +90 216 594 57 99 W : http://uroonkoloji.org E : uroonkoloji@uroonkoloji.org Booth nr. : I37 Urooncology Association of Turkey (UAT) was established in 1999 in order to improve the quality and set the standards of urooncology in Turkey by postgraduate education and training of urologists, UAT also aims to conduct basic and clinical research in respective areas as well as publish original books of urooncoloy, and arrange national and international scientific meeting and congresses. The physicians from any specialty related with urooncology such as urologists, radiation oncologists, medical oncologists, pathologists, radiologists etc. could apply to be a member of our association. Currently, Urooncology Association has more than 300 active members and approximately 1000 members on digital sections.

UROTECH & UROVISION Medi-Globe-Strasse 1-5, 83101 Achenmuehle, Germany T : +49 803 297 32 00 F : +49 803 297 32 11 W : www.urotech.com / www.urovision.de E : export@urotech.com Booth nr. : G66 UROTECH & UROVISION has proven to be a reliable industry partner for urology and endourology communities. In our German facilities, we design specialty products for hospital and practice settings. Quality and flexibility are the crucial attributes to characterise our dynamic corporation. Our competent distributors abroad deliver a maximum of service and reliability and support our customers to provide for the best possible therapeutic settings for their patients. We do so considering ourselves to be a system provider for all fields of urology and offering ideal industry-wide solutions for both urological practises and urological hospital departments.

UROTECH is the only company worldwide that provides ureteral stents and nephrostomy catheters coated with phosphorylcholine, in order to reduce complications related with such implants and thus to extend the indwelling time.

VERATHON MEDICAL EUROPE B.V. Linnaeusweg 11, 3401 MS IJsselstein, The Netherlands T : +31 30 687 0570 F : +31 30 687 0512 W : http://verathon.com E : SalesEU@verathon.com;

TechnicalServiceEU@verathon.com;

CustomerCareEU@verathon.com Booth nr. : A19 Verathon® designs, manufactures and distributes reliable, state-of-the-art medical devices and services that offer a meaningful improvement in patient care to the health care community. The company’s flagship brand, BladderScan® bladder volume measurement instruments, is used in Urology, Acute Care, Primary Care, and Extended Care and is considered a standard of care. Noninvasive and easy to use, the BladderScan helps prevent unnecessary urinary catheterizations, reduces rates of catheter-associated urinary tract infection, and helps diagnose urinary-related problems and helps monitor post-operative urinary retention

VISION-SCIENCES, INC. 40 Ramland Road South, 10962 Orangeburg, United States of America T : +1 845-365-0600 F : +1 845-365-0620 W : www.visionsciences.com E : info@visionsciences.com Booth nr. : I28

Vision-Sciences, Inc. brings to the urology community EndoSheath® Cystoscopy and is the manufacturer of state-of-the art, flexible video (Distal Chip) and fiberoptic Uromedica, Inc is the manufacturer of ACT® and ProACT™ endoscopy systems that employ the use of EndoSheath® designed to treat stress urinary incontinence(SUI) in technology, which is the sterile, disposable cover/ women and men respectively. These minimally invasive barrier for flexible endoscopes. EndoSheath® Cystoscopy medical devices are adjustable balloons, considered to be provides a sterile, disposable operative channel for every permanent implants with no manipulation required by the procedure, allows for rapid cystoscope cleaning, less patient to void. Uromedica has treated over 11,000 patients exposure to toxic chemicals, enhanced Infection Control, less repair and maintenance costs, as well as an increase throughout the world.

Balloon volume may be easily increased or decreased in staff productivity. With EndoSheath® Cystoscopy, through the subcutaneous port by a physician to tailor the urologists have the best in endoscopic imaging, optimal therapeutic effect to the patients needs. ProACT and ACT practice efficiency, along with enhanced patient and staff are unique, patented designs. safety.

21-23 March 2015

T F W Booth nr.

: +34 934 159 560 : +34 932 377 928 : www.cysticlean.com : I11

Vita Green Group is a company that produces and markets health supplements and Medical Device products (Cysticlean 240 mg PAC)

WORLD FEDERATION OF INCONTINENT PATIENTS - WFIP Louis Couperuslaan 1, 2343 DZ Oegstgeest, The Netherlands T : +39 (0)80 5093389 F : +39 (0)80 5619181 W : www.wfip.org E : finco@finco.org Booth nr. : I43

The World Federation of Incontinent Patients (WFIP) is a global federation of national patient organizations for sufferers of incontinence and related pelvic floor disorders. The Federation is dedicated to promoting worldwide the interests of patients and patient associations. The Federation provides its individual member associations with comprehensive and up-to-date information and guidelines and educational resources.

It seeks international co-operation and consensus via BAUS: The British Association of Urological Surgeons advocacy, public health education and contact with official was founded in 1945 and exists to promote the highest and scientific bodies and other patient advocacy groups standards of practice in urology, for the benefit of patients, worldwide. WFIP is officially recognized by the EAU as by fostering education, research and clinical excellence. an affiliate partner and is at the forefront of the latest BAUS is a registered charity and qualified medical developments in healthcare such as patient reported practitioners practicing in the field of urological surgery outcomes and European eHealth initiatives. WFIP sits are eligible to apply for membership. on numerous EU and Brussels - based health-centred committees.

WCE 2015: We invite you to participate in the 33rd World WFIP is a member of the European Patients Forum (EPF) and Congress of Endourology and SWL, the world’s premier the International Alliance of Patient Organizations (IAPO) endourological conference 1 - 4 October 2015 at the ICC at ExCeL London. We believe that with the meeting coming to For further information please visit Booth Number I43 London, one of the world’s most exciting cities, delegates www.wfip.org and their partners will enjoy an unparalleled educational email: info@icpatienten.nl and social experience. We have the opportunity to collaborate in the development of a world-class scientific meeting and together we can create connections that will WYMEDICAL LTD enhance the education of urologists, advance endourology 13 Foundry Way, PE19 8TR St. Neots, United Kingdom T : +44 1480 211 505 as a specialty and improve patient care internationally.

Registration will open in early 2015.

F : +44 8721 158 380 W : www.wymedical.com E : info@wymedical.com WELLSPECT HEALTHCARE Booth nr. : I40 P.O. Box 14, SE-431 21 MÖLNDAL, Sweden T : +46 31 376 40 00 WyMedical is a UK leading manufacturer and distributor F : +46 31 376 30 10 of Urology products such as catheters and meatal dilators.

W : www.wellspect.com We develop quality products which make a difference to a E : Use contact form at patient quality of life.

www.wellspect.com WyMedical has over 20 years’ clinical experience in the Booth nr. : F78 Urology sector to enable WyMedical to identify areas where products can be improved.

Wellspect HealthCare, the name behind the family of LoFric catheters, is a leading global provider of innovative Our Meatal Dilator is now a market leader in the UK for meatal stenosis with its tapered tip and hydrophilic urological and surgical solutions.

We passionately strive to make a real difference every day coating it has become the clinician’s choice.

Our tapered and soft tip catheters are now widely used for to everyone who needs our products and services. That quality and comfort and where other standard catheters is why every solution bearing the Wellspect HealthCare are difficult or uncomfortable to insert for patients. name carries with it the trust and dependability built on more than 30 years of life-improving performance.

Come visit us on our stand for a demonstration and further information.

WCE 2015 & BAUS

35-43 Lincoln’s Inn Fields, WC2A 3PE London, United Kingdom T : +44 207 869 6950 F : +44 207 404 5048 W : www.wce2015.com & www.baus.org.uk E : events@baus.org.uk Booth nr. : A17

WILEY 9600 Garsington Road, OX4 2DQ Oxford, United Kingdom T : +44 1865 776868 F : +44 1865 714591 W : www.wiley.com E : swaterhous@wiley.com Booth nr. : G62 Wiley is a global provider of content-enabled solutions to improve outcomes in research, education and professional practice with online tools, journals, books, databases, reference works and laboratory protocols. With strengths in every major academic, scientific and professional field, Wiley proudly partners with over 800 prestigious societies representing two million members, one of which is with BJUI a global, innovative journal. Edited by Professor Prokar Dasgupta; BJUI is published 18 times per annum covering original articles, reviews and educational articles.

WISEPRESS MEDICAL BOOKSHOP 25 High Path, Merton Abbey, SW19 2JL London, United Kingdom T : +44 208 715 1812 F : +44 208 715 1722 W : www.wisepress.com E : bookshop@wisepress.com Booth nr. : G56 Wisepress.com, Europe’s leading conference bookseller, has a complete range of books and journals relevant to the themes of the meeting. Books can be purchased at the stand or, if you would rather not carry them, posted to you – Wisepress will deliver worldwide. In addition to attending 200 conferences per year, Wisepress has a comprehensive medical and scientific bookshop online with great offers.

XODUS MEDICAL, INC. 702 Prominence Drive, 15068 New Kensington PA, United States of America T : +1 724.337.5500 F : +1 724.337.0555 W : www.xodusmedical.com E : mpark@xodusmedical.com Booth nr. : H03

ZEPHYR SURGICAL IMPLANTS route des Jeunes 4, 1227 Acacias, Switzerland T : +41 78 693 73 48 F : +41 22 327 10 11 W : www.zephyr-si.com E : llorens1@mac.com Booth nr. : A08 ZEPHYR Surgical Implants is a team motivated by the desire to provide healthy and effective solutions for urological disorders. In 2005, after much research and development, our team developed innovative surgical prosthesis.

We call it the Artificial Urinary Sphincter.

In 2007, we established ourselves as an International Company dedicated to developing and manufacturing the ZSI 375, our Artificial Urinary Sphicter.

In 2012 we further added to our range of surgical implants with the introduction of the ZSI 475, a 3 component Hydraulic Penile Implant.

Since then, our team has grown to distribute in all continents of the globe, in over 1000 cases, and is gaining a reputation as a reliable, healthy and effective developer of Urological Implants.

Exhibition Guide

Alphabetical list of Exhibitors EXHIBITOR

BOOTH NR.

EXHIBITOR

A

F

A.M.I. GMBH C56 AAU (ARAB ASSOCIATION OF UROLOGY) I38 ACCORDION MEDICAL F93 ACCU-TECH CO., LTD. B70 AEU ASOCIACIÓN ESPAÑOLA DE UROLOGÍA D73 ALBYN MEDICAL B74 ALLERGAN D72 ALLIUM LTD. D59 AMERICAN MEDICAL SYSTEMS (AMS) C10 AMERICAN UROLOGICAL ASSOCIATION (AUA) D57 AMGEN (EUROPE) GMBH C22 ANDROMEDA MEDIZINISCHE SYSTEME GMBH I07 ANGIODYNAMICS A06 & G96 APOGEPHA ARZNEIMITTEL GMBH G01 APPLIED MEDICAL EUROPE C03 ASTELLAS PHARMA EUROPE LTD. D02

FERRING INTERNATIONAL CENTER S.A.

B B. BRAUN AESCULAP AG BACTIGUARD AB BARD LTD BAYER HEALTHCARE BESINS HEALTHCARE BIOBOT SURGICAL PTE LTD BIOLITEC BIOMEDICAL TECHNOLOGY GMBH BIONORICA SE BK ULTRASOUND BOSTON SCIENTIFIC INTERNATIONAL BOWA-ELECTRONIC GMBH & CO. KG

F94 A39 I19 F02 C44 I18 A54 C68 G20 B16 H28

C CANADIAN UROLOGICAL ASSOCIATION (CUA CANADA) I16 CARESONO TECHNOLOGY CO., LTD H64 CATERING A02 CAU (CONFEDERACIÓN AMERICANA DE UROLOGÍA) I22 CHARGE & CONNECT AREA G74 CHINESE UROLOGICAL ASSOCIATION (CUA CHINA) I20 COLOPLAST - PORGÈS F75 COMBAT MEDICAL LTD G06 CONCILE GMBH A34 COOK MEDICAL F66 CURAN MEDICAL BV D69

D 3D SYSTEMS-SIMBIONIX PRODUCTS DIREX DORNIER MEDTECH EUROPE GMBH DYNAMESH BY FEG TEXTILTECHNIK MBH

G98 H20 G52 A31

E EAU BOOTH A42 EAU HISTORICAL EXHIBITION A42 EAU MUNICH 2016 A42 EAU RESEARCH FOUNDATION A42 EAU VIDEO LIBRARY A20 EDAP TMS C46 ELMED MEDICAL SYSTEMS H08 ELMEDICAL LTD. B76 ELSEVIER A13 ELVATION MEDICAL GMBH C65 EMED SP. Z O. O. SP. K. A11 EMS ELECTRO MEDICAL SYSTEMS S.A. F86 ENDOCARE, INC. G04 ENDOCONTROL D61 EPONA MEDICAL G102 ERASMUS CONFERENCES TOURS & TRAVEL H22 ERASMUS MC G100 ERBE ELEKTROMEDIZIN GMBH H40 ESSM A21 EU-ACME A42 EUROMEDICAL GMBH H51 EUROPA UOMO I39 EUROPEAN BOARD OF UROLOGY A42 EUROPEAN TUBEROUS SCLEROSIS ASSOCIATION A25 EUROPEAN UROLOGY A01 EXACT IMAGING (FORMERLY IMAGISTX) G02

Exhibition Guide

BOOTH NR.

