Status:
ACTIVE_NOT_RECRUITING
Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD
Lead Sponsor:
European Association of Urology Research Foundation
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Urinary Incontinence
Urinary Incontinence, Stress
Eligibility:
FEMALE
18+ years
Brief Summary
Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency
Detailed Description
This will be a prospective non-controlled cohort study evaluating the outcomes of artificial urinary sphincter (AUS) implantation surgery (Robot-assisted, Laparoscopic, Open or other) in female patien...
Eligibility Criteria
Inclusion
- Patient should be Female and aged over 18 years.
- The patient will undergo an initial AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.
- Participant is willing and able to give informed consent for participation in the Registry
- Patient is able to complete the questionnaires.
Exclusion
- \- Participating center is unable to contribute consecutive patients.
Key Trial Info
Start Date :
June 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 20 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04114266
Start Date
June 23 2020
End Date
April 20 2026
Last Update
August 19 2025
Active Locations (19)
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1
Universitair Ziekenhuis Gent
Ghent, Belgium
2
University Hospital Leuven
Leuven, Belgium, 3000
3
Thomayer Hospital
Prague, Czechia
4
University Hospital Bordeaux
Bordeaux, France