Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
This study is currently recruiting participants.
Verified January 2013 by Uroplasty, Inc
Sponsor:
Uroplasty, Inc
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT01666405
First received: August 10, 2012
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Fecal Incontinence |
Device: Urgent(R) PC Neuromodulation System |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence |
Resource links provided by NLM:
Further study details as provided by Uroplasty, Inc:
Primary Outcome Measures:
- Effectiveness [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]To characterize adverse events experienced throughout the study
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Urgent(R) PC Neuromodulation System
Urgent(R) PC Neuromodulation System
|
Device: 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).
|
Detailed Description:
Pilot Study
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666405
Contacts
| Contact: Megan O'Toole | 952-426-6153 | megan.otoole@uroplasty.com |
| Contact: Katie Welliver | 952-426-6182 | katie.welliver@uroplasty.com |
Locations
| United States, Minnesota | |
| Minnesota Colon and Rectal Surgery Associates, Ltd. | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Jan Mullins, RN 651-225-7815 | |
| United States, Washington | |
| Providence Health and Services | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Joan Milton 509-474-4323 joan.e.milton@providence.org | |
| Principal Investigator: Shane McNevin, MD | |
Sponsors and Collaborators
Uroplasty, Inc
More Information
No publications provided
| Responsible Party: | Uroplasty, Inc |
| ClinicalTrials.gov Identifier: | NCT01666405 History of Changes |
| Other Study ID Numbers: | UPC032012 |
| Study First Received: | August 10, 2012 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Uroplasty, Inc:
|
Fecal Incontinence Bowel Incontinence |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013