A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence

Recruiting now

Conditions studied: Urinary Incontinence, Stress

In brief

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.

Key facts

Study ID

NCT04098822

Run by

Coloplast A/S

People needed

130

Starts

2017-06-29

Expected to finish

2026-12-01

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Implanted with the Virtue® Male Sling System

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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