Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study
- Conditions
- Fecal Incontinence
- Interventions
- Drug: Botulinum Toxin A (Botox )
- Registration Number
- NCT06785844
- Lead Sponsor
- Shaare Zedek Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Botulinum toxin Botulinum Toxin A (Botox ) -
- Primary Outcome Measures
Name Time Method median number of FI episodes/week at 1-month post-intervention compared to baseline 3-months post-intervention 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.
- Secondary Outcome Measures
Name Time Method Mean number of complete bowel movements/week compared to baseline according to diary. 3-months post-intervention Median number of FI episodes/week at 3-months post-intervention, compared to baseline diary. 3-months post-intervention Rate of patients with a 50% decrease in mean FI episodes/week compared to baseline diary. 3-months post-intervention Rate of patients with daily FI episodes (at least 1 episode/day) compared to baseline. 3-months post-intervention 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"? 3-months post-intervention 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. 3-months post-intervention
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