NCT01170728

Virtue® Male Sling Fixation Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Coloplast Virtue® Male Sling	The Virtue Male sling is a class II single use implantable sub-urethral, permanent, non-absorbable, support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-07-27
• Last updated: 2015-08-24

Locations

10 sites across 1 country: United States