Intra-rectal Botulinum Toxin Injection for Children with Non-Retentive Fecal Incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective open-label pilot study in children aged 4 to 18 with intractable non-retentive fecal incontinence. Participants undergo anorectal manometry and a colonic transit study, then receive a course of rectal botulinum toxin injections and are followed for 15 weeks to monitor changes in fecal incontinence frequency. The study aims to assess safety and potential efficacy in reducing FI episodes. Eligibility includes a history of FI for more than 6 months, at least 3 episodes per week, and normal colonic transit and RAIR, among other criteria. The lead sponsor is Shaare Zedek Medical Center in Jerusalem, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shaare Zedek Medical Center
  Jerusalem, Israel Recruiting

Study contacts

• Study coordinator: Dotan Yogev, MD
• Email: dotany@szmc.org
• Phone: 97225645027

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.