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
The pre-pubic approach of the tension free vaginal sling placement is a new approach in the treatment of SUI. The retropubic approach of the tension free vaginal sling is the standard method of device delivery; in addition a suprapubic and a transobturator approach are alternative methods of delivery. All of these delivery approach systems are intended to place the mesh "tension free" in the mid-urethra.
There are currently no studies that investigate the pre-pubic delivery approach in the United States. However, the largest series of cases in Europe using the pre-pubic system was done by Ulmsten (published in the European Journal of Obstetrics and Gynecology and Reproductive Biology) 107 (2003) 205-207, titled " Pre-Pubic tension free vaginal tape application: an alternative to classic tension free vaginal tape application in selected patients with SUI."
The primary objective of this study is to evaluate the feasibility of using a pre-pubic approach to the placement of a mid-urethral vaginal mesh.
- Demonstrate the mesh can be properly placed in the mid-urethra using a pre-pubic approach;
- Assess the performance of the delivery device by measuring the ease of use, technical complexity, and instrument difficulties
Stress Urinary Incontinence
Intrinsic Sphincter Deficiency
Device: Prefyx PPS™ System
Device: Advantage ™ System
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Single-Arm, 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|
- Measuring the amount of time to complete successful pre-pubic delivery approach and placement of the mesh in the mid-urethra and the number of difficulties associated with the placement [ Time Frame: post procedure ] [ Designated as safety issue: No ]
- Document all types and number of complications associated with the pre-pubic delivery approach and mesh placement in the mid-urethra [ Time Frame: post procedure ] [ Designated as safety issue: No ]
- Physician-Procedure satisfaction questionnaire [ Time Frame: post procedure ] [ Designated as safety issue: No ]
- The percentage of patients who remain continent or improved following treatment at timed intervals [ Time Frame: 10 days, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
- The percentage of patients who report substantial improvement and consider the surgery successful, as measured by patient self-reporting [ Time Frame: 10 days, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Female patients Greater than or 18 years of age, diagnosed with Stress Urinary Incontinence (SUI).
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.