Risperidone for the Treatment of Retentive Fecal Incontinence in Children and Adolescents: A Randomize Clinical Trial

Background: Functional retentive overflow incontinence (Retentive FI) is the most common cause of fecal soiling in children. Based on the clinical experiences, patients with retentive FI and comorbid psychiatric disorders, were accelerated in their treatment of fecal incontinence when they were being treated with Risperidone for their psychiatric comorbidities, therefore this study was conducted to evaluate the effect of Risperidone in the treatment of Retentive FI in children and adolescents. Method: In this double-blind randomized clinical trial, 170 patients aged 4-16 years eligible for the study were randomly divided into two groups receiving Risperidone (n=70) and placebo (n=70). About half of these patients had newly diagnosed psychiatric disorders and were drug naïve, this was considered in their division. Participants received a daily dose of 0.25-0.5 mg every 12 hours of Risperidone syrup (intervention group) or maltodextrin (placebo group) for 12 weeks. Sociodemographic data including age, sex, weight, height, BMI and BMI z-score (equivalent BMI-for-age percentile), and socioeconomic status were recorded. nocturnal fecal incontinence, diurnal fecal incontinence and painful defecations information was collected from subjects. Results: : 136 participants (69 on Risperidone and 67 on placebo) completed the intervention. Mean age of participant in the intervention and placebo groups were 7.2±2.4 years and 8.0±3.1 y, respectively. The mean number of nocturnal fecal incontinence (P trend =0.39), diurnal fecal incontinence (P trend =0.48) and painful defecations for participants with and without psychiatric comorbidities were not significantly different between the groups (P=0.49, P=0.47, respectively). While, a significant interaction was observed between time and psychiatric comorbidities (P <0.001) for diurnal fecal incontinence after treatment with Risperidone. Conclusion: Based on our findings in this study, Risperidone, used commonly for psychiatric disorders in children and adolescents, may be useful in the treatment of retentive fecal incontinence in the presence of psychiatric comorbidities, and along with other interventions.