Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence



Status:Terminated
Conditions:Gastrointestinal, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:April 2015

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A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence

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).

Pilot Study

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
We found this trial at
6
sites
San Francisco, California
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Cincinnati, OH
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Houston, TX
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4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
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Los Angeles, CA
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Minneapolis, MN
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Spokane, Washington 99204
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Spokane, WA
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