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

Urinary Incontinence Clinical Trial

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 Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04114266
Study type Observational [Patient Registry]
Source European Association of Urology Research Foundation
Contact Joni Kats, MSc
Phone +31263890677
Email j.kats@uroweb.org
Status Recruiting
Phase
Start date June 23, 2020
Completion date December 23, 2026
View Details
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