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

Bladder Outlet Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01388348
• Other study ID #: mmc 022-2011
• Status: Not yet recruiting
• Phase: N/A
• First received: February 15, 2011
• Last updated: July 4, 2011
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Meir Medical Center
• Contact: Ilan Leibovitch, MD
• Phone: +97297471557
• Email: leibovitchi[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of benign prostatic hyperplasia (BPH)

• has indication for urodynamic evaluation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bladder Outlet Obstruction
• Urinary Bladder Neck Obstruction

Intervention

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

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Holter to confirm or exclude of bladder outlet obstruction		one recording at the time of urodynamic testing.approximatly one minute	No