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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01779349

Enrollment

Registered

2013-01-30

Start date

2013-07-31

Completion date

2015-06-30

Last updated

2014-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Outlet Obstruction

Keywords

benign prostatic hyperplasia (BPH), acoustic vibration

Brief 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.

Interventions

DEVICEDynamic 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026