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

Primary Purpose

Fecal Incontinence

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Urgent(R) PC Neuromodulation System
Sponsored by
Uroplasty, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal Incontinence, Bowel Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Los Angeles Medical Center
  • UCSF Center for Colorectal Surgery
  • Minnesota Colon and Rectal Surgery Associates, Ltd.
  • The Lindner Center for Research and Education at The Christ Hospital
  • Colorectal Surgical Asociates
  • Providence Health and Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urgent(R) PC Neuromodulation System

Arm Description

Urgent(R) PC Neuromodulation System

Outcomes

Primary Outcome Measures

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
Safety
To characterize adverse events experienced throughout the study

Secondary Outcome Measures

Full Information

First Posted
August 10, 2012
Last Updated
October 28, 2015
Sponsor
Uroplasty, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01666405
Brief Title
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Official Title
A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
business reasons
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uroplasty, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Pilot Study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal Incontinence, Bowel Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urgent(R) PC Neuromodulation System
Arm Type
Experimental
Arm Description
Urgent(R) PC Neuromodulation System
Intervention Type
Device
Intervention Name(s)
Urgent(R) PC Neuromodulation System
Intervention Description
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).
Primary Outcome Measure Information:
Title
Effectiveness
Description
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
Time Frame
18 weeks
Title
Safety
Description
To characterize adverse events experienced throughout the study
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCSF Center for Colorectal Surgery
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Minnesota Colon and Rectal Surgery Associates, Ltd.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
The Lindner Center for Research and Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Colorectal Surgical Asociates
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Providence Health and Services
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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