The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 6
- 主要终点
- The number of children achieving complete dryness (complete responders)
研究概览
简要总结
The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment efficacy.
The hypothesis is that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with MNE and subsequent treatment tailoring improves the response to first-line treatment approach.
详细描述
This is a randomized, controlled study.
This study will be performed at Aarhus University Hospital (Denmark), Ghent University Hospital (Belgium) and Hospital of Zhengzhou University (China) following the same protocol.
According to the initial randomization, children will be allocated to treatment without (group A) or with (group B) prior clinical characterization based on home recordings.
Group A: The children will be randomized to either an enuresis alarm or desmopressin without evaluating the home recordings.
Group B: The home recordings will be evaluated and treatment will be based on the recordings. Desmopressin will be administered to the children with nocturnal polyuria and the conditional alarm to the children with reduced bladder capacity. Children with nocturnal polyuria and reduced bladder capacity will be treated with both desmopressin and conditional alarm. Children with neither nocturnal polyuria nor reduced bladder capacity will again be randomized to either desmopressin or alarm treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The children and the parents will not know, if there treatment is based on home recordings or not.
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-14 years.
- •Three or more wet nights per week regarding the home registrations.
排除标准
- •Ongoing constipation and/or faecal incontinence.
- •Daytime symptoms such as urgency, frequency or incontinence.
- •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.
- •Prior or ongoing treatment with alarm, desmopressin or anticholinergics.
- •Ongoing medication that may interfere with the parameters tested.
- •Pregnant or lactating girl.
- •Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatremia or SIADH.
- •Hypersensitivity / allergy to substances in the tablets.
研究组 & 干预措施
Treatment without evaluating the home recordings, medicin.
Children will receive desmopressin without evaluating the home recordings.
干预措施: Desmopressin (Drug)
Treatment without evaluating the home recordings, alarm.
Children will receive conditional alarm without evaluating the home recordings.
干预措施: Conditional alarm (Device)
Treatment based on home recordings, polyuria.
Children with polyuria based on the home recordings will receive desmopressin.
干预措施: Desmopressin (Drug)
Treatment based on home recordings, reduced bladder capacity.
Children with reduced bladder capacity based on the home recordings will receive the conditional alarm.
干预措施: Conditional alarm (Device)
Treatment based on home recordings, both.
Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm.
干预措施: Desmopressin (Drug)
Treatment based on home recordings, both.
Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm.
干预措施: Conditional alarm (Device)
Treatment based on home recordings, none.
Children with neither nocturnal polyuria nor reduced bladder capacity based on the home recordings will be randomized to either desmopressin or alarm treatment. If there is no effect of the treatment, the treatment can be switched.
干预措施: Desmopressin (Drug)
Treatment based on home recordings, none.
Children with neither nocturnal polyuria nor reduced bladder capacity based on the home recordings will be randomized to either desmopressin or alarm treatment. If there is no effect of the treatment, the treatment can be switched.
干预措施: Conditional alarm (Device)
结局指标
主要结局
The number of children achieving complete dryness (complete responders)
时间窗: Eight weeks
Evaluated by home recordings
The number of children who responded to the treatment
时间窗: Eight weeks
Evaluated by home recordings
次要结局
- Change in wet nights(Eight weeks)