Back to resultsDiagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
Primary Purpose
Bladder Outlet Obstruction
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dynamic Urine Vibration "Holter"
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Outlet Obstruction focused on measuring benign prostatic hyperplasia (BPH), acoustic vibration
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of benign prostatic hyperplasia (BPH)
- has indication for urodynamic evaluation
Sites / Locations
- Meir Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dynamic Urine Vibration "Holter"
Arm Description
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
Outcomes
Primary Outcome Measures
Efficacy of Holter to confirm or exclude of bladder outlet obstruction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01388348
Brief Title
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
Official Title
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Outlet Obstruction
Keywords
benign prostatic hyperplasia (BPH), acoustic vibration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dynamic Urine Vibration "Holter"
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Dynamic Urine Vibration "Holter"
Intervention Description
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 Measure Information:
Title
Efficacy of Holter to confirm or exclude of bladder outlet obstruction
Time Frame
one recording at the time of urodynamic testing.approximatly one minute
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of benign prostatic hyperplasia (BPH)
has indication for urodynamic evaluation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Leibovitch, MD
Phone
+97297471557
Email
leibovitchi@clalit.org.il
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ilan leibovitch, md
Phone
+97297471557
Email
leibovitchi@clalit.org.il
First Name & Middle Initial & Last Name & Degree
ilan leibovitch, MD
12. IPD Sharing Statement
Learn more about this trial
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
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