Clinical Trial

Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence

Study acronym: SATURN
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
This will be a prospective collection of pre-defined parameters on the treatment of male stress urinary incontinence by an artificial urinary sphincter (AUS) and male sling. The data collection will be undertaken from multiple centers in Europe. The participation will be by open invitation to all members of the Female \& Functional Section of the EAU (ESFFU) along with other urologists undertaking these procedures. There will be a call via the European Association of urology (EAU) to all European Urologists to register for database entry. There will be no restriction on the number of patients enrolled as long as they are consecutive. The aim is to have a long term collection of the data set from as many centers as possible. An initial assessment for the robustness of the data collection will be undertaken at 3 months by a nominated steering committee. However, the first clinical evaluation of the data collected will commence at 1 year by the steering committee. Thereafter, the evaluations will be performed after every 2 years.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2016-04-27; most recent amendment 2026-01-29.
Status change: Recruiting → Active, Not Recruiting 2022-01-25
Status change: Not Yet Recruiting → Recruiting 2017-07-25
Trial Details
NCT Number NCT02757274
Lead Sponsor European Association of Urology Research Foundation
Collaborators: Boston Scientific Corporation
Conditions Urinary Incontinence, Stress
Enrollment 1,054 participants
Start Date 2017-02-22
Primary Completion 2027-02-22 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-02