Reliability of Home Uroflowmetery Using a Disposable Digital Device

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Flometrica Ltd.
Sponsor:
Information provided by (Responsible Party):
Flometrica Ltd.
ClinicalTrials.gov Identifier:
NCT02026674
First received: December 24, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Lower Urinary Tract Symptoms
Device: FloRite

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Reliability of Home Uroflowmetery Using a Disposable Digital Device in Comparison to Standard Clinical Uroflowmetry in Men With LUTS

Resource links provided by NLM:


Further study details as provided by Flometrica Ltd.:

Primary Outcome Measures:
  • Usability evaluation of the FloRite™ system with LUTS patients. [ Time Frame: Dec-2014 ] [ Designated as safety issue: No ]

    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 Qmax (Max Flow Rate) [ Time Frame: Dec-2014 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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].


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FloRite
LUTS patients that used FloRite for home urine flow diagnostics.
Device: FloRite
Disposable home use urine flow meter.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026674

Contacts
Contact: Zeev Cohen, M.Sc. +972-52-4471297 zeev@flometrica.cm

Locations
Israel
"Meir" Hospital Recruiting
Kfar-Saba, Israel
Contact: Ilan Leibovitch, Prof.    +972-9-747-1557    Leibovitchi@clalit.org.il   
Principal Investigator: Ilan Leibovitch, Prof.         
Sponsors and Collaborators
Flometrica Ltd.
Investigators
Principal Investigator: Ilan Leibovitch, Prof. "Meir" Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Flometrica Ltd.
ClinicalTrials.gov Identifier: NCT02026674     History of Changes
Other Study ID Numbers: FLO-ISR-01
Study First Received: December 24, 2013
Last Updated: January 13, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Flometrica Ltd.:
urineflow
luts
urine flow
uroflometry
bph

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014