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.
BMC Pediatr. 2019 Nov 9;19(1):421. doi: 10.1186/s12887-019-1797-8.
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.
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.
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.
Australian and New Zealand Clinical Trials Registration Number: 12618000288224.
23 February 2018, version 1.1.
遗尿症（NE），又称“尿床”，是一种夜间发生的尿失禁形式，发生在年幼的孩子身上。遗尿症的诊断对孩子来说可能具有社交破坏性和心理压力。父母最常用来管理遗尿症的策略是在夜间叫醒孩子上厕所，并在睡前限制孩子的饮水量。行为或教育疗法，如尿疗或膀胱训练，被广泛接受，并被认为是儿童非神经源性下尿路功能障碍的主流治疗选择。药物治疗也发挥着辅助作用。然而，目前没有有效的金标准疗法或干预措施来有效管理遗尿症。
本研究旨在确定一种草药组合治疗儿童遗尿症的疗效。本研究的目标人群是 80 名年龄在 6 至 14 岁（男女）之间的儿童，每周有≥3 次原发性夜间遗尿症（湿夜）。实验组将每天服用一到两粒胶囊，每粒胶囊含有 420 毫克 Urox®（Seipel Group，Brisbane，Australia）的专利混合物，其中包含 Cratevox™（Crataeva nurvala L；Capparidaceae；Varuna）茎皮提取物，标准化为 1.5%羽扇豆醇：非标准化问荆（Equisetum arvense L.；Equisetaceae；马尾草）茎提取物；和非标准化鹰爪枫（Lindera aggregata Sims.）。本研究的主要结果是夜尿症的频率。次要结果包括安全性、生活质量和日间尿失禁。每个参与者将参与试验 32 周，包括前 8 周每两周与研究团队联系一次，然后每 8 周联系一次，直到试验完成。
本研究检验了一种针对许多儿童普遍存在的未充分研究的健康状况的新疗法。尽管有几种治疗遗尿症的方法，但没有足够的证据支持任何一种干预措施，因此，这项随机安慰剂对照二期试验将是对这种疾病潜在新疗法的重要贡献。
澳大利亚和新西兰临床试验注册号：12618000288224。
2018 年 2 月 23 日，第 1.1 版。
