BE Technologies Mobile Uroflowmetry Validation Study
BE Technologies Mobile Uroflowmetry Validation Study
This research study is studying MenHealth Mobile Uroflowmetry as a diagnostic tool for LUTS
 (lower urinary tract symptoms), a group of conditions involving the bladder, urinary
 sphincter, urethra and the prostate.
As men age, they are at higher risk of developing lower urinary tract symptoms. The cause or
 source of these symptoms can range from overactive bladder (OAB), urethral stricture disease,
 and benign prostatic hyperplasia (BPH).

 Patients are also often asked to return to clinic to perform a uroflow test in order to:

 1. Evaluate for expected post surgical improvement in flow or

 2. To investigate the urinary flow in men with new lower urinary tract complaints.

 The in-office uroflow test involves an office visit, which often requires a patient copay and
 other health care resources. In addition, it is performed in an artificial "high pressure"
 environment and many patients find it difficult to present with a full bladder due to their
 lower urinary tract symptoms.

 This research may help us determine whether an "at home" uroflow test can be used to obtain
 similar diagnostic data in the patient's natural environment, without the need for an
 in-office visit. A patient's test results taken at home in a comfortable environment could be
 reliable and informative for both the patient and the doctor. This data can then be used to
 determine the appropriate management.

 The purpose of this research study is to conduct a performance validation of MenHealth
 Uroflowmetry application by comparing data obtained by MenHealth Uroflowmetry application
 with the data obtained by a standard office Uroflowmeter.

 The study is investigational. Its goal is to study and compare test results obtained by the
 study subject using MenHealth application with the test results obtained from the subject's
 office uroflow test.

 About 60 subjects will participate in this study. The 60 subjects will comprise two groups:
 Group 1/Symptomatic (45 subjects) and Group 2/Asymptomatic (15 subjects).

 Subject participation in this study will last approximately 2 weeks and will include 2 study
 visits to the study center. At the end of the 2 week period, subjects should have a minimum
 of 10 reliable uroflowmetry tests done at home.
Inclusion Criteria:

 -  You have to be a male patient.

 -  You must have a smartphone (iPhone or Android).

 -  For Group 1 (Symptomatic), you are at least 35 years old and have already been
 diagnosed with BPH or Overactive Bladder (OAB) condition OR you are presenting at
 least one of the following BPH / OAB symptoms: frequent or urgent need to urinate,
 increased frequency of urination at night (nocturia), difficulty starting urination,
 weak urine stream or a stream that stops and starts, dribbling at the end of
 urination, inability to completely empty the bladder, experience urge incontinence -
 the involuntary loss of urine immediately following an urgent need to urinate.

 -  For Group 2 (Asymptomatic), you are at least 18 years old and have not been diagnosed
 with BPH or OAB, and you are not presenting any of the above symptoms.

 Exclusion Criteria:

 -  Male younger than 18 or older than 90

 -  Female