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

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.

Conditions

• Fecal Incontinence (FI)
• Anorectal Malformations

Interventions

BEHAVIORAL

Behavioral Therapy

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

OTHER

Kegel Exercise

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

DEVICE

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.

DIAGNOSTIC_TEST

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

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".

Sponsors & Collaborators

• National Institute of Diabetes and Endocrinology, Egypt

  collaborator UNKNOWN

• El Galaa Teaching Hospital

  collaborator OTHER

• Benha Children Hospital

  collaborator OTHER

• Benha University

  collaborator OTHER

• Sinai University

  lead OTHER

Principal Investigators

• GOTHI · National Institute for Teaching Hospitals and Institutes

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-02

Primary Completion

2025-03-20

Completion

2025-06-03

Countries

• Egypt

Study Locations