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

Uroplasty

Status and phase

Terminated

Phase 1

Conditions

Fecal Incontinence

Treatments

Device: Urgent(R) PC Neuromodulation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01666405

UPC032012

Details and patient eligibility

About

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).

Full description

Pilot Study

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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