Clinical Research Directory
Browse clinical research sites, groups, and studies.
A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence
Sponsor: Coloplast A/S
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.
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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
130
Start Date
2017-06-29
Completion Date
2026-12
Last Updated
2023-02-21
Healthy Volunteers
No
Conditions
Interventions
Virtue male sling
The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from in-trinsic sphincter deficiency (ISD). The sling is manufactured from polypropylene and is sold for single use only. The device is a quadratic sling and consists of a knitted monofilament polypropylene mesh. The body of the device provides surface area for supporting the bulbous urethra.
Locations (13)
CHU Angers
Angers, France
Jean Minjoz Hospital
Besançon, France
CHU de Caen
Caen, France
Centre Hospitalier Chalon Sur Saône William Morey
Chalon-sur-Saône, France
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
CHU Carémeau
Nîmes, France
Clinique Urologique Nantes-Atlantis
Saint-Herblain, France
Clinique Paul Picquet
Sens, France
Ospedale Generale Regionale F. Miull
Acquaviva delle Fonti, Italy