Bladder Outlet Obstruction
Conditions
Keywords
benign prostatic hyperplasia (BPH), acoustic vibration
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.
Interventions
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
Sponsors
Meir Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of benign prostatic hyperplasia (BPH) * has indication for urodynamic evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Holter to confirm or exclude of bladder outlet obstruction | one recording at the time of urodynamic testing.approximatly one minute |
Countries
Israel
Contacts
Primary ContactIlan Leibovitch, MD
Outcome results
None listed