reliability of home uroflowmetery using a disposable digital device

Conditions: Lower Urinary Tract Symptoms

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.

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.

Eligibility criteria:
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

Keywords: urineflow luts urine flow uroflometry bph