Reliability of Home Uroflowmetery Using a Disposable Digital Device
NCT ID: NCT02026674
Last Updated: 2014-01-14
Study Results
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2013-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FloRite
LUTS patients that used FloRite for home urine flow diagnostics.
FloRite
Disposable home use urine flow meter.
Interventions
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FloRite
Disposable home use urine flow meter.
Eligibility Criteria
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Inclusion Criteria
* Male 18\<Age \<65
* Ability to speak, read and understand instructions
* Patient willing to sign an Informed Consent
Exclusion Criteria
* Infectious diseases
* Catheterized patients
* Buried penis due to obesity
18 Years
65 Years
MALE
No
Sponsors
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Flometrica Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ilan Leibovitch, Prof.
Role: PRINCIPAL_INVESTIGATOR
Meir Hospital
Locations
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"Meir" Hospital
Kfar Saba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FLO-ISR-01
Identifier Type: -
Identifier Source: org_study_id
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