EAU Research Foundation presents... Check out the EAU RF’s presentations at this year’s congress Christien Caris, MSc Clinical Project Manager EAU Research Foundation Arnhem (NL)
c.caris@uroweb.org
Dr. Raymond Schipper Clinical Project Manager EAU Research Foundation Arnhem (NL) r.schipper@ uroweb.org
Dr. Wim Witjes Scientific and Clinical Research Director EAU Research Foundation Arnhem (NL) w.witjes@ uroweb.org The EAU Research Foundation is giving an update on its projects at the 36th Annual EAU Congress. One of these is the Phoenix registry. Phoenix is a registry entitled ‘Prospective Registry for patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction’. The aim of the registry is to collect prospective data from 1000 patients with a penile prosthesis implant. The plan is to collect data from all Penile Prosthesis Implants (PPI) that are used in daily urological practice, so all surgeons who implant these prostheses are welcome to participate! This will enable us to create a synopsis on patient and partner satisfaction as well as assess the mechanical reliability of the different PPIs on the market.
interviews, the modified English QoLSPP was finalised and used for translation into the other required languages. These translations, together with the translated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire (patient and partner version), are being tested locally (and modified where needed) by means of patient interviews. Some countries have already finished the interviewing process, while others have some delay due to COVID-19, among other reasons. The progress of the translation and cross-cultural adaptation of the QoLSPP will be reported in Poster Session 17 ‘Male sexual Figure 1: Inclusion rate of the SATURN Registry (cut-off date 20 April 2021). The blue line shows the recruitment rate if no new centers would have been added dysfunction’ (P0499), which from February 2020 will take place on Saturday, 10 July 2021, 11.00 – 12.00 hours in Virtual Room 8. Validation of the translated rate is defined as urinary continence with no need for References: questionnaires will be part of the Phoenix project. Van der Aa F., Heesakkers J., Martens F., Thiruchelvam N., use of pads or the use of one light security pad. Publications will be generated on the translation and Bjartell A., Caris C., Schipper R., Witjes W., Hamid R. PROMS (quality of life (QoL); incontinence) and clinical validation process. (2019). Prospective European registry for patients data are collected from study visits at baseline (BL) undergoing surgery for male stress urinary incontinence: before surgery; at the time of surgery; six weeks An initial report of the registry ‘SATURN’. European (activation of AUS); 12 weeks and one year post“We aim to include European Urology Supplements. 18. e1063. DOI: 10.1016/ surgery. Mid-term follow up will consist of annual centres who offer Penile Prosthesis patient contacts after one year post-surgery, up to and S1569-9056(19)30767-5 Van der Aa F., Heesakkers J., Martens F., Nilsen O.J., Zachoval including year 10.
Implants for their patients with erectile dysfunction.”
For those countries where the interviews have been finished, the translated questionnaires can be finalized and implemented in the Phoenix database, which will allow these countries to start recruiting patients. We expect to first start enrollment in Italy, Belgium, the UK and Spain, followed at a later stage by Portugal, the Netherlands, Germany, Sweden and France. The EAU RF is very eager to start this interesting project.
Participating centres for our Registry still needed We aim to include European Centres who offer PPI for their patients with erectile dysfunction. High as well as low volume centres can participate, in order to get The ultimate goal is to demonstrate that this a good representation of daily clinical practice. In this therapeutic option is an excellent treatment in registry we will collect pre-defined parameters patients with refractory Erectile Dysfunction (ED) who related to this kind of surgery. All registered devices did not respond to previous treatments. Furthermore that are used as implant in daily urological practice it should be possible to identify clinical and surgical should be included. No extra visits will be required to factors that correlate with patient outcome, surgical collect the data, patients are seen on a regular basis complications and mechanical reliability of the according to standard clinical practice. Patient devices used in daily urological practice. With the inclusion should be consecutive. Quite some centres results, treatment recommendations and guidelines have already shown interest in setting up such a can be further improved resulting in better care for registry and are willing to participate by contributing this group of ED patients. their patient data after receipt of the patient’s consent. ADDITIONAL CENTRES ARE WELCOME. Should you be interested in participating in this Within this registry various patient questionnaires registry, please inform the EAU RF by sending an related to sexual function, treatment satisfaction and quality of life will be used. Since not all questionnaires email to C.Caris@uroweb.org. were available