At a glance
ClinicalIndex Comparison RecordN/ACompleted· 207 enrolled
Drug / intervention
TOPAS Treatment for Fecal Incontinencedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)
In Brief
A clinical study evaluating TOPAS Treatment for Fecal Incontinence for Fecal Incontinence. Completed, enrolled 207 participants across 14 sites.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartApr 2010
Primary CompletionNov 2013
Study CompletionApr 2016
TodayJul 2026
First PostedMar 22, 2010
Enrollment StartApr 1, 2010
Primary CompletionNov 1, 2013
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.3 years ago
Interventions
TOPAS Treatment for Fecal Incontinencedevice
The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.