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临床试验/NCT03399877
NCT03399877Unknown不适用

A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography

Yonsei University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
51
试验地点
1
主要终点
maximum flow rate(Qmax=cc/s)

研究概览

简要总结

Uroflowmetry(UF) has been the standard first-line diagnostic tool for the evaluation of pediatric voiding dysfunction. But recently, UF combined with pelvic flow electromyography(EMG) is emphasized and recommended to analyze the separate contributions of the detrusor and bladder outlet and sole UF is discouraged except for the follow-up study after abnormal UF/EMG result(Bauer et al., 2015). However, electrode itself can disturb pelvic floor relaxation and there is no evidence about necessity of consecutive UF/EMG test. Therefore, the investigators are going to compare three different methods (Primary-Secondary: UF/EMG-UF/EMG, UF/EMG-sole UF, sole UF-UF/EMG)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •children aged 5 to 11.9 who visit pediatric urology department for enuresis.

排除标准

  • •If children have experience of performing uroflowmetry or uroflowmetry-electromyography.
  • •If children do not cooperate on performing the test
  • •If enuresis is caused by neurological or anatomical problem.

研究组 & 干预措施

Uroflowmetry-Combining electromygraphy with uroflowmetry

Experimental

Children who assigned Group C firstly perform uroflowmetry solely. and subsequently perform uroflowmetry-electromyography.

干预措施: Uroflowmetry-Combining electromyography with uroflowmetry (Group C) (Biological)

Combining electromygraphy with uroflowmetry

Active Comparator

Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography

干预措施: Combining electromyography with uroflowmetry (group A) (Biological)

Uroflowmetry

Active Comparator

Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform uroflowmetry solely.

干预措施: Uroflowmetry(Group B) (Biological)

结局指标

主要结局

maximum flow rate(Qmax=cc/s)

时间窗: One day

The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.

次要结局

  • synergy or dyssynergy between the bladder and the pelvic floor.(One day)
  • Uroflow curve pattern(One day)
  • post void residual(One day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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