Monitoring the Virtue® Male Sling for urinary incontinence in men
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
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 |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Coloplast A/S Industry-sponsored |
| Locations | 13 sites (Angers and 12 other locations) |
| Trial ID | NCT04098822 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men who have been implanted with the Virtue® Male Sling System for urinary incontinence.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Angers and 12 other locations
- 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)
- 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)
- CHU Carémeau — Nîmes, France (Recruiting)
- Clinique Urologique Nantes-Atlantis — Saint-Herblain, France (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.