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Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

Bladder Outlet Obstruction Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01779349
Study type Interventional
Source P. Square Medical Ltd
Contact
Status Suspended
Phase N/A
Start date July 2013
Completion date June 2015
View Details
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