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Published (Version of record)CC BY-NC-ND V4.0, Open Access
Published (Version of record)CC BY-NC-ND V4.0, Open
Journal article
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, Vol.93, pp.1-8
12/2021
PMID: 34628241
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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.
Details
- Title
- 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
- Creators
- Janet Schloss - Southern Cross UniversityKimberley Ryan - The Royal Brisbane Women's Hospital, Herston, Brisbane, AustraliaAmie Steel - University of Technology Sydney
- Publication Details
- Phytomedicine, Vol.93, pp.1-8
- Publisher
- Elsevier GmbH
- Grant note
- This trial was co-funded by Seipel Group Pty Ltd and the Queensland State Government of Australia, Innovation Connections Grant (ICG000348) from the Department of Industry, Innovation and Science.
- Identifiers
- 991012968486002368
- Copyright
- © 2021 The Authors. Published by Elsevier GmbH. This is an open access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/).
- Academic Unit
- Faculty of Health; School of Health and Human Sciences; National Centre for Naturopathic Medicine
- Language
- English
- Resource Type
- Journal article