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

Shaare Zedek Medical Center

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Fecal Incontinence

Treatments: Drug: Botulinum Toxin A (Botox )

Study type: Interventional

Funder types: Other

Identifiers

NCT06785844

Intra-rectal Botulinum toxin

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Botulinum toxin

Experimental group

Treatment:

Drug: Botulinum Toxin A (Botox )