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临床试验/NCT01214525
NCT01214525已完成不适用

The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Improved maximal urine flow

研究概览

简要总结

The improvement in uroflow and postvoid residual urine in children after urethral meatotomy for meatal stenosis. The hypothesis is that there is an improvement in both parameters, thus justifying the procedure.

详细描述

Urethral meatal stenosis is a known complication of circumcision occuring in up to 3% of newborns undergoing circumcision. It is customary to perform a meatotomy in order to prevent bladder outlet obstruction, although bladder outlet obstruction has never been proven and improvement has only been proved in a single, small, retrospective study. Our intention is to evaluate the improvement in objective parameters (uroflow and postvoid residual urine) after urethral meatotomy by measuring these parameter before the procedure, one month after the procedure and one year after the procedure. Symptoms assessment will also be performed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Toilet trained children
  • Before puberty
  • No other urologic disease that might affect the measurements
  • Primary (first) repair

排除标准

  • Children unable to urinate on command
  • Children that have started their sexual puberty
  • Children with other urologic disease that might affect the study measurements
  • Recurrent stenosis after previous repair

结局指标

主要结局

Improved maximal urine flow

时间窗: one month and one year

次要结局

  • Improved (reduced) postvoid residual urine(One month and one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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