General Organization for Teaching Hospitals and Institutes
Cairo, Cairo Governorate, 11562, Egypt
NCT Number: NCT07099339
This randomized controlled clinical trial aims to evaluate the effect of pudendal nerve electrical stimulation on fecal incontinence in children with repaired anorectal malformation. Ithe investigators are hypothesized that PNES will significantly improve continence scores, reduce the frequency of fecal incontinent episodes, and enhance the overall quality of life in this vulnerable pediatric population, thereby addressing a critical unmet need in their long-term care.
Children with repaired anorectal malformation may benefit more from combined pudendal nerve electrical stimulation with behavioral therapy and pelvic floor muscles training in improving fecal incontinence.
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Notify Me6 year–9 year
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 11562, Egypt
Anorectal malformation (ARM), commonly known as imperforate anus, represent a spectrum of congenital anomalies where the anus and rectum do not form properly during fetal development, these malformations vary widely in severity, from a simple membrane covering the anal opening to complex defects cloacal malformations involving abnormal connections (fistulas) to the urinary or genital tracts.
Fecal incontinence in this population can stem from various factors, including impaired anorectal sensation, compromised sphincter function, and abnormal bowel motility, severely impacting a child's quality of life, psychosocial development, and integration into social activities.
Current management strategies for FI in children with repaired ARM typically involve a multi-faceted approach, including dietary modifications, laxatives, enemas, and bowel management programs.
Exercises such as Kegels, where children are taught to contract and relax these muscles, are commonly employed to enhance voluntary control and improve the ability to hold stool.
The pudendal nerve plays a vital role in maintaining fecal continence by innervating the external anal sphincter EAS bilaterally by the somatic fibers of the 2nd, 3rd, and 4th sacral roots through its connections to the sacral reflex arc, contributing to rectal sensation, and coordinating pelvic floor muscle function.
All children treated by Behavioral Therapy and Kegel Exercise, and by Pudendal Nerve Electrical Stimulation for the study group.
Outcome Measures: All children were evaluated before the commencement (pretreatment) and after 3 successive months of treatment (posttreatment). The anal sphincter muscle activity peak was assessed by anal pressure sensor and bowel diary was used for tracking defecation frequency and fecal leakage episodes daily.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation.
Other names: Cognitive-Behavioral Therapy, Behavioral Modifications
Kegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions.
Other names: Pelvic Floor Muscles Training
Pudendal Nerve Electrical Stimulation applied bilateral to the right and left pudendal by inserting rectal stimulator electrode anally with the other surface electrode at sacral region.
Other names: Anal Electrical Stimulation, Anorectal Electrical Stimulation, Intra-anal Electrical Stimulation
Anal Sphincter Muscle Activity Peak was evaluated using anal pressure sensor (in mmHg) = anal squeeze pressure during maximum voluntary contraction - resting anal pressure at rest or resting tone as baseline activity
Other names: Pelvic Floor Muscles Activity, Anorectal Manometer
Defecation Frequency and Fecal Leakage Episodes collected from the Bowel Diary that documenting bowel events daily through a period of time "a week".
Time frame: Baseline and after three months
Anal Sphincter Muscle Activity Peak was evaluated using anal pressure sensor (in mmHg) = anal squeeze pressure during maximum voluntary contraction - resting anal pressure at rest or resting tone as baseline activity.
Time frame: Baseline and after three months
Defecation Frequency collected from the bowel diary that documenting bowel events daily through a period of time "a week".
Time frame: Baseline and after three months
Fecal Leakage Episodes collected from the bowel diary that documenting bowel events daily through a period of time "a week".
Sinai University
Other
Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Randomized Controlled Clinical Trial
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