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

NCT04114266 | Active Not Recruiting

• 1 other identifier: EAU-RF 2019-01
• Study Type: observational
• Target: 180
• Locations: 7 countries
• Sites: 19

Brief Summary

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

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms; Urination Disorders; Urologic Diseases

Keywords

Urologic Surgical Procedure; Female

Outcome Measures

Primary Outcomes (1)

• Cure rate

  Cure rate is defined as urinary continence with no pads used or use of 1 light security pad.The cure rate after 5 years of study follow up will be calculated together with its 95% Confidence Intervals, for the total patient group as well as for each of the AUS implantation surgery procedures (Robot-assisted, Laparoscopic, Open, or other).

  Up to 5 years post surgery

Secondary Outcomes (18)

• Time being incontinence-free

  Up to 5 years post surgery

• ICIQ-Urinary Incontinence-Short Form Questionnaire (ICIQ-UI-SF)

  At each of the evaluation points up to 5 years post surgery

• ICIQ-Female Sexual Matters Associated with Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)

  At each of the evaluation points up to 5 years post surgery

• ICIQ- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

  At each of the evaluation points up to 5 years post surgery

• 24-hour pad tests

  At each of the evaluation points up to 5 years post surgery

Interventions

Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I) OTHER

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

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients undergoing AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.

You may qualify if:

• 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.

You may not qualify if:

• \- Participating center is unable to contribute consecutive patients.

Sponsors & Collaborators

• European Association of Urology Research Foundation: lead
• Boston Scientific Corporation: collaborator

Study Sites (19)

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

Thomayer Hospital

Prague, Czechia

Location

University Hospital Bordeaux

Bordeaux, France

Location

CHU de Lille

Lille, France

Location

CHU de Limoges

Limoges, France

Location

Hôpital Lyon Sud

Lyon, France

Location

Hôpital la Conception

Marseille, France

Location

Clinique urologique CHU de NANTES

Nantes, France

Location

University Hospital of Nimes

Nîmes, France

Location

Hôpital de la Pitié-Salpêtrière

Paris, France

Location

University of Rennes, Department of Urology

Rennes, 35000, France

Location

CHU Rangueil

Toulouse, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, France

Location

Klinikum Lippe

Detmold, Germany

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Hospital de La Princesa

Madrid, Spain

Location

Marqués de Valdecilla University Hospital

Santander, Spain

Location

Addenbrooks Hospital

Cambridge, United Kingdom

Location

Related Links

• EAU Research Foundation Website

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms; Urination Disorders; Urologic Diseases

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Benoit Peyronnet, Dr.

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 3, 2019
• Study Start: June 23, 2020
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

GB (1); BE (2); NL (1); CZ (1); FR (11); DE (1); ES (2)