GALIL MEDICAL B04 GE HEALTHCARE H66 GENOMIC HEALTH, INC. C63 GRENA LTD G79 GRUPO TAPER S.A. H28 GSK E20

H

IBSA INSTITUT BIOCHIMIQUE SA I02 INTERMEDIC ARFRAN SA I35 INTUITIVE SURGICAL D20 INVIDIA MEDICAL GMBH & CO.KG I32 INVIVO G30 IPSEN PHARMA E08 ISTEM MEDIKAL C69

J D40 B08

K KARL STORZ GMBH & CO.KG E46 KITALPHA MED LTD H26 KLS MARTIN GROUP G12 KOELIS C57

L LABORIE B32 LENUS PHARMA I14 LISA LASER PRODUCTS OHG F03 LP SURGICAL FIBERS/LASER PERIPHERALS A15 LUMENIS (GERMANY) GMBH B60 LUT GMBH F96

M M.A.S. MEDICAL S.R.L. C72 MAVIG I29 MCUBE TECHNOLOGY CO., LTD. I06 MEDA CO., LTD. D63 MEDAC GMBH B28 MEDCOM GMBH AND WATSON MEDICAL C01 MEDICA S.P.A. I34 MEDICAL MEASUREMENT SYSTEMS B.V. G90 MEDISPEC LTD A27 MEDI SURG GMBH H24 MEDI-TATE LTD I45 MEDKONSULT C66 MEDPRO MEDICAL A50 MEDTRONIC INTERNATIONAL TRADING SÀRL A30 MENARINI - THE MENARINI GROUP F30 MIANYANG MEIKE G28 MIM SOFTWARE INC. A41 MIMIC TECHNOLOGIES, INC G94 MONTAVIT GMBH A09 MTS MEDICAL UG G34 MYRIAD GENETICS GMBH A28

N NANOVIBRONIX LTD. NEOMEDIC INTERNATIONAL NEOTRACT, INC. NOVAMEDTEK

G10 B82 E36 A35 B02 B52

Q QUANTA SYSTEM SPA

G44

R-ACTION DISTRIBUTION SÀRL REALTON RECORDATI S.P.A. RICHARD WOLF GMBH ROCAMED RSU (RUSSIAN SOCIETY OF UROLOGY)

I33 A37 F14 F42 H52 I36

S SANDOZ INTERNATIONAL GMBH B44 SIEMENS HEALTHCARE F54 SIGNOSTICS A52 SIU - SOCIETÀ ITALIANA DI UROLOGIA A23 SOCIEDAD MEXICANA DE UROLOGIA A.C. (SMU) I24 SOCIÉTÉ INTERNATIONALE D’UROLOGIE (SIU) D86 SONACARE I08 SONY PROFESSIONAL EUROPE H01 SPECIALITY EUROPEAN PHARMA H04 STORZ MEDICAL AG E46 SURGIQUEST, INC. C34 SYNERGO RITE MEDICAL ENTERPRISES EUROPE B.V. B12 SYSMEX EUROPE GMBH C64

T TAEWOONG MEDICAL, CO. LTD D65 TAKEDA F63 TAU (TURKISH ASSOCIATION OF UROLOGY) F91 TELEFLEX B78 TIME RESEARCH LIMITED A12 TRIBUTE PHARMACEUTICALS CANADA INC. C02 TRISTEL SOLUTIONS LIMITED D88

U UEG MEDICAL UPCOMING MEETINGS AREA UROMED KURT DREWS KG UROMEDICA, INC. UROONCOLOGY ASSOCIATION OF TURKEY (UAT) UROTECH & UROVISION

C62 I03 D01 B80 I37 G66

V VERATHON MEDICAL EUROPE B.V. VISION-SCIENCES, INC. VITA GREEN EUROPA S.A.

A19 I28 I11

W WCE 2015 & BAUS A17 WELLSPECT HEALTHCARE F78 WILEY G62 WISEPRESS MEDICAL BOOKSHOP G56 WORLD FEDERATION OF INCONTINENT PATIENTS - WFIP I43 WYMEDICAL LTD I40

X I41 A14 A36 I32

O OCEANA THERAPEUTICS LTD OLYMPUS EUROPA SE & CO. KG OPKO DIAGNOSTICS OPTIMUM MEDICAL OVERTOOM LTD. A DIVISION OF OMS

PAJUNK GMBH PHYSION SRL PIERRE FABRE MÉDICAMENT POLYDIAGNOST GMBH PROFOUND MEDICAL INC. PROMEDON

R C38

I

JANSSEN PHARMACEUTICAL COMPANIES JENA SURGICAL

BOOTH NR.

P B20

G

HITACHI MEDICAL SYSTEMS EUROPE

EXHIBITOR

XODUS MEDICAL, INC.

H03

Y YOUNG UROLOGISTS / RESIDENTS CORNER

A42

Z I33 D60 F01 I42 A50

ZEPHYR SURGICAL IMPLANTS (ZSI)

A08

21-23 March 2015

Novel approaches to ureteroscopy Flexible URS offers viable options but technical refinements are needed

Z I M M E R / M A D I C H AMS EAU StoneLight 30 Ad | EAU

7540 Marketplace Drive, Minneapolis MN 55344 Size: 295mm x 420mm + 3mm BLEED

Dr. Guido Giusti Head Stone Center & European Training Center in Endourology Humanitas Research Hospital Milan (IT) tweet at @GuidoGiusti Co-Author: S. Proietti, Humanitas Research Hospital, Milan (IT) Lucio Anneo Seneca said “Magna pars est profectus velle proficere” (The greater part of progress is the desire to progress).

Reflecting what Seneca said, the evolution of ureteroscopy has been a relentless pursuit for improvement. Historically, it started fortuitously in 1912 when Young inadvertently introduced a pediatric cystoscope into a severe dilated right ureter and was pleasantly astonished by the renal pelvis. Since then, the advancements in the endourological armamentarium, the evolution of ureteroscopes, and the introduction of holmium laser lithotripters have improved success, patient safety and comfort, and made the use of ureteroscopy (URS) for urinary calculi increasingly attractive and widespread. The aim of this lecture is to provide an overview of all novel approaches to URS. Indications Apart from general problems and untreated urinary tract infections, URS can be performed in all patients without any specific contraindications. Bearing this in mind, even the most difficult clinical scenarios such as pregnancy, obesity, bleeding diathesis, calyceal diverticula, kidney malformations and spinal deformities, do not constitute a barrier to perform URS. Stones larger than 2 cm In 2013, the EAU’s Guidelines on Urolithiasis for the first time listed flexible URS (fURS), which was considered inappropriate until a few years ago, as a viable option for stones larger than 2 cm1. According to literature2,3, multistage fURS can achieve stone-free rate (SFR) comparable to that of percutaneous nephrolithotomy (PCNL) with lower complications rate.

However, stratifying the results, it is clear that 3 cm should be considered the upper limit over which reduced invasiveness of fURS is outweighed by a lower stone-free rate and excessive number of retreatments, and consequently PCNL is still the procedure of choice.

A radical change in mentality will be needed if endourologists are to accept the idea of a multistage procedure. In addition, detailed and honest patient counselling is of paramount importance so that patients have all the necessary information to allow them to choose the procedure that best fits their expectations for the treatment of stones greater than 2 cm in diameter.

LC.

Ureteral Access Sheath (UAS) UAS represents something without which modern fURS cannot be carried out. In fact, UAS allows continuous irrigation outflow (so that excessive intrarenal pressure peaks are prevented), multiple quick entries and exits during fragments’ extraction, and the preservation of costly flexible scopes. Usually a UAS consists of an inner introducer and an outer highly hydrophilic tube, the sheath itself. Traditionally, this device is passed up into the collecting system alongside a coaxial hydrophilic working wire while a second safety guide-wire is left outside the sheath to maintain a safe access to the upper urinary tract (Figure 1).

Figure 1: UAS with the working and the safety guidewire

Once in place, both the introducer and the working wire are removed and the system is ready to accommodate the flexible ureteroscope. Recently, a new revolutionary UAS has been developed (RetraceTM, Porges-Coloplast, Denmark and Flexor parallel, Cook, Bloomington, USA): the novelty of this device is a lateral orifice on the distal part of the introducer through which a hydrophilic guide-wire can pass, leading the advancement of UAS acting in the same time as both the working and safety wire (Figure 2).

repeatedly perforated, chipped, or fragmented, in comparison with “dancing” or “painting” the surface with the laser. Provided that pulverization should always be attempted, an endourologist should also be prepared for residual fragments retrieval: last-generation nitinol stones’ extractors are fundamental for a fruitful basketing after lasertripsy.

With regard to laser fibers, although small-diameter fibers ablate as much as their large-diameter counterparts, they are more prone to fiber tip degradation due to ‘burn-back’ effect. However, this drawback is largely compensated by better irrigation, better scope deflection, and less retropulsion. A last issue to be addressed is whether to use reusable or disposable fibers: according to a report in the literature there is a general feeling that disposable ones, even though a little bit more costly in the short-term, can be cost-effective in the long-term because of a significant reduction in scope damage11.

Antiretropulsion devices Several studies of ureteroscopic treatment for ureteral stones have reported that most stone clearance failures can be attributed to stone fragment retropulsion. Stone retropulsion can result in increased operative time and cost resulting from adjuvant fURS . Different stone-trapping devices have been developed with this purpose: Stone Cone™, the PercSys Accordion®, the NTrap® and XenX™.

Recently a revolutionary device named BackStop® gel has been introduced: this is a reverse thermosensitive gel that, once injected in the ureter beyond the stone, forms at body temperature a solid plug able to prevent stone retro-migration and dissolves with instillation of cold water after lithotripsy.

Our own technique is to add some drops of indigo carmine before injection to make the plug identifiable by color, making it easier to localize (Figure 3). Our experience provides support to the previous report in which it has been demonstrated that this device ensures a statistically significant lower rate of retropulsion.

Figure 2: UAS with the lateral orifice where the working wire passes, becoming the safety one

Placement of UAS is not without potential harm to the ureter which has been found to be present in up to 46% of patients8. As such, with the safety guide-wire still in place, careful ureter exploration should be carried before removing both UAS and scope in order to identify all lesions to the ureteral wall caused by its placement. This is a critical step; unfortunately, complication-free fURS does not exist, but its immediate recognition is crucial to enable the best management, thereby highly reducing potential long-lasting sequelae.

Possible limitations of the device are the lack of tactile feedback: impact of this problem is limited by the ability of Roboflex Avicenna to deliver graduated movements to the flexible scope. Similarly, the robot does not allow for basketing of fragments after lasertripsy and partial undocking of the device can be needed with consequent increase of operative time.

As such, Roboflex Avicenna represents a promising device that, so far, has demonstrated safety and effect in terms of the improvement of ergonomics.

Extracorporeal Lithotripsy (SWL) endoscopically controlled by FURS (LECURS) This technique introduces the new concept of SWL endoscopically controlled by simultaneous fURS .

Potential advantages of this combination are: fURS allows stone visualization and intrarenal relocation and SWL is performed under direct vision allowing constant focal zone adjustment for ideal stone fragmentation. Moreover, lasertripsy can be carried out in case of SWL-resistant stone14.

SPIES technology Recently, an innovative endoscopic visualization technique named STORZ Professional Image Enhancement System (SPIES) has been introduced.

The system acquired white-light images and through different digital imaging modes can be used to enhance the sharpness of the displayed images and provide specific color renderings. As a matter of fact, the system offers five different modalities of tissutal visualization, three with white light (CLARA, CHROMA, CLARA+CHROMA) (Figure 5) and two with chromatic transition (SPECTRA A and B) (Figure 6). To date, no clinical data are available about this promising enhancement system.

Figure 5: Visualization of renal stones with white light (left) and with CLARA+CHROMA modality (right) Figure 3: Stone fragments into the ureter during lithotripsy with Backstop gel®

Innovations: Robot-assisted FURS FURS remains a challenging technique that requires specific endourologic skills, which sometimes cause hand-wrist fatigue and other ergonomic problems12 on surgeons that may compromise outcomes. With this in mind, researchers from Turkey developed a robotic device named Roboflex Avicenna, whose aim is to improve fURS outcomes reducing side effects on both the surgeons and the endoscopes. It consists of two elements, the surgeon’s console and the manipulator of the flexible digital scope (Photo 4).

Laser Even after three decades since its introduction, the best laser lithotripter settings and the most appropriate laser fibers to achieve the best lithotripsy performance are still being debated.

Newer digital fURS have been developed with the intent to increase the quality of vision. They are supplied with the “chip-on-the-tip” technology, with the tip of these instruments housing digital sensors.

All of these digital scopes guarantee an incredible high-resolution image that facilitates the surgeon to navigate the collecting system more quickly and efficiently when compared to fiber-optic scopes. Due to these digital sensors, no camera has to be connected to the scope. Moreover, the tip of these complicated instruments allocates also LED light carriers so that there is no need for an external light source or the connection to a light cable.

The first provides an adjustable seat with arm rest and two joysticks: the right one modulates deflection and is similar to the hand piece of any traditional On the contrary, higher power levels and high flexible scopes. The left joystick allows rotation to frequency lithotripsy are not necessarily associated with each side as well as advancement and retraction of a better ablation performance. Recently, last-generation the ureteroscope. The manipulator consists of the laser machines also provide the possibility to modulate motor system and the robotic arm, which holds and pulse duration offering a new long-pulse mode. This moves the ureteroscope. setting is significantly less ablative than traditional short-pulse lithotripter settings, but on the contrary leads to less fiber tip degradation and less retropulsion that can be particularly useful whenever stone push-back should be prevented.

Although a clear superiority in terms of SFR has not been demonstrated, digital scopes allow the surgeon to save 20-25% operative time4. A major issue remains regarding durability which, apart from some exceptions5,6, is very short with an average of around 30 cases. Thus, disposable flexible scopes have been developed (PolyscopeTM, Germany and Semiflex,

Saglam et al. achieved a satisfying 80% stone-free rate after a single stage in 81 patients13. Of note, the improvement of the ergonomics appeared to be statistically significant. Moreover, the functions provided by Roboflex Avicenna, such as the introduction of laser fiber only with the scope straight, stepwise motorised advancement of the laser fiber and force-controlled deflection mechanism, seemed to contribute significantly to longer life span of ureteroscopes (67 cases in this series). Lastly, a surgeons’ radiation exposure is significantly reduced.

This guarantees similar insertion rates but also time and cost savings7. Different diameters are available: the actual trend is to use UAS around 10F in order to respect the ureters’ anatomy.

Armamentarium: Flexible ureteroscopes FURS are divided in two categories: fiberoptic and digital. Fiberoptic scopes provide a good visualization by means of fiber-optic bundles with a number of fibers ranging between 3400 up to more than 5000 fibers. Quality of vision is good enough to succeed in stone surgery but of course “moire” effect is still present. The advantage of these scopes is still their smaller diameter.

Saturday, 21 March 2015

8:58 AM

Maxiflex, New Orleans , USA). Unfortunately their quality in terms of both vision and manoeuvrability is not good enough to consider them as an alternative to a traditional scope but only complementary to them.

Nevertheless, innovation develops quickly and future trends in this field are supposed to come shortly.

Holmium laser lithotripters allow the urologist to modulate the main parameters influencing the outcome of lasertripsy procedures, but some are more important than others. Pulse energy is one of the most important factors affecting ablation and procedure speed, especially if the total power remains the same.

So far, no reliable study has proven that any particular lithotripter setting is better than another with respect to the prevention of large-stone fragment generation9,10. Moreover, fragment size may be influenced by stones’ hardness and, most importantly, by the surgical technique, i.e., keeping minimal Figure 4: Roboflex Avicenna during robot assisted fURS distance from the stone and whether the stone is procedure

Figure 6: Visualization of upper urinary tract tumour with white light (left) and with SPECTRA A modality (right)

Future trends FURS is an effective tool capable of treating the majority of urinary stones even in the most complicated clinical scenarios. Nevertheless, it should not be considered a sort of panacea for all stones, and there is room, although limited, left for SWL and PCNL. Future developments are needed to make fURS play a more fundamental role in the future, and these are: increasing the definition of view with digital scopes, developing high-quality disposable scopes, and exploring the potentiality of robot-assisted fURS and new lasers to improve the dusting effect on every kind of stones.

Due to space constraints the reference list has been omitted. Interested readers can send a request for the complete list at EUT@uroweb.org.

Saturday, 21 March 11.15-14.00: Joint Meeting of the EAU Robotic Urology Section (ERUS) and the EAU Section of Uro-Technology (ESUT)

EUT Congress News

17

The role of ischemia Ischemia time: key surgeon-dependent predictor of renal damage during partial nephrectomy Asso. Prof. Francesco Porpiglia San Luigi Gonzaga Hospital Dept. of Urology, University of Turin Turin (IT)

Experiences have progressively led to the increasing use of methods to better evaluate baseline and postoperative RF. Moreover, with the general consensus of the maximum preservation of RF, PN evolved with new techniques aimed to WIT reduction17-22 and to maximum preservation of nephronic mass23.

would give a positive message: if it is true that high grade of recommendation studies are lacking, we are anyway satisfied with the available literature because there is general consensus in some recent messages we can find, specifically:

1. Minimally-invasive PN is recommended for all T1 tumors.

Our experience 2. Robotic system is a facilitator of surgery. It is able We began our studies on WIT during laparoscopic PN to shorten learning curve for technique and in 2007. They all had the strength of the evaluation of acceptable WIT with respect to conventional RF by renal scintigraphy. We were forced to take this laparoscopy33,34. It widens indications to PN even choice as we decided to focus on the setting of the According to the current international urological Clamping of the renal artery can be performed at different for non-skilled laparoscopic surgeons. guidelines, partial nephrectomy (PN) is the standard normal contralateral kidney. While literature was levels if external branches of renal artery are accurately 3. Robotic system allows for saving more kidney misleading in accepting very high cut-offs for WIT, we dissected treatment for T1 renal tumors1,2. A bloodless field is units when embarking in PN for complex lesions. essential for achieving the best oncological outcome. published a study based on a cohort of patients with 4. Assessment of quality of RF after PN should today Indeed, the conventional technique includes clamping WITs over 30 minutes to demonstrate that irreversible include the estimation of GFR and ideally renal renal damage occurred with ischemia over 32 of the renal artery. scintigraphy. This is particularly true in the setting No difference in complications’ and positive surgical minutes24. margins’ rate were found. Accordingly, no differences of bilateral kidneys.

The side effect is renal ischemia (warm ischemia), 5. The extent of acute ischemic injury should be were found in trifecta achievement’s rate among the which can lead to ischemic damage to the kidney, The evolution of surgical skills including early more precisely and more precociously measured groups. Our preliminary conclusion was that global with potential onset of acute/chronic renal functional unclamping technique, clamping on demand technique ischemia below 25 minutes versus selective clamping by biomarkers of renal cellular injury. loss. To increase clamping time without leading to and running suture with sliding clips technique was or no clamping causes the same amount of loss of RF 6. Assessment of quantity of renal parenchyma lowering average WITs, and we published a study in severe kidney damage, cooling of the kidney (the so removed by means of renal scans and/or in the operated kidney. Results should be confirmed called cold ischemia)3 can be used to increase kidney 2012 based on patients with WITs ranging from a couple by larger sample sizes. volumetric imaging techniques would be useful32. tolerance to ischemia. Warm/cold ischemia time is the of minutes until 35 minutes. In this study, with wide 7. Even when avoiding renal ischemia, some renal most important surgeon-dependent predictor of renal consensus of contemporary literature, the 25 minutes damage is recorded, with preoperative factors like Assessment of renal function and renal damage functional damage. Type and duration of ischemia cut-off was fixed: minimum damage when WIT was baseline renal function, presence of a solitary Assessment of RF is the core business of the topic: it is together with non-modifiable factors such as baseline kept within 25 minutes, consistent irreversible damage very important to have a rigorous assessment either kidney, age, gender, tumor size and complexity renal function and amount of preserved healthy renal when WIT was over 25 minutes25. (nowadays evaluable by standardized preoperatively or postoperatively. Serum creatinine is parenchyma play an important role in determining nephrometric systems) and a paramount surgical the easiest and most commonly used tool to assess RF post-partial renal function (RF).

The study had a one-year only follow-up duration; factor, namely the amount of healthy kidney after PN, but its concentrations are affected by age, what would have happened during a longer parenchyma preserved can impact on RF after PN. sex and muscle mass27. Moreover, in normal contralateral kidney setting it has limited reliability28.

In recent years, the diffusion of minimally-invasive PN follow-up? To give an answer, we published a The prevention of ischemic renal damage should has limited the feasibility of renal hypothermia, giving four-year follow-up study in 2012 in which we Determination of GFR by creatinine clearance or by undoubtedly be one of the main goals of PN, together with the proper tumor excision with the the majority of indications to warm ischemia evaluated that post-partial renal damage assessed by estimation with dedicated formulas is more accurate minimum resection of healthy parenchyma with technique. The main challenge is therefore to limit the renal scintigraphy was stable over time after the third in estimating RF29,30. postoperative month in all cases26. Moreover, no new negative surgical margins. duration of warm ischemia time (WIT) during onset of cardiovascular diseases was registered minimally-invasive PN as it has been demonstrated Obviously, the most reliable method to assess RF in that prevention of chronic kidney disease (CKD) new during the follow-up period. patients with bilateral kidneys would be evaluating onset is crucial in improving quality of life and survival. split-renal function by renal scintigraphy, but its On the basis of our finding, we stopped scintigraphic widespread use is still limited. We vastly used this We can say that the challenge of RF preservation has follow-up of patients who underwent PN after the tool in our experience as mentioned above. been driving the evolution of minimally-invasive PN third month. With the ongoing surgeon’s learning No difference in RF of operated kidney was found for 10 years. Several techniques have been reported curve and looking for the lowest damage as possible, among those going clampless, going for selective aimed to reduce WIT on one hand, and the maximum we published in 2012 a feasibility study about clamping or going for global ischemia if keeping WIT preservation of nephronic mass on the other, with the clampless laparoscopic PN: in selected cases and with below 25 minutes. common goal of maximum GFR preservation. consistent laparoscopic experience, tumor resection could be performed with safety and efficacy without We think that this is a very important point for Technological innovations such as advent of robotic clamping of renal artery. At this point our question urologists beginning with PN. They won’t be forced to surgery are being discussed as facilitator of surgery was “Is it true that no ischemia means no damage?” learn the nightmare of a PN performed without Three accessory arteries has bees dissected. The clamping can to lower WIT and improve resection technique. clamping of renal artery! On the other hand, it is true be modulated on the basis of the tumor location Moreover, researches about new instruments and We answered in 2014 by publishing a comparative that if a surgeon is very skilled and opts for a markers to measure renal ischemic damage have study on RF between a cohort of “clampless” patients clampless approach, patients with poorer baseline RF been introduced, together with dedicated software and a cohort of patients who underwent laparoscopic will benefit from it.

In conclusion, RF recovery after PN is strongly for volumetric assessment4-6.

PN with clamping of renal artery. No significant associated with preoperative renal function and difference about loss of RF was recorded between Another promising chapter of RF assessment are amount of preserved kidney. WIT is an important “clampless” and “clamped” cohort if ischemia time The role of ischemia biomarkers of subclinical cellular injury31,32. They modifiable surgical factor impacting on postoperative Elective indications for PN were expanded as it has was kept within 25 minutes threshold. would be recommended in clinical practice. Several of RF: WIT over 25 minutes should be avoided35 and if been demonstrated that it allows better preservation them have been investigated but further studies are longer ischemia is anticipated, cold ischemia should of RF7-10. Prevention of CKD has paramount But a trend towards a lower loss of RF was recorded needed before they can be introduced in routine be employed, especially in the imperative setting. practice. We closely studied the most promising one Maximum quantity of renal parenchyma should be importance, CKD being an independent risk factor for in clampless cohort, especially in those patients with as being non-invasive (it can be dosed in urine preserved, and the classical concept of PN should be the development of cardiovascular events and death poorer baseline RF. Maybe statistical significance from any cause11. would have been reached if studying a larger sample samples too): the Neutrophil gelatinase-associated abandoned in favor of enucleation/enucleoresection sizes. Expanding indications of clampless technique to lipocalin (NGAL), in the setting of laparoscopic PN techniques allowing for the maximum residual Extensive literature has been produced on this topic. all the renal masses who came to our observation with or without clamping of renal artery. amount of nephronic mass.

Two simplified considerations can be drawn. allowed us to collect a cohort of patients with selective We further conclude that with a normal contralateral clamping: in these patients a selective/super-selective In our experience, available as published abstract First, in the setting of bilateral kidneys, PN for a T1 (on the basis of anatomy of renal artery extra-renal during this congress, we observed a statistically kidney, everything that happens below 25 minutes, renal tumor rarely results in permanent loss of global branches) clamping on demand was performed significant increase of NGAL values from baseline to perhaps, is not so clinically relevant. On the other renal function12. Second, if we analyze literature about during the resection due to consistent bleeding to 24 hours in clamped patients (p=0.03) while, in hand, if a surgeon is able to perform a good PN with clampless ones, no significant increase was found WIT below 25 minutes, he can consider himself renal ischemia since 40 years ago and in recent years ensure the good visualization of the resection bed. until five days after surgery (<0.01). satisfied. But he should know that if he continues the we will discover that ischemia “time” reduction done evolution of his minimally-invasive NSS technique is about a couple of minutes. But we should We published our preliminary experience about underline that during these decades a great selective clamping in a comparative study about no For both groups no differences were found when going towards no ischemia/non-global ischemia theoretical evolution has occurred, with paradoxes ischemia vs selective ischemia vs global ischemia, specifically testing NGAL baseline versus third- month techniques36, there are some benefits especially in available as abstract during this congress. Neither value. When comparing differences between clamped patients with poorer baseline RF or solitary kidney. along the way13,14. and clampless cohort in terms of NGAL values, the eGFR nor percentage of loss of RF, according to renal only significant difference was observed 24 hours Before the advent of nephron sparing surgery (NSS) scintigraphy parameters, was significantly different Thus, a very skilled surgeon with a wide range of after surgery (p=0.04). for renal tumors, 30 minutes cut-off was accepted and among the groups. At multivariate analysis no techniques in managing renal pedicle during PN is used 40 years ago in surgery for complex renal independent factors of higher loss of RF were found. able to “personalize” ischemia on the basis of In conclusion, in comparison to clampless patients, stones. In contrast, ten years ago some authors were preoperative patient’s characteristics (baseline RF, clamped patients had a steeper and faster increase of comorbidities, solitary kidney condition, etc…), to using higher cut-offs for WIT at the beginning of NGAL documenting more acute renal damage, even learning curves of laparoscopic NSS; basing their achieve the maximum preservation of nephronic mass without correlation with ischemia time (mean WIT = study on serum creatinine only, Bhayani et al. in and RF, and the maximum perioperative safety and 2004, affirmed that WIT up to 55 minutes was not 16.9 minutes). We underline, that in all patients, oncological efficacy. Yes, this is the practical real movement of neither serum creatinine nor eGFR was trifecta we want. significantly influencing long-term renal function after observed when comparing baseline to post-partial laparoscopic PN. They concluded that during laparoscopic PN efforts to minimize WIT were setting, showing the major reliability of NGAL in acute Due to space constraints the reference list has been important but they should have “not jeopardized renal damage assessment. omitted. Interested readers can send a request for cancer control”15! the complete list at EUT@uroweb.org.

