NCT07366476

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
May 2026Nov 2026

First Submitted

Initial submission to the registry

December 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

December 17, 2025

Last Update Submit

May 5, 2026

Conditions

Fecal Incontinence (FI)Anorectal Malformations

Keywords

fecal incontinenceanorectal malformationbiofeedbackanal electrical stimulationpelvic floor muscles training

Outcome Measures

Primary Outcomes (1)

  • anal sphincter muscle activity

    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 Outcomes (1)

  • fecal soiling frequency

    a weak before treatment and the last weak of treatment

Study Arms (2)

ES group

EXPERIMENTAL

receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy

Behavioral: behavioral therapyDevice: electrical stimulationOther: pelvic floor muscles training

Combined group

EXPERIMENTAL

receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy

Behavioral: behavioral therapyDevice: biofeedbackDevice: electrical stimulation

Interventions

behavioral therapyBEHAVIORAL

instructions, diet and toilet modification, motivation and reinforcement

Combined groupES group
biofeedbackDEVICE

animated biofeedback for pelvic floor muscles training

Combined group
electrical stimulationDEVICE

anal electrical stimulation to stimulate pelvic floor muscles

Combined groupES group
pelvic floor muscles trainingOTHER

exercises to reeducate pelvic floor muscles control

ES group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El-Galaa Teaching Hospital

Cairo, Qalyubia Governorate, 11698, Egypt

Location

MeSH Terms

Conditions

Fecal IncontinenceAnorectal Malformations

Interventions

Behavior TherapyBiofeedback, PsychologyElectric Stimulation

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesComplementary TherapiesTherapeuticsFeedback, PsychologicalPhysical StimulationInvestigative Techniques

Study Officials

  • Rabab S Mohamed, PhD

    El Galaa Teaching Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amany G Atiaa, PhD

CONTACT

+201100120004amany.atia@su.edu.eg

Seham M Abd El-Moghny, PhD

CONTACT

+201006920495dr.siham@gothi.gov.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
who run the randomization process
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized comparative clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 26, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

EG(1)