Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Comparative Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sinai University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- anal sphincter muscle activity
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
who run the randomization process
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ES group
receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy
Intervention: behavioral therapy (Behavioral)
ES group
receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy
Intervention: electrical stimulation (Device)
ES group
receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy
Intervention: pelvic floor muscles training (Other)
Combined group
receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy
Intervention: behavioral therapy (Behavioral)
Combined group
receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy
Intervention: biofeedback (Device)
Combined group
receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy
Intervention: electrical stimulation (Device)
Outcomes
Primary Outcomes
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
- fecal soiling frequency(a weak before treatment and the last weak of treatment)
Investigators
Amany Gomaa Atiaa
Lecturer
Sinai University