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

Janet Schloss; Kimberley Ryan; Amie Steel

doi:10.1016/j.phymed.2021.153783

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

Phytomedicine. 2021 Dec:93:153783. doi: 10.1016/j.phymed.2021.153783. Epub 2021 Sep 29.

Authors

Janet Schloss¹, Kimberley Ryan², Amie Steel³

Affiliations

¹ National Centre for Naturopathic Medicine, Southern Cross University, Lismore, NSW, Australia; Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney Australia. Electronic address: janet.schloss@scu.edu.au.
² The Royal Brisbane Women's Hospital, Herston, Brisbane, Australia.
³ Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney Australia.

PMID: 34628241
DOI: 10.1016/j.phymed.2021.153783

Abstract

Background: 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.

Hypothesis/purpose: To determine if a herbal capsule formulation taken once daily can reduce incidence and frequency of nocturnal enuresis in children.

Study design: 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® (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.

Results: 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 = 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).

Conclusion: Urox® (Bedtime Buddy®) may assist children in reducing nocturnal enuresis compared to placebo. In addition, it may assist in reducing daily incontinence and urinary urgency.

Keywords: Bedwetting; Bladder control; Herbal medicine; Nocturnal enuresis; Urinary incontinence; Urinary urgency.

Publication types

Randomized Controlled Trial

MeSH terms

Adolescent
Australia
Child
Double-Blind Method
Female
Humans
Male
Nocturnal Enuresis* / drug therapy
Quality of Life