Reliability of Home Uroflowmetery Using a Disposable Digital Device

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02026674
• Other study ID #: FLO-ISR-01
• Status: Recruiting
• Phase: N/A
• First received: December 24, 2013
• Last updated: January 13, 2014
• Start date: December 2013

Study information

• Verified date: January 2014
• Source: Flometrica Ltd.
• Contact: Zeev Cohen, M.Sc.
• Phone: +972-52-4471297
• Email: zeev[@]flometrica.cm
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Device:
• FloRite
Disposable home use urine flow meter.

Locations

Country	Name	City	State
Israel	"Meir" Hospital	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Flometrica Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability evaluation of the FloRite™ system with LUTS patients.	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	Dec-2014	No
Secondary	Comparison of Qmax (Max Flow Rate)	Comparison of uroflowmetric parameters of Qmax as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].	Dec-2014	No
Secondary	Comparison of Tdelay	Comparison of uroflowmetric parameters of Tdelay as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].	Dec-2014	No
Secondary	Comparison of uroflowmetric parameter: T100 - Voiding Time	Comparison of uroflowmetric parameters of T100 as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].	Dec-2014	No
Secondary	Comparison of uroflowmetric parameters of TQ - Flow Time	Comparison of uroflowmetric parameters of TQ - Flow Time as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].	Dec-2014	No
Secondary	Comparison of uroflowmetric parameters of Tqmax - Time to max Flow	Comparison of uroflowmetric parameters of Tqmax - Time to max Flow as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].	Dec-2014	No
Secondary	Comparison of uroflowmetric parameters of Qave	Comparison of uroflowmetric parameters of Qave as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].	Dec-2014	No
Secondary	Comparison of uroflowmetric parameters of Vcomp - Voided volume	Comparison of uroflowmetric parameters of Vcomp - Voided volume as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].	Dec-2014	No

External Links

•   Sponsor web site.