At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
TOPASdevice
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.
Evaluation of the Outcomes of Restoring Pelvic Floor Support Using TOPAS, AMS Pelvic Floor Support System, in Women With Moderate Fecal Incontinence Symptoms
In Brief
A Phase 2 clinical trial evaluating TOPAS for Fecal Incontinence. Completed, enrolled 29 participants across 5 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedNov 2007
Primary CompletionDec 2010
Study CompletionDec 2012
TodayJul 2026
First PostedNov 29, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2010
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.6 years ago
Interventions
TOPASdevice
A mesh sling permanently implanted to increase pelvic floor support