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NCT Number: NCT07366476

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

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.

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El-Galaa Teaching Hospital

Cairo, Qalyubia Governorate, 11698, Egypt

Location contact

Amany G Atiaa, PhD

SUB_INVESTIGATOR

Mohamed I Elsepaee, PhD

SUB_INVESTIGATOR

Mohammad A Seada, PhD

SUB_INVESTIGATOR

Rabab S Mohamed, PhD

CONTACT

[email protected]

+201146101160

Rabab S Mohamed, PhD

PRINCIPAL_INVESTIGATOR

Seham M Abd El-Moghny, PhD

CONTACT

[email protected]

+201006920495

Seham M Abd El-Moghny, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral therapy

Behavioral

instructions, diet and toilet modification, motivation and reinforcement

biofeedback

Device

animated biofeedback for pelvic floor muscles training

Electrical Stimulation

Device

anal electrical stimulation to stimulate pelvic floor muscles

pelvic floor muscles training

Other

exercises to reeducate pelvic floor muscles control

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amany G Atiaa, PhD

CONTACT

[email protected]

+201100120004

Seham M Abd El-Moghny, PhD

CONTACT

[email protected]

+201006920495

Sponsors and collaborators

Lead sponsor

Sinai University

Other

Collaborators

  • El Galaa Teaching Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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