NCT00856778

Virtue® Male Incontinence Sling Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Virtue® Male Incontinence Sling	The 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 intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-03-06
• Last updated: 2014-04-29
• Results posted: 2014-04-14

Locations

11 sites across 2 countries: United States, Canada