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NCT00535301 · ClinicalTrials.gov registry record · Phase 4
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
A Phase 4 study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
NCT00535301: Completed Phase 4 study, sponsored by Kaiser Permanente.
NCT00535301 is a Phase 4 study that has completed, run by Kaiser Permanente. The registered enrollment target is 75 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00535301, a Phase 4 study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
Study Summary
The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.
Primary Outcome
Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal
Interventions
- DEVICE grafted anterior prolapse repair
- PROCEDURE sutured anterior vaginal prolapse repair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
What the finished NCT00535301 record still lists
NCT00535301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which grafted anterior prolapse repair is the first listed.
NCT00535301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00535301 about?
NCT00535301 is a clinical study titled "Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair". The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.
What is the current status of trial NCT00535301?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2005-01. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00535301?
The interventions under investigation include: grafted anterior prolapse repair (DEVICE), sutured anterior vaginal prolapse repair (PROCEDURE).
Who is sponsoring clinical trial NCT00535301?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00535301's enrollment target sits among peer trials
75 1002nd of 2000 higher than 974 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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