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