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

Launched by SHAARE ZEDEK MEDICAL CENTER · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for children who experience fecal incontinence, which means they have difficulty controlling their bowel movements. Specifically, the study is looking at the use of rectal botulinum toxin injections (RBI), a treatment that has shown promise in adults but has not yet been tested in children. The goal is to see if this treatment can help children aged 4 to 18 who have had fecal incontinence for more than six months and have frequent accidents, occurring three or more times a week.

To be eligible for the trial, children must not have any other medical conditions that explain their incontinence, and certain tests will be done to ensure their bowel function is normal. Those who participate will receive one course of the RBI treatment, and their bowel habits will be monitored over a 15-week period to evaluate how well the treatment works and if it is safe. This study hopes to provide new options for managing this challenging condition in children and improve their quality of life.

Gender

ALL

Eligibility criteria

• 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.