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临床试验/NCT00238680
NCT00238680已完成不适用

The Effect of Programmable Timer in Bladder Rehabilitation Treatment of Idiopathic Overactive Bladder in Children

University of Aarhus2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.

研究概览

简要总结

The purpose of this study is to evaluate the effect of bladder rehabilitation in a non-selected group of children with idiopathic overactive bladder and to clarify whether the effect of the treatment can be increased by addition of a programmable timer

详细描述

Daytime urinary incontinence is common in children. At the age of 7 a prevalence of 2-9 % has been reported. Daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. Daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified.

The symptom based diagnosis OAB (overactive bladder) is most often used to describe daytime urinary incontinence in children. OAB is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency.

When urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment in children with OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. The treatment consist of instruction in good micturition habits including toilet position, sufficient fluid intake and voidings at predefined intervals. The treatment effect is to a large degree dependent upon the ability of the children to void at fixed intervals. Children at the age of 5-10 yrs generally find this difficult and a programmable timer seems be an useful instrument in order to remind the child of voiding at fixed times. However there has not been published studies of the effect of programmable timer.

Hypothesis:

  • Daytime urinary incontinence in children aged 5-15 with idiophatic OAB can in 50 % of cases be cured by bladder rehabilitation
  • The compliance of the bladder rehabilitation treatment can for each individual be increased by adding a programmable timer to the 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
None

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Daytime urinary incontinence with at least 1 episode of at least 1 ml per week
  • More than 6 voidings per day
  • Informed consent

排除标准

  • Known diseases of the kidneys or urinary tract besides OAB
  • Receiving treatment with drugs that have an effect on the urine production or bladder function

结局指标

主要结局

Clinical effects evaluated by home registrations of incontinence episodes and frequency volume charts at specified intervals.

次要结局

  • Bladder capacity measure before and after treatment.

研究者

申办方类型
Other

研究点 (2)

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