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NCT00688298 · ClinicalTrials.gov registry record · NA
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
A NA study of Stress Urinary Incontinence and Intrinsic Sphincter Deficiency, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT00688298 is a NA study of Stress Urinary Incontinence and Intrinsic Sphincter Deficiency that has completed, run by Boston Scientific Corporation. The registered enrollment target is 100 participants, below the 160-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00688298, a NA study of Stress Urinary Incontinence and Intrinsic Sphincter Deficiency, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DEVICE Prefyx PPS™ System
- DEVICE Advantage ™ System
Study Locations (1)
New York
- North Shore University Hospital - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2004-05 |
| Est. Completion | 2008-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00688298
The ClinicalTrials.gov registry entry for NCT00688298 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 160-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (37% lower). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Prefyx PPS™ System is the first listed.
NCT00688298 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00688298 about?
NCT00688298 is a clinical study titled "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 deliver...
What is the current status of trial NCT00688298?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2004-05. Estimated completion is 2008-03.
What conditions does trial NCT00688298 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence, Intrinsic Sphincter Deficiency.
What interventions are being tested in trial NCT00688298?
The interventions under investigation include: Prefyx PPS™ System (DEVICE), Advantage ™ System (DEVICE).
Who is sponsoring clinical trial NCT00688298?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00688298 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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