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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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00688298
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date May 2004
Completion date March 2008
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