Discussion and conclusion Saturday, 21 March Fortunately, other authors and previously cited The current evidences about renal ischemia and PN authors themselves had doubts about the safety of are mainly based on prospective case-series and 8.30-11.00: Plenary Session 1 long ischemia times16. The risk of an irreversible renal Normal vascular anatomy of the left kidney. Two branches Controversies in surgical oncology in bladder retrospective comparative studies, with their inherent damage was pointed out. The major issue was to (anterior and posterior, respectively) arise from the main and kidney limitations. Prospective randomized studies would be base researches on serum creatinine only. renal artery. recommended to increase the evidence level. But we 18

EUT Congress News

Saturday, 21 March 2015

Future of biodiversity studies on the male genital tract Studies will yield new insights on the impact of STIs on male genital disorders ones from so-called “high-risk populations,” such as men having sex with men or HIV-positive patients, to deepen our knowledge on the impact of STIs on the male genital disorders.

fact, oncogenic HPV types were detected with proficiency in the WHO HPV LabNet global proficiency panel method in above 15% beta-globin positive samples.

Dr. Vitaly Smelov IARC WHO, Infections and Cancer Biology Group Lyon (FR)

This implies that caution is required when interpreting presence of DNA as an “infection.” In the light of all the above, the use of new diagnostic technologies would make a breakthrough in the studies of viral and bacterial epidemiology in the male.

Prostate cancer is the most common non-cutaneous cancer among males but despite its tremendous impact on the male population, the risk factors for developing the malignancy are not well known.

The novel metagenomic sequencing (MGS) approach allows comprehensive high-throughput analyses in a sample without prior cloning and has become instrumental in the discovery of new viruses in humans.

Among the exogenous factors that might affect the risk of development and progression of prostate cancer are histories of chronic inflammation of the prostate gland and, often primary acquired, sexually transmitted infections (STI).

“Potentially, sexually more risky behavior may increase the risk of acquiring viral infections.”

The physical access to the prostate gland is limited and current guidelines recommend the evaluation of expressed prostate secretion (EPS) by microscopy and culturing in patients with prostatitis-like symptoms and a prostate biopsy for confirming malignancy.

Although some studies speculate on a lower cumulative risk for development of prostate cancer in the presence of acute prostatitis, and lower prostate cancer incidence rates in HIV-positive compared with HIV-negative men, the relation between prostate chronic inflammation and prostate cancer in the presence of urogenital and sexually transmitted infections might be far more complex.

Recently, compared to analysis of urethral samples only, the analysis of EPS was found to increase the prevalence of human papillomavirus (HPV) infection, a causative agent for cervical malignancy and the most common STI worldwide, with additional 26% (Table 1).

DNA viruses are known to integrate into the host genome and contribute to carcinogenesis through insertional mutagenesis.

Table 1: Detection of human papillomavirus (HPV) infection in the male distal urethra as compared to in expressed prostate secretions HPV types

Urethra (%)

Prostate (%)

Urethra or Prostate (%)

Urethra and Prostate (%)

HPV+ men, in total

195 (25.9)

245 (32.6)

360 (47.9)

80 (10.6)

HPV- men, in total

557 (74.1)

507 (67.4)

674 (89.6)

390 (51.9)

HR-HPV+ men

184 (24.5)

208 (27.7)

316 (42.0)

76 (10.1)

LR-HPV + men

81 (10.8)

125 (16.6)

189 (25.1)

17 (2.3)

Single HPV infection

156 (20.8)

184 (24.5)

296 (39.4)

44 (4.9)

Multiple HPV infection

39 (5.2)

61 (8.1)

95 (12.6)

5 (0.7)

Number of studied men, total

752

Footnote: HR-HPV – high-risk, oncogenic HPV types, LR-HPV – low-risk, non-oncogenic HPV types Adapted from: Smelov V, Eklund C, Bzhalava D, Novikov A, Dillner J. Expressed prostate secretions in the study of human papillomavirus epidemiology in the male. PLoS One. 2013 Jun 14;8(6):e66630. doi: 10.1371/journal.pone.0066630. Print 2013.

Interestingly, HPV DNA in EPS samples was found to be less common among men above 40 years of age.

Absence of HPV DNA in prostate cancers, which occur among the elderly, does therefore not contradict the possibility that HPV (or other viruses) may infect prostatic epithelium among younger, sexually active men.

Thus, by the time prostate cancer has been developed, no viruses could be detected with currently used “classical” diagnostic technologies.

Contrary, MGS allows detecting the “signature” or “fingerprint” of viruses or bacteria in the host cells by the time the malignancy has been developed but the causative infection has resolved.

EPS might represent an informative sample material for the study of viral epidemiology in men, which is also easy to obtain during a routine non-invasive urological examination.

The recent first-in-principle study on MGS of EPS found no viruses but several bacterial reads in men run in Karolinska Institutet (Stockholm, Sweden) with prostatic chronic inflammation, with opposite results obtained for men with prostatic malignancy, supporting the potential role of viral infections in (Table 2) the prostate carcinogenesis.

In fact, large serological studies have supported the role of viral infection in prostate malignancy.

However, NAAT technologies-based studies applied for the detection of infections in the prostate show inconsistent associations, party attributed to chance, bias, or confounding by unknown risk factors in different male populations.

Potentially, sexually more risky behavior may increase the risk of acquiring viral infections. In this respect, the detailed history, including the data on Studying prostate gland specimens collected from different male populations in pre-cancer previously experienced period using new technologies will yield new insignts on microbiota of the male urogenital tract sexually transmitted diseases, past and current sexual behavior status The further application of new MGS technologies could be of great importance in the urological studies would improve the findings, since the significance of of microbiome in the male genital tract. sequencing data is based on the number of sequencing reads. Importantly, while the methods Studying specimens consecutively collected among remain expensive, the MGS-related costs tend to the different male populations in pre-cancer period decrease over time. that represent the prostate gland, including EPS, and adjacent genital sites with the use of novel Further studies should focus on the detection of viral technologies will broaden the knowledge on infections in pre-cancer period; in fact, by the time microbiota of the urogenital tract in men, prostate cancer has been developed, no viruses could epidemiology of urogenital and sexually transmitted be detected with currently used classical technologies. infections, and estimate their role in developing of prostate disorders.

A similar tactic has shown its efficacy for Merkel cell polyomavirus, in which studying required large In the era of personalized medicine such knowledge cohorts and extended follow-ups. The virus has will allow the development of strategies on been found to be an etiological agent of a rare prevention of prostate carcinogenesis.

Merkel cell cancer, while high MCV antibody level appeared already long before the tumor.

Saturday, 21 March It is possible that analysis of a larger number of 10.15-14.00: Joint meeting of the EAU Section of patients will reveal whether some of the microbes Andrological Urology (ESAU) and the EAU detected are associated with clinical diseases.

Section of Infections in Urology (ESIU) Andrological implications of urogenital In this respect, future studies should also focus on imfections different groups of male populations, including the

Tumour MicroEnvironment

It’s time to change the way we think about prostate cancer

Date of Preparation: February 2015

The analysis was also limited with the selection of specimens, low numbers of patients and employment of previous generation sequencing equipment.

New MGS technologies However, the very recent MGS discoveries on extended numbers of prospectively collected EPS samples are in the line with the primary discoveries on detecting more viral reads in the prostate secretions obtained from men with prostate malignancy than without, with all detected DNA viruses listed by the WHO/International Agency for Research on Cancer as oncogenic.

Presence of viral DNA Of note, the presence of viral DNA is not always proof of infection, as it might represent environmental contamination. Recent discoveries on HPV DNA prevalence on “environmental surfaces” (originally, toilet seats in international airports’ restrooms in 13 countries) found comparable with those reported from high-sexual, risk-taking groups in humans. In

GSK Sponsored Symposium

How, why, when risk stratification in newly diagnosed BPH patients with moderate symptoms

Table 2: Number of reads in patients with and without prostate cancer (PCa) from metagenomic sequencing Division

Controls (no PCa)

Cases (PCa+)

Human

17439 (64.3%)

9457 (66.8%)

Bacteria

2443 (9.0%)

733 (5.2%)

Viruses

1837 (6.8%)

2818 (19.9%)

Phages

1934 (0.5%)

108 (0.8%)

Other

2267 (8.4%)

426 (3.0%)

Unknown

1185 (4.4%)

614 (4.3%)

Negative control (water) TOTAL

0

0

27105

14156

Adapted from: Smelov V, Arroyo Mühr LS, Bzhalava D, Brown LJ, Komyakov B, Dillner J. Metagenomic sequencing of expressed prostate secretions. J Med Virol. 2014 Dec;86(12):2042-8. doi: 10.1002/jmv.23900. Epub 2014 Feb 14.

Saturday, 21 March 2015

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Date of Preparation 02 /15 CEM/Pharma/0001/15b

Saturday 21 March 18:00-19:30 Stockholm Room Ficha Técnica disponible en el stand Full SmPC available at the booth

EUT Congress News

19

Treatment strategies for CRPC in 2015 and beyond Next research wave will focus on identifying the best sequence and combination of agents Prof. Fred Saad Professor and Chief of Urology Director of Urologic Oncology University of Montreal Hospital Center Monreal (CA)

phosphatase) appear to further improve the overall survival advantage. It was also reassuring that after 49 months of follow-up, adverse events remained very much in line with earlier reports. Also of clinical importance was the significant delay in use of chemotherapy, delay in opiate use and decline in performance status.

Blocking AR signalling Enzlautamide targets the androgen receptor in a much more significant fashion than previously used AR inhibitors. Not only does enzalutamide block AR The primary approach to the systemic treatment of binding of androgens, it also inhibits AR translocation metastatic prostate cancer (PCa) is androgen into the nucleus and binding to the DNA. We have for deprivation therapy (ADT) which aims to lower serum sometime known that AR is actually over expressed testosterone levels to castrate level. Despite initial and hypersensitive to androgens in the CRPC state. By high response rates (>80%), most men eventually effectively inhibiting the AR, enzalutamide develop progressive disease following ADT; this is significantly improved outcome in metastatic CRPC in referred to as castration-resistant prostate cancer patients following chemotherapy. The phase 3 study (CRPC). included 1,200 patients that had progressed after at least one docetaxel-based chemotherapy regimen6.

Patients were randomized 2 to 1 between Until recently, therapeutic options which could be offered to patients with metastatic CRPC (mCRPC) enzalutamide and placebo. were very limited (docetaxel, mitoxantrone, zoledronic acid).

The study was terminated early given the significant improvement of 4.8 months (P<0.001) in overall Since 2010, there has been a rapid evolution in survival with a 36% reduction in the risk of death. It targeted therapeutic options for patients with mCRPC. also improved median rPFS by 5.4 months (P<0.001) Current and emerging intervention strategies in phase and increased time to PSA progression by 5.3 months III trials include androgen synthesis inhibitors, (P<0.001). Significant improvements in pain control androgen receptor (AR) signaling inhibitors, systemic and quality of life endpoints were positively in favour chemotherapy, immunotherapy, and radionuclide of enzalutamide. The drug was very well tolerated therapy. with no difference in serious adverse events with the placebo arm except for seven cases of seizures (0.9%) Inhibition of androgen biosynthesis of which almost all cases had an underlying factor that Abiraterone acts via inhibition of CYP-17 lyase and may have contributed. In 2014 the results with hydroxylase, enzymes essential for androgen enzalutamide in the chemo-naive setting were production. This results in a profound reduction in reported7. androgen production at the level of the testes, adrenals and even intra-cellular production of The study showed significant improvements in the androgens by the cancer cell itself. In order to two primary endpoints, radiographic progression attenuate mineralocorticoid-like effects that arise (rPFS) as well as overall survival (OS). An impressive from an increase in aldosterone production when 81% improvement of rPFS compared to placebo and a abiraterone is given on its own, prednisone is always 29% reduction in the risk of death (p=0.0001) were co-administered with it. The phase 3 study included reported. The time to chemotherapy initiation was also improved by 65%. These results were obtained 1,200 patients who had progressed after at least one even though this was the first chemo naïve study to prior docetaxel based chemotherapy regimen.

Patients were randomized 2 to 1 between abiraterone include patients with visceral metastases. Of note were the PSA response rates (declines of 50%) of 1000 mg plus prednisone daily versus placebo plus 78% and a measurable response rate of 59% (19% CR prednisone. and 40% PR).

The study published was in the NEJM in 2011 and reported a 3.9 month improvement in overall survival Predicting resistance to abiraterone and enzalutamide? with a 36% reduction in the risk of death2. Patients also had significant reductions in PSA and improved Abiraterone and Enzalutamide offer well-tolerated and effective therapeutic options for patients with PFS as well as pain control compared to patients having received placebo plus prednisone. Tolerability mCRPC; however a subset of patients does not respond. Being able to predict resistance to ARwas generally very good with very few grade 3-4 targeting therapies has been an intense focus of toxicities mainly related to fluid retention and hypokalemia. A second study using abiraterone in research. One hypothesis was that the presence of chemotherapy-naive mCRPC patients showed median androgen-receptor splice variant 7 (AR-V7) in tumors would be associated with resistance to enzalutamide radiographic progression-free survival (rPFS) of 16.5 and abiraterone. This appears to have been confirmed months with abiraterone /prednisone vs. 8.3 months in a study published in the NEJM in 2014 by the with placebo/prednisone (HR 0.53; 95% CI, 0.4-0.62; Hopkins group. They found that patients with P<0.001). detectable AR-V7 in their CTC’s had significantly worse outcomes when treated with both abiraterone Overall survival was improved with abiraterone at and enzalutamide.

