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

Phase 1

Terminated

• Conditions: Fecal Incontinence
• Interventions: Device: Urgent(R) PC Neuromodulation System

• Registration Number: NCT01666405
• Lead Sponsor: Uroplasty, Inc

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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urgent(R) PC Neuromodulation System	Urgent(R) PC Neuromodulation System	Urgent(R) PC Neuromodulation System

Primary Outcome Measures

Name	Time	Method
Effectiveness	18 weeks	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	18 weeks	To characterize adverse events experienced throughout the study

Trial Locations

Locations (6)

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

Colorectal Surgical Asociates; 🇺🇸 Houston, Texas, United States

Minnesota Colon and Rectal Surgery Associates, Ltd.; 🇺🇸 Minneapolis, Minnesota, United States

The Lindner Center for Research and Education at The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

UCSF Center for Colorectal Surgery; 🇺🇸 San Francisco, California, United States

Providence Health and Services; 🇺🇸 Spokane, Washington, United States