NCT01779349

Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: P. Square Medical Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Outlet Obstruction

Interventions

Type	Name	Description
DEVICE	Dynamic Urine Vibration "Holter"	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

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-01-30
• Last updated: 2014-10-31

Locations

2 sites across 1 country: Israel