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临床试验/NCT01779349
NCT01779349暂停不适用

Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" With Correlation to Pressure Flow Study and Uroflowmetry.

P. Square Medical Ltd4 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
45
试验地点
4
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 and to the standard free flowmetry test. 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
None

入排标准

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

入选标准

  • clinical diagnosis of benign prostatic hyperplasia (BPH)
  • has indication for urodynamic evaluation
  • Males 18 years and older
  • Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.

排除标准

  • Any condition which, in the investigator opinion, makes the patient unsuitable

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

  • Efficacy of Holter to supply the free flowmetry test curve & values.(One recording at the time of urodynamic testing. (approximatly one minute))

研究者

发起方
P. Square Medical Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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