Anorectal Malformations, Fecal Incontinence (FI)
Conditions
Keywords
Pudendal Nerve Electrical Stimulation, Fecal Incontinence, Children, Repaired, Anorectal Malformation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Therapy
Behavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation.
OTHERKegel Exercise
Kegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions.
DEVICEPudendal Nerve Electrical Stimulation
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.
DIAGNOSTIC_TESTAnal Sphincter Muscle Activity Peak
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
DIAGNOSTIC_TESTBowel Diary Documentation
Defecation Frequency and Fecal Leakage Episodes collected from the Bowel Diary that documenting bowel events daily through a period of time a week.
Sponsors
National Institute of Diabetes and Endocrinology, Egypt
El Galaa Teaching Hospital
Benha Children Hospital
Benha University
Sinai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the assessor didn't know the grouping of children, intervention received, the data of first assessment.
Intervention model description
Randomized Controlled Clinical Trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* children ages ranged from 6 to 9 years and complain of involuntary leakage of feces with a history of anorectal surgical repair MRI revealed the degree of muscle development Fair/Hypoplastic identifiable but less developed or asymmetrical muscles * they can do minimal palpable voluntary contraction of anal sphincter muscle * they were able to follow instructions during the testing and treatment procedures.
Exclusion criteria
* with severe hypoplasia or complete agenesis/absence of parts of the sphincter complex Poor/Barely Identifiable/Absent, evidenced by MRI, * children with post-colon surgery other than ARM, neurologic/neuropathic disorder, spinal cord lesion, sensory or hearing deficits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anal Sphincter Muscles Activity Peak | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Defecation Frequency | Baseline and after three months | Defecation Frequency collected from the bowel diary that documenting bowel events daily through a period of time a week. |
| Fecal Leakage Episodes | 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. |
Countries
Egypt
Outcome results
None listed