NCT02026674

Reliability of Home Uroflowmetery Using a Disposable Digital Device

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Flometrica Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	FloRite	Disposable home use urine flow meter.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-12-01
• First posted: 2014-01-03
• Last updated: 2014-01-14

Locations

1 site across 1 country: Israel