Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

Not Applicable

Suspended

• Conditions: Bladder Outlet Obstruction
• Interventions: Device: Dynamic Urine Vibration "Holter"

• Registration Number: NCT01779349
• Lead Sponsor: P. Square Medical Ltd

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Study Start: 2013-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-10-31
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic Urine Vibration "Holter"	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

Primary Outcome Measures

Name	Time	Method
Efficacy of Holter to confirm or exclude of bladder outlet obstruction	One recording at the time of urodynamic testing. (approximatly one minute)

Secondary Outcome Measures

Name	Time	Method
Efficacy of Holter to supply the free flowmetry test curve & values.	One recording at the time of urodynamic testing. (approximatly one minute)

Trial Locations

Locations (2)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel