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

Active, not recruiting

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

• Registration Number: NCT04114266
• Lead Sponsor: European Association of Urology Research Foundation

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Study Start: 2020-06-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-06-23
• Study Completion: 2026-12-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate	Up to 5 years post surgery	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).

Secondary Outcome Measures

Name	Time	Method
Urodynamic parameter Maximum urinary flow during pressure-flow study	At baseline, week 12 after surgery	The change of Maximum urinary flow during pressure-flow study (ml/s) will be compared with baseline.
Urodynamic parameter Maximum cystometric capacity	At baseline, week 12 after surgery	The change of Maximum cystometric capacity (ml) will be compared with baseline.
Maximum free urinary flow	At baseline, week 6, week 12 after surgery	The change in Maximum free urinary flow (ml/s) will be compared to baseline.
Revision-free rate	At 1, 2, 3, 4, 5 years of Registry follow-up	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
ICIQ-Urinary Incontinence-Short Form Questionnaire (ICIQ-UI-SF)	At each of the evaluation points up to 5 years post surgery	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.
24-hour pad tests	At each of the evaluation points up to 5 years post surgery	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.
ICIQ-Female Sexual Matters Associated with Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)	At each of the evaluation points up to 5 years post surgery	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.
Urodynamic parameter Detrusor overactivity	At baseline, week 12 after surgery	The change of Detrusor overactivity (yes/no) will be compared with baseline.
Main conclusion of Urodynamic investigations	At baseline, week 12 after surgery	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.
Time being incontinence-free	Up to 5 years post surgery	Time being incontinence-free which is defined as the interval being continent after surgery to the date of incontinence recurrence
Urodynamic parameter Maximum detrusor pressure during pressure-flow study	At baseline, week 12 after surgery	The change of Maximum detrusor pressure during pressure-flow study (cm H20) will be compared with baseline.
Post void Residual Volume	At baseline, week 6, week 12 after surgery	The change in Post void Residual Volume (ml) will be compared to baseline.
ICIQ- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)	At each of the evaluation points up to 5 years post surgery	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.
Urodynamic parameter Volume at leakage	At baseline, week 12 after surgery	The change of the Volume at leakage (ml) will be compared with baseline.
Urodynamic parameter Detrusor pressure at Max flow during pressure-flow study	At baseline, week 12 after surgery	The change of Detrusor pressure at Max flow during pressure-flow study (cm H20) will be compared with baseline.
Urodynamic parameter Retrograde leak point pressure	At baseline, week 12 after surgery	The change of Retrograde leak point pressure (cm H20) will be compared with baseline.
Number of patients with complications	During surgery and up to 5 years after surgery	Type of complications, associated symptoms and whether or not a revision was needed will be recorded.
Time being revision-free	Up to 5 years post-surgery	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

Trial Locations

Locations (25)

Pole de Sante du Plateau; 🇫🇷 Meudon, France

University Hospital Leuven; 🇧🇪 Leuven, Belgium

Hôpital la Conception; 🇫🇷 Marseille, France

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerp, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Thomayer Hospital; 🇨🇿 Prague, Czechia

Pole sante sud; 🇫🇷 Le Mans, France

University Hospital Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Lyon Sud; 🇫🇷 Lyon, France

Clinique urologique CHU de NANTES; 🇫🇷 Nantes, France

University Hospital of Nimes; 🇫🇷 Nîmes, France

University of Rennes, Department of Urology; 🇫🇷 Rennes, France

Hôpital de la Pitié-Salpêtrière; 🇫🇷 Paris, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Hopital Foch; 🇫🇷 Suresnes, France

Hospital Ramón y Cajal.; 🇪🇸 Madrid, Spain

Hospital de La Princesa; 🇪🇸 Madrid, Spain

CHU Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France

CHU Rangueil; 🇫🇷 Toulouse, France

Klinikum Lippe; 🇩🇪 Detmold, Germany

Maastricht UMC+; 🇳🇱 Maastricht, Netherlands

Marqués de Valdecilla University Hospital; 🇪🇸 Santander, Spain

Addenbrooks Hospital; 🇬🇧 Cambridge, United Kingdom

CHU de Limoges; 🇫🇷 Limoges, France

CHU de Lille; 🇫🇷 Lille, France