35.3 months vs. 30.1 months for prednisone alone, a 21% reduction in the risk of death with this novel agent (P of 0.0151 did not reach the pre-specified Among men receiving enzalutamide or abiraterone, value of 0.0035 for statistical significance)3,4. The final AR-V7-positive patients had statistically significantly results of the study were published in 2015 and lower PSA response rates than AR-V7-negative patients and shorter PSA progression-free survival, clinical or confirmed a statistically significant overall survival improvement5. This is even more impressive when radiographic progression-free survival, and overall one considers the fact that 44% of patients on survival. These results strongly suggest that detection placebo had ended up actually getting abiratérone of AR-V7 may be associated with resistance to and 80% of patients had received subsequent therapy enzalutamide and abiraterone. These patients should at the time of analysis. probably be considered for immediate chemotherapy and this may be a first step in our efforts to personalize Of interest are the sub- analyses that suggest earlier and rationally choose the best therapeutic options for treatment (no pain, lower PSA and lower alkaline individual patients with mCRPC.8

Therapies for mCRPC adapted from Bishr and Saad Nature reviews in urology 20131.

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Chemotherapeutic agents Until recently, disease progression or docetaxel toxicity left patients with no life-prolonging secondline treatment options. Cabazitaxel provides new second-line therapeutic regimens to manage patients with mCRPC following docetaxel. Results from the Phase 3 study, demonstrated a 30% reduction in the risk of death with cabazitaxel in docetaxel-progressed mCRPC, making it the first agent to significantly improve OS in docetaxel-resistant or refractory mCRPC (15.1 months in the cabazitaxel plus prednisone group vs 12.7 months in the mitoxantrone plus prednisone group; HR 0.70, 95% CI 0.59-0.83; p<0.0001).9 Statistically significant improvements were also observed in PFS (2.8 months vs 1.4 months) and PSA response rates (39.2% vs 17.8%; p=0.0002) in patients treated with cabazitaxel plus prednisone versus mitoxantrone plus prednisone. Phase III clinical trials are underway for the assessment of lowered dose of cabazitaxel (20 mg/m2) in the PROSELICA trial and for the use of cabazitaxel in the chemotherapy-naïve setting in the FIRSTANA trial.

Radiopharmaceuticals The importance of bone-targeting agents cannot be understated as >90% of patients with mCRPC develop bone metastases (likely due to ADT-associated osteoclast activation). Bone metastases result in weakened bone integrity and associated skeletal complications (such as pathologic fractures, radiotherapy or surgery to bone, hypercalcemia, and spinal cord compression), significant morbidity, and decreased QoL. To date the bone targeted therapies in the form of zoledronic acid and denosumab have been effective in reducing skeletal complications but without improvements in overall survival.

Radium-223 dichloride, an alpha-emitter, targets bone metastases with high-energy alpha particles of short range (<100µm; dose to bone marrow is therefore low) and is the first bone targeted-agent to show an improvement in OS in mCRPC patients.10 In the pivotal international, randomized phase III ALSYMPCA trial, treatment with radium-223 resulted in a statistically significant improvement in median OS of 3.6 months (14.9 months with radium-223 vs 11.3 months with placebo; HR 0.70; p<0.001) in patients with symptomatic mCRPC (>2 bone metastases and no visceral metastases) who had either received prior docetaxel, refused docetaxel, or were not eligible for docetaxel (57% pre-treated with docetaxel and 43% untreated with docetaxel).10 In addition to a favorable safety profile (minimal myelotoxicity), the frequency of symptomatic skeletal events (SSEs) was reduced in the radium-223 treated group with an improved time to first SSE (15.6 months vs 9.8 months; HR 0.66; p<0.001) and an increased QoL response rate (25% vs 16%; p<0.02).10 There is also evidence of a dose-dependent effect of radium-223 on disease biomarkers such as serum levels of bone alkaline phosphatase (ALP) suggesting that control of bone disease with radium-223 may affect cancer-related outcomes. The low-toxicity profile and non-overlapping mechanism of action of radium-223 with other agents could yield a potential for combination treatment with other therapies to develop even more effective strategies. Clinical trials are being planned to address these issues.

Immunotherapeutic agents Prostate cancer cells overexpress several tumorassociated antigens, such as PSA, prostatic acid phosphatase (PAP), and prostate-specific membrane antigens, and the indolent time course of metastatic disease potentially allows for the generation of an antitumor response making them vulnerable to immune-based therapies. Two immunotherapeutic strategies are currently being developed: therapeutic cancer vaccines and immune checkpoint inhibitors.

Exciting new research continues using both the hormonal and non-hormonal strategies that also include novel targeted agents

vaccine. In a phase II randomized, controlled, and blinded study PROSTVAC-V/F demonstrated a 44% reduction in the death rate and an 8.5 month improvement in the median OS (HR 0.56; p< 0.0061).12 The phase 3 study completed recruitment in 2014 and results are expected over the next two to three years.

Ipilimumab, an immune checkpoint inhibitor, is a human monoclonal antibody that binds to cytotoxic T lymphocyte-associated antigen 4 (CTLA4) negatively regulating T-cell activation, and exhibits an increased antitumor immune response either alone or in combination with GM-CSF or radiotherapy.13,14 The phase 3 chemo naïve study is expected to report over the next year.

The role of the urologist Beyond all the positive effects of these effective hormonal agents, the most attractive features for both patients and physicians are their ease of administration and excellent toxicity profiles compared to cytotoxics. For many patients who are not candidates for chemotherapy or who refuse chemotherapy we now have options that are available.

For urologists interested in being involved in the management of mCRPC these therapeutic options may allow them to continue to manage patients further along the disease spectrum. However it is important to keep in mind that these patients will require a team approach since although the drugs may be easier to handle than cytotoxics, the disease remains a challenge and all patients will eventually succumb.

It will be critical to know when patients should go on to subsequent therapy before they progress to a point where they are no longer able to tolerate cytotoxics that will continue to play a pivotal role in mCRPC. Future perspectives The next wave of research will focus on figuring out the best sequence, or possible combination, of agents.

Another area of interest is preventing or delaying the appearance of metastases in patients who are castration resistant but with no clinical evidence of metastases. So far there is no approved regimen for these patients who are obviously at high risk.

A hormonal approach appears logical and there are now ongoing phase 3 studies using a new AR inhibitor ARN 509 as well as enzalutamide to establish their role in this area of unmet medical need. Also in clinical trials is the earlier introduction of these agents in patients with hormone-sensitive advanced prostate cancer to attempt to increase efficacy of standard ADT. The hope will be to eventually cure more patients with high-risk cancer with an aggressive but rational multi-modal approach.

Conclusion Exciting new research continues using both the hormonal and non-hormonal strategies that also include novel targeted agents. It is very much welcome that physicians treating mCRPC will have a growing armamentarium to tackle the disease. The Sipuleucel-T is an activated cellular immunotherapy, challenge will be learning how, when and in whom to utilizing autologous antigen-presenting cells activated use these agents. A rational and biologically-based ex vivo with a recombinant fusion protein containing approach will avoid unnecessary harm to patients as PAP linked to granulocyte-macrophage colonywell as our healthcare systems. stimulating factor (GM-CSF), an immune-cell activator. The phase III IMPACT study showed that Due to space constraints the reference list has been despite no change in PFS or PSA response compared omitted. Interested readers can send a request for with placebo, sipuleucel-T showed a 4.1 month the complete list at EUT@uroweb.org. median survival benefit (25.8 months vs 21.7 months) and a 22% reduction in the risk for death (HR=0.775; Friday, 20 March p=0.03) in patients with asymptomatic or minimally 13.15-15.45: Urology Beyond Europe symptomatic mCRPC.11 Joint Session of the European Association of Urology (EAU) and the Société Internationale Other immunotherapeutic agents being developed d’Urologie (SIU) include PROSTVAC-V/F, a pox viral PSA-targeted Saturday, 21 March 2015

Today’s European Urology Events 1. Introduction to social media - J.W.F. Catto, Sheffield (UK)

Social Media course March 21st

2. Social media for beginners - M.R. Cooperberg, San Francisco (US) 3. Why social media matters - D. Murphy, Melbourne (AU) 4. Using social media in medicine - A. Kutikov (US) 5. Examples of best practice - M.R. Cooperberg, San Francisco (US) 6. Trends and developments in social media - D. Murphy, Melbourne (AU) 7. www.europeanurology.com - A. Kutikov (US) 8. Questions and answers - J.W.F. Catto, Sheffield (UK)

An Introduction to social media.

Why this is important for urologists.

Surgery in Motion March 21st

Panel: J.W.F. Catto, Sheffield (GB), M. Graefen, Hamburg (DE), A. Mottrie, Aalst (BE)

To be held in room N109-110 from 11.00 to 14.00

12.00 - 12.05 Introduction: J.W.F. Catto, Sheffield (GB) A. Mottrie, Aalst (BE) 12.5 - 12.25 Robot-assisted sacrocolpopexy for pelvic organ prolapse: Surgical technique and outcomes at a single high-volume institution: A. Ploumidis, Athens (GR)

Initial Clinical Experience: S. Leslie, Hollywood (US) 13.05 - 13.25 Robotic nephroureterectomy: A simplified approach requiring no patient repositioning or robot redocking: H. Zargar, Cleveland (US) 13.25 - 13.45 A new robot for flexible ureteroscopy: Development and early clinical results: R. Saglam, Ankara (TR)

12.25 - 12.45 A Hybrid Radioactive and Fluorescent Tracer for Sentinel Node Biopsy in Penile Carcinoma as a Potential Replacement for Blue Dye: O.R. Brouwer, Amsterdam (NL)

13.45 - 14.00 Discussion: J.W.F. Catto, Sheffield (GB) A. Mottrie, Aalst (BE)

12.45 - 13.05 Transvesical Robotic Simple Prostatectomy:

To be held in room Stockholm, from 12.00 to 14.00

Come and see the Residents Corner Award winners accept their prize:

Residents’ Corner Awards

Propensity-Matched Comparison of Morbidity and Costs of Open and Robot-Assisted Radical Cystectomies: A Contemporary Population-Based Analysis in the United States Jeffrey J. Leow, Stephen W. Reese, Wei Jiang, Stuart R. Lipsitz, Joaquim Bellmunt, QuocDien Trinh, Benjamin I. Chung, Adam S. Kibel, Steven L. Chang Issue: 3, Volume: 66, Pages: 569 - 576 Survival Outcome and Treatment Response of Patients with Late Relapse from Renal Cell Carcinoma in the Era of Targeted Therapy Nils Kroeger, Toni K. Choueiri, Jae-Lyn Lee, Georg A. Bjarnason, Jennifer J. Knox, Mary J. MacKenzie, Lori Wood, Sandy Srinivas, Ulka N. Vaishamayan, Sun-Young Rha, Sumanta K. Pal, Takeshi Yuasa, Frede Donskov, Neeraj Agarwal, Min-Han Tan, Aristotelis Bamias, Christian K. Kollmannsberger, Scott A. North, Brian I. Rini, Daniel Y.C. Heng Issue: 6, Volume: 65, Pages: 1086 – 1092

March 21st

To be held at 17.15 at the end of Residents and Young Urologists Day in room N105-106

europeanurology.com Saturday, 21 March 2015

EUT Congress News

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Robot-assisted renal surgery ESU Course 7: Robotic pyeloplasty- multichannel or single technique Dr. Nicolòmaria Buffi University Vita-Salute San Raffaele Dept. of Urology Milan (IT)

The surgical management of ureteropelvic junction obstruction (UPJO) has dramatically evolved over the past 20 years due to the development of new technologies.

Since its introduction into clinical practice in 1993, laparoscopic pyeloplasty (LP) has progressively gained popularity and acceptance in the urologic community and has become a well-established surgical option for UPJO treatment. The long-term results are comparable with those of open surgery with success rates ranging from 90% to >95%.

LP is performed using both the transperitoneal and retroperitoneal approaches. Nevertheless, it remains a technically demanding procedure requiring high proficiency in laparoscopic suturing and endoscopic skills.

Thus, with its dependence on extensive and precise intracorporeal suturing, LP is one of the laparoscopic procedures most likely to benefit from robotic assistance. In the last five years, the worldwide spread of robotic surgical machines, such as the da Vinci system (Intuitive Surgical), has changed the way urologists approach complex laparoscopic reconstructive procedures.

was performed using running sutures to fasten the procedure. The posterior aspect of the anastomosis is performed, and then the double pigtail ureteral stent is inserted.

Once the stent is correctly positioned, the anterior aspect of the anastomosis is completed. At the end of the procedure, once complete hemostasis is achieved, a suction drain is left in place. In the case of a crossing vessel, a dismembered pyeloplasty with transposition of the reanastomosed ureter ventral to the vessels was performed.

Transperitoneal robot-assisted pyeloplasty Patients are positioned in a 60° flank position with the bed flexed. Pneumoperitoneum is induced with the Hasson technique, typically in the umbilical area for aesthetic reasons. In obese patients the optical port is positioned on the pararectal line 2.3 cm cranially to the umbilicus. The two operative robotic ports are positioned respectively at the midpoint between the anterior superior iliac spine and the umbilicus and on the pararectal line 1 cm beyond the costal arch.

The 5-mm assistant port is positioned on the midline at the midpoint between the umbilicus and the xiphoid process. A 30° laparoscope (down) is routinely used. The right side of the parietal peritoneum, overlying Gerota’s fascia, is incised, and the target structures (the ureter, the dilated renal pelvis, and eventually the aberrant crossing vessels) are exposed.

On the left side, typically the white line of Toldt is incised and the left colon is mobilized medially to expose Gerota’s fascia, which is incised isolating the target structures.

Robot-assisted pyeloplasty (RAP) is usually performed by the transperitoneal approach even though recent reports have stated the retroperitoneal robot-assisted LP approach is feasible and efficient.

