跳至主要内容
临床试验/NCT01388348
NCT01388348Unknown不适用

Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年7月1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
100
试验地点
1
主要终点
Efficacy of Holter to confirm or exclude of bladder outlet obstruction

研究概览

简要总结

Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine Vibration "Holter" based on a Urine Flow Vibration Analysis technology. The acoustic vibration sensor is a small device that records the vibration due to urine flow. The patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. The analysis is performed off-line and the results are compared to the results of a standard pressure flow study. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •clinical diagnosis of benign prostatic hyperplasia (BPH)
  • •has indication for urodynamic evaluation

排除标准

  • 未提供

研究组 & 干预措施

Dynamic Urine Vibration "Holter"

Experimental

each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration "Holter" and then urodynamically by pressure flow study

干预措施: Dynamic Urine Vibration "Holter" (Device)

结局指标

主要结局

Efficacy of Holter to confirm or exclude of bladder outlet obstruction

时间窗: one recording at the time of urodynamic testing.approximatly one minute

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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