Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study

Clalit Health Services

Status: Unknown

Conditions: Bladder Outlet Obstruction

Treatments: Device: Dynamic Urine Vibration "Holter"

Study type: Interventional

Funder types: Other

Identifiers

NCT01388348

mmc 022-2011

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• clinical diagnosis of benign prostatic hyperplasia (BPH)
• has indication for urodynamic evaluation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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100 participants in 1 patient group

Dynamic Urine Vibration "Holter"

Experimental group

Description:

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

Treatment:

Device: Dynamic Urine Vibration "Holter"