Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change of copeptin at baseline and after 28 days during routine desmopressin therapy
研究概览
简要总结
Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigmatism.
The only available medical treatment option is the vasopressin analogum Desmopressin®. However, according to the literature, only one third of patients shows a good treatment response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side effects like water intoxication and hypertension.
Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in patients with MEN compared to controls and lower in patients with severe bed wetting compared to patients with only slight bed wetting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children at the age between 5 and 16 years
- •Diagnosis of monosymptomatic nocturnal enuresis
- •Completion of uroflowmetry and bladder sonography if possible
- •Completion of home recording charts of bed wetting episodes if possible
- •Willingness to use Desmopressin® treatment
排除标准
- •Children with daytime enuresis
- •Children with lower urinary tract symptoms and infection
- •Children with structural abnormalities of the urinary tract
- •Children with chronic illness, esp. renal failure, hypertension, congenital heart disease, diabetes mellitus and diabetes insipidus.
结局指标
主要结局
Change of copeptin at baseline and after 28 days during routine desmopressin therapy
时间窗: morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy
次要结局
未报告次要终点