Clinical trial NCT06785844: Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study
Official title: Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Fecal Incontinence
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 14
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: median number of FI episodes/week at 1-month post-intervention compared to baseline
timeFrame: 3-months post-intervention
Secondary outcomes:
measure: Median number of FI episodes/week at 3-months post-intervention, compared to baseline diary.
timeFrame: 3-months post-intervention
measure: Rate of patients with a 50% decrease in mean FI episodes/week compared to baseline diary.
timeFrame: 3-months post-intervention
measure: Rate of patients with daily FI episodes (at least 1 episode/day) compared to baseline.
timeFrame: 3-months post-intervention
measure: Mean number of complete bowel movements/week compared to baseline according to diary.
timeFrame: 3-months post-intervention
measure: Parents and patient's general impression of the treatment using the following questions: "Was the treatment useful/beneficial?"; "Did the treatment improve your quality of life"?
timeFrame: 3-months post-intervention
measure: Rate of RBI-associated major and minor adverse events. Patients will be questioned according to list, as well as allowed to add adverse events not listed.
timeFrame: 3-months post-intervention
Other outcomes:
Locations:
Study officials:
References:
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