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

European Association of Urology Research Foundation

Status: Active, not recruiting

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

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04114266

EAU-RF 2019-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.