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