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ACTIVE NOT RECRUITING
NCT04114266

Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD

Sponsor: European Association of Urology Research Foundation

View on ClinicalTrials.gov

Summary

Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency

Official title: Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2020-06-23

Completion Date

2026-04-20

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (19)

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