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Not yet recruiting NCT07366476

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

No phase Interventional Fecal Incontinence (FI) Anorectal Malformations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: behavioral therapy, biofeedback, electrical stimulation, pelvic floor muscles training.
Who it may be relevant to
Registry conditions: Fecal Incontinence (FI), Anorectal Malformations. Basic parameters: 6 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Behavioral behavioral therapy
    instructions, diet and toilet modification, motivation and reinforcement
  • Device biofeedback
    animated biofeedback for pelvic floor muscles training
  • Device electrical stimulation
    anal electrical stimulation to stimulate pelvic floor muscles
  • Other pelvic floor muscles training
    exercises to reeducate pelvic floor muscles control

Primary outcome measures

  • anal sphincter muscle activity [Time frame: before and after 3 months of treatment]
Secondary outcome measures (1)
  • fecal soiling frequency [Time frame: a weak before treatment and the last weak of treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • El-Galaa Teaching Hospital — Cairo

Identifiers

NCT: NCT07366476 · HG000124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