In slender patients with a dilated pelvis, a transmesocolic approach can be used to directly reach the target structures. The pyeloplasty technique is similar to what has already been described when performing the retroperitoneoscopic approach.

Retroperitoneoscopic robot-assisted pyeloplasty Patients are positioned in the full flank position, with the bed flexed to bridge the surgical area and to increase the space between the iliac crest and the costal arch.

Single-site robotic-assisted pyeloplasty Laparoendoscopic single-site surgery (LESS) has been proposed as an evolutionary step beyond standard laparoscopy and, since its introduction, has been increasingly adopted by urologists worldwide.

The retroperitoneum is bluntly entered at the tip of the 12th rib using two S retractors through a 1.5-cm skin incision. The retroperitoneal space is created by using balloon dissection using our previously described technique. The 12-mm Hasson-style optical port is positioned at the tip of the 12th rib.

The adoption of this technique is mainly driven by the hypothesis that the minimization of the skin incision to gain access to the abdominal or pelvic cavities may benefit patients in terms of port-related complications, recovery time, postoperative pain, and cosmetic results.

The other two operative 8-mm robotic trocars are positioned at the conjunction of the 12th rib with the “erector spinae” muscle and at the level of the anterior axillary line 6–8 cm cranially to the iliac crest, respectively. The assistant 5-mm port is positioned along the erector spinae muscle, some centimeters cranially to the iliac crest, and is used for suction, retraction, and needle insertion/removal. The da Vinci robotic system is then positioned with the arms entering 25–30° anteriorly to the head of the patient.

A 30° optic is always used. Gerota’s fascia is longitudinally incised to widen the surgical area and to directly expose the target structures, such as the ureter, the dilated renal pelvis, and the stenotic UPJ.

“Single site robotic-assisted pyeloplasty is feasible, reproducible and has better cosmesic results.”

Robotic bipolar forceps and monopolar scissors are used to dissect the proximal ureter and the dilated renal pelvis. The stenotic UPJ is excised; the ureter was then spatulated longitudinally and the pyeloplasty performed according to the AndersonHynes technique.

The plasty is performed with an interrupted 5-0 Vicryl suture with an RB2 curved needle in the first 12 patients. In the last series, the plasty reconfiguration

However, this technique remains highly challenging, even for expert laparoscopic surgeons. Although application of the da Vinci robotic single-port platform (Intuitive Surgical) combined with 8-mm standard instruments has the potential to overcome some of these challenges, such as the steep learning curve and difficult intracorporeal suturing, reports to date reveal only a marginal benefit of this approach, largely due to internal and external robotic-arm clashing.

More recently, LESS has been merged with robotassisted surgery (R-LESS) using a new, robotic, single-site platform with 5-mm flexible instruments.

Evidence supporting R-LESS pyeloplasty has been limited to a single small case series.

The new da Vinci single-site robotic surgery platform is a semirigid robotic operative system designed to work with the Intuitive da Vinci Si Surgical System (Intuitive Surgical). The system, which incorporates a multi-channel single port that accommodates two curved robotic cannulas, allows for the passage of interchangeable semirigid instruments that cross each other within the trocar so that the right-entering instrument becomes the left-sided operative instrument in the abdominal cavity and vice versa.

The master-slave software of the da Vinci platform automatically exchanges the master-slave controls allowing the surgeon at the console to control the tip Robot-assisted pyeloplasty has the same results as open of the instrument with his right hand at the right side surgery but has a short learning curve and better suture quality of the surgical field and the opposite for the left.

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Robotic-assisted surgery has the same results as open surgery but with a short learning curve for surgeons and a shorter hospital stay benefit for patients

Unfortunately, the surgical instruments do not have the wrist at the tip like conventional robotic da Vinci instruments do. In addition to the robot-controlled instruments and optic (a 30° scope down oriented), the specifically designed port allows for the access of additional one or two conventional laparoscopic entrances for the assistant.

anatomical situations and surgical history. Roboticassisted pyeloplasty offers all the advantages of minimally invasive surgery, such as: • • •

Short hospital stay; Quicker return to normal activities; Improved cosmesis (Single site robotic-assisted pyeloplasty); and Reduced morbidity

Conclusions • Robotic-assisted pyeloplasty has the same results as open surgery. Compared to a laparoscopic technique, Single site robotic-assisted pyeloplasty is feasible, robotic-assisted pyeloplasty has a short learning curve reproducible and has better cosmesic results. and a better suturing quality.

Saturday, 21 March The urologist must be familiar both with the 14.30-17.30: ESU Course 7 transperitoneal and retroperitoneoscopic approach to Robot renal surgery offer the best approach to the patient, related to

The EAU History Office presents: 30 Milestones in Urology Urologists have many reasons to be proud of their contributions to medical history. To underline this fact and to mark the 30th Annual EAU Congress, 30 different aspects of this important medical specialisation have been bundled together in 30 Milestones in Urology.

This attractive volume looks at key elements in urological theory and practice, both past and present. The self-contained texts are presented in a concise, varied and original manner, supported with numerous high-quality illustrations. It is a book that not only every urologist will want to read, but also every doctor or paramedic who has an interest in the history of medicine.

•

30 Milestones is available free of charge for all EAU Members visiting the 30th Annual EAU Congress. Pick up your copy at the EAU Booth, while stocks last!

In the words of the authors: Within the totality of medicine, which remains both an art and a science, urology is a fascinating and flourishing specialisation. Urologists can rightly be proud of what they have achieved throughout the long course of medical history. They have been founders and pioneers in many different areas of knowledge and expertise.

30 Milestones in Urology by Erik Felderhof, Johan J. Mattelaer, Friedrich Moll, Dirk Schultheiss and Philip Van Kerrebroeck.

of the heroic period of modern urology, with the founding of major urological centres in cities like Paris, London, Berlin and Vienna. This breakthrough went hand in hand with the invention of the most important urological instrument of them all: the cystoscope, demonstrated by Maximilian Nitze in Vienna in 1879. This made it possible to look inside the human body for the very first time.

It was also with the aid of a cystoscope that Georg Kelling performed the first laparascopy in 1901.

Is it not the case that circumcision, castration and lithotomy are the oldest known surgical procedures in which the patients actually survived? And is it not true that uroscopy, the careful examination of urine in a clear glass matula, is the oldest diagnostic tool in all of medicine?

Urologists were the pioneers of minimally invasive surgery. The development of ESWL (extracorporeal shock wave lithotripsy) made it possible to use shock waves passed into the body exteriorly to shatter stones in the bladder, kidney or ureter. The percutaneous litholapaxy procedure meant an end to painful lumbotomy for the removal of pyelum stones.

After many centuries of groundbreaking work by the ‘piss lookers’, barber-surgeons and stone cutters, who we can now consider to be the proto-urologists, the final years of the 19th century witnessed the start

Similarly, urologists were amongst the first to embrace laparascopic surgery with enthusiasm, even for major operations, and today robot-surgery is already well-established in many urological departments.

Saturday, 21 March 2015

Evolving technology in the diagnosis of urothelial cancer Lack of published studies systematically assessing photo dynamic diagnosis in the upper urinary tract Dr. Jochen Walz Department of Urology Institut PaoliCalmettes Cancer Centre Marseille (FR)

Recently, the diagnosis as well as the management of urothelial cancer improved due to new technologies.

Here especially the use of the photodynamic diagnosis (PDD) has changed the current practice.1 PDD is performed using blue light with a wave length of 360-450nm after intravesical instillation of 5-aminolaevulinic acid (ALA) or hexaminolaevulinic acid (HAL) prior to the procedure. These molecules are converted to protoporphyrin IX which is then absorbed by healthy cells, yet remains accumulated in tumor cells. Under blue light excitation, the accumulated pigment emits red fluorescence, while normal bladder tissue remains blue. This allows the identification of urothelial cancer tissue in the bladder.

Despite this PDD is associated with a risk of false positive lesions, which decreases its specificity relative to standard resection (white light). The reasons for this can be the phenomenon of tangential fluorescence as well as inflammation due to previous resections or due to previous BCG-therapy. For this reason it is recommended to use PDD only at distance of BCG therapy (12 weeks) in order to avoid false positive detections.2 In order to perform PDD special equipment is necessary such as special optics, cameras and light sources, which is associated with a certain investment. Moreover, either 5-aminolaevulinic acid or hexaminolaevulinic acid needs to be instilled into the bladder before the procedure. Both are costly drugs. Therefore, PDD is associated to an increase of costs relative to standard work-up with white light.

NBI in bladder cancer The use of NBI in the management of bladder cancer is less evaluated in the literature than PDD. A recent meta-analysis including 611 patients showed that the use of NBI relative to white light increased the detection rate of urothelial cancer lesions by 17% (95% CI: 10-25).5 The additional detection of CIS with NBI relative to white light was increased by 28% (95% CI: 14-45). This report highlighted that the use of NBI also seems to be especially of benefit in patients with CIS. Currently, there is few data addressing the rate of residual tumor at a second resection but tumor persistence at first cystoscopy was reduced by NBI from 17% to 4% and from 31% to 15% for white light and NBI, respectively, in two separate studies.6,7 Similar to PDD, this is only of relevance if it translates into a better cancer control. So far data on cancer control using NBI is limited. One study addressed this endpoint and showed with NBI a 18% lower recurrence rate at 12 months relative to white light (33% vs. 51%).7 Further research addressing this outcome is necessary before clear conclusions in favor of NBI can be drawn for clinical practice. On the long-term both technologies need to provide proof of favorable impact on cancer progression and cancer-specific survival.

Moreover, it is necessary to investigate the cost effectiveness of these technologies in daily practice that should ideally translate in a lower overall cost of bladder cancer management on a population base when using PDD or NBI. For the time being, due to the availability of better data, PDD is recommended by the EAU Guidelines and should be performed instead of random biopsies when bladder CIS or high-grade tumor is suspected (e.g., positive cytology, recurrent tumor with previous history of a high-grade lesion).

Evolving technology for the upper urinary tract The use of new technologies for the management of upper urinary tract urothelial cancer is also very interesting since the same improvements in diagnosis and management could be expected and are of clinical importance. Their use is unfortunately limited or difficult due to anatomical (very restricted space) Another evolving technology aiming to improve the and technical issues (need of small instruments, management of bladder cancer is the use of narrow limited access). Especially the need of instillation of band imaging (NBI).3 NBI enhances the contrast between normal urothelium and hypervascular cancer 5-aminolaevulinic acid or hexaminolaevulinic acid before the procedure renders the use of PDD in the tissue based on the principle that the penetration of light into tissue is increasing with increasing upper tract difficult. Preliminary data is based on the wavelength. By illuminating the tissue with specific administration of oral ALA three to four hours before wavelengths that are absorbed by hemoglobin (blue the procedure.

415nm and green 540 nm), the hypervascular tissue appear dark green against a light pink appearance of The use of PDD in the upper tract increased the normal tissue. detection rate of uothelial cancer by 27% relative to white light.8 In the upper urinary tract the use of NBI NBI is also associated with the same limitations as PDD is more convenient since only a specific camera for regarding the low specificity due to false positive the ureteroscope is necessary to do this exam. The data addressing the use of NBI in urinary upper tract lesions (inflammation) but does not need the instillation of a drug before the procedure. Therefore, it urothelial cancer is very limited and only preliminary is possible to use it in detecting and treating urothelail data is available. In one study the use of NBI in the cancer of the upper urinary tract, where the use of PDD upper tract provided additional diagnostic information is more cumbersome. To perform NBI, there is also the such as additionally detected cancer lesions in 14% need of special equipment such as a special camera or and identification of extended tumor limits in 9%, endoscope but there are no additional costs per resulting in an improved cancer detection rate of procedure. It is therefore less costly than PDD. 23%.9 PDD in bladder cancer The use of PDD in the management of bladder cancer was widely evaluated in the literature. A recent meta-analysis including 900 patients showed the use of PDD relative to white light increased the detection rate of urothelial cancer lesions by 20% (95% CI: 8-35).1 The additional detection of CIS with PDD relative to white light was increased by 39% (95% CI: 23-57). This highlights that the use of PDD is especially of benefit in patients with CIS, a cancer subtype that clearly represents a diagnostic challenge.

Moreover, the rate of residual tumor at a second resection due to incomplete resection at the first resection was decreased by the use of PDD from 35% with white light to 15% with PDD. However, this is only of relevance if it translates into better cancer control such as recurrence-free survival. Several studies addressed this endpoint and showed with PDD a 16-27% higher recurrence-free survival rate at 12 month and a 12-15% higher recurrence-free survival rate at 24 months, all of them being significant.1 Another meta-analysis addressing the recurrence rates in 634 patients showed significant 24% risk reduction in favor of PDD relative to white light where patients with PDD showed a recurrence rate of 36% vs. 45% with white light.4 Saturday, 21 March 2015

No published studies Currently, there are no studies published evaluating the use of PDD or NBI in the same systematic fashion as it was done for urothelial cancer of the bladder. In view of this single centre experiences, no conclusion about the clinical value of PDD or NBI in the upper urinary tract is possible. It is clear that improved diagnosis and treatment of urothelial cancer in the upper urinary tract is of high interest as reliable diagnosis and estimation of disease extent could substantially change the management by allowing endoscopic conservative treatment options. Other evolving technologies that might be helpful with this task in the future are optical coherence tomography and confocal laser endomicroscopy. So far, only very preliminary data with this technology is available.

References 1. Kausch I, Sommerauer M, Montorsi F, Stenzl A, Jacqmin D, Jichlinski P, et al. Photodynamic diagnosis in non-muscle-invasive bladder cancer: a systematic review and cumulative analysis of prospective studies. Eur Urol.

2010;57:595-606.

