A Phase 2 placebo controlled, double-blind randomised clinical trial assessing the efficacy of a Herbal supplement for Nocturnal Enuresis in Children

The aim of the study is to determine the effectiveness of a herbal combination capsule (Urox - Bedtime Buddy™), in the treating children aged 6-14 years who experience bed-wetting. It is hypothesised that the combination capsule will reduce the frequency of bed- wetting in children and therefore improve the physical, psycho social and social well being of the child. The trial aims to recruit 62 children in a randomised control trial where the child will receive either the active herbal combination capsule or a placebo. They will take the capsule daily for 8 weeks and record frequency of wet nights in a diary. The parent and child will also complete a validated questionnaire on the impact of bed-wetting on the child quality of life at various time-points in the trial. After the trial is completed follow up phone calls will measure frequency of nocturnal enuresis as well as day time continence questions at 16, 24 and 32 weeks.