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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 130 (estimated) |
| Sponsor | Coloplast A/S Industry-sponsored |
| Locations | 13 sites (Angers and 12 other locations) |
| Status | Recruiting |
| Started | June 29, 2017 |
| Main results expected | December 2024 |
| Study ends | December 2026 |
| Registry record updated | February 21, 2023 |
| Trial ID | NCT04098822 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
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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
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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
- Principal investigator: René Yiou, Pr — CHU Henri Mondor, Créteil, France
- Study coordinator: Hugo Ryckebusch, Dr
- Email: frhr@coloplast.com
- Phone: +33 1 40 83 68 52
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Mobile app-guided pelvic floor rehab vs. in-person rehab for urinary leakage in adult women
A randomized study tests whether a mobile app-guided program can help adult women with urinary leakage as well as traditional in-person pelvic floor rehabilitation.
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This study will try a 10-minute high-intensity trampoline session to see if it causes urine leakage or short-term changes in pelvic floor structure in active women aged 18–40 who do not usually leak.
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This study is testing a new way to see if the stiffness of tissue around the urethra can help doctors better diagnose stress urinary incontinence in women.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.