Clinical trial NCT02026674: Reliability of Home Uroflowmetery Using a Disposable Digital Device
Official title: Reliability of Home Uroflowmetery Using a Disposable Digital Device in Comparison to Standard Clinical Uroflowmetry in Men With LUTS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: urineflow
luts
urine flow
uroflometry
bph
Lead sponsor: Flometrica Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-03
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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

Primary outcomes:
measure: Usability evaluation of the FloRite™ system with LUTS patients.
timeFrame: Dec-2014
Secondary outcomes:
measure: Comparison of Qmax (Max Flow Rate)
timeFrame: Dec-2014
measure: Comparison of Tdelay
timeFrame: Dec-2014
measure: Comparison of uroflowmetric parameter: T100 - Voiding Time
timeFrame: Dec-2014
measure: Comparison of uroflowmetric parameters of TQ - Flow Time
timeFrame: Dec-2014
measure: Comparison of uroflowmetric parameters of Tqmax - Time to max Flow
timeFrame: Dec-2014
measure: Comparison of uroflowmetric parameters of Qave
timeFrame: Dec-2014
measure: Comparison of uroflowmetric parameters of Vcomp - Voided volume
timeFrame: Dec-2014
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: "Meir" Hospital
Study officials:
affiliation: Meir Hospital
name: Ilan Leibovitch, Prof.
role: PRINCIPAL_INVESTIGATOR
References: