Status:
RECRUITING
A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence
Lead Sponsor:
Coloplast A/S
Conditions:
Urinary Incontinence, Stress
Eligibility:
MALE
18+ years
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 dev...
Detailed 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 foll...
Eligibility Criteria
Inclusion
- Implanted with the Virtue® Male Sling System
Exclusion
- 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
Key Trial Info
Start Date :
June 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04098822
Start Date
June 29 2017
End Date
December 1 2026
Last Update
February 21 2023
Active Locations (13)
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1
CHU Angers
Angers, France, 49933
2
Jean Minjoz Hospital
Besançon, France, 25030
3
CHU de Caen
Caen, France, 14033
4
Centre Hospitalier Chalon Sur Saône William Morey
Chalon-sur-Saône, France, 71321