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Completed Phase 1Phase 2 Interventional Results available

Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms

ClinicalTrials.gov ID: NCT00565136

Public ClinicalTrials.gov record NCT00565136. 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.

ClinicalTrials.gov public records Last synced Nov 3, 2026, 6:50 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of the Outcomes of Restoring Pelvic Floor Support Using TOPAS, AMS Pelvic Floor Support System, in Women With Moderate Fecal Incontinence Symptoms

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT00565136
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
ASTORA Women's Health
Industry
Enrollment
29 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
21 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
Sep 2007 (Type not available)
Primary completion
Dec 2010 (Actual)
Completion
Dec 2012 (Actual)
Last update posted
May 23, 2016

2007 – 2012

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Mount Auburn Hospital Cambridge Massachusetts 02138 —
University of Minnesota Minneapolis Minnesota 55454 —
The Christ Hospital Cincinnati Ohio 45219 —
St. Lukes Hospital Allentown Pennsylvania 97205 —
Sacred Heart Hospital Spokane Washington 99204 —

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 NCT00565136, 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 May 23, 2016 · Synced Nov 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00565136 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →