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
Public ClinicalTrials.gov record NCT00688298. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00688298
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 100 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2004 (Type not available)
- Primary completion
- Mar 2007 (Actual)
- Completion
- Mar 2008 (Actual)
- Last update posted
- Nov 12, 2020
2004 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00688298, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2020 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00688298 live on ClinicalTrials.gov.