Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

P. Square Medical

Status: Suspended

Conditions: Bladder Outlet Obstruction

Treatments: Device: Dynamic Urine Vibration "Holter"

Study type: Interventional

Funder types: Industry

Identifiers

NCT01779349

PSM - 005

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 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.

Enrollment: 45 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

Any condition which, in the investigator opinion, makes the patient unsuitable

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 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"