Bladder Outlet Obstruction Clinical Trial
Official title:
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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