Lower Urinary Tract SymptomsNCT02026674
Reliability of Home Uroflowmetery Using a Disposable Digital Device
A study testing FloRite in people with Lower Urinary Tract Symptoms, run by Flometrica Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- FloRite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LUTS patients
- Male 18<Age <65
- Ability to speak, read and understand instructions
- Patient willing to sign an Informed Consent
Who cannot join
- Mentally disabled patients
- Infectious diseases
- Catheterized patients
- Buried penis due to obesity
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
"Meir" Hospital
Kfar Saba
Ilan Leibovitch, Prof., +972-9-747-1557, Leibovitchi@clalit.org.il
Ilan Leibovitch, Prof.
About this study
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.
Read the 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
- Being tested
- FloRite
- Keywords
- urineflow, luts, urine flow, uroflometry, bph
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloRiteDevice
Disposable home use urine flow meter.
| Study group | Role | What they receive |
|---|---|---|
| FloRite | Experimental | LUTS patients that used FloRite for home urine flow diagnostics. Receives: Device: FloRite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Dec-2014
Secondary outcomes (7)
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].
Measured: Dec-2014
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].
Measured: Dec-2014
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].
Measured: Dec-2014
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].
Measured: Dec-2014
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].
Measured: Dec-2014
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].
Measured: Dec-2014
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].
Measured: Dec-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flometrica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilan Leibovitch, Prof., Principal investigator, Meir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026674
- Sponsor's protocol ID
- FLO-ISR-01
- Status last verified
- Jan 2014
- First submitted
- 24 Dec 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Home Uroflowmetery Using a Disposable Digital Device in Comparison to Standard Clinical Uroflowmetry in Men With LUTS
- ClinicalTrials.gov ID
- NCT02026674
- Acronym / sponsor ID
- FLO-ISR-01
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- urineflow, luts, urine flow, uroflometry, bph
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Flometrica Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FloRite | Experimental | Device: FloRiteLUTS patients that used FloRite for home urine flow diagnostics. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- LUTS patients
- Male 18<Age <65
- Ability to speak, read and understand instructions
- Patient willing to sign an Informed Consent
Key exclusion criteria (4 listed)
- Mentally disabled patients
- Infectious diseases
- Catheterized patients
- Buried penis due to obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FloRiteDisposable home use urine flow meter. | Device | FloRite |
Primary outcome
Usability evaluation of the FloRite™ system with LUTS patients.
Time frame: Dec-2014
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
7 secondary outcomes
Comparison of Qmax (Max Flow Rate)
Time frame: Dec-2014
Comparison of Tdelay
Time frame: Dec-2014
Comparison of uroflowmetric parameter: T100 - Voiding Time
Time frame: Dec-2014
Comparison of uroflowmetric parameters of TQ - Flow Time
Time frame: Dec-2014
Comparison of uroflowmetric parameters of Tqmax - Time to max Flow
Time frame: Dec-2014
Comparison of uroflowmetric parameters of Qave
Time frame: Dec-2014
Comparison of uroflowmetric parameters of Vcomp - Voided volume
Time frame: Dec-2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Leibovitch, Prof. principal investigator
Meir Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FloRite in people with Lower Urinary Tract Symptoms, run by Flometrica Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeev Cohen, M.Sc. (+972-52-4471297, zeev@flometrica.cm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability evaluation of the FloRite™ system with LUTS patients. (time frame: Dec-2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.