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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
behavioral therapy
Behavioralinstructions, diet and toilet modification, motivation and reinforcement
biofeedback
Deviceanimated biofeedback for pelvic floor muscles training
electrical stimulation
Deviceanal electrical stimulation to stimulate pelvic floor muscles
pelvic floor muscles training
Other interventionexercises to reeducate pelvic floor muscles control
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Locations
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Sponsors and contacts
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Sinai University
Lead sponsor
El Galaa Teaching Hospital
Collaborator
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