We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01388348
Recruitment Status : Unknown
Verified July 2011 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2011
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Meir Medical Center

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

Condition or disease Intervention/treatment
Bladder Outlet Obstruction Device: Dynamic Urine Vibration "Holter"

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
Study Start Date : July 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Efficacy of Holter to confirm or exclude of bladder outlet obstruction [ Time Frame: one recording at the time of urodynamic testing.approximatly one minute ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of benign prostatic hyperplasia (BPH)
  • has indication for urodynamic evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388348


Contacts
Contact: Ilan Leibovitch, MD +97297471557 leibovitchi@clalit.org.il

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 44281
Contact: ilan leibovitch, md    +97297471557    leibovitchi@clalit.org.il   
Principal Investigator: ilan leibovitch, MD         
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Ilan Leibovitch MD, Meir medical center
ClinicalTrials.gov Identifier: NCT01388348     History of Changes
Other Study ID Numbers: mmc 022-2011
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by Meir Medical Center:
benign prostatic hyperplasia (BPH)
acoustic vibration

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