2. Draga RO, Grimbergen MC, Kok ET, Jonges TN, van Swol CF, Bosch JL. Photodynamic diagnosis (5-aminolevulinic acid) of transitional cell carcinoma after bacillus Calmette-Guerin immunotherapy and mitomycin C

PDD of carcinoma in situ

PDD of pTa tumors

intravesical therapy. Eur Urol. 2010;57:655-60.

Editorial Note: Due to space constraints the reference 3. Cauberg EC, Kloen S, Visser M, de la Rosette JJ, Babjuk list has been shortened. Interested readers can M, Soukup V, et al. Narrow band imaging cystoscopy request for the complete list by sending an email to improves the detection of non-muscle-invasive bladder EUT@uroweb.org. cancer. Urology. 2010;76:658-63.

4. Burger M, Grossman HB, Droller M, Schmidbauer J, Friday, March 20 Hermann G, Dragoescu O, et al. Photodynamic diagnosis 13.15-15.45: Urology Beyond Europe of non-muscle-invasive bladder cancer with Joint Session of the European Association of hexaminolevulinate cystoscopy: a meta-analysis of Urology (EAU) and the Japanese Urological detection and recurrence based on raw data. Eur Urol.

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Saturday, 21 March 2015

New EAUN guidelines to benefit bladder cancer patients EAUN workshop to launch new guidelines on bladder instillations Giulia Villa, RN EAUN Board member Milan (IT)

The chance to participate in developing the EAUN Intravesical instillation in non-muscle invasive bladder cancer guidelines has inspired me since being part of an international group of expert colleagues is a once in a lifetime opportunity!

It’s an amazing opportunity for many reasons: it creates an open forum among colleagues to share and collate the best advice and recommendations treating of bladder cancer patients. It gives us a chance to see how we measure up with expert colleagues regarding the best available procedures, and allows the exchange of ideas related to the challenges and difficulties we encounter in clinical practice. Moreover, we can also analyse possible strategies on how to implement these recommendations.

particular interest are those about intermittent urethral catheterisation in adults, continent urinary diversion and transrectal ultrasound guided biopsy of the prostate. The majority of these guidelines has also been translated to other languages and is periodically submitted to a rigorous process of revision and update. The guidelines are also available free of charge via the EAUN’s website.

Holistic nursing care The most recent EAUN guidelines tackled intravesical instillation with mitomycin C and bacillus Calmette-Guérin (BCG) in non-muscle invasive bladder cancer, a topic of debate among nurses, particularly with regards to safety during treatment and patient education. The skills a nurse must possess to manage this procedure extend beyond the clinical setting but also touch on education and social skills since the treatment pathway also includes the guidance of patients during a treatment course that often takes several weeks (with possible repeat procedures).

Discussing this topic also led to in-depth analysis, which is particularly needed within the Italian context since many issues are still being debated.

Last but not least, it gives nurses a chance to strengthen and learn rigorous methodological approaches, such as those used for the creation of these guidelines.

In the European Union, the age-standardised incidence rate for bladder cancer is 27 per 100,000 for men and six per 100,000 for women (Ferlay et al., 2008a). Bladder cancer incidence has dropped in some registries, possibly reflecting the decreased impact of causative agents, mainly smoking and occupational exposure (Bosetti et al., 2011). Mortality from bladder cancer has also decreased, possibly reflecting an increased standard of care (Ferlay et al., 2008b). Approximately 75% of patients with bladder cancer present with a disease confined to the mucosa (stage Ta, CIS) or submucosa (stage T1). These categories are grouped as non-muscle-invasive bladder tumours.

The EAUN, among its many important roles, is active in the development, implementation, and revision of the guidelines used by nurses who work in urology.

A lot of work has been done in recent years to assist colleagues with guidelines distribution and implementation. Among the published guidelines, of

Non-muscle invasive bladder cancer (NMIBC) has a high prevalence due to low progression rates and long-term survival in many cases (Burger et al., 2013).

From the prognostic viewpoint, NMIBC falls into one of three categories: low-risk, intermediate-risk and high-risk for progression and recurrence according to

the European Organization for Research and Treatment of Cancer criteria (Babjuk et al., 2013).

Based on tumour risk category, the EAU Guidelines recommend a specific intravesical treatment (Babjuk et al., 2013).

focused on education prior to instillation, followed by the management principles on nursing The EAUN guidelines aim to provide recommendations interventions, including insightful recommendations on behavioural conduct, evidence-based and shared for treatment management (patient assessment, by experts for an optimal treatment regimen. These preparation of intravesical medication, recommendations must support the clinical decisions administration, and patient education). The next of the professional based on his experience, enabling chapter explained the recommendations regarding him to evaluate and personalise the assistance given complications and side effects of BCG and to the patient, while considering clinical settings and mitomycin C, how to reduce risk of side effects and conditions, patient preferences and available manage side effects. The final chapter summarised resources. the literature on patient quality of life.

Guidelines development The process of guidelines development began in September 2013, with the creation of the team, coordinated by Susanne Vahr (DK), an expert colleague who has worked on guidelines development, and composed of five other nurses, namely, W. De Blok (NL), B. Thoft Jensen (DK), N. Love-Retinger (US), B. Turner (UK), G. Villa (IT) and urologist Jan Hrbácek (CZ). Each panel member developed a part of the guidelines, which was then shared and discussed with the other members. The final version was then subjected to external blinded review.

The third part of the guidelines consists of documents, which help the nurse understand what has to be documented. Aside from examples there is a glossary section with abbreviations and an appendix, including many useful recommendations presented in summary tables and lists, such as a checklist of patient information, management options for side effects (associated with intravesical BCG), examples of training documents, and detailed step-by-step documentation of the procedures for BCG and mitomycin C instillation.

Copies of the new guideline are available at the EAUN Booth in Hall 7 after the presentation of the guideline during the workshop dedicated to this topic. The workshop will be held tomorrow, 22 March, in Hall 7, Room Istanbul from 9 to 9.45 hrs.

The written guidelines are made up of three parts.

The first part is methodological and explicitly described the process used for writing guidelines and the definitions of terms. The second and principal part Due to space constraints the reference list has been included chapters regarding indications and omitted. Interested readers can send a request for contraindications to intravesical instillation, and the the complete list at EUT@uroweb.org. alternatives to the use of bacillus Calmette-Guérin and mitomycin C. These are followed by chapters on care pathway and safety.

Sunday, 22 March 09.00-09.45: Workshop 5, 16th EAUN In these chapters, the European Safety Regulation, International Meeting risk factors and exposure are presented, which are Intravesical instillation very important for the safety of nurses, healthcare workers, and patients. The succeeding chapter

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ADVERTORIAL

Improving therapeutic management of NMIBC En-bloc resection – The future standard of care?

To date transurethral resection of bladder tumours (TURBT) is the cornerstone of treatment for non-muscle invasive bladder carcinoma (NMIBC)1. However, there is evidence of a high rate of tumour recurrence after primary resection. About 50-70% of all patients will have a recurrence after their initial treatment2. Despite all technological advances, NMIBC therefore continues to represent a challenging pathology.

The comparably insufficient therapeutic management of NMIBC might be associated with the limitations of conventional TURBT techniques and with an inadequate accuracy of standard white light cystoscopy (WLC)3. It has been observed that almost 81% of the tumours recurred at the site of previous resection, which indirectly hypothesizes that the technique of resecting the tumour is not adequate4.

Studies suggest that “en-bloc” resection could end the poor oncological safety profile of the “incise and scatter” principle behind the transurethral resection. The question to address is whether this technique is feasible for all NMIBC patients. gastrointestinal surgery, the tumour is elevated from the bladder with a submucosal fluid cushion. By elevating the mucosa, the resection level is raised and the risk of perforation of the muscularis is reduced.

Initial study results prove the feasibility of waterjet hydrodissection for removing bladder tumours. In contrast to conventional TURBT, this new technique allows the pathologist to assess the entire lamina propria and the resection edges due to the en-bloc resection and to determine invasiveness as well as R0 Successful management of NMIBC not only relies on versus R1 resection10. Another technique, using a adequate initial resection but also on accurate front-firing green-light laser to en-bloc enucleate histological diagnosis. Understaging can adversely bladder tumours has recently being published and affect the survival of the patient. The risk of tumour was demonstrated to be effective and safe for understaging by initial TURBT was discovered by treatment of NMIBC. Moreover, it may improve the investigation of cystectomy specimens. It is known accurate valuation of tumour stage and prediction of that as much as 40% of clinically T1 tumours are postoperative prognosis, although long-term upstaged to pathologic muscle-invasive disease5. Even outcomes and prospective clinical trials are needed11. though conventional TURBT, where tumour is removed in piecemeal, has been in practice for many While the objective of en-bloc resection is the removal years, issues like absence of detrusor in of the tumour in its vertical extension and a more histopathology report and incomplete resection accurate pathological evaluation after the resection, continue to plague the adequacy of TURBT. HAL-guided blue-light cystoscopy helps to ensure the complete removal of the tumour in its lateral Based on the current knowledge of the recurrence extension. The combination of both techniques process, there is evidence to suggest that a significant therefore might be instrumental in removing the percentage of recurrences result from residual tumour tumour complete in order to lower recurrence rates. left behind at resection or growth of previously undetected lesions6. HAL-guided blue-light cystoscopy Tumour visibility – Decisive to visualize tumour (BLC) increases the detection rate for small or margins indistinct lesions that can go unseen under cystoscopy An important factor that influences the outcome of the with white light alone7. Findings of a recently initial TURBT is the visibility of tumours. HAL-guided published study suggest that performance of blue-light cystoscopy improves visualisation of HAL-guided TUR-BT can be of prognostic importance8. tumours at first TURBT, helps the urologist to identify Data from this retrospective analysis demonstrate that tumour margins and confirms complete clearance of HAL guided TUR-BT in bladder cancer patients, who lesions. As a result, the amount of tumour that is later progressed to requiring RC, significantly surgically removed is increased, and the risk of increased the three year overall survival (p=0.037) and tumour recurrence is reduced. Also, HAL-guided the median three year recurrence free survival blue-light cystoscopy can be used to confirm the (p=0.002). efficacy of treatment and to identify any previously missed or recurrent tumours. Improved detection and Improving the quality of initial tumour removal reduced risk of recurrence is in turn associated with lower overall costs in managing bladder cancer The so called en-bloc resection technique is one of the ways to improve the quality of initial tumour compared to WLC12. The 2014 update of the EAU removal. The idea behind this approach is to Guidelines also acknowledges the clinical value of completely remove the tumour without incision and BLC. The guidelines recommend the use of scattering of the tumour tissue. By not “touching” the fluorescence-guided resection, as being more tumour it is assumed that the resection results and sensitive than conventional white-light cystoscopy for the recurrence rates can be improved. The first detection of tumours.13 reported en-bloc resection of bladder tumours was described by Ukai and colleagues in 2000. Ukai used “En-bloc” resection – State-of-affairs a modified loop, which was cut in half, trimmed and In 2014 Kramer et al. reviewed the currently available bent to form a ‘‘J’’9. They made a circular incision data and found no randomized controlled clinical around the tumour keeping a distance of about 5 trials dealing with en-bloc resection of bladder mm. Subsequently, the tumour was bluntly dissected tumours14. Most of the publications were based on from the bottom considering the incision line. prospective observational trials with less than forty Including the detrusor muscle was requisite while patients. They arrive at the conclusion that any performing the resection and at the end, the tumor available energy source can be used, since en-bloc was retrieved in one piece. This has been the basic resection is a methodical approach. In cases of small concept of en-bloc resection since then. tumours less than 1 cm, “en-bloc” removal by standard single wire resection loop is the most Different principles of en-bloc resection of bladder indicated approach, as it prevents tumoral cells from tumours using alternative energy resources (e.g. scattering by extracting the lesion in a single piece. In holmium laser, thulium laser and the water-jet these situations, a special attention must be given to HybridKnife®) have been published in the last years. the complete and deep resection of the tumoral base while including part of the underlying muscular layer All the techniques have in common that a circular in the specimen. incision of the mucosa, with a safety margin, surrounding the tumour is achieved and that Nevertheless, though the appeal for en-bloc resection subsequent blunt en-bloc preparation of the complete is evident, attention must be paid to the current limitations of this approach. The feasibility of en-bloc tumour, including detrusor muscle, is performed. resection still is depending on tumour size and Waterjet hydrodissection (HybridKnife®) is a new location. Furthermore, technical equipment like technology for removing superficial bladder tumours. extraction bags still have to be improved.

With this technique, already established in endoscopic

Currently available studies on en-bloc resection provide encouraging data on the reduction of the recurrence rate typical of non-muscle invasive bladder tumours. New techniques to achieve en-bloc resection like the water-jet HybridKnife® system are constantly studied in further trials15.

HAL-guided cystoscopy holds promise in assisting en-bloc resections by helping to visualize tumour margins and confirming complete clearance of lesions12. HAL- guided en-bloc resection of bladder

EUT Congress News

Nevertheless, even though the feasibility of en-bloc resection has been demonstrated it still cannot be applied to all tumours and is currently considered to be experimental since available data is extremely heterogeneous illustrating a lack of standardized protocols14.

Interview with Prof. Fred Witjes (Radboud UMC, Nijmegen, The Netherlands)

The aim of initial TURBT is to remove all visible tumours and obtain tissue for accurate histological diagnosis. Conventional TURBT involves piecemeal resection of the tumour, which runs counter to established oncological principles of removing any tumour intact and if possible in a non-touch technique. The high rate of recurrence begs the question as to whether TURBT should be modified to provide en-bloc resection of the specimen.

26

tumours may represent a potential option for selected patients and may help to overcome the limitations of a conventional TURBT.

Do you think the concept of “incise and scatter” during standard TURB needs to be changed since it is against the basic principle of oncological surgery?

“If possible, yes. One limiting factor of the surgical ‘incise and scatter’ technique is that it might contribute to tumour recurrence. En-bloc resection of tumours would be far preferable and demands further development and evaluation.”

How can this approach influence the bladder cancer therapy?

“Still randomized controlled clinical trials dealing with en-bloc resection are missing. If it indeed lowers the recurrence rates (probably not progression rates) it should become the new standard in smaller tumours (let say a bit over 1 cm maximum).”

For which patient group en-bloc TURB is feasible and safe (according to guidelines)?

“The concept of en-bloc resection has appeal; however, its application is limited by the size of the tumour and to me this also is the central selection criterion. The higher the grade the less willing I would be to incise the tumour, so the better it should be if the resection is en-bloc. Moreover, we should clearly visualize a tumour in case of an en-bloc resection. For that, HAL guidance seems ideal.”

Is en-bloc transurethral resection better than conventional techniques in terms of recurrence and progression?

“Theoretically it would make sense that the resection results and the recurrence rates can be improved with en-bloc resection but this has not been comprehensively proven yet. However, en-bloc techniques allow for more accurate pathologic staging of initial tumour (>90%). This better possibility for pathological assessment is a clear advantage of this approach.”

About Innovators in BC® While the number of active participants is constantly growing and after a very fruitful first year the Innovators in BC® will again present the “Bladder Cancer Topic of the Year” at this year’s EAU meeting in Madrid. Urologists and oncologists from several countries once more voted for the bladder cancer topic they believe should be further discussed and high on the agenda in 2015.

Innovators in BC® (www.innovators-in-bc.com) aims to change the way doctors and healthcare professionals look at bladder cancer. The main objective of this website is to provide science based information in order to raise awareness of bladder cancer in general, and to share information, experience and material with in-depth educational background. Its content has been compiled by medical professionals and is updated regularly by providing news about bladder cancer, summaries of congresses, current studies and publications. The website shares educational material for doctors, such as slide kits and patient cases. Moreover, improving early detection and intervention cystoscopy and resection could reduce the risk of subsequent recurrence and progression, for the patients’ benefit. The potential of Innovators in BC® will increase with its number of

Does currently available data allow for any conclusion about en-bloc resection of urothelial cancer?

“The performance of TURBT is constantly evolving; various techniques using different kinds of loops and laser have been described and studied. The feasibility of en-bloc resection has been demonstrated as well.

However, en-bloc resection still cannot be applied to all tumours and is currently only preferable for selected patients. Therapy always should be tailored in accordance with the particularities of each case.”

users. As a “living tool” the website requires the active participation and engagement of urologists and oncologists who could edit new content and raise the interest of the audience. Innovators in BC® is a restricted area for medical practitioners only from Austria, Belgium, Czech Republic, France (www. innovators-in-bc.fr), Germany, the Netherlands, Spain and Switzerland, developed by Ipsen. Without any commercial purpose the platform aims to be neutral and independent.

References 1. Sureka et al., Indian J Urol. 2014; 30(2):144-149 2. Thomas et al., Eur Urol Suppl 2008; 7:524-528 3. Filbeck et al., J Urol. 2002; 168(1):67-71.

4. Grimm et al., J Urol. 2003; 170:433-437 5. Dutta et al., J Urol. 2001; 166(2):490-3.

6. Brausi et al., Eur Urol. 2002; 41:523-531 7. Burger et al., Eur Urol. 2013 Nov;64(5):846-54 8. Gakis et al., World J Urol 2015, article in press 9. Ukai et al., J Urol. 2000; 163(3):878-9 10. Nagele et al., World J Urol. 2011; 29(4):423-7 11. He et al., J Endourol. 2014; 28(8):975-9 12. Witjes et al., Eur Urol. 2014; 66:863-871 13. Babjuk et al., EAU 2014; April 2014.

14. Kramer et al., Min Inv Ther.2014; 23:206-213 15. Fritsche et al., J Endourol 2011;25: 1599-603

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+1 Campaign: Optimal links between nurses and doctors Chapple, Drudge-Coates speak on effective teamwork through shared responsibility

By Joel Vega The EAU and the EAUN have embarked on a long-term plan to effectively boost the collaboration of urology nurses and urologists, while at the same time focusing on the challenges posed by cultural diversity across Europe.

The EUT spoke to EAU Secretary General Prof. Chris Chapple and EAUN Chair Lawrence Drudge-Coates regarding the goals of the +1 Campaign, to review the potential obstacles to any programme directed at the education of European nurses. The question is how to reach the goal of best integrating the work of urologists and nurses in achieving optimal patient care. Below is the edited transcript of the Q&A interview with Prof. Chapple and Mr. Drudge-Coates: Q: In what specific ways can the teamwork between urologists and urology-specialised nurses be further improved considering that more clinical tasks are being performed by nurses?

Drudge-Coates: The purpose of the +1 campaign is for clinicians to invest in their clinical staff (i.e. urology nurses) as part of a multi-professional approach to help optimise patient care through education – the team being only as good as the weakest link. For urologists their role is often very finite but for the nurses it’s how nurses can impact on, for example, the initial assessment diagnosis, follow-up care and long-term management and their roles alongside other areas like oncology, etc.

However not all urology nursing areas are as developed and as new treatments occur nurses need to know about these as they are often involved in their delivery. The focus of education through the EAUN and the +1 campaign is to provide education either through online courses, or the annual EAUN meeting. The +1 campaign recognises that while urology nurses and urologists have different roles, it’s the recognition that they are working towards the same goal of optimising patient care.

Chapple: Accredited education and training are an important potential in order for nurses to be signed off, but the tasks and subjects tackled will be influenced by the individual health care system that the nurse works in. Much of the training at present is on a local or ad-hoc basis rather than being based on national standards for nursing. Nevertheless currently certainly in our health care system, it produces the desired outcome for any local needs. In the UK nowadays, there are more training options being offered to nurses because of the pressure on clinical services and need to have more nursing colleagues involved more directly in aspects of urological care which in the past were considered to lie within the realm of the urologist. I realise that this is not considered appropriate or necessary though in a number of other European healthcare systems.

EAUN Chair Lawrence Drudge-Coates

Saturday, 21 March 2015

Q: In your respective clinics, have you seen more training opportunities or education programmes in recent years being offered to nurses? If yes, what was the impact on the daily work routine and if there are none, what could be the obstacles?

Drudge-Coates: Yes, more and more courses are being made available but are not urology nursingspecific. They are also costly and can be difficult to access. Since nurses are unable to take time off, they often have to pay for these courses themselves which I see as counterproductive when this education will positively impact on patient care and treatment outcomes. The EAUN bridges this gap by providing up-to-date nursing education. For example the Evidence-based Guidelines for Best Practice in Urological Care cover a number of topics including catheterisation. In my own clinic, with rapid advances in treatment, there is the need to always be ahead of the game in terms of education – but it is difficult to get time off and other ways of getting this education have to be looked at.

Chapple: The amount of work that we are trying to do has been gradually increasing because of increased demand for urological services – particularly with the aging population and therefore the extended role of nursing colleagues has become important in helping us to deal with the daily work routine and provide the best quality of care, in particular relating to follow up management, diagnostic care and counselling. This (+1 Campaign) therefore in our context would be considered to be a very positive initiative.

Q: The EAUN as an international organisation faces the challenge of addressing the concerns of nurses coming from various cultures and in a region where language and mobility present obstacles. In what ways can the EAU and the EAUN work together to offer education and training programmes?

Chapple: The major challenges the EAUN has in addressing the ideal role for nurses from different cultures and regions are as follows. Firstly, relating to linguistic issues. Secondly, to the way in which the local urological practice is structured, which is dependent on the number of urologists per capita in the population and the way in which healthcare is reimbursed, in particular whether there is direct payment to doctors per case, or whether as part of a national health system. Doctors are usually salaried in the government sector in a number of countries such as the UK and are therefore only too grateful for help in dealing with the workload in the most effective fashion.

Drudge-Coates: There will always be challenges to meeting the needs of nursing education. The benefit of a EAU-EAUN approach allows the potential for areas of education to be highlighted through existing EAU relationships with national organisations, where there is no urology nursing society. Thus, it is important for the EAU to advocate not just the development of urologists but also urology nurses as a multiprofessional approach to care. There are huge

EAU Secretary General Prof. Chris Chapple

opportunities to collaborate and complement existing meetings held by the EAU or for the EAU to advertise the role of the EAUN at these meetings. Ultimately, we have to listen to our members to determine what their needs are. We have to be flexible, current and innovative.

Q: There is the challenge of cost-cutting among hospitals and lack of personnel across Europe. At the same time there is the pressure for more efficient work procedures. How would the EAU and the EAUN address these issues?

Chapple: The integrated approach between nurses and urologists working closely together is very successful in our system. In particular, nurses also have the opportunity to take more time to discuss matters with patients and their role in counselling is very important, particularly those related to cancer and surgical procedures, such as for stress Chapple: It is very clear the extended role of nurses incontinence, reconstructive urology, urinary diversion has proved to be enormously successful in the UK where nurses deal with catheter care and continence and stoma care. The EAU and the EAUN are working management. In hospitals, nurses can prescribe drugs together to formulate policies; but recognise that it is essential to work CLOSELY with the National Urological after suitable certification and can provide specialist Societies to address the issue of how best to deliver roles, particularly in oncology and continence support to urological nurses in each individual management. In addition, nurses can carry out a country. This is considered to be such an important number of procedures, not only relating to catheters issue that it will be an important point of discussion at and bladder instillations, but also in the context, for this year’s EAU National Urological Societies Meeting. instance, of conducting urodynamic evaluations and minor procedures such as cystoscopies under local Drudge-Coates: The work force issue is one of the ever anaesthesia. There is also the potential for nurses to growing problems that we face. We have to consider be involved as surgical assistants. current clinical roles for urology nurses perhaps more, Drudge-Coates: In my experience, urology nurses are for example, in hybrid oncology-urology nurse’s role (across specialities). We also have to consider how we a part of the team for robotic surgery preoperatively, protect urology as a speciality and the specialised during surgery and postoperatively, and in work force required and how we develop newly streamlining patient care, providing consistency in qualified nurses in urology areas and core training patient care and follow-up as part of the urology needs so that skills are transferable across the team approach. They provide clinical input for European Union. These discussions are already taking oncology patients managed initially by urologists. place and the EAUN is involved.

They work alongside urologists when patients are given their diagnosis by providing support and Q: Finally, how would you envision the future of organising timely approaches to diagnostic collaborative teamwork among urologists and nurses? investigations.

Do you expect tangible achievements in the next five years or would it take some time before real changes Q: More and more urology procedures use minimal can be realised? invasive technology which leads to clinical practices where nurses assume a crucial role. Do you think this challenge is being systematically addressed by hospital Drudge-Coates: Urologists need to invest in the education of their nurses such as supporting them for decision-makers and professional organisations?

EAUN membership and not assume it’s being done or leave it to their managers. There is a need for a Drudge-Coates: I don’t think this challenge is being met consistently by hospital decision-makers and this change in mind-set, change in pre-conceived ideas for urologists to look outside what they perceive as relates to providing the necessary training. So often the roles of nurses, and consider the possibilities of there is an imbalance in the training given in one what the role of urology nurses could be. Changes hospital compared to another. There is a need for have already happened but it’s how urologists can consistency. For nurses, there is a greater need for champion the role of their urology nurses that will protocol-led or clinical assessment competencies to maintain this momentum. be obtained and the necessity to standardise approaches, where possible. This is where Chapple: Certainly, there is a lot to do and achieve organisations can help in education and competency and we are basically building the support systems in development which is recognised as the standard – the best possible way that we can. This, of course, and again of paramount important is the EAU-EAUN takes time. The potentials are there, we just need to collaboration. create bridges and effective links and continue the dialogue, and widen our understanding of the Chapple: The EAU and the EAUN should work challenges and their possible solutions based on together to identify the perceived needs in terms of education and training for nurses in different cultural realistic expectations. To reiterate my previous settings, rather than trying to dictate a model which is comment, the EAU should closely collaborate with the EAUN by identifying the needs in education and based on the personal experiences of particular training for nurses in each country, but within the individuals involved in running either of these context of Europe’s diverse cultural settings and in organisations. The challenge is that there is disparity across Europe in terms of the way in which urology is close collaboration with each Urological National Society. provided and funded.

Q: Can you cite specific examples of good hospital practices from your experience where urologists and nurses effectively complement their work to achieve better or optimal patient care?

EUT Congress News

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Prostate Cancer

Heart & ADT: Managing benefit/risk ratio SCIENTIFIC PROGRAMME Time

Presenter

Title

17:45–17:50 Chair: Alexandre de la Taille (France)

Welcome and introduction

17:50–18:10 Alexandre de la Taille

ADT and side effects – are all medications the same?

18:10–18:30 Jehonathan Pinthus (Canada)

Understanding the mechanisms behind ADT and cardiovascular risk

18:30–18:50 Patrick Davey (UK)

ADT and cardiovascular risk: A cardiologist’s perspective

18:50–19:10 Johannes Wolff (Germany)

Intermittent androgen deprivation: Still a valid treatment option?

19:10–19:15 Alexandre de la Taille

Concluding remarks

SUNDAY 22 MARCH, 2015 Room N101–102, 17:45 -19:15 IFEMA - FERIA DE MADRID, AVENIDA DEL PARTENÓN 5, MADRID, SPAIN Visit us at Booth 20/Hall 9 32

EUT Congress News FN/1898/2014/ECO

Saturday, 21 March 2015