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Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

NCT ID: NCT01779349

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Bladder Outlet Obstruction

Keywords

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benign prostatic hyperplasia (BPH) acoustic vibration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Dynamic Urine Vibration "Holter"

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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P. Square Medical Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haim Matzkin, Prof.

Role: PRINCIPAL_INVESTIGATOR

Urology Department Director, Tel Aviv Sourasky Medical Center

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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PSM - 005

Identifier Type: -

Identifier Source: org_study_id