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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
  Purpose

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.


Condition Intervention
Bladder Outlet Obstruction
 Device: Dynamic Urine Vibration "Holter"

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" With Correlation to Pressure Flow Study and Uroflowmetry.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by P. Square Medical Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: May 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779349

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Haim Matzkin, Prof.         hmatzkin@tasmc.health.gov.il    
Principal Investigator: Haim Matzkin, Prof.            
Sponsors and Collaborators
P. Square Medical Ltd
Investigators
Principal Investigator: Haim Matzkin, Prof. Urology Department Director, Tel Aviv Sourasky Medical Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: P. Square Medical Ltd
ClinicalTrials.gov Identifier: NCT01779349     History of Changes
Other Study ID Numbers: PSM - 005
Study First Received: January 28, 2013
Last Updated: April 9, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by P. Square Medical Ltd:
benign prostatic hyperplasia (BPH)
acoustic vibration

Additional relevant MeSH terms:
Urinary Bladder Neck Obstruction
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 23, 2013