Clinical trial Recruiting at 6 sites Observational Ages 18 and up Men only

Monitoring the Virtue® Male Sling for urinary incontinence in men

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

Run by Coloplast A/S · NCT04098822 · Data updated 2026-11-12

This study is looking to see how well the Virtue® Male Sling helps men with urinary incontinence after prostate surgery and how safe it is over time.

More Urinary Incontinence , Stress trials

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment130 (estimated)
SponsorColoplast A/S
Industry-sponsored
Locations13 sites (Angers and 12 other locations)
StatusRecruiting
StartedJune 29, 2017
Main results expectedDecember 2024
Study endsDecember 2026
Registry record updatedFebruary 21, 2023
Trial IDNCT04098822 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men who have been implanted with the Virtue® Male Sling System for urinary incontinence.

Probably not a fit

Patients who do not have the Virtue® Male Sling implanted or those whose indication for implantation is not related to male urinary incontinence may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect real-world data on the effectiveness and safety of the Virtue® Male Sling System in men suffering from post-prostatectomy urinary incontinence. It involves a multicenter, prospective, non-interventional follow-up of patients who have received the sling, with assessments conducted at baseline, 1-3 months, and 12 months post-implantation. Patients will also complete questionnaires annually for two additional years to monitor their progress and outcomes.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the Virtue® Male Sling, potentially improving treatment options for men with urinary incontinence.

How similar studies have gone: While this study is focused on a specific device, similar observational studies have shown success in monitoring the effectiveness of surgical interventions for urinary incontinence.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • CHU Angers
    Angers, France
    Recruiting
  • Jean Minjoz Hospital
    Besançon, France
    Recruiting
  • CHU de Caen
    Caen, France
    Recruiting
  • Centre Hospitalier Chalon Sur Saône William Morey
    Chalon-sur-Saône, France
    Recruiting
  • CHU Carémeau
    Nîmes, France
    Recruiting
  • Clinique Urologique Nantes-Atlantis
    Saint-Herblain, France
    Recruiting
Show 7 more locations
  • Groupe Hospitalier Henri Mendor
    Créteil, France
    Terminated
  • Claude Huriez Hospital
    Lille, France
    Withdrawn
  • Clinique Mutualiste de la Porte de l'Orient
    Lorient, France
    Completed
  • Edouard Herriot Hospital
    Lyon, France
    Completed
  • Clinique de l'Esperance
    Mougins, France
    Completed
  • Clinique Paul Picquet
    Sens, France
    Withdrawn
  • Ospedale Generale Regionale F. Miull
    Acquaviva delle Fonti, Italy
    Withdrawn

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.