Bladder Outlet Obstruction Observation Using Dynamic Urin... | NCT01779349

Studies
Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

NCT01779349

Sponsor

P. Square Medical Ltd

Status

Suspended

Last Update Posted

Oct 31, 2014Estimated

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Bladder Outlet Obstruction

Interventions

Dynamic Urine Vibration "Holter"

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sensor calibration and other R&D activities

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2014

Last Update Posted Date

Oct 31, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dynamic Urine Vibration "Holter"	Experimental	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	Device: Dynamic Urine Vibration "Holter"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dynamic Urine Vibration "Holter"	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haim Matzkin, Prof.	Urology Department Director, Tel Aviv Sourasky Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Center		Jerusalem		91120	Israel
Tel Aviv Sourasky Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D001748	Urinary Bladder Neck Obstruction
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D014524	Urethral Obstruction
D014522	Urethral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided