Virtue® Male Sling Fixation Study

TerminatedOBSERVATIONAL
Enrollment

44

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Stress Urinary Incontinence
Interventions
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.

Trial Locations (10)

10016

NYU Urology Associates, New York

28207

McKay Urology, Charlotte

29572

Carolina Urologic Research Center, Myrtle Beach

30308

Midtown Urology, Atlanta

32803

Winter Park Urology, Orlando

60637

University of Chicago Medical Center, Chicago

76017

Urology Associates of North Texas, Arlington

85054

Mayo Clinic Arizona, Phoenix

92154

Kaiser Permanente, San Diego

94305

Stanford University Medical Center, Stanford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY