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

Active, not recruitingOBSERVATIONAL
Enrollment

180

Participants

Timeline

Start Date

June 23, 2020

Primary Completion Date

April 20, 2026

Study Completion Date

April 20, 2026

Conditions
Urinary IncontinenceUrinary Incontinence, StressLower Urinary Tract SymptomsUrination DisordersUrologic Diseases
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."

Trial Locations (19)

3000

University Hospital Leuven, Leuven

35000

University of Rennes, Department of Urology, Rennes

Unknown

Universitair Ziekenhuis Gent, Ghent

Thomayer Hospital, Prague

University Hospital Bordeaux, Bordeaux

CHU de Lille, Lille

CHU de Limoges, Limoges

Hôpital Lyon Sud, Lyon

Hôpital la Conception, Marseille

Clinique urologique CHU de NANTES, Nantes

University Hospital of Nimes, Nîmes

Hôpital de la Pitié-Salpêtrière, Paris

CHU Rangueil, Toulouse

CHU Nancy, Vandœuvre-lès-Nancy

Klinikum Lippe, Detmold

Maastricht UMC+, Maastricht

Hospital de La Princesa, Madrid

Marqués de Valdecilla University Hospital, Santander

Addenbrooks Hospital, Cambridge

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

European Association of Urology Research Foundation

OTHER

NCT04114266 - Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD | Biotech Hunter | Biotech Hunter