BACKGROUND: Functional constipation is a common problem in the pediatric population and can present with retentive fecal incontinence.The current regimen of toilet training, education, and oral laxatives like polyethylene glycol (PEG) succeeds in about 50% of children, leaving a large group of non-responders. Low-volume transanal irrigation (L-TAI) is a newer, less time-consuming option compared to high-volume TAI, where a small amount of water is used to clear the rectum.Currently, L-TAI is used for treating fecal incontinence in children and adolescents, but to our knowledge the efficacy and tolerability of L-TAI has not yet been investigated in the pediatric population.
METHODS: A two-arm randomized controlled trial (n=50), including children aged 4-14 years suffering from retentive fecal incontinence. All included children were refractory to at least two months treatment with oral laxatives (stool softeners). Children were included across three pediatric departments in Denmark.The children were randomized into two treatment groups (n=25 each).
Group A continued oral laxative treatment and thus worked as a control group. Group B received L-TAI (Qufora ® IrriSedo MiniGo) as add-on. The study period was six weeks including visits at inclusion and completion, as well as a phone call halfway through. At each visit, data concerning bowel habits was collected, and rectal diameter was measured using trans abdominal ultrasound. Throughout the study, children and parents completed daily questionnaires on bowel movements, incontinence episodes, and treatment adherence.
RESULTS: Inclusion is on-going with 48 inclusions of 50 anticipated. The following is preliminary data. Final data will be presented at the ICCS conference.Of the 32 participants in the preliminary analysis, 21 (66%) were boys and 11 (34%) were girls. Mean age at time of inclusion was 6.75 years (range 4;12)
The primary outcome was reduction in number of fecal incontinence episodes per week. Participants were classified as either non-responders (0-49% reduction) or responders (partial response = 50-99% reduction or full response = 100% reduction) according to ICCS classification.
Response (partial or full) was obtained in 26.67 % of the control group and 76.47 % in the L-TAI group (RR 2.87, 95 % CI 1.19; 6.91), p = 0.005. A secondary outcome was change in rectal diameter, measured on trans abdominal ultrasound. We estimated a mean decrease in diameter for both groups at 6 weeks follow-up. A trend towards a greater reduction in rectal diameter was observed in the L-TAI group, with a point estimate of the difference being 3.7 mm (95% CI -0.8; 8.3).
Further analysis, including data on FC based on ROME-IV-criteria, WHO-5-well-being score, and changes in urinary incontinence will be presented at the conference.
CONCLUSIONS: Based on preliminary results, L-TAI is effective as add-on to oral laxatives in treating retentive fecal incontinence in children.
