Enuresis Alarm for Treatment of Urinary Incontinence in Children With Combined Daytime Incontinence and Enuresis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 8
- 主要终点
- Change in Daytime incontinence-score
研究概览
简要总结
The aim is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating urinary incontinence children with combined daytime incontinence and enuresis. The study will include children who suffers for combined daytime incontinence and enuresis and referred to one of the pediatric departments were offed to participate. Participants are randomized to 8 weeks treatment with either enuresis alarm and timer watch assist urotherapy or solely timer watch assisted urotherapy.
详细描述
Urinary incontinence are common disorders of school age children. Approximately 3.8 - 16.9 % of first grade children suffer from daytime incontinence (DUI) depending on the definitions. Half of the children with DUI suffers for enuresis (NE) too. The background for combined DUI and enuresis is in most children functional overactive bladder (OAB).
At present DUI is treated first with urotherapi, if insufficient bladder modulating drugs are added. When daytime continence is achieved, the enuresis is handled using (in cases of small bladder capacity) an enuresis alarm.
Whether daytime continence is a prerequisite for treating NE or whether enuresis alarm may positively influence DUI treatment has not been studies in a RCT previously.
The aim of this study is to examine whether alarm therapy in addition to urotherapy can have a beneficial effect in treating children with combined daytime incontinence and enuresis. Thus the hypothesis are:
- That the enuresis alarm therapy is beneficial in DUI treatment.
- That it is possible to treat enuresis before daytime continence has been achieved
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
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-14 years
- •Completed "Tørfisk" (Danish version of the Bower "Dry pie" Incontinence diary 1) and bladder diary (containing frequency and volume of voiding, fluid intake through 48 hours as well as 7 days night registering of nocturnal urine production (NUP) and wet nights.)
- •A minimum of 2 wet days per week
- •A minimum of 2 wet nights per week.
- •Average NUP (aNUP) on wet nights of less than 130 % of expected bladder capacity (EBC=30*(age+1))
- •Obtained oral and written informed consent from the participant and both custody holders.
排除标准
- •Known renal- or urinary tracts anomalies that affects the incontinence
- •Ongoing urinary tracts infection (UTI)
- •Ongoing obstipation defined by ROM IV criteria
- •Glycosuria or proteinuria
- •Previously received treatment with anticholinergics
- •Previously received treatment with enuresis alarm
- •Sign on neurological or structural cause of the incontinence
- •Reduced compliance for alarm treatment defined as use of the alarm less than 80 % of the nights of the treatment period.
研究组 & 干预措施
Standard Urotherapy without enuresis alarm
Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch.
干预措施: Timer watch (Rodger) (Device)
Standard Urotherapy with enuresis alarm
Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch. In addition an enuresis alarm will be provided and worn by the participants during the night.
干预措施: Enuresis Alarm Rodger and Timer watch (Rodger) (Device)
Standard Urotherapy with enuresis alarm
Standard urotherapy inclunding normalized fluid intake and times voidings. The timed voiding regime of every 2 hours will be assisted by a timer Watch. In addition an enuresis alarm will be provided and worn by the participants during the night.
干预措施: Timer watch (Rodger) (Device)
结局指标
主要结局
Change in Daytime incontinence-score
时间窗: Score will be calculated pre intervention, at week 2, 4, 6, and 8 of intervention
Incontinence-score calculated from Drypie scale between 0-21
Change in Relative number of wet nights
时间窗: Will be calculated from registrations at baseline and week 8 of intervention
Number of wet nights pr week
次要结局
- Change in Daytime urinary incontinence episodes (DUI episodes)(Will be calculated from 48h registrations at baseline and at week 8 of intervention)
- Change in MVV (maximal voided volume)(Will be calculated from 48h registrations at baseline and at week 8 of intervention)
研究者
Søren Hagstrøm, MD PhD
Consultant
Aalborg University Hospital