Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study

Early Phase 1Not Yet RecruitingNCT06785844

Shaare Zedek Medical Center14 enrolled

Overview

Background: Fecal Incontinence (FI) is a frustrating and prevalent GI condition with profound social implications and a marked effect on quality of life. Treatment options are limited for children whose FI is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (NRFI). Rectal botulinum injections (RBI) have recently shown promise for the treatment of FI in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children. Objectives: To evaluate the efficacy and safety of RBI in children with non-retentive fecal incontinence. Methods: A prospective open-label pilot study. Children with intractable NRFI will be screened using anorectal manometry and a colonic transit study. Eligible patients will receive one course of RBI and data regarding FI frequency will be prospectively collected during a 15-week period. Significance: New treatment options for children with intractable fecal incontinence are highly in need. The current study aims to introduce a new treatment modality into pediatric research and patient care.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fecal Incontinence

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children 4-18 years old with fecal incontinence for a period greater than 6 months. * FI frequency of ≥ 3 episodes/week. * After appropriate medical evaluation, FI cannot be explained by another medical condition. * Normal colonic transit study, defined as passage of 80% of markers on day * Normal RAIR on anorectal manometry Exclusion Criteria: * Patients currently fulfilling rome IV criteria for functional constipation. * Patients with evidence of fecal retention. * Patients who had had good response to treatment for overflow incontinence. * Absent RAIR on anorectal manometry. * Any radiologic evidence of dochylosigmoid or distended colon. * Any known organic condition that may affect bowel transit.

Outcomes

Primary Outcomes

median number of FI episodes/week at 1-month post-intervention compared to baseline

median number of FI episodes/week at 1-month post-intervention compared to baseline. The median FI episodes/week will be calculated based on the 21-day diary. FI episode minimal definition: any episode of soiling requiring change of underwear/clothes/washing-up.