in the required languages, the Principal Investigators: questionnaires have been professionally translated Dr. Koen Van Renterghem, Hasselt, Belgium according to the international ISPOR guidelines Dr. Federico Deho, Milano, Italy (the professional society for health economics and outcomes research), including forward and backward Collaborators: translation, as well as cognitive debriefing. Cognitive Boston Scientific Corporation debriefing consists of testing the translated questionnaires on a small group of relevant patients Coloplast Corporation in order to test alternative wording and to check Sponsor: EAU Research Foundation understandability, interpretation, and cultural relevance of the translation. This testing was done by Novel update of SATURN Registry presented at means of patient and partner interviews. EAU21 The Phoenix National Coordinators have identified a Artificial urinary sphincter (AUS) implantation has person within their department to conduct these been the standard of care for refractory male stress interviews. Several meetings have taken place during urinary incontinence (SUI) for many years. Nowadays, which the interviewers were informed about the new surgical procedures with devices like slings (fixed background of cognitive debriefing and were and adjustable) are increasingly used. Currently, there instructed how to conduct the interviews. are no clear recommendations for which patient factors would identify the best surgical treatment The Quality of Life and Sexuality with Penile Prosthesis options for SUI with either AUS or sling. questionnaire (QoLSPP), which was only available in Italian was translated to English first. The wording of The objectives of the SATURN Registry are to evaluate the English translation was improved, in deliberation the effects of surgical treatment of SUI with currently with the Italian designers of the questionnaire, based available devices and to determine prognostic factors on comments provided during the interviewer which may help to identify clinical and surgical instruction meetings. Following two rounds of patient variables that correlate with (un)favourable outcomes. EAU Research Foundation
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EUT Congress News
To date (cut-off date 20 April 2021), 847 patients have been recruited over a period of 50 months in centres from the Netherlands (2 centres, 159 patients), Belgium (5 centres, 258 patients), Czech Republic (1 centre, 48 patients), Spain (10 centres, 151 patients), Germany (3 centre, 10 patients), Norway (2 centres, 134 patients), the United Kingdom (3 centres, 47 patients), Italy (1 centre, 37 patients) and Finland (1 centre, 3 patients).
“Results reported will include (…) main causes of SUI, types of RP procedure, and (in)continence status after 3 months, 1 year and 2 years of follow-up.” Due to the COVID-19 pandemic, elective surgery has been limited over the past year. Inclusion at the centres that were already recruiting pre-COVID-19 (on which the expected trend was based) declined during COVID-19 (see Figure 1, blue line). However, with the addition of six new recruiting centres the current inclusion rate (see Figure 1, red line) is in accordance with the expectations/trend preCOVID-19 to reach the target of 1000 included patients at the end of 2021 (see Figure 1, green dotted trend line). The update of the SATURN Registry will be presented by Dr. Frank Martens (Nijmegen, NL) in Poster Session 4 ‘Male and female stress urinary incontinence – evaluation and surgical solutions’ (P0108), which will take place on Thursday 8 July 2021, 11.00 – 12.00 hours in Virtual Room 9. Results reported will include types of devices implanted, main causes of SUI, types of RP procedure, and (in) continence status after 3 months, 1 year and 2 years of follow-up.
R., de Kort L., Romero Otero J., Thiruchelvam N., Bjartell A., Caris C., Schipper R., Witjes W., Hamid R. Prospective registry for patients undergoing surgery for male stress urinary incontinence in multiple European centres. an update of the registry ‘SATURN’. European Urology Open Science 2020;19 (Suppl 2):e464. DOI: 10.1016/S26661683(20)32876-7 Heesakkers J., Van der Aa F., Martens F., Nilsen O.J., Zachoval R., de Kort L., Romero Otero J., Thiruchelvam N., Bjartell A., Caris C., Schipper R., Witjes W., Hamid R. Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence in Multiple European Centres. A novel update of the European Registry ‘SATURN’. ICS2020. Abstract 134. https://www.youtube. com/watch?v=HiGivCpQ_YQ
Principal Investigator: Rizwan Hamid, London, United Kingdom Protocol Writing, - and Steering Committee: Rizwan Hamid, United Kingdom Nikesh Thiruchelvam, United Kingdom Frank Van der Aa, Belgium John Heesakkers, The Netherlands Wim Witjes, The Netherlands Collaborator: Boston Scientific Corporation Sponsor: EAU Research Foundation Thursday 8 July, 11.00 – 12.00 CEST Poster Session 04 Male and female stress urinary incontinence Evaluation and surgical solutions Virtual Room 9 Saturday 10 July, 11.00 – 12.00 CEST Poster Session 17 Male sexual dysfunction Virtual Room 8
The aim is to recruit 1000 male patients undergoing surgery for treatment of SUI with AUS or sling. Cure June/July 2021
