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临床试验/NCT05146258
NCT05146258已完成不适用

The Effectivity of the Voiding School for Symptom Reduction and Quality of Life in Children With Lower Urinary Tract Symptoms

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月14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
60
试验地点
1
主要终点
Lower Urinary Tract Symptoms - VVSDES

研究概览

简要总结

Lower urinary tract dysfunction (LUTD) is a common pathology within children and shows a wide spectrum of lower urinary tract symptoms (LUTS). These symptoms have a significant impact on a child's well-being. For the treatment of LUTS in children urotherapy, a non-medicamentous form of therapy, is implemented as standard therapy. It can be described as a bladder re-education and rehabilitation programme where the participants are informed on the anatomy and physiology of the normal and pathological urinary system. Urotherapy has been offered as individual therapy for a long time but is now also offered as group therapy (the voiding school). This is, as compared to the individual therapy, more cost-effective and gives the participants the feeling not to be alone in the situation. The effectiveness of the individual therapy for children with LUTD has already been determined, however little research has been done on the effectiveness of urotherapy in group (the voiding class). The present study wants to investigate the effect of the group therapy on the symptoms and quality of life of children with LUTD.

详细描述

The current study is a prospective cohort-study in which information of the impact of the voiding class on the symptoms and well-being of the children is obtained through two questionnaires, respectively the Vancouver Symptom Score for Dysfunctional Elimination Syndrome (VSSDES) and the Paediatric Incontinence Questionnaire (PinQ). Participants of this study are as well asked to complete drinking and voiding charts and nocturnal diaries. These questionnaires and documents are filled in before and after the voiding class. The collected data will be further analysed statistically trough Statistical Package for the Social Sciences (SPPS), to determine significant improvements in symptoms and quality of life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children (5-12 years old)
  • children with LUTS
  • children who follow voiding school, with or without previously failed training

排除标准

  • children >12 years ol and <5 years old
  • children who suffer from solely faecal problems without lower urinary tract symptoms
  • children who are currently following a different kind of therapy concerning the LUTS, than VC
  • children with neurological disorders or anatomical variations of the bladder
  • children who underwent surgical intervention of the bladder

结局指标

主要结局

Lower Urinary Tract Symptoms - VVSDES

时间窗: through study completion, average of 3 months

Amount of LUTS before and after the voiding class measured by the Vancouver symptom score for dysfunctional elimination syndrome (VSSDES)

Well-being of the child - PinQ

时间窗: through study completion, average of 3 months

The effect of the voiding class on the QoL measured by the Paediatric incontinence questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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