Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 31, 2004

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2008

Conditions
Stress Urinary IncontinenceIntrinsic Sphincter Deficiency
Interventions
DEVICE

Prefyx PPS™ System

A mesh implant intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

DEVICE

Advantage ™ System

The Advantage Mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

Trial Locations (1)

11030

North Shore University Hospital, Manhasset

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT00688298 - Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter