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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorSinai University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children with repaired anorectal malformation

evident spared anal sphincter muscles by MRI

the age range from 6 to 10 years

able to follow instructions

Disqualifiers

children with absent anal sphincter muscles by MRI

children with post-colon surgery other than ARM

neurologic/neuropathic disorder

sensory or hearing deficits

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    exercises to reeducate pelvic floor muscles control

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ES groupExperimental treatment 3 interventions
Group B: Combined groupExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
before and after 3 months of treatment

Secondary outcomes

1

fecal soiling frequency

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

Time frame
a weak before treatment and the last weak of treatment

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

El-Galaa Teaching Hospital Status unavailable 11698, Cairo, Qalyubia GovernorateEgyptEgypt

Sponsors and contacts

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Sinai University

Lead sponsor

El Galaa Teaching Hospital

Collaborator

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