Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

NACompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

October 31, 2015

Conditions
Female Stress Urinary Incontinence
Interventions
DEVICE

Ajust Adjustable Single-Incision Sling

The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Trial Locations (6)

17110

Manjon Gynecology, Harrisburg

18105

Institute for Female Pelvic Medicine and Reconstructive Surgery, Allentown

29169

Southern Uroynecology, West Columbia

49503

Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health, Grand Rapids

92663

Clark Center for Urogynecology, Newport Beach

08540

Princeton Urogynecology, Princeton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY

NCT01290796 - Clinical Evaluation of Ajust™ in Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter