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

NCT01388348 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-07-06

No results posted yet for this study

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. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.

Conditions

  • Bladder Outlet Obstruction

Interventions

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

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388348 on ClinicalTrials.gov