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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.
BMC Pediatr 2019; 19(1):421BPed

Abstract

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 non-neurogenic 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 any one intervention and as such this randomised placebo-controlled phase II trial will be an important contribution to understanding potential new treatments for this condition.

TRIAL REGISTRATION

Australian and New Zealand Clinical Trials Registration Number: 12618000288224.

PROTOCOL

23 February 2018, version 1.1.

Authors+Show Affiliations

Office of Research, Endeavour College of Natural Health, Brisbane, Australia. Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney, Australia.Office of Research, Endeavour College of Natural Health, Brisbane, Australia.Office of Research, Endeavour College of Natural Health, Brisbane, Australia. Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney, Australia.Office of Research, Endeavour College of Natural Health, Brisbane, Australia. amie.steel@uts.edu.au. Australian Research Centre in Complementary and Integrative Medicine, Faculty of Health, University of Technology Sydney, Sydney, Australia. amie.steel@uts.edu.au.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31706286

Citation

Schloss, Janet, et al. "A Randomised, Double-blind, Placebo-controlled Clinical Trial Assessing the Efficacy of Bedtime Buddy® for the Treatment of Nocturnal Enuresis in Children." BMC Pediatrics, vol. 19, no. 1, 2019, p. 421.
Schloss J, Ryan K, Reid R, et al. A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children. BMC Pediatr. 2019;19(1):421.
Schloss, J., Ryan, K., Reid, R., & Steel, A. (2019). A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children. BMC Pediatrics, 19(1), p. 421. doi:10.1186/s12887-019-1797-8.
Schloss J, et al. A Randomised, Double-blind, Placebo-controlled Clinical Trial Assessing the Efficacy of Bedtime Buddy® for the Treatment of Nocturnal Enuresis in Children. BMC Pediatr. 2019 Nov 9;19(1):421. PubMed PMID: 31706286.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomised, double-blind, placebo-controlled clinical trial assessing the efficacy of bedtime buddy® for the treatment of nocturnal enuresis in children. AU - Schloss,Janet, AU - Ryan,Kimberley, AU - Reid,Rebecca, AU - Steel,Amie, Y1 - 2019/11/09/ PY - 2018/12/04/received PY - 2019/10/21/accepted PY - 2019/11/11/entrez PY - 2019/11/11/pubmed PY - 2019/11/11/medline KW - Bladder incontinence KW - Herbal medicine KW - Nocturnal enuresis SP - 421 EP - 421 JF - BMC pediatrics JO - BMC Pediatr VL - 19 IS - 1 N2 - 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 non-neurogenic 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 any one intervention and as such this randomised placebo-controlled phase II trial will be an important contribution to understanding potential new treatments for this condition. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registration Number: 12618000288224. PROTOCOL: 23 February 2018, version 1.1. SN - 1471-2431 UR - https://www.unboundmedicine.com/medline/citation/31706286/A_randomised,_double-blind,_placebo-controlled_clinical_trial_assessing_the_efficacy_of_bedtime_buddy®_for_the_treatment_of_nocturnal_enuresis_in_children L2 - https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-019-1797-8 DB - PRIME DP - Unbound Medicine ER -