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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Uroplasty, Inc
ClinicalTrials.gov Identifier:
NCT01666405
First received: August 10, 2012
Last updated: March 5, 2014
Last verified: March 2014
  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: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666405

Locations
United States, California
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
UCSF Center for Colorectal Surgery
San Francisco, California, United States
United States, Minnesota
Minnesota Colon and Rectal Surgery Associates, Ltd.
Minneapolis, Minnesota, United States, 55407
United States, Ohio
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
United States, Texas
Colorectal Surgical Asociates
Houston, Texas, United States
United States, Washington
Providence Health and Services
Spokane, Washington, United States, 99204
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: March 5, 2014
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 July 23, 2014