Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation

May 5, 2026 updated by: Amany Gomaa Atiaa, Sinai University

Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Comparative Randomized Clinical Trial

This study aimed to investigate and compare the effect of electrical stimulation and biofeedback with electrical stimulation alone on fecal incontinence in children with repaired imperforate anus, with ages from 6 to 10 years.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A comparative, randomized, clinical trial regarding children who complain of fecal incontinence after operative repair of imperforate anus, to evaluate the effect of biofeedback assisted pelvic floor muscles training through animated games combined with anal electrical stimulation and anal electrical stimulation with pelvic floor muscles training through measuring anal muscles activity and implementing a bowel diary.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Qalyubia Governorate
      • Cairo, Qalyubia Governorate, Egypt, 11698
        • El-Galaa Teaching Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Seham M Abd El-Moghny, PhD
        • Principal Investigator:
          • Rabab S Mohamed, PhD
        • Sub-Investigator:
          • Amany G Atiaa, PhD
        • Sub-Investigator:
          • Mohamed I Elsepaee, PhD
        • Sub-Investigator:
          • Mohammad A Seada, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • children with repaired anorectal malformation
  • evident spared anal sphincter muscles by MRI
  • the age range from 6 to 10 years
  • able to follow instructions
  • Faecal symptoms will be evaluated for a month to confirm study eligibility.

Exclusion Criteria:

  • children with absent anal sphincter muscles by MRI
  • children with post-colon surgery other than ARM
  • neurologic/neuropathic disorder
  • sensory or hearing deficits
  • psychological disturbances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ES group
receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy
Behavioral: behavioral therapy
instructions, diet and toilet modification, motivation and reinforcement
Device: electrical stimulation
anal electrical stimulation to stimulate pelvic floor muscles
Other: pelvic floor muscles training
exercises to reeducate pelvic floor muscles control
Experimental: Combined group
receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy
Behavioral: behavioral therapy
instructions, diet and toilet modification, motivation and reinforcement
Device: electrical stimulation
anal electrical stimulation to stimulate pelvic floor muscles
Device: biofeedback
animated biofeedback for pelvic floor muscles training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anal sphincter muscle activity
Time Frame: before and after 3 months of treatment
The anal sphincter muscles, comprising the internal and external sphincters, play a critical role in maintaining continence and regulating the release of feces. In the context of fecal incontinence in children with repaired anorectal malformation, the activity of these muscles is crucial for understanding their functional restoration post-surgery. Electrical stimulation and biofeedback therapies aim to enhance the tone and coordination of these muscles, improving their ability to control defecation. By assessing the activity of the anal sphincter muscles through method like pressure measurement, the study will determine how these interventions influence muscle function and whether they contribute to a reduction in fecal incontinence episodes. The analysis of sphincter muscle activity is key in evaluating the effectiveness of these therapies in strengthening the muscles and improving overall bowel control.
before and after 3 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fecal soiling frequency
Time Frame: a weak before treatment and the last weak of treatment

Fecal soiling refers to the involuntary leakage of small amounts of stool or mucus, which can result in stains or marks on clothing or bedding. This condition is often associated with fecal incontinence, where individuals are unable to control the release of stool. Fecal soiling frequency refers to how often these incidents occur within a given timeframe, typically measured over a day, week, or month.

The frequency of fecal soiling can vary significantly from one individual to another, depending on the severity of incontinence, the functionality of the anal sphincters, and other factors such as diet, bowel habits, and the effectiveness of any treatments or interventions. It is often used as a key indicator in clinical studies to assess the effectiveness of treatments for fecal incontinence, such as biofeedback, electrical stimulation, or pelvic floor rehabilitation.

Tracking fecal soiling frequency helps clinicians understand the patient's condition, determine the severity of their
a weak before treatment and the last weak of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinai University

Collaborators

El Galaa Teaching Hospital

Investigators

  • Principal Investigator: Rabab S Mohamed, PhD, El Galaa Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HG000124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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