Clinical trial NCT04098822: A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence
Official title: A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort in Subjects With Male Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Incontinence, Stress
Keywords: Urinary Incontinence, Stress
Suburethral Slings
Prostatectomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient implanted with Virtue® Male Sling System to treat post-prostatectomy urinary incontience

Brief summary: The purpose of this study is to monitor the use of Virtue® Male Sling in a real world population and collect medical data on effectiveness and to monitor safety of Virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.

Detailed description: This project will be launched after the first introduction of Virtue® Male Sling in Europe. This study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with Virtue® Male Sling System by urologists who are experienced in the device. The patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). Routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. Then questionnaires will be mailed annually during 2 additional years.

Eligibility criteria: Inclusion Criteria:

* Implanted with the Virtue® Male Sling System

Exclusion Criteria:

* Refuses to be included in the survey or that their medical data will be used for research purposes.
* Indication for the Virtue® Male Sling System implantation is not for the treatment of male urinary incontinence

Primary outcomes:
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Pad weight testing
timeFrame: Baseline, 8 weeks and 12 months
measure: Uroflowmetry
timeFrame: Baseline, 8 weeks, 12 months
measure: Post-void residual (PVR) volume
timeFrame: Baseline, 8 weeks, 12 months
measure: Pad Use
timeFrame: Baseline, 8 weeks, 12, 24, 36 months
measure: International Consultation on Incontinence Questionnaire (ICIQ-UI)
timeFrame: Baseline, 8 weeks, 12, 24, 36 months
measure: Subject global satisfaction questionnaire
timeFrame: 8 weeks, 12, 24, 36 months
measure: Incontinence quality of life questionnaire (I-QoL)
timeFrame: Baseline, 8 weeks, 12, 24, 36 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: Jean Minjoz Hospital
city: Caen
country: France
facility: CHU de Caen
city: Chalon-sur-Saône
country: France
facility: Centre Hospitalier Chalon Sur Saône William Morey
city: Créteil
country: France
facility: Groupe Hospitalier Henri Mendor
city: Lille
country: France
facility: Claude Huriez Hospital
city: Lorient
country: France
facility: Clinique Mutualiste de la Porte de l'Orient
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Mougins
country: France
facility: Clinique de l'Esperance
city: Nîmes
country: France
facility: CHU Carémeau
city: Saint-Herblain
country: France
facility: Clinique Urologique Nantes-Atlantis
city: Sens
country: France
facility: Clinique Paul Picquet
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale Generale Regionale F. Miull
Study officials:
affiliation: CHU Henri Mondor, Créteil, France
name: René Yiou, Pr
role: PRINCIPAL_INVESTIGATOR
References: