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

Sinai University

Status: Enrolling

Conditions: Fecal Incontinence (FI); Anorectal Malformations

Treatments: Behavioral: behavioral therapy; Other: pelvic floor muscles training; Device: biofeedback; Device: electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07366476

HG000124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

ES group

Experimental group

Description:

receive anal electrical stimulation, pelvic floor muscles training, and behavioral therapy

Treatment:

Device: electrical stimulation

Other: pelvic floor muscles training

Behavioral: behavioral therapy

Combined group

Experimental group

Description:

receive animated biofeedback in combination with anal electrical stimulation and behavioral therapy

Treatment:

Device: electrical stimulation

Device: biofeedback

Behavioral: behavioral therapy