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Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

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ClinicalTrials.gov Identifier: NCT01779349
Recruitment Status : Suspended (sensor calibration and other R&D activities)
First Posted : January 30, 2013
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
P. Square Medical Ltd

Tracking Information
First Submitted Date  ICMJE January 28, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date October 31, 2014
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
Efficacy of Holter to confirm or exclude of bladder outlet obstruction [ Time Frame: One recording at the time of urodynamic testing. (approximatly one minute) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
Efficacy of Holter to supply the free flowmetry test curve & values. [ Time Frame: One recording at the time of urodynamic testing. (approximatly one minute) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"
Official Title  ICMJE Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" With Correlation to Pressure Flow Study and Uroflowmetry.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Bladder Outlet Obstruction
Intervention  ICMJE 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
Study Arms  ICMJE 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"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 28, 2013)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779349
Other Study ID Numbers  ICMJE PSM - 005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party P. Square Medical Ltd
Study Sponsor  ICMJE P. Square Medical Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haim Matzkin, Prof. Urology Department Director, Tel Aviv Sourasky Medical Center
PRS Account P. Square Medical Ltd
Verification Date October 2014

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