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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01666405
• Other study ID #: UPC032012
• Status: Terminated
• Phase: Phase 1
• First received: August 10, 2012
• Last updated: October 28, 2015
• Start date: August 2012
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Uroplasty, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

Pilot Study

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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).

Locations

Country	Name	City	State
United States	The Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
United States	Colorectal Surgical Asociates	Houston	Texas
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Minnesota Colon and Rectal Surgery Associates, Ltd.	Minneapolis	Minnesota
United States	UCSF Center for Colorectal Surgery	San Francisco	California
United States	Providence Health and Services	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Uroplasty, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Safety	To characterize adverse events experienced throughout the study	18 weeks	Yes