EAU Research Foundation presents

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.

The ultimate goal is to demonstrate that this therapeutic option is an excellent treatment in patients with refractory Erectile Dysfunction (ED) who did not respond to previous treatments. Furthermore it should be possible to identify clinical and surgical factors that correlate with patient outcome, surgical complications and mechanical reliability of the devices used in daily urological practice. With the results, treatment recommendations and guidelines can be further improved resulting in better care for this group of ED patients.

Within this registry various patient questionnaires related to sexual function, treatment satisfaction and quality of life will be used. Since not all questionnaires were available in the required languages, the questionnaires have been professionally translated according to the international ISPOR guidelines (the professional society for health economics and outcomes research), including forward and backward translation, as well as cognitive debriefing. Cognitive debriefing consists of testing the translated questionnaires on a small group of relevant patients in order to test alternative wording and to check understandability, interpretation, and cultural relevance of the translation. This testing was done by means of patient and partner interviews.

The Phoenix National Coordinators have identified a person within their department to conduct these interviews. Several meetings have taken place during which the interviewers were informed about the background of cognitive debriefing and were instructed how to conduct the interviews.

The Quality of Life and Sexuality with Penile Prosthesis questionnaire (QoLSPP), which was only available in Italian was translated to English first. The wording of the English translation was improved, in deliberation with the Italian designers of the questionnaire, based on comments provided during the interviewer instruction meetings. Following two rounds of patient 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 dysfunction’ (P0499), which will take place on Saturday, 10 July 2021, 11.00 – 12.00 hours in Virtual Room 8. Validation of the translated questionnaires will be part of the Phoenix project. Publications will be generated on the translation and validation process.

“We aim to include European centres who offer Penile Prosthesis 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 a good representation of daily clinical practice. In this registry we will collect pre-defined parameters related to this kind of surgery. All registered devices that are used as implant in daily urological practice should be included. No extra visits will be required to collect the data, patients are seen on a regular basis according to standard clinical practice. Patient inclusion should be consecutive. Quite some centres have already shown interest in setting up such a registry and are willing to participate by contributing their patient data after receipt of the patient’s consent. ADDITIONAL CENTRES ARE WELCOME. Should you be interested in participating in this registry, please inform the EAU RF by sending an email to C.Caris@uroweb.org. Principal Investigators: Dr. Koen Van Renterghem, Hasselt, Belgium Dr. Federico Deho, Milano, Italy Collaborators: Boston Scientific Corporation Coloplast Corporation

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 from February 2020 References: Van der Aa F., Heesakkers J., Martens F., Thiruchelvam N., Bjartell A., Caris C., Schipper R., Witjes W., Hamid R. (2019). Prospective European registry for patients undergoing surgery for male stress urinary incontinence: An initial report of the registry ‘SATURN’. European Urology Supplements. 18. e1063. DOI: 10.1016/ S1569-9056(19)30767-5 Van der Aa F., Heesakkers J., 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. 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 “Results reported will include (…) Male Stress Urinary Incontinence in Multiple European Centres. A novel update of the European Registry main causes of SUI, types of RP ‘SATURN’. ICS2020. Abstract 134. https://www.youtube. procedure, and (in)continence com/watch?v=HiGivCpQ_YQ status after 3 months, 1 year and Principal Investigator: 2 years of follow-up.” Rizwan Hamid, London, United Kingdom Protocol Writing, - and Steering Committee: Due to the COVID-19 pandemic, elective surgery has Rizwan Hamid, United Kingdom been limited over the past year. Inclusion at the Nikesh Thiruchelvam, United Kingdom centres that were already recruiting pre-COVID-19 Frank Van der Aa, Belgium (on which the expected trend was based) declined John Heesakkers, The Netherlands during COVID-19 (see Figure 1, blue line). However, Wim Witjes, The Netherlands with the addition of six new recruiting centres the current inclusion rate (see Figure 1, red line) is in Collaborator: accordance with the expectations/trend pre- Boston Scientific Corporation COVID-19 to reach the target of 1000 included patients at the end of 2021 (see Figure 1, green Sponsor: dotted trend line). EAU Research Foundation The update of the SATURN Registry will be Thursday 8 July, 11.00 – 12.00 CEST presented by Dr. Frank Martens (Nijmegen, NL) in Poster Session 04 Poster Session 4 ‘Male and female stress urinary Male and female stress urinary incontinence - incontinence – evaluation and surgical solutions’ Evaluation and surgical solutions (P0108), which will take place on Thursday 8 July Virtual Room 9 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 Saturday 10 July, 11.00 – 12.00 CEST Poster Session 17 Male sexual dysfunctionof follow-up. Virtual Room 8

Sponsor: EAU Research Foundation

Novel update of SATURN Registry presented at EAU21 Artificial urinary sphincter (AUS) implantation has been the standard of care for refractory male stress urinary incontinence (SUI) for many years. Nowadays, new surgical procedures with devices like slings (fixed and adjustable) are increasingly used. Currently, there are no clear recommendations for which patient factors would identify the best surgical treatment options for SUI with either AUS or sling.

The objectives of the SATURN Registry are to evaluate the effects of surgical treatment of SUI with currently available devices and to determine prognostic factors which may help to identify clinical and surgical variables that correlate with (un)favourable outcomes. rate is defined as urinary continence with no need for use of pads or the use of one light security pad. PROMS (quality of life (QoL); incontinence) and clinical data are collected from study visits at baseline (BL) before surgery; at the time of surgery; six weeks (activation of AUS); 12 weeks and one year postsurgery. Mid-term follow up will consist of annual patient contacts after one year post-surgery, up to and including year 10.

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).