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.
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
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.
Single group
Botulinum Toxin A (Botox )
DrugBotulinum Toxin injection
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.
Median number of FI episodes/week at 3-months post-intervention, compared to baseline diary.
Rate of patients with a 50% decrease in mean FI episodes/week compared to baseline diary.
Rate of patients with daily FI episodes (at least 1 episode/day) compared to baseline.
Mean number of complete bowel movements/week compared to baseline according to diary.
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