Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation

NCT ID: NCT07099339

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-02
• Study Completion Date: 2025-06-03

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.

Conditions

Fecal Incontinence (FI); Anorectal Malformations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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.

Group Type: EXPERIMENTAL

Behavioral Therapy

Intervention Type: BEHAVIORAL

Behavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation.

Kegel Exercise

Intervention Type: OTHER

Kegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions.

Anal Sphincter Muscle Activity Peak

Intervention Type: 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

Bowel Diary Documentation

Intervention Type: 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".

Study Group

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.

Group Type: EXPERIMENTAL

Behavioral Therapy

Intervention Type: BEHAVIORAL

Behavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation.

Kegel Exercise

Intervention Type: OTHER

Kegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions.

Pudendal Nerve Electrical Stimulation

Intervention Type: 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.

Anal Sphincter Muscle Activity Peak

Intervention Type: 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

Bowel Diary Documentation

Intervention Type: 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".

Interventions

Behavioral Therapy

Behavioral Therapy in form of: Learning and advices, Dietary modifications, Toilet pattern modification, Motivational rewarding system, and Diary documentation.

Intervention Type: BEHAVIORAL

Kegel Exercise

Kegel Exercise done by contracting and relaxing pelvic floor muscles for seconds with hold and repetitions.

Intervention Type: OTHER

Pudendal 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.

Intervention Type: DEVICE

Anal 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

Intervention Type: DIAGNOSTIC_TEST

Bowel 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".

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Cognitive-Behavioral Therapy; Behavioral Modifications; Pelvic Floor Muscles Training; Anal Electrical Stimulation; Anorectal Electrical Stimulation; Intra-anal Electrical Stimulation; Pelvic Floor Muscles Activity; Anorectal Manometer

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Endocrinology, Egypt

UNKNOWN

Sponsor Role: collaborator

El Galaa Teaching Hospital

OTHER

Sponsor Role: collaborator

Benha Children Hospital

OTHER

Sponsor Role: collaborator

Benha University

OTHER

Sponsor Role: collaborator

Sinai University

OTHER

Sponsor Role: lead

Responsible Party

Amany Gomaa Atiaa

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GOTHI

Role: STUDY_CHAIR

National Institute for Teaching Hospitals and Institutes

Locations

General Organization for Teaching Hospitals and Institutes

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

HB000145

Identifier Type: -

Identifier Source: org_study_id