A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence

Last updated: February 17, 2023
Sponsor: Coloplast A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Treatment

N/A

Clinical Study ID

NCT04098822
SU018
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Implanted with the Virtue® Male Sling System

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 130
Study Start date:
June 29, 2017
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • CHU Angers

    Angers, 49933
    France

    Active - Recruiting

  • Jean Minjoz Hospital

    Besançon, 25030
    France

    Active - Recruiting

  • CHU de Caen

    Caen, 14033
    France

    Active - Recruiting

  • Centre Hospitalier Chalon Sur Saône William Morey

    Chalon-sur-Saône, 71321
    France

    Active - Recruiting

  • Groupe Hospitalier Henri Mendor

    Créteil, 94010
    France

    Terminated

  • Claude Huriez Hospital

    Lille, 59037
    France

    Site Not Available

  • Clinique Mutualiste de la Porte de l'Orient

    Lorient, 56100
    France

    Completed

  • Edouard Herriot Hospital

    Lyon, 69003
    France

    Completed

  • Clinique de l'Esperance

    Mougins, 06250
    France

    Completed

  • CHU Carémeau

    Nîmes, 30029
    France

    Active - Recruiting

  • Clinique Urologique Nantes-Atlantis

    Saint-Herblain, 44800
    France

    Active - Recruiting

  • Clinique Paul Picquet

    Sens, 89000
    France

    Site Not Available

  • Ospedale Generale Regionale F. Miull

    Acquaviva Delle Fonti, 70021
    Italy

    Site Not Available

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