Biomarkers in Urine for Children With Monosymptomatic Nocturnal Enuresis and Nocturnal Polyuria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Metabolites.
研究概览
简要总结
The aim of the study is to identify protein markers in relation to the enuresis related nocturnal polyuria by using mass spectrometry on nocturnal urine samples. A biomarker for nocturnal polyuria would simplify an important part of the clinical characterization of enuresis patients.
详细描述
Involuntary voiding during sleep, nocturnal enuresis (NE), affects 7-10 % of all 7-year-olds, and 0.5-2 % of young adults. Night-time polyuria is one of the main pathogenic mechanisms. Today, the only method to diagnose nocturnal polyuria is home recordings involving diaper weight and registrations of first morning voids, which is very time-consuming. By using mass spectrometry (proteomics and metabolomics) on nocturnal urine samples from children with NE, the investigators aim to identify protein markers in relation to nocturnal polyuria. The perspective is to simplify an important part of the clinical characterization of NE patients.
This hypothesis-generating pilot project will be performed on 10 boys with NE. The children will have to collect:
- Urine at bedtime on a wet and a dry night.
- Urine during a wet night through a collecting device (non-invasive).
- First morning voided volume following both a wet and a dry night.
Furthermore, we will include 10 children without NE, who will collect urine during a dry night (first morning voided volume).
Endpoints are any biomarkers in urine found to be associated with nocturnal polyuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Monosymptomatic nocturnal enuresis with at least one dry night per week.
- •Nocturnal polyuria defined as nocturnal urine production on wet nights greater than 130 % of expected bladder capacity for age.
- •Normal bladder capacity defined as maximum voided volume excluding first morning voided volume bigger than expected bladder capacity for age.
排除标准
- •Recurrent urinary tract infections.
- •Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated.
- •Neurological and/or known clinically significant anatomical abnormalities of the urinary tract.
- •Former operations in the urinary tract.
- •Ongoing medication that may interfere with the parameters tested.
- •If the child is receiving treatment for nocturnal enuresis (desmopressin, alarm or anticholinergics), the treatment has to be paused 1 week before urine collection.
- •Furthermore, we will include 10 children without nocturnal enuresis and otherwise healthy.
结局指标
主要结局
Metabolites.
时间窗: Up to 1 week.
By targeted mass spectrometry.
Proteins.
时间窗: Up to 1 week.
By using mass spectrometry (proteomics). For all children, any proteins related to nocturnal polyuria will be detected.
次要结局
- Concentration of creatinine in the urine samples.(Up to 1 week.)
- Total urine volume in each sample.(Up to 1 week.)
- Osmolality in the urine samples.(Up to 1 week.)