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

Urinary Incontinence Clinical Trial

— VENUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114266
• Other study ID #: EAU-RF 2019-01
• Status: Recruiting
• Start date: June 23, 2020
• Est. completion date: December 23, 2026

Study information

• Verified date: January 2024
• Source: European Association of Urology Research Foundation
• Contact: Joni Kats, MSc
• Phone: +31263890677
• Email: j.kats[@]uroweb.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 23, 2026
• Est. primary completion date: June 23, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Lower Urinary Tract Symptoms
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urination Disorders
• Urologic Diseases

Intervention

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

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerp
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	University Hospital Leuven	Leuven
Czechia	Thomayer Hospital	Prague
France	University Hospital Bordeaux	Bordeaux
France	Pole sante sud	Le Mans
France	CHU de Lille	Lille
France	CHU de Limoges	Limoges
France	Hôpital Lyon Sud	Lyon
France	Hôpital la Conception	Marseille
France	Pole de Sante du Plateau	Meudon
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	Hôpital Charles Nicolle	Rouen
France	Hopital Foch	Suresnes
France	CHU Rangueil	Toulouse
France	CHU Nancy	Vandœuvre-lès-Nancy
Germany	Klinikum Lippe	Detmold
Netherlands	Maastricht UMC+	Maastricht
Spain	Hospital de La Princesa	Madrid
Spain	Hospital Ramón y Cajal.	Madrid
Spain	Marqués de Valdecilla University Hospital	Santander
United Kingdom	Addenbrooks Hospital	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
European Association of Urology Research Foundation	Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Urodynamic parameter Volume at leakage	The change of the Volume at leakage (ml) will be compared with baseline.	At baseline, week 12 after surgery
Secondary	Urodynamic parameter Detrusor overactivity	The change of Detrusor overactivity (yes/no) will be compared with baseline.	At baseline, week 12 after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Urodynamic parameter Maximum cystometric capacity	The change of Maximum cystometric capacity (ml) will be compared with baseline.	At baseline, week 12 after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   EAU Research Foundation Website