Clinical Trial: Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Brief Summary: The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).
Detailed Summary: Pilot Study
Sponsor: Uroplasty, Inc
Current Primary Outcome:
- Effectiveness [ Time Frame: 18 weeks ]To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline
- Safety [ Time Frame: 18 weeks ]To characterize adverse events experienced throughout the study
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Uroplasty, Inc
Dates:
Date Received: August 10, 2012
Date Started: August 2012
Date Completion:
Last Updated: October 28, 2015
Last Verified: October 2015