Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

Bladder Outlet Obstruction Clinical Trial

Official title:

Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" With Correlation to Pressure Flow Study and Uroflowmetry.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01779349
• Other study ID #: PSM - 005
• Status: Suspended
• Phase: N/A
• First received: January 28, 2013
• Last updated: October 30, 2014
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2014
• Source: P. Square Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• 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 and to the standard free flowmetry test. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 45
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• 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

• Males 18 years and older

• Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.

Exclusion Criteria:

Any condition which, in the investigator opinion, makes the patient unsuitable

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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	Hadassah Medical Center	Jerusalem
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
P. Square Medical Ltd

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
Secondary	Efficacy of Holter to supply the free flowmetry test curve & values.		One recording at the time of urodynamic testing. (approximatly one minute)	No