44
Participants
Start Date
July 31, 2010
Primary Completion Date
June 30, 2014
Study Completion Date
June 30, 2014
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.
NYU Urology Associates, New York
McKay Urology, Charlotte
Carolina Urologic Research Center, Myrtle Beach
Midtown Urology, Atlanta
Winter Park Urology, Orlando
University of Chicago Medical Center, Chicago
Urology Associates of North Texas, Arlington
Mayo Clinic Arizona, Phoenix
Kaiser Permanente, San Diego
Stanford University Medical Center, Stanford
Lead Sponsor
Coloplast A/S
INDUSTRY