Lower Urinary Tract Symptoms Clinical Trial
Official title:
Reliability of Home Uroflowmetery Using a Disposable Digital Device in Comparison to Standard Clinical Uroflowmetry in Men With LUTS
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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