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NCT00565136 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
A Phase 1 study of Fecal Incontinence, sponsored by ASTORA Women's Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 5
- Study locations
NCT00565136: Completed Phase 1 study of Fecal Incontinence, sponsored by ASTORA Women's Health.
NCT00565136 is a Phase 1 study of Fecal Incontinence that has completed, run by ASTORA Women's Health. The registered enrollment target is 29 participants, below the 334-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00565136, a Phase 1 study of Fecal Incontinence, has completed, sponsored by ASTORA Women's Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 5
- Study locations
Study Summary
The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence
Primary Outcome
Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.
Conditions Studied
Interventions
- DEVICE TOPAS
Study Locations (5)
Massachusetts
- Mount Auburn Hospital - Cambridge
Minnesota
- University of Minnesota - Minneapolis
Ohio
- The Christ Hospital - Cincinnati
Pennsylvania
- St. Lukes Hospital - Allentown
Washington
- Sacred Heart Hospital - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2007-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT00565136 record still lists
NCT00565136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 334-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which TOPAS is the first listed.
NCT00565136 lists 5 locations in 5 states (Massachusetts, Minnesota, Ohio).
Frequently Asked Questions
What is clinical trial NCT00565136 about?
NCT00565136 is a clinical study titled "Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms". The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence
What is the current status of trial NCT00565136?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2007-09. Estimated completion is 2012-12.
What conditions does trial NCT00565136 study?
This clinical trial studies the following conditions: Fecal Incontinence.
What interventions are being tested in trial NCT00565136?
The interventions under investigation include: TOPAS (DEVICE).
Who is sponsoring clinical trial NCT00565136?
This trial is sponsored by ASTORA Women's Health, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00565136 being conducted?
This trial has 5 study locations across Massachusetts, Minnesota, Ohio, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fecal Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00565136's enrollment target sits among peer trials
29 16th of 22 higher than 7 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence 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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