Clinical trial NCT04114266: Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD
Official title: Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Urination Disorders
Urologic Diseases
Keywords: Urologic Surgical Procedure
Female
Lead sponsor: European Association of Urology Research Foundation
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2019-10-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cure rate
timeFrame: Up to 5 years post surgery
Secondary outcomes:
measure: Time being incontinence-free
timeFrame: Up to 5 years post surgery
measure: ICIQ-Urinary Incontinence-Short Form Questionnaire (ICIQ-UI-SF)
timeFrame: At each of the evaluation points up to 5 years post surgery
measure: ICIQ-Female Sexual Matters Associated with Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)
timeFrame: At each of the evaluation points up to 5 years post surgery
measure: ICIQ- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
timeFrame: At each of the evaluation points up to 5 years post surgery
measure: 24-hour pad tests
timeFrame: At each of the evaluation points up to 5 years post surgery
measure: Urodynamic parameter Volume at leakage
timeFrame: At baseline, week 12 after surgery
measure: Urodynamic parameter Detrusor overactivity
timeFrame: At baseline, week 12 after surgery
measure: Urodynamic parameter Maximum detrusor pressure during pressure-flow study
timeFrame: At baseline, week 12 after surgery
measure: Urodynamic parameter Detrusor pressure at Max flow during pressure-flow study
timeFrame: At baseline, week 12 after surgery
measure: Urodynamic parameter Maximum urinary flow during pressure-flow study
timeFrame: At baseline, week 12 after surgery
measure: Urodynamic parameter Maximum cystometric capacity
timeFrame: At baseline, week 12 after surgery
measure: Urodynamic parameter Retrograde leak point pressure
timeFrame: At baseline, week 12 after surgery
measure: Main conclusion of Urodynamic investigations
timeFrame: At baseline, week 12 after surgery
measure: Maximum free urinary flow
timeFrame: At baseline, week 6, week 12 after surgery
measure: Post void Residual Volume
timeFrame: At baseline, week 6, week 12 after surgery
measure: Number of patients with complications
timeFrame: During surgery and up to 5 years after surgery
measure: Time being revision-free
timeFrame: Up to 5 years post-surgery
measure: Revision-free rate
timeFrame: At 1, 2, 3, 4, 5 years of Registry follow-up
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Prague
country: Czechia
facility: Thomayer Hospital
city: Bordeaux
country: France
facility: University Hospital Bordeaux
city: Le Mans
country: France
facility: Pole sante sud
city: Lille
country: France
facility: CHU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hôpital Lyon Sud
city: Marseille
country: France
facility: Hôpital la Conception
city: Meudon
country: France
facility: Pole de Sante du Plateau
city: Nantes
country: France
facility: Clinique urologique CHU de NANTES
city: Nîmes
country: France
facility: University Hospital of Nimes
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
city: Rennes
country: France
facility: University of Rennes, Department of Urology
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Suresnes
country: France
facility: Hopital Foch
city: Toulouse
country: France
facility: CHU Rangueil
city: Vandœuvre-lès-Nancy
country: France
facility: CHU Nancy
city: Detmold
country: Germany
facility: Klinikum Lippe
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal.
city: Santander
country: Spain
facility: Marqués de Valdecilla University Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooks Hospital
Study officials:
affiliation: Rennes University Hospital
name: Benoit Peyronnet, Dr.
role: PRINCIPAL_INVESTIGATOR
References: