Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Stopped early · Phase 1
Conditions studied: Fecal Incontinence
In brief
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).
Key facts
- Study ID
- NCT01666405
- Run by
- Uroplasty, Inc
- People needed
- 30
- Starts
- 2012-08-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2015-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.)
You may not qualify if…
- 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
Where it is running
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
- UCSF Center for Colorectal Surgery — San Francisco, California, United States
- Minnesota Colon and Rectal Surgery Associates, Ltd. — Minneapolis, Minnesota, United States
- The Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
- Colorectal Surgical Asociates — Houston, Texas, United States
- Providence Health and Services — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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