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
NCT number | NCT02026674 |
Other study ID # | FLO-ISR-01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | December 24, 2013 |
Last updated | January 13, 2014 |
Start date | December 2013 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Israel | "Meir" Hospital | Kfar-Saba |
Lead Sponsor | Collaborator |
---|---|
Flometrica Ltd. |
Israel,
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 |
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