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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01388348
First received: February 15, 2011
Last updated: July 4, 2011
Last verified: July 2011

February 15, 2011
July 4, 2011
July 2011
December 2011   (final data collection date for primary outcome measure)
Efficacy of Holter to confirm or exclude of bladder outlet obstruction [ Time Frame: one recording at the time of urodynamic testing.approximatly one minute ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01388348 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study

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.

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Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Bladder Outlet Obstruction
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
Experimental: 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
Intervention: Device: Dynamic Urine Vibration "Holter"
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical diagnosis of benign prostatic hyperplasia (BPH)
  • has indication for urodynamic evaluation
Male
18 Years and older
No
Contact: Ilan Leibovitch, MD +97297471557 leibovitchi@clalit.org.il
Israel
 
NCT01388348
mmc 022-2011
No
Ilan Leibovitch MD, Meir medical center
Meir Medical Center
Not Provided
Not Provided
Meir Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP