Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
Inclusion Criteria:
- clinical diagnosis of benign prostatic hyperplasia (BPH)
- has indication for urodynamic evaluation
Contacts and Locations| Contact: Ilan Leibovitch, MD | +97297471557 | leibovitchi@clalit.org.il |
| 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 | |
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 May 19, 2013