Reliability of Home Uroflowmetery Using a Disposable Digital Device

Flometrica

Status: Unknown

Conditions: Lower Urinary Tract Symptoms

Treatments: Device: FloRite

Study type: Interventional

Funder types: Industry

Identifiers

NCT02026674

FLO-ISR-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

FloRite

Experimental group

Description:

LUTS patients that used FloRite for home urine flow diagnostics.

Treatment:

Device: FloRite