Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
Public ClinicalTrials.gov record NCT01090739. 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
An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
Study identification
- NCT ID
- NCT01090739
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 207 participants
Conditions and interventions
Conditions
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
- Apr 2010 (Type not available)
- Primary completion
- Nov 2013 (Actual)
- Completion
- Apr 2016 (Actual)
- Last update posted
- Aug 26, 2016
2010 – 2016
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California SF - Mt Zion Medical Center | San Francisco | California | 94115 | — |
| University of South Florida | Tampa | Florida | 33605 | — |
| Cleveland Clinic Foundation - Florida | Weston | Florida | 33331 | — |
| Raybon OB-GYN | Toccoa | Georgia | 30577 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Atlantic Health System | Morristown | New Jersey | 07960 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation - Ohio | Cleveland | Ohio | 44195 | — |
| University of Oklahoma | Oklahoma City | Oklahoma | 76104 | — |
| St. Luke's Hospital | Allentown | Pennsylvania | 18104 | — |
| Womens Hospital of Texas | Houston | Texas | 77054 | — |
| Sacred Heart Medical Center | 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 NCT01090739, 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 Aug 26, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01090739 live on ClinicalTrials.gov.