Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD
NCT ID: NCT04114266
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
180 participants
OBSERVATIONAL
2020-06-23
2026-04-20
Brief Summary
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Detailed Description
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An initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed after 1 year by a nominated steering committee. Thereafter, the evaluations will be performed after every year until end of Registry.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I)
Artificial Urinary Sphincter Surgery (Robot-assisted, Laparoscopic, Open, or other) for Female Stress Urinary Incontinence due to intrinsic sphincter deficiency is according to standard practice. Patients scheduled for this type of surgery will be asked to participate in this Registry.
At baseline and follow-up, the patients will be required to fill in Questionnaires, i.e. ICIQ -Urinary Incontinence - Short Form (ICIQ-UI-SF), ICIQ Female Sexual Matters associated with Lower Urinary Tract Symptoms ( ICIQ-FLUTSsex), ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), Patient Global Impression of Improvement-I (PGI-I) which are commonly used in daily practice to assess urinary incontinence, sexual function and quality of life. During the yearly visits, patients will not be required to come for a clinical visit as the questionnaires and a Follow-up form can be completed by post, e-mail or phone call.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
FEMALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
European Association of Urology Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Benoit Peyronnet, Dr.
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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Universitair Ziekenhuis Gent
Ghent, , Belgium
University Hospital Leuven
Leuven, , Belgium
Thomayer Hospital
Prague, , Czechia
University Hospital Bordeaux
Bordeaux, , France
CHU de Lille
Lille, , France
CHU de Limoges
Limoges, , France
Hôpital Lyon Sud
Lyon, , France
Hôpital la Conception
Marseille, , France
Clinique urologique CHU de NANTES
Nantes, , France
University Hospital of Nimes
Nîmes, , France
Hôpital de la Pitié-Salpêtrière
Paris, , France
University of Rennes, Department of Urology
Rennes, , France
CHU Rangueil
Toulouse, , France
CHU Nancy
Vandœuvre-lès-Nancy, , France
Klinikum Lippe
Detmold, , Germany
Maastricht UMC+
Maastricht, , Netherlands
Hospital de La Princesa
Madrid, , Spain
Marqués de Valdecilla University Hospital
Santander, , Spain
Addenbrooks Hospital
Cambridge, , United Kingdom
Countries
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Related Links
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EAU Research Foundation Website
Other Identifiers
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EAU-RF 2019-01
Identifier Type: -
Identifier Source: org_study_id
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