A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children

Janet Schloss; Kimberley Ryan; Rebecca Reid; Amie Steel

doi:10.1186/s12887-019-1797-8

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A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children

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A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children

Janet Schloss, Kimberley Ryan, Rebecca Reid and Amie Steel

BMC pediatrics, Vol.19, pp.1-14

09/11/2019

DOI: https://doi.org/10.1186/s12887-019-1797-8

PMCID: PMC6842251

PMID: 31706286

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Abstract

Bladder incontinence

Herbal medicine

Nocturnal enuresis

Study Protocol

Background: Nocturnal enuresis (NE), or ‘bedwetting’, is a form of night-time urinary incontinence occurring in younger children. A diagnosis of NE can be socially disruptive and psychologically stressful for a child. The most common strategies used by parents to manage NE are waking the child during the night to use the bathroom and limiting the child’s water intake before going to bed. Behavioural or educational therapies for NE such as urotherapy or bladder retraining are widely accepted and considered as a mainstream treatment option for nonneurogenic lower urinary tract dysfunction in children. Pharmacotherapy also plays an ancillary role. However, there is no gold standard therapy or intervention to effectively manage NE. Methods: This study aims to determine the efficacy of a herbal combination in the treatment of NE in children. The target population for this study is 80 children aged between 6 and 14 years old (males and females) who have primary nocturnal enuresis ≥3 per week (wet nights). The active group will receive one or two capsules per day containing 420 mg of a proprietary blend of Urox® (Seipel Group, Brisbane, Australia) containing Cratevox™ (Crataeva nurvala L; Capparidaceae; Varuna) stem bark extract standardised for 1.5% lupeol: non-standardised Equisetum arvense L. (Equisetaceae; Horsetail) stem extract; and, non-standardised Lindera aggregata Sims. The primary outcome for this study is the frequency of nocturia. Secondary outcomes include safety, quality of life, and daytime incontinence. Each participation will be involved in the trial for 32 weeks including contact with the research team every 2 weeks for the first 8 weeks and then every 8 weeks until trial completion. Discussion: This study examines a novel treatment for an under-researched health condition affecting many children. Despite the availability of several therapies for NE, there is insufficient evidence to support the use of anyone intervention and as such this randomised placebo-controlled phase II trial will be an important contribution to understanding potential new treatments for this condition.

Details

Title: A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children
Creators: Janet Schloss - University of Technology Sydney
Kimberley Ryan - Endeavour College of Natural Health
Rebecca Reid - University of Technology Sydney
Amie Steel - University of Technology Sydney
Publication Details: BMC pediatrics, Vol.19, pp.1-14
Publisher: BioMed Central
Grant note: Siepel Group Pty Ltd. is funding the cost of this trial with the support of an Innovation Connections Grant (ICG000348) from the Department of Industry, Innovation and Science. Funding for this trial covers all direct costs. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Identifiers: 991013036340002368
Copyright: © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Academic Unit: National Centre for Naturopathic Medicine
Language: English
Resource Type: Journal article

A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children

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