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
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|ClinicalTrials.gov Identifier: NCT00688298|
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : June 2, 2008
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
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence Intrinsic Sphincter Deficiency||Device: Prefyx PPS™ System Device: Advantage ™ System||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2008|
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.
- 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 ]
- 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 ]
- Physician-Procedure satisfaction questionnaire [ Time Frame: post procedure ]
- The percentage of patients who remain continent or improved following treatment at timed intervals [ Time Frame: 10 days, 3 months, 6 months, 12 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688298
|Study Chair:||Lind, M.D.||North Shore University Hospital|
|Study Director:||Walsh, M.D.||Boston Scientific Corporation|