Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD (VENUS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Urologic Diseases; Lower Urinary Tract Symptoms; Urinary Incontinence; Urination Disorders; Urinary Incontinence, Stress
• Intervention / Treatment: Other: Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I)

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 patients. The data collection will be undertaken from multiple centres in Europe. The participation will be by open invitation from the Urologists from the European Society of Female & Functional Urology Section of the European Association of Urology (ESFFU) to all its members along with other surgeons undertaking these procedures. The aim is to recruit a total of 150 patients in 2 years whereafter patients will be followed until the end of Registry which is 5 years after inclusion of the first patient. There will be no restriction on the number of patients enrolled as long as they are consecutive. The aim is to have a long-term collection of the dataset from as many centres as possible.

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Joni Kats, MSc; Phone Number: +31263890677; Email: j.kats@uroweb.org
• Study Contact Backup: Name: Wim Wtjes, Dr.; Phone Number: +31263890677; Email: w.witjes@uroweb.org

Study Locations

• Belgium
  • Antwerp, Belgium
    • Not yet recruiting
    • Universitair Ziekenhuis Antwerpen
    • Principal Investigator: Stephan De Wachter, Prof. Dr.
  • Gent, Belgium
    • Not yet recruiting
    • Universitair Ziekenhuis Gent
    • Principal Investigator: François Hervé, MD. PhD
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospital Leuven
    • Principal Investigator: Frank Van der Aa, Prof. Dr.
• Czechia
  • Prague, Czechia
    • Recruiting
    • Thomayer Hospital
    • Principal Investigator: Roman Zachoval, doc. MUDr
• France
  • Bordeaux, France
    • Recruiting
    • University Hospital Bordeaux
    • Principal Investigator: Grégoire Capon, Dr
  • Le Mans, France
    • Not yet recruiting
    • Pôle Santé Sud
    • Principal Investigator: Olivier Belas, Dr.
  • Lille, France
    • Recruiting
    • CHU de Lille
    • Principal Investigator: Xavier Biardeau, Dr.
  • Limoges, France
    • Recruiting
    • CHU de Limoges
    • Principal Investigator: Aurelien Descazeaud, Prof. Dr.
  • Lyon, France
    • Recruiting
    • Hopital Lyon Sud
    • Principal Investigator: Alain Ruffion, Dr.
  • Marseille, France
    • Recruiting
    • Hopital La Conception
    • Principal Investigator: Gilles Karsenty, Prof.
  • Meudon, France
    • Not yet recruiting
    • Pole de Sante du Plateau
    • Principal Investigator: Vincent Cardot, Dr.
  • Nantes, France
    • Recruiting
    • Clinique urologique CHU de NANTES
    • Principal Investigator: Marie Aimee Perrouin Verbe, Dr.
  • Nîmes, France
    • Recruiting
    • University Hospital of Nîmes
    • Principal Investigator: Laurent Wagner, Dr.
  • Paris, France
    • Recruiting
    • Hôpital de la Pitié-Salpêtrière
    • Principal Investigator: Emmanuel Chartier-Kastler, Prof.
  • Rennes, France, 35000
    • Recruiting
    • University of Rennes, Department of Urology
    • Principal Investigator: Benoit Peyronnet, Dr.
  • Rouen, France
    • Not yet recruiting
    • Hopital Charles Nicolle
    • Principal Investigator: Jean-Nicolas Cornu
  • Suresnes, France
    • Not yet recruiting
    • Hôpital FOCH
    • Principal Investigator: Adrien Vidart
  • Toulouse, France
    • Not yet recruiting
    • CHU Rangueil
    • Principal Investigator: Xavier Game
  • Vandœuvre-lès-Nancy, France
    • Recruiting
    • Chu Nancy
    • Principal Investigator: Pierre Lecoanet, Prof. Dr.
• Germany
  • Detmold, Germany
    • Recruiting
    • Klinikum Lippe
    • Principal Investigator: Karl-Dietrich Sievert, Dr.
• Netherlands
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht UMC+
    • Principal Investigator: Gommert van Koeveringe
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital de La Princesa
    • Principal Investigator: Luis López-Fando Lavalle, Dr.
  • Madrid, Spain
    • Recruiting
    • Hospital Ramón y Cajal.
    • Principal Investigator: Mercedes Ruiz Hernández, PhD
  • Santander, Spain
    • Recruiting
    • Marqués de Valdecilla University Hospital
    • Principal Investigator: Paola Calleja Hermosa
• United Kingdom
  • Cambridge, United Kingdom
    • Recruiting
    • Addenbrooks Hospital
    • Principal Investigator: Nikesh Thiruchelvam, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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 Criteria:

