Reliability of Home Uroflowmetery Using a Disposable Digital Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reliability of Home Uroflowmetery Using a Disposable Digital Device in Comparison to Standard Clinical Uroflowmetry in Men With LUTS

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: FloRite


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FloRite<br>LUTS patients that used FloRite for home urine flow diagnostics. | Device: FloRite<br>* Disposable home use urine flow meter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Qmax (Max Flow Rate) | Comparison of uroflowmetric parameters of Qmax as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7]. | Dec-2014 | 
| Comparison of Tdelay | Comparison of uroflowmetric parameters of Tdelay as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7]. | Dec-2014 | 
| Comparison of uroflowmetric parameter: T100 - Voiding Time | Comparison of uroflowmetric parameters of T100 as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7]. | Dec-2014 | 
| Comparison of uroflowmetric parameters of TQ - Flow Time | 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]. | Dec-2014 | 
| Comparison of uroflowmetric parameters of Tqmax - Time to max Flow | 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]. | Dec-2014 | 
| Comparison of uroflowmetric parameters of Qave | Comparison of uroflowmetric parameters of Qave as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7]. | Dec-2014 | 
| Comparison of uroflowmetric parameters of Vcomp - Voided volume | 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]. | Dec-2014 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urineflow, luts, urine flow, uroflometry, bph