Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2025
CompletedFirst Submitted
Initial submission to the registry
July 25, 2025
CompletedFirst Posted
Study publicly available on registry
August 1, 2025
CompletedAugust 17, 2025
August 1, 2025
5 months
July 25, 2025
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Defecation Frequency
Baseline and after three months
Fecal Leakage Episodes
Baseline and after three months
Study Arms (2)
Control Group
EXPERIMENTALControl 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.
Study Group
EXPERIMENTALStudy 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.
Interventions
Behavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation.
Kegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions.
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.
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
Defecation Frequency and Fecal Leakage Episodes collected from the Bowel Diary that documenting bowel events daily through a period of time "a week".
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sinai Universitylead
- National Institute of Diabetes and Endocrinology, Egyptcollaborator
- El Galaa Teaching Hospitalcollaborator
- Benha Children Hospitalcollaborator
- Benha Universitycollaborator
Study Sites (1)
General Organization for Teaching Hospitals and Institutes
Cairo, Cairo Governorate, 11562, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
GOTHI
National Institute for Teaching Hospitals and Institutes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- the assessor didn't know the grouping of children, intervention received, the data of first assessment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
July 25, 2025
First Posted
August 1, 2025
Study Start
November 2, 2024
Primary Completion
March 20, 2025
Study Completion
June 3, 2025
Last Updated
August 17, 2025
Record last verified: 2025-08