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Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

Primary Purpose

Bladder Outlet Obstruction

Status

Suspended

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Dynamic Urine Vibration "Holter"

About this trial

This is an interventional diagnostic trial for Bladder Outlet Obstruction focused on measuring benign prostatic hyperplasia (BPH), acoustic vibration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Hadassah Medical Center
Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dynamic Urine Vibration "Holter"

Arm Description

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

Outcomes

Primary Outcome Measures

Efficacy of Holter to confirm or exclude of bladder outlet obstruction

Secondary Outcome Measures

Efficacy of Holter to supply the free flowmetry test curve & values.

Full Information

NCT ID

NCT01779349

First Posted

January 28, 2013

Last Updated

October 30, 2014

Sponsor

P. Square Medical Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01779349

Brief Title

Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Suspended

Why Stopped

sensor calibration and other R&D activities

Study Start Date

July 2013 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

P. Square Medical Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Outlet Obstruction

Keywords

benign prostatic hyperplasia (BPH), acoustic vibration

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dynamic Urine Vibration "Holter"

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Dynamic Urine Vibration "Holter"

Intervention Description

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 Measure Information:

Title

Efficacy of Holter to confirm or exclude of bladder outlet obstruction

Time Frame

One recording at the time of urodynamic testing. (approximatly one minute)

Secondary Outcome Measure Information:

Title

Efficacy of Holter to supply the free flowmetry test curve & values.

Time Frame

One recording at the time of urodynamic testing. (approximatly one minute)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haim Matzkin, Prof.

Organizational Affiliation

Urology Department Director, Tel Aviv Sourasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Tel Aviv Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

12. IPD Sharing Statement

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Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

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