Outcomes Study Educational Visualisation Tool BPH

BPH Outcomes Study - Educational Visualisation Tool is intended for educational purposes and not for clinical use. The BPH tool is solely intended to inform healthcare professionals to help visualise and understand the results of the statistical modelling published by Gravas S et al 2022. The BPH Tool has not been validated for and is not intended for clinical use with individual patients. It is not intended to substitute for medical advice or intended to drive or inform to take decisions with diagnosis or therapeutic purposes of any condition for any individual patients.

References: 1. Gravas S, et al. EAU Guidelines on the Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO), 2021. Available at: http://uroweb.org/guideline/treatmentof-non-neurogenic-maleluts/ Accessed March 2023. 2. Avodart Italy SmPC Summary of Product Characteristics (SmPC) effective 22 October 2020. 3. Combodart Italy SmPC Summary of Product Characteristics (SmPC) effective 22 October 2020.

Abbreviations: BPH, benign prostatic hyperplasia; LUTS/BPH, lower urinary tract symptoms secondary to benign prostatic hyperplasia. In Italy the registered trade name for dutasteride is Avodart and for dutasteride-tamsulosin is Combodart.

Abbreviated Product Information – Avodart

Soft Capsules 0,5 mg

Prescription SSN

Class A*

Price € 11,78**

*Providing system: medicinal product subject to medical prescription (RR) ** Without prejudice to any reductions and/or modifications imposed authoritatively by the competent Health Authority.

Therapeutic Indications

Avodart is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction of the risk of acute urinary retention and surgery with moderate to severe symptoms of benign prostatic hyperplasia

Posology and method of administration

Avodart can be administrated alone or in combination with the alpha blocker tamsulosin (0,4 mg). Adults (including the elderly): The recommended dose is one capsule (0.5 mg) taken orally per day. The capsules must be swallowed whole and must not be chewed or opened as contact with the contents of the capsule may cause irritation of the oropharyngeal mucosa. The capsules can be taken with or without food. Although early improvement can be seen, it may take up to 6 months before a response to treatment is achieved. No dose adjustment is required in the elderly. The most commonly observed adverse reactions include impotence, altered (decreased) libido, ejaculation disorder, breast disorder.

Full SmPC of AVODART (23 November 2017) for EU is available athttps://mri.cts-mrp.eu/portal/details?productnumber=SE/H/0304/001

Scan the QR code to access the Italian SmPC of Avodart

Abbreviated Product Information – Combodart

Hard capsules 0,5 mg

No prescription SSN

Class C*

Price € 36,00**

*Providing system: medicinal product subject to medical prescription (RR) ** Without prejudice to any reductions and/or modifications imposed authoritatively by the competent Health Authority.

Therapeutic Indications

Combodart is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction of the risk of acute urinary retention and surgery with moderate to severe symptoms of benign prostatic hyperplasia

Posology and method of administration

The recommended dose of Combodart is one capsule (0.5 mg/0.4 mg) once a day.

When appropriate, Combodart can be used to replace dutasteride and tamsulosin hydrochloride used together in current dual therapy to simplify treatment.

When clinically appropriate, a direct switch from dutasteride or tamsulosin hydrochloride monotherapy to Combodart may be considered. The most commonly observed adverse reactions include dizziness, impotence, altered (decreased) libido, ejaculation disorder, breast disorder.

Full SmPC of COMBODART (23 November 2017) for EU is available athttps://mri.cts-mrp.eu/portal/details?productnumber=DE/H/2251/001

Scan the QR code to access the Italian SmPC of Combodart

For the use of registered medical practitioner or a Hospital or a Laboratory only. Avodart/Duodart is for use in men only. Avodart/Duodart trade marks are owned by or licensed to the GSK group of companies.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

The British ProtecT trial update was presented by Prof. Freddie Hamdy (GB): “Survival from clinicallylocalised prostate cancer (PCa) remains very high over a median of 15 years (96-97%), irrespective of treatment allocation. Men with metastases do not necessarily die from PCa and those who do, they have lethality features yet to be identifiable, and are not easily impacted by multimodality treatment approaches.”

Prof. Hamdy concluded that current riskstratification methods are unreliable and that new tools are needed. However, the indications for active monitoring or surveillance can be expanded safely to intermediate-risk disease. Treatment decisions need to balance “trade-offs” between the reduction of metastases, long-term hormones, and local progression with radical treatments against their short-, medium-, and long-term impacts on sexual, urinary, and bowel function.

On QoL, Prof. Jenny Donovan (GB) told the plenary session’s audience that based on the newlypublished patient-reported outcomes, “Men newly-diagnosed with localised PCa can now carefully assess the trade-offs between the benefits and harms of treatment options: in the short, medium, and long-term and using their own values and priorities to make prudent and well-informed treatment decisions.”

European Urology Today

Editor-in-Chief

Prof. J.O.R. Sønksen, Herlev (DK)

Section Editors

Prof. T.E. Bjerklund Johansen, Oslo (NO)

Dr. B.C. Bujoreanu, Cluj Napoca (RO)

Prof. O. Hakenberg, Rostock (DE)

Dr. P. Østergren, Copenhagen (DK)

Dr. G. Ploussard, Toulouse (FR)

Prof. J. Rassweiler, Heilbronn (DE)

Prof. O. Reich, Munich (DE)

Prof. F. Sanguedolce, Barcelona (ES)

Prof. S. Tekgül, Ankara (TR)

Special Guest Editor

Mr. J. Catto, Sheffield (GB)

Founding Editor

Prof. F. Debruyne, Nijmegen (NL)

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E. De Groot-Rivera, Arnhem (NL)

S. Fitts, Arnhem (NL)

L. Keizer, Arnhem (NL)

H. Lurvink, Arnhem (NL)

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Disclaimer

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

Challenges in urogenital infections

In his presentation, oncologist Prof. Andrea Alimonti (CH) stated that intra-tumoural microbiome plays a role in the development of prostate cancer (PCa).

“The microbial species that reside in the urinary tract might be initiators of chronic inflammation in the prostate, ultimately leading to PCa by causing the development of PIA (proliferative inflammatory atrophy). Several species of pro-inflammatory bacteria and/or known uropathogens are enriched in men with PCa. The prostate tumour microbiota is different from the one of normal tissues.”

During the state-of-the-art lecture “Pathophysiology and the role of the host in urosepsis”, Dr. Zafer Tandoğdu (GB) stated that sepsis is no longer considered as SIRS (systemic inflammatory response syndrome). “Sepsis is a dysregulated host response with both pro- and anti-inflammatory processes. It is important that we understand timely recognition before the transition to sepsis, and early warning scores can help detect that. We should be mindful that if there is an infection, there can be sepsis,” said Dr. Tandoğdu.

Day 4: UroEvidenceHub

Prof. James N’Dow (GB) presented details on the EAU’s Data Initiatives, with an overview of current and upcoming efforts by the EAU to host, manage and process real-world clinical data to fill evidence gaps in current urological knowledge.

In the setting up of the new UroEvidenceHub, the first pilot of which will deal with PCa, the EAU hopes to use real-world evidence to better individualise patient care. The new “data haven” project will build on established experience and (non-urological) expertise the EAU has with the PIONEER network and OPTIMA partnership.

Part of this session also addressed the highlytopical subject of Artificial Intelligence (AI) and how it might transform urology in the coming years. Dr. Michael Bussmann (DE) and Prof. Philippe Lambin (NL) explained the basic principles for successful use of AI and its expected applications within urology. The most likely tasks to be taken over by AI include image analysis, diagnosis, treatment planning, patient monitoring, administrative tasks, research and even aiding in a “hands-on” way on improving surgeons’ accuracy when operating robotically.

Urinary stones

In his lecture on new laser technologies, Prof. Olivier Traxer (FR) had three important take home messages. He shared the formula Energy x Frequency = Power, or J x Hz = Watts, emphasising the importance of energy and power, over frequency. Secondly, when evaluating the effectiveness of new laser technology, the real-life application should be leading as laboratory settings cannot always be reproduced bedside. Finally, Prof. Traxer presented a useful rule of thumb for the audience: for kidney stones, work from surface to centre and always use 20-25W or less. For ureteral stones, from centre to surface and using a lower frequency range of 12-15W.

Plenary Session: Men’s Health

Ass. Prof. Faysal Yafi (US) presented his lecture on “Wearables for erectile quality: Catchy gadget or valuable clinical instrument?”, with a summary of what is currently the market and what is planned for the market in the near future.

“Wearable (electronic) devices/gadgets are gaining popularity amongst consumers and investigators for sexual function tracking, erectile dysfunction (ED) and premature ejaculation (PE).

The prevalence of male sexual dysfunction increases with age, with over 50% of men aged 40 to 70 years reporting some degree of ED. Prevalence has also become increasingly common in young men as well, with 14.1% of males aged 18-31 reporting a diagnosis of ED and growing trends show reliance on PDE5i for erectile function in younger men.”

Best of EAU23 sessions

New to the scientific programme this year was the Special Session “Best of EAU23 Abstracts: An expert discussion” which showcased top-tier research on oncological and non-oncological topics, including three prize winning abstracts.

Under the oncology category, the top-prize winning abstract A1163: Proteomic profiling of muscleinvasive bladder cancer treated with neoadjuvant chemotherapy described four pre-NAC and two post-NAC proteomic clusters with distinct biology and survival outcomes, alongside novel prognostic biomarkers.

The second prize was given to A0890: The Stockholm3 prostate cancer screening trial (STHLM3): An interim analysis of mortality results after 6.5 years of follow-up which concluded that the results cautiously suggest a potential effect on reducing PCa mortality by a single intensive screening intervention using PSA and Stockholm3 in combination to the cost of increasing PCa incidence. Longer-term follow-up is needed and is underway.

Dr.

Tutolo (IT) presents the non-oncology

First prize-winning abstract 'Similar artefact susceptibility for water- and air-filled urodynamic systems' (A0693 )

Abstract A0693: Similar artefact susceptibility for water- and air-filled urodynamic systems: Results from a randomised controlled non-inferiority trial received the top prize of the non-oncology category. The research results demonstrated that AFS are non-inferior to WFS regarding overall quality of urodynamic traces. However, both measurement systems have particular pitfalls that need to be known for problem solving during urodynamic investigation (UDI) and require awareness for accurate interpretation of UDI.

The congress concluded with the Special Session “Best of EAU23: Take-home messages”, whereby a panel of experts shared the congress highlights on 10 topics, from liquid biopsy to early detection of PCa, paediatrics, BCa, functional urology, stones, benign prostatic hyperplasia, andrology, and imaging.

Access more EAU23 content

All webcasts, videos, posters and full-text abstracts are currently accessible via the EAU23 Resource Centre. Delegates have full access. If you did not attend EAU23, you can still register for on-demand access to explore all scientific content shared during the congress. Please note that accreditation is no longer valid. For more details, see www.eau23.org/rc