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| Name | Class |
|---|---|
| National Institute of Diabetes and Endocrinology, Egypt | UNKNOWN |
| El Galaa Teaching Hospital | OTHER |
| Benha Children Hospital | OTHER |
| Benha University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Experimental | Control Group children treated by Behavioral Therapy and Kegel Exercise, evaluated by assessing Anal Sphincter Muscle Activity Peak by anal pressure sensor and tracking Defecation Frequency and Fecal Leakage Episodes from the bowel diary. |
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| Study Group | Experimental | Study Group children treated by Behavioral Therapy, Kegel Exercise, and Pudendal Nerve Electrical Stimulation, evaluated by assessing Anal Sphincter Muscle Activity Peak by anal pressure sensor and tracking Defecation Frequency and Fecal Leakage Episodes from the bowel diary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Therapy | Behavioral | Behavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation. |
| Measure | Description | Time Frame |
|---|---|---|
| Anal Sphincter Muscles 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. | Baseline and after three months |
| Measure | Description | Time Frame |
|---|---|---|
| Defecation Frequency | Defecation Frequency collected from the bowel diary that documenting bowel events daily through a period of time "a week". | Baseline and after three months |
| Fecal Leakage Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GOTHI | National Institute for Teaching Hospitals and Institutes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Organization for Teaching Hospitals and Institutes | Cairo | Cairo Governorate | 11562 | Egypt |
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| OTHER |
Randomized Controlled Clinical Trial
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the assessor didn't know the grouping of children, intervention received, the data of first assessment.
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| Kegel Exercise | Other | Kegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions. |
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| Pudendal Nerve Electrical Stimulation | Device | 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. |
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| Anal Sphincter Muscle Activity Peak | Diagnostic Test | 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 |
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| Bowel Diary Documentation | Diagnostic Test | Defecation Frequency and Fecal Leakage Episodes collected from the Bowel Diary that documenting bowel events daily through a period of time "a week". |
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Fecal Leakage Episodes collected from the bowel diary that documenting bowel events daily through a period of time "a week".
| Baseline and after three months |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D000071056 | Anorectal Malformations |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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