NCT01666405
Terminated
Phase 1
A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
ConditionsFecal Incontinence
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- Uroplasty, Inc
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- Effectiveness
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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 Description
Pilot Study
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter)
- •Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.)
Exclusion Criteria
- •Pregnancy or intention to become pregnant during the course of the study
- •Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.)
- •Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function
- •Prone to excessive bleeding or bleeding diathesis
Outcomes
Primary Outcomes
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
Study Sites (6)
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