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
Coloplast A/S
130 participants
Jun 29, 2017
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
Inclusion Criteria1
- Implanted with the Virtue® Male Sling System
Exclusion Criteria2
- 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
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Interventions
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)
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NCT04098822