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Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

This study is not yet open for participant recruitment.
Verified April 2013 by P. Square Medical Ltd
Sponsor:
Information provided by (Responsible Party):
P. Square Medical Ltd
ClinicalTrials.gov Identifier:
NCT01779349
First received: January 28, 2013
Last updated: April 9, 2013
Last verified: April 2013
History of Changes

January 28, 2013
April 9, 2013
May 2013
July 2013   (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 NCT01779349 on ClinicalTrials.gov Archive Site
Efficacy of Holter to supply the free flowmetry test curve & values. [ Time Frame: One recording at the time of urodynamic testing. (approximatly one minute) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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
45
November 2013
July 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Not Provided
Israel
 
NCT01779349
PSM - 005
Yes
P. Square Medical Ltd
P. Square Medical Ltd
Not Provided
Principal Investigator: Haim Matzkin, Prof. Urology Department Director, Tel Aviv Sourasky Medical Center
P. Square Medical Ltd
April 2013

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