INITIAL RESULTS FROM THE SATURN STUDY, A MULTINATIONAL MULTICENTERED PROSPECTIVE SURGICAL REGISTRY ON OVER 1000 MEN WITH POST PROSTATECTOMY INCONTINENCE

Heesakkers J1, Martens F2, Van der Aa F3, Thiruchelvam N4, Witjes W5, Caris C5, Kats J5, Hamid R6, On behalf of the EAU Research Foundation SATURN Registry Study Group .7

Research Type

Clinical

Abstract Category

Prostate Clinical / Surgical

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Abstract 714
Late Breaking Abstracts
Scientific Podium Session 39
Thursday 28th September 2023
08:30 - 08:45
Room 104CD
Prospective Study Prolapse Symptoms Stress Urinary Incontinence
1. Department of Urology, Radboudumc Nijmegen & Maastricht UMC+, 2. Department of Urology, Radboudumc Nijmegen, 3. Department of Urology, University hospital Leuven, 4. Department of Urology, Addenbrooke’s hospital, Cambridge University Hospitals Trust, 5. EAU Research Foundation, 6. Department of Urology, University College London Hospitals, 7. Belgium: V/d Aa F; Everaert K; Van Renterghem K; Van Bruwaene S; De Wachter S. Czech Republic: Zachoval R, Prague. Germany: Hüsch T; Queissert F; Fisch M. Spain: Martinez-Salamanca J; Romero-Otero J; Castro Diaz D; Puche-Sanz I; Gago J; Lledó E; Landis S; Fraile Poblador A; Romero Hoyuela A; Gómez de Vicente JM. Finland: Tikkinen KAO; UK: Hamid R; Thiruchelvam N; Sahai A. Italy: Sacco E. The Netherlands Heesakkers J, Martens F; De Korte L. Norway: Nilsen OJ; Pedersen JM.
Presenter
J

John Heesakkers

Links

Abstract

Hypothesis / aims of study
A well designed and executed patient registry can provide a real-world view of clinical treatment practices and the resulting safety and effectiveness, especially if long-term follow-up is enabled. In surgery it reflects better the situation in real life than an RCT because of a better external validity and because  equipoise is hard to avoid. This is also the reason why the EAU guidelines office recommends to include results of registries in the guidelines. The EAU-Research Foundation and Boston Scientific International supported registry “Surgery for male incontinence with ArTificial URiNary sphincters and slings“ (SATURN) was developed to include every certified implantable  device for the surgical treatment of male SUI for evaluation of short and long term efficacy and complications of these procedures along with impact on Quality of Life.
Study design, materials and methods
Primary objective of this study is the cure rate (1 security pad max per day) of surgical procedures for male SUI during 10 year follow-up with regular analysis at various intervals.

Secondary objectives are to determine other outcomes of surgical treatment of male SUI for each of the devices, and to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes.
Results
Twenty-eight centres in nine European countries included 1039 patients consecutively from January 2017 to May 2022. For the first time we present the first results of this trial which are the one year follow-up data. For reason of numbers and clarity  the Advance XP and the AMS800 are depicted separately. Other slings and artificial urinary sphincters are grouped together.  Figure 1 depicts the flow chart of the registry, figure 2 the inclusion per country.

Results at one year Of 877 patients 1 year FU information was available (of 162 patient no one year FU data are available: 88 patients went off study prior or at year 1 and of 74 patients FU data are missing. Reasons for end of study are listed in table 5.

Results of the 24 hour padtest at baseline, one year and the difference of the various devices are listed in table 6 and figure 7.

Of the patients without 24 hr padtest the question was asked whether the patient was completely incontinent at baseline (Table 8) and what the (in)continence status was after one year of follow-up (Table 9).

Revisions Thirteen percent (n=132) of patients had one or more revision within one year after implant. Of the patients with AMS800, 109 AUS patients had 121 revisions in total (10%). Reasons were: persisting incontinence (n=16), complications with explant (n=52), malfunction (n=24), or other reasons (n=29). Two percent (n=23) patients with slings had 30 revisions within one year. Seventeen of these had persisting incontinence, 6 had complications and 7 were revised because of other reasons.

The scores at baseline and at one year for the various devices on the EQ 5D 5L question ‘How is your life today?’ (0-100, 100 is perfect, in most countries the mean is around 80) Figure 12.

Patient Reported Outcomes For the various devices the sum scores of the ICIQ-UI SF (consisting of frequency of incontinence, amount of incontinence and interference of incontinence with daily life) are depicted for baseline in figure 10 and at one year at figure 11.
Interpretation of results
This is the first report of the EAU-RF SATURN trial: a prospective real world registry on surgical outcomes for post prostatectomy incontinence in men. The registry is designed for 10 year follow-up of 1039 patients in a real life setting who are treated according to local best practice. The intention is to show a better reflection of daily practice as compared to a difficult to execute surgical RCT which often lacks external validity. Our initial results show that artificial urinary sphincters (AUS) are implanted in patients with more severe incontinence at baseline.  The downside of this is that AUS have more implications for the patient (hand dexterity, less “natural voiding” as an manipulation is needed by the patient) and more revisions within one year were observed.
Concluding message
Looking at self-reported continence and satisfaction it is striking to see that for patients every improvement is important whether it is a huge or a smaller difference. There will be on-going follow-up over 10 years in order to evaluate efficacy and satisfaction of surgical treatment for male SUI.
Figure 1 Flow chart 10 year follow up
Figure 2 Number of included patients per country (number of centers)
Figure 3 Baseline characteristics
Figure 4 Types of implant
Figure 5 Reasons for end of study per device type
Figure 6 24hr Padtest at baseline (n=666) and one year (n=162)
Figure 7 Result of 24 hour pad test at baseline and at one year for the various devices
Figure 8 Self reported: complete incontinence at baseline
Figure 9 Self reported: continence status at one year follow-up
Figure 10 Baseline mean sum scores of ICIQ-UI-SF (the higher the worse)
Figure 11 Mean sum scores of ICIQ-UI-SF at one year follow up
Figure 12 Baseline EQ-5D-5L question: How is your life today?
Figure 13 One year score on EQ-5D-5L question: How is your life today?
Disclosures
Funding EAU RF and Boston Scientific Clinical Trial Yes Registration Number ClinicalTrials.gov NCT02757274 RCT No Subjects Human Ethics Committee Radboud UMC NL METC Helsinki Yes Informed Consent Yes
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