- Participating center is unable to contribute consecutive patients.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time being incontinence-free	Time being incontinence-free which is defined as the interval being continent after surgery to the date of incontinence recurrence	Up to 5 years post surgery
ICIQ-Urinary Incontinence-Short Form Questionnaire (ICIQ-UI-SF)	The ICIQ-UI-SF is a questionnaire evaluating 4 question items (Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item) . The score can range from 0 to 25. Mean ICIQ-UI-SF scores will be calculated at the indicated time points and numbers /percentages of patients in the different surgery categories. Also change in ICIQ-UI-SF score compared to baseline will be calculated.	At each of the evaluation points up to 5 years post surgery
ICIQ-Female Sexual Matters Associated with Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)	The ICIQ-FLUTSsex is a questionnaire evaluating 4 question items (Pain/discomfort because of dry vagina, Impact of urinary symptoms, Pain with sexual intercourse, Urine leakage with sexual intercourse). The score can range from 0 to 54. Mean ICIQ-FLUTSsex scores will be calculated at the indicated time points and numbers /percentages of patients in the different surgery categories. Also change in ICIQ-FLUTSsex compared to baseline will be calculated.	At each of the evaluation points up to 5 years post surgery
ICIQ- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)	The ICIQ-LUTSqol is a questionnaire evaluating 20 question items on quality of life in urinary incontinent patients with particular reference to social effects. The score can range from 19-76 overall score with greater values indicating increased impact on quality of life. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. Mean ICIQ-LUTSqol scores will be calculated at the indicated time points and numbers /percentages of patients in the different surgery categories. Also change in ICIQ-LUTSqol compared to baseline will be calculated.	At each of the evaluation points up to 5 years post surgery
24-hour pad tests	The results of the 24-hour pad tests (number of pads, grammes of leakage weight) at each of the evaluation points during follow up. The change of results of the 24-hour pad tests will also be compared with baseline over time.	At each of the evaluation points up to 5 years post surgery
Urodynamic parameter Volume at leakage	The change of the Volume at leakage (ml) will be compared with baseline.	At baseline, week 12 after surgery
Urodynamic parameter Detrusor overactivity	The change of Detrusor overactivity (yes/no) will be compared with baseline.	At baseline, week 12 after surgery
Urodynamic parameter Maximum detrusor pressure during pressure-flow study	The change of Maximum detrusor pressure during pressure-flow study (cm H20) will be compared with baseline.	At baseline, week 12 after surgery
Urodynamic parameter Detrusor pressure at Max flow during pressure-flow study	The change of Detrusor pressure at Max flow during pressure-flow study (cm H20) will be compared with baseline.	At baseline, week 12 after surgery
Urodynamic parameter Maximum urinary flow during pressure-flow study	The change of Maximum urinary flow during pressure-flow study (ml/s) will be compared with baseline.	At baseline, week 12 after surgery
Urodynamic parameter Maximum cystometric capacity	The change of Maximum cystometric capacity (ml) will be compared with baseline.	At baseline, week 12 after surgery
Urodynamic parameter Retrograde leak point pressure	The change of Retrograde leak point pressure (cm H20) will be compared with baseline.	At baseline, week 12 after surgery
Main conclusion of Urodynamic investigations	Main conclusion of Urodynamic investigations (Pure stress incontinence, Pure urgency incontinence, Mixed stress, urgency incontinence) will be compared with baseline.mic investigation (Pure stress incontinence, Pure urgency incontinence, Mixed stress, urgency incontinence).The change of Urodynamic parameters will be compared with baseline.	At baseline, week 12 after surgery
Maximum free urinary flow	The change in Maximum free urinary flow (ml/s) will be compared to baseline.	At baseline, week 6, week 12 after surgery
Post void Residual Volume	The change in Post void Residual Volume (ml) will be compared to baseline.	At baseline, week 6, week 12 after surgery
Number of patients with complications	Type of complications, associated symptoms and whether or not a revision was needed will be recorded.	During surgery and up to 5 years after surgery
Time being revision-free	The interval from the date of surgery to the date of revision whereby revision is defined as any urogenital surgical intervention that is related to the function, placement, or site reaction to the implanted device	Up to 5 years post-surgery
Revision-free rate	The number of patients who are revision-free compared to the total number of patients, whereby revision is defined as any urogenital surgical intervention that is related to the function, placement, or site reaction to the implanted device	At 1, 2, 3, 4, 5 years of Registry follow-up

Collaborators and Investigators

• Sponsor: European Association of Urology Research Foundation
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Benoit Peyronnet, Dr., Rennes University Hospital

Publications and helpful links

Helpful Links

• EAU Research Foundation website

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Estimated): June 23, 2025
• Study Completion (Estimated): December 23, 2026

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Female; Urologic Surgical Procedure
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urological Manifestations; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Lower Urinary Tract Symptoms; Enuresis; Urinary Incontinence, Stress; Urologic Diseases; Urination Disorders
• Other Study ID Numbers: EAU-RF 2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Investigators may share pseudonymised individual data with residents/urologist interested to analyze and publish the results of the registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No