Fecal Incontinence
Conditions
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.
Interventions
Botulinum Toxin injection
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Median number of FI episodes/week at 3-months post-intervention, compared to baseline diary. | 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 |
| Mean number of complete bowel movements/week compared to baseline according to diary. | 3-months post-intervention |
Contacts
Primary ContactDotan Yogev, MD
Outcome results
None listed