RecruitingNCT04098822

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

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


Sponsor

Coloplast A/S

Enrollment

130 participants

Start Date

Jun 29, 2017

Study Type

OBSERVATIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Virtue male sling for people with urinary incontinence, stress. The study is currently recruiting participants at 13 locations. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtue 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

View Full Details on ClinicalTrials.gov

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NCT04098822


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