Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
NCT ID: NCT01666405
Last Updated: 2015-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
30 participants
INTERVENTIONAL
2012-08-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Urgent(R) PC Neuromodulation System
Urgent(R) PC Neuromodulation System
Urgent(R) PC Neuromodulation System
The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS).
Interventions
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Urgent(R) PC Neuromodulation System
The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Uroplasty, Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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UPC032012
Identifier Type: -
Identifier Source: org_study_id
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