Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration Holter

Study Overview
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Brief Summary
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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.

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

Conditions
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Bladder Outlet Obstruction

Intervention / Treatment
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* Device: Dynamic Urine Vibration Holter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic Urine Vibration Holter<br>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 | Device: Dynamic Urine Vibration Holter<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Holter to confirm or exclude of bladder outlet obstruction |  | One recording at the time of urodynamic testing. (approximatly one minute) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Holter to supply the free flowmetry test curve & values. |  | One recording at the time of urodynamic testing. (approximatly one minute) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign prostatic hyperplasia (BPH), acoustic vibration