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
  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. 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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

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 ]

Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ilan Leibovitch MD, Meir medical center
ClinicalTrials.gov Identifier: NCT01388348     History of Changes
Other Study ID Numbers: mmc 022-2011
Study First Received: February 15, 2011
Last Updated: July 4, 2011
Health Authority: Israel: Clalit Health Services

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

ClinicalTrials.gov processed this record on July 29, 2014