Study Stopped
business reasons
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
1 other identifier
interventional
30
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2012
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 10, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedOctober 29, 2015
October 1, 2015
2.7 years
August 10, 2012
October 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Effectiveness
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
18 weeks
Safety
To characterize adverse events experienced throughout the study
18 weeks
Study Arms (1)
Urgent(R) PC Neuromodulation System
EXPERIMENTALUrgent(R) PC Neuromodulation System
Interventions
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uroplasty, Inclead
Study Sites (6)
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
UCSF Center for Colorectal Surgery
San Francisco, California, 94158, United States
Minnesota Colon and Rectal Surgery Associates, Ltd.
Minneapolis, Minnesota, 55407, United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
Colorectal Surgical Asociates
Houston, Texas, 77054, United States
Providence Health and Services
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2012
First Posted
August 16, 2012
Study Start
August 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
October 29, 2015
Record last verified: 2015-10