Reliability of Home Uroflowmetery Using a Disposable Digital Device
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 24, 2013
CompletedFirst Posted
Study publicly available on registry
January 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedJanuary 14, 2014
January 1, 2014
1 year
December 24, 2013
January 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Usability evaluation of the FloRite™ system with LUTS patients.
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
Dec-2014
Secondary Outcomes (7)
Comparison of Qmax (Max Flow Rate)
Dec-2014
Comparison of Tdelay
Dec-2014
Comparison of uroflowmetric parameter: T100 - Voiding Time
Dec-2014
Comparison of uroflowmetric parameters of TQ - Flow Time
Dec-2014
Comparison of uroflowmetric parameters of Tqmax - Time to max Flow
Dec-2014
- +2 more secondary outcomes
Study Arms (1)
FloRite
EXPERIMENTALLUTS patients that used FloRite for home urine flow diagnostics.
Interventions
Eligibility Criteria
You may qualify if:
- LUTS patients
- Male 18\<Age \<65
- Ability to speak, read and understand instructions
- Patient willing to sign an Informed Consent
You may not qualify if:
- Mentally disabled patients
- Infectious diseases
- Catheterized patients
- Buried penis due to obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Flometrica Ltd.lead
Study Sites (1)
"Meir" Hospital
Kfar Saba, Israel
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilan Leibovitch, Prof.
Meir Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2013
First Posted
January 3, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Last Updated
January 14, 2014
Record last verified: 2014-01