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NCT00475540 · ClinicalTrials.gov registry record · NA
Efficacy Study of Vaginal Mesh for Prolapse
A NA study, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT00475540: Completed NA study, sponsored by Medstar Health Research Institute.
NCT00475540 is a NA study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00475540, a NA study, has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study Summary
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
Primary Outcome
3 different measures for Anatomic cure using POPQ measurements: 1. POP-Q at Stage I or less\* (POP-Q points Ba, Bp or C -1 or less); 2. no prolapse beyond the hymen (Ba, Bp or C 0 or less); 3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no. Patient Satisfaction using Patient Global Imp
Interventions
- DEVICE synthetic monofilament polypropylene mesh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2007-01 |
| Est. Completion | 2013-08 |
| Phase | NA |
What the finished NCT00475540 record still lists
NCT00475540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which synthetic monofilament polypropylene mesh is the first listed.
NCT00475540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00475540 about?
NCT00475540 is a clinical study titled "Efficacy Study of Vaginal Mesh for Prolapse". The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared t...
What is the current status of trial NCT00475540?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2007-01. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00475540?
The interventions under investigation include: synthetic monofilament polypropylene mesh (DEVICE).
Who is sponsoring clinical trial NCT00475540?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00475540's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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