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

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 2, 2024

Primary Completion Date

March 20, 2025

Study Completion Date

June 3, 2025

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."

Trial Locations (1)

11562

General Organization for Teaching Hospitals and Institutes, Cairo

All Listed Sponsors
collaborator

National Institute of Diabetes and Endocrinology, Egypt

UNKNOWN

collaborator

El Galaa Teaching Hospital

OTHER

collaborator

Benha Children Hospital

OTHER

collaborator

Benha University

OTHER

lead

Sinai University

OTHER

NCT07099339 - Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation | Biotech Hunter | Biotech Hunter