A randomised, double-blind, placebo-controlled clinical trial found that a novel herbal formula Urox® (Bedtime Buddy®) assisted children for the treatment of nocturnal enuresis.

[{"label":"BACKGROUND","text":"Nocturnal enuresis or 'bedwetting', is a form of night-time urinary incontinence occurring in younger children. A diagnosis can be socially disruptive and psychologically stressful for a child. The most common strategies used by parents are waking the child during the night to use the bathroom and limiting the child's water intake before going to bed."},{"label":"HYPOTHESIS\/PURPOSE","text":"To determine if a herbal capsule formulation taken once daily can reduce incidence and frequency of nocturnal enuresis in children."},{"label":"STUDY DESIGN","text":"This randomised double-blind placebo-controlled trial evaluated the efficacy of an herbal medicine product to reduce the symptoms of nocturnal enuresis. Participants, aged between 6 and 14 years of age, were recruited from the community in Australia. They were randomised via computerised random-number generation at study enrolment to receive one or two oral capsules in the morning of either Urox\u00ae (Bedtime Buddy\u00ae) or placebo. The Paediatric Quality of life (Pin-Q) was used as a quality-of-life measure and waking wet, fluid intake and urinary urgency per week were monitored."},{"label":"RESULTS","text":"Forty-one children completed the trial with an attrition rate of 16%. There were more males (64.6%) compared to females (35.4%) and the mean age was 8.6 years. Forty-one point seven percentages (41.7%) of participants had improvements in bed wetting by two months which was a highly clinically relevant effect (Cohen's D\u00a0=\u00a00.98). The primary outcome found that there was a statistically significant reduction in NE (p\u00a0=\u00a00.034; CI 0.086-2.095) and between groups using longitudinal analysis (p\u00a0=\u00a00.04, Coefficient -1.12, CI 95% -2.20 - -0.04). In the secondary outcomes, urinary urgency reduced statistically significantly for the intervention (p\u00a0=\u00a00.002; a reduction of 18.3% difference for Bedtime Buddy compared to an increase of 3.7% for the placebo)."},{"label":"CONCLUSION","text":"Urox\u00ae (Bedtime Buddy\u00ae) may assist children in reducing nocturnal enuresis compared to placebo. In addition, it may assist in reducing daily incontinence and urinary urgency."},{"copyright":"Copyright \u00a9 2021 The Authors. Published by Elsevier GmbH.. All rights reserved."}]