Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence in Multiple European Centres. A novel update of the European Registry ‘SATURN’

Heesakkers J1, Van der Aa F2, Martens F1, Nilsen O3, Zachoval4, de Kort L5, Romero Otero6, Thiruchelvam N7, Bjartell A8, Caris C8, Schipper R8, Witjes W8, Hamid R9

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

Abstract 134
Incontinence from Prostate Cancer Treatment
Scientific Podium Short Oral Session 9
On-Demand
Male Stress Urinary Incontinence Surgery Prospective Study Clinical Trial
1. Radboud UMC, Dept. of Urology, Nijmegen, The Netherlands, 2. University Hospitals Leuven, Dept. of Urology, Leuven, Belgium, 3. Oslo University Hospital, Rikshospitalet, Oslo, Norway, 4. Thomayer Hospital, Dept. of Urology, Prague, Czech Republic, 5. UMC Utrecht, Dept. of Urology, Utrecht, The Netherlands, 6. University Hospital 12 de Octubre, Dept. of Urology, Madrid, Spain, 7. Addenbrooke's Hospital, Dept. of Urology, Cambridge, United Kingdom, 8. EAU Research Foundation, Central Research Office, Arnhem, The Netherlands, 9. Royal National Orthopaedic Hospital, Dept. of Urology, Stanmore, United Kingdom
Presenter
J

John Heesakkers

Links

Abstract

Hypothesis / aims of study
Artificial urinary sphincter (AUS) or AMS800  implantation has been the standard of care for refractory male stress urinary incontinence (SUI). New procedures with other devices are increasingly used. Prospective multicentre outcome data are lacking. There are no clear recommendations which patient factors determine the best treatment option for SUI. The prospective registry for patients undergoing surgery for male stress urinary incontinence SATURN: Surgery for mAle incontinence with arTificial Urinary sphincters and slings, a EAU Reference Network, was started to overcome these issues. Objectives of this registry are to prospectively evaluate the effects (efficacy, complications/revisions and PROMs) of surgical treatment of SUI with current available devices and to determine prognostic factors that correlate with outcomes.
Study design, materials and methods
The aim of the Saturn registry is to prospectively recruit 1000 male patients undergoing implant surgery to treat SUI. All existing devices are registered. The patients will be followed up for 10 years with regard to safety and efficacy.   Cure rate is defined as no pad use or the use of 1 security pad. PROMS (quality of life; incontinence, technical failures, infection and or erosion, pain, handling of device, etcetera) and clinical data are collected from study visits at baseline; date of surgery; 6 weeks for activation in case of AUS or devices that need to be activated, 12 weeks post-surgery   and yearly post-surgery up to year 10.
Results
After obtaining ethical committee approval in 2016, so far 587 patients have been recruited over 38 months in the Netherlands (2 centres, n=132), Belgium (4 centres, n=189), Czech Republic (1 centre, n=39), Spain (8 centres, n=99), Germany (3 centres, n=7), United Kingdom (2 centres, n=32), Norway (1 centre, n=82) and Italy (1 centre, n=16). 27 % of participating centres included more than 25 patients/year, while 45% of centres included less than 10 patients/year. Recruitment speed is currently 40 patients/month. Devices used were AMS 800TM (66.1 %), Victo Plus TM (4.2 %), ZSI 375 TM (0.5%), Argus TM Sling (2.4%), Advance XP TM (18.1%), ATOMS TM (4.4 %), ProACT TM (3.3%), Virtue Sling TM (0.5%), Reemex TM (0.2 %) and TiLOOP (0.2 %). 56% of centres use 2 or more techniques to treat SUI. 
The main cause of SUI was radical prostatectomy (RP) (81.6 %), radiotherapy (RT) (5.2 %), minimally invasive  treatments for voiding LUTS (9.1 %), or other (4.1 %). In case of RP as main cause of SUI, the type of procedure was Open Prostatectomy (OP)  (28.5 %), Laparoscopic Prostatectomy (17.3 %) (LAP), Robot Assisted Radical Prostatectomy (RARP) (50.2 %) or other (4.0 %). From these patients, 28.5% have undergone adjuvant RT.  40.1 % of AUS patients and 15.4 % of Sling patients had a history of RT. 36 (6.1 %) patients underwent device explant with a median time from surgery to explantation of 15 weeks (AUS) vs. 66 weeks (Sling).
Interpretation of results
Baseline data show a 2:1 distribution of AUS compared to other devices. The major cause of SUI was prostatectomy which in most cases was performed by RARP. Prospective collection of  predefined data from patients undergoing surgical SUI treatment in multiple European centres will enable evaluation of long term efficacy, safety and impact on QoL. Due to the real life setting we will be able to analyze the value of different techniques but also the significance of centre and patient characteristics. With the current inclusion rate planned recruitment numbers are achievable and the registry will yield clinically useful and long term results.
Concluding message
Prospective multicentered data are, also for surgical treatments for stress urinary incontinence in males, of utmost importance to select the best treatment option for patients. Based on non-biased data patients can select that treatment option that fits them best, based on solid expectations about efficacy and complications that they might encounter. 
The Saturn prospective registry helps in fulfilling these needs and  provides honest data about treatments which enables patients to select the optimal treatment, based on the possibilities and experience per participating center.
Disclosures
Funding Unrestricted grant from Boston Scientific Clinical Trial Yes Registration Number The EAU Research Foundation # EAU-RF 2016-01 RCT No Subjects Human Ethics Committee CMO Radboudumc Nijmegen, the Netherlands Helsinki Yes Informed Consent Yes
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