NCT00565136

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: ASTORA Women's Health · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a multi-center study under a common protocol. Approximately 20-30 patients will be enrolled across 5 sites in the U.S. The study population is females at least 21 years of age who have attempted but have not been satisfied with conservative therapy for their fecal incontinence symptoms. The study follow-up is two years.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	TOPAS	A mesh sling permanently implanted to increase pelvic floor support

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-12-01
• Completion: 2012-12-01
• First posted: 2007-11-29
• Last updated: 2016-05-23
• Results posted: 2013-08-22

Locations

5 sites across 1 country: United States