Efficacy of low volume transanal irrigation in children with retentive fecal incontinence: A randomized controlled trial

Abstract

Objectives: To assess whether low-volume transanal irrigation (L-TAI) is effective as add-on to oral laxative therapy for children with functional constipation and retentive fecal incontinence. Methods: Two-arm randomized controlled trial, including children aged 4–14 suffering from retentive fecal incontinence. All included children were refractory to at least 2 months treatment with stool softening oral laxatives. Children were included across three pediatric departments in Denmark and randomized into two treatment groups. Treatment duration was 6 weeks. The control group continued oral laxative therapy. The intervention group received L-TAI as add-on. The primary objective was evaluating reduction in fecal incontinence episodes. Secondary objectives included assessment of constipation symptoms, rectal diameter, and well-being based on the WHO-5 questionnaire. Participants were classified as nonresponders (0%–49% reduction) or responders (partial response = 50%–99% reduction, or full response = 100% reduction). Results: Fifty children were included. The respective median ages were 7 (interquartile range [IQR] = 3) in the intervention group and 6 years (IQR = 1) in the control group. In the intervention group, 75% were responders with 35% experiencing full response, while 33% in the control group were responders, with 4.8% experiencing full response (p = 0.007 and p = 0.020 for response and full response respectively). At follow-up, 55% of the intervention group and 90.5% of the control group still met ROME-IV criteria for constipation (p = 0.010). Conclusions: L-TAI is effective as add-on to oral laxatives in treating fecal incontinence and constipation. Further studies with longer follow-up periods are needed to assess long-term effects. Clinical Trial identification number: NCT05570318 (https://clinicaltrials.gov/study/NCT05570318).