Neuromodulation for Accidental Bowel Leakage

Summary

This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women.

The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.

Conditions

• Fecal Incontinence
• Bowel Incontinence

Interventions

DEVICE

ES-130

The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Duke University

  collaborator OTHER

• Women and Infants Hospital of Rhode Island

  collaborator OTHER

• RTI International

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Texas Southwestern Medical Center

  collaborator OTHER

• NICHD Pelvic Floor Disorders Network

  lead NETWORK

Principal Investigators

• Halina M Zyczynski, MD · Magee-Women's Hospital, Department of Obstetrics and Gynecology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-09

Primary Completion

2020-03-09

Completion

2020-03-09

FDA Device

Yes

Countries

• United States

Study Locations