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Reliability of Home Uroflowmetery Using a Disposable Digital Device

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ClinicalTrials.gov Identifier: NCT02026674
Recruitment Status : Unknown
Verified January 2014 by Flometrica Ltd..
Recruitment status was:  Recruiting
First Posted : January 3, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Flometrica Ltd.

December 24, 2013
January 3, 2014
January 14, 2014
December 2013
December 2014   (Final data collection date for primary outcome measure)
Usability evaluation of the FloRite™ system with LUTS patients. [ Time Frame: Dec-2014 ]

Primary outcome measures

• Successful use of FloRite™ system in LUTS patients, defined as:

  • Successful unpacking and installation
  • Successful understanding of the user manual
  • Ability of the patients to operate the device as define by a successful test completion and data transmission
  • Successful retrieval of the DOK
  • Absence of:
  • Device dropping down
  • Urination outside the container
  • Urination on the electronic unit
Same as current
Complete list of historical versions of study NCT02026674 on ClinicalTrials.gov Archive Site
  • Comparison of Qmax (Max Flow Rate) [ Time Frame: Dec-2014 ]
    Comparison of uroflowmetric parameters of Qmax as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
  • Comparison of Tdelay [ Time Frame: Dec-2014 ]
    Comparison of uroflowmetric parameters of Tdelay as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
  • Comparison of uroflowmetric parameter: T100 - Voiding Time [ Time Frame: Dec-2014 ]
    Comparison of uroflowmetric parameters of T100 as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
  • Comparison of uroflowmetric parameters of TQ - Flow Time [ Time Frame: Dec-2014 ]
    Comparison of uroflowmetric parameters of TQ - Flow Time as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
  • Comparison of uroflowmetric parameters of Tqmax - Time to max Flow [ Time Frame: Dec-2014 ]
    Comparison of uroflowmetric parameters of Tqmax - Time to max Flow as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
  • Comparison of uroflowmetric parameters of Qave [ Time Frame: Dec-2014 ]
    Comparison of uroflowmetric parameters of Qave as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
  • Comparison of uroflowmetric parameters of Vcomp - Voided volume [ Time Frame: Dec-2014 ]
    Comparison of uroflowmetric parameters of Vcomp - Voided volume as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Same as current
Not Provided
Not Provided
 
Reliability of Home Uroflowmetery Using a Disposable Digital Device
Reliability of Home Uroflowmetery Using a Disposable Digital Device in Comparison to Standard Clinical Uroflowmetry in Men With LUTS

The FloRite™ device is a disposable urine flow meter, indicated for use in a home setting.

The device provides Urofowmetry measurements, similar to clinic's measurements. Clinic-based uroflowmetry has some flaws; the setting is artificial and often it is difficult to void at the desired moment. Moreover, a single measurement of the voided parameters is a poor representative of the patient condition due to high variability of the measured parameters. Performing multiple Urofowmetry measurements provides representative and more accurate results, in a more patient-friendly, cost effective method.

The FloRite™ product is a disposable urine flow meter. The patient needs to urinate into the device and at the end of urination the patient needs to disconnect a USB drive from the device, dispose the device's container and keep the USB drive that contains the test data.

Primary objectives:

• Usability evaluation of the FloRite™ system with LUTS patients.

Secondary objectives:

  • Comparison of uroflowmetric parameters obtained using home disposable digital uroflowmetry device with standard clinic-based uroflowmetry.
  • Evaluation of diurnal variations in uroflowmetric parameters obtained using home uroflowmetry

Primary outcome measures

• Successful use of FloRite™ system in LUTS patients, defined as:

  • Successful unpacking and installation
  • Successful understanding of the user manual
  • Ability of the patients to operate the device as define by a successful test completion and data transmission
  • Successful retrieval of the DOK
  • Absence of:
  • Device dropping down
  • Urination outside the container
  • Urination on the electronic unit

Secondary outcome measures:

• Comparison of uroflowmetric parameters as measured by

FloRite™ system and standard clinical uroflowmetry as defined by [Time Frame: Days 0, 1, 6 and 7]:

  • Qmax - Max Flow Rate

    • Evaluation of diurnal variations in uroflowmetric parameters obtained using home uroflowmetry as defined by [Time Frame: Days 1, 6]:

  • Urine flow graph
  • Tdelay - Delay time
  • T100 - Voiding Time
  • TQ - Flow Time
  • Tqmax - Time to max Flow
  • Qmax - Max Flow Rate
  • Qave - Average Flow Rate
  • Vcomp - Voided Volume Up to 30 completed patients

Inclusion criteria

  • LUTS patients
  • Male 18<Age <65
  • Ability to speak, read and understand instructions
  • Patient willing to sign an Informed Consent Exclusion criteria
  • Mentally disabled patients
  • Infectious diseases
  • Catheterized patients
  • Buried penis due to obesity The patients will be consented if found eligible. Prospective, self- controlled, interventional, clinical study

On the baseline visit, after eligibility is confirmed and after consenting the patients, the following steps will be taken:

  • Standard clinical uroflowmetry
  • Training how to use the system
  • Unpacking and setting up the device (supervised by an observer)

The following day, the patient will perform home test with the FloRite™ system. Similar test will be conducted on Day 6 of the study.

The test results will be transferred either by e- mailing the data stored on the DOK or by bringing the DOK itself to the clinic on the 7th day.

On Day 7 of the study, the patients will be asked to return to the clinic for standard clinical uroflowmetry. In addition, the patient will fill a satisfaction questionnaire.

All the measurements must be standard and performed at around the same time.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Lower Urinary Tract Symptoms
Device: FloRite
Disposable home use urine flow meter.
Experimental: FloRite
LUTS patients that used FloRite for home urine flow diagnostics.
Intervention: Device: FloRite
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
Not Provided
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • LUTS patients
  • Male 18<Age <65
  • Ability to speak, read and understand instructions
  • Patient willing to sign an Informed Consent

Exclusion criteria:

  • Mentally disabled patients
  • Infectious diseases
  • Catheterized patients
  • Buried penis due to obesity
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT02026674
FLO-ISR-01
No
Not Provided
Not Provided
Flometrica Ltd.
Flometrica Ltd.
Not Provided
Principal Investigator: Ilan Leibovitch, Prof. "Meir" Hospital
Flometrica Ltd.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP