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

Abstract

BackgroundNocturnal 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. Hypothesis/PurposeTo determine if a herbal capsule formulation taken once daily can reduce incidence and frequency of nocturnal enuresis in children. Study DesignThis 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® (Bedtime Buddy®) 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. ResultsForty-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 = 0.98). The primary outcome found that there was a statistically significant reduction in NE (p = 0.034; CI 0.086–2.095) and between groups using longitudinal analysis (p = 0.04, Coefficient -1.12, CI 95% -2.20 - -0.04). In the secondary outcomes, urinary urgency reduced statistically significantly for the intervention (p = 0.002; a reduction of 18.3% difference for Bedtime Buddy compared to an increase of 3.7% for the placebo). ConclusionUrox® (Bedtime Buddy®) may assist children in reducing nocturnal enuresis compared to placebo. In addition, it may assist in reducing daily incontinence and urinary urgency.