CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 166 enrolled
Drug / intervention
ES-130device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03278613
NCT03278613N/ACompleted
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Neuromodulation for Accidental Bowel Leakage

NICHD Pelvic Floor Disorders Network·interventional·Posted Sep 11, 2017·Updated Jun 3, 2025

In Brief

A clinical study evaluating ES-130 for Fecal Incontinence and Bowel Incontinence. Completed, enrolled 166 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence, Bowel Incontinence
CountriesUnited States
CollaboratorsUniversity of Alabama at Birmingham, University of California, San Diego, Duke University, Women and Infants Hospital of Rhode Island, RTI International, University of Pennsylvania, University of Pittsburgh, Kaiser Permanente, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Texas Southwestern Medical Center

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 11, 2017
Enrollment StartFeb 9, 2018
Primary CompletionMar 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.8 years ago

Interventions

ES-130device

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.