NCT04098822 A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence
| NCT ID | NCT04098822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Coloplast A/S |
| Condition | Urinary Incontinence, Stress |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2017-06-29 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2017-06-29 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
René Yiou, Pr
PRINCIPAL INVESTIGATOR
CHU Henri Mondor, Créteil, France
Frequently Asked Questions
Who can join the NCT04098822 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Urinary Incontinence, Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04098822 currently recruiting?
Yes, NCT04098822 is actively recruiting participants. Contact the research team at frhr@coloplast.com for enrollment information.
Where is the NCT04098822 trial being conducted?
This trial is being conducted at Angers, France, Besançon, France, Caen, France, Chalon-sur-Saône, France and 9 additional locations.
Who is sponsoring the NCT04098822 clinical trial?
NCT04098822 is sponsored by Coloplast A/S. The principal investigator is René Yiou, Pr at CHU Henri Mondor, Créteil, France. The trial plans to enroll 130 participants.