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临床试验/NCT00148005
NCT00148005已完成不适用

Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2004年9月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
Prevalence of micturition disorders

研究概览

简要总结

Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability

详细描述

Overview of the problem by a questionnaire, diary of micturition and drinking behaviour, filled out by the parents or by the staff of the institution.

Investigation of the etiology by clinical and functional examination (uroflowmetry, bladder scan, video-urodynamic examination).

Frequency:

  • Uroflowmetry: two periods of two weeks, with 6 weeks break between both periods. During the follow-up period every 3 months during 12 months
  • Bladder scan: once during the periods of the uroflowmetry
  • Video-urodynamic examination: once in selected participants, after consent of the parents
  • Adaptation of the drinking behaviour: start after two weeks of observation, after uroflowmetry and bladder scan. Continuous proces.
  • Therapeutic measures (medication, miction clock): start after 10 weeks of observation or after video-urodynamic examination.

Development of a therapeutic plan: adaptation of the micturition and drinking behaviour, anticholinergic therapy.

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
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with a motoric and/or mental disability
  • 4-14 years

排除标准

  • Known neurogenic bladder disorder

结局指标

主要结局

Prevalence of micturition disorders

Etiology of micturition disorders after 10 weeks observation

Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation

次要结局

  • Efficacy of the therapy after 3, 6, 9, 12 months

研究者

申办方类型
Other

研究点 (2)

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