BE Technologies Mobile Uroflowmetry Validation Study
Condition: BPH; BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms; BPH Without Urinary Obstruction; BPH Without Urinary Obstruction With Other Lower Urinary Tract Symptoms; Lower Urinary Tract Symptoms; Overactive Bladder; Overactive Bladder Syndrome; Urinary Obstruction; Urinary Incontinence, Urge
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MenHealth Uroflowmeter
Intervention type(s): Device
Intervention description(s): MenHealth Uroflowmeter is a mobile application and FDA cleared medical device that analyzes the sound of urine hitting the toilet water when a male urinates and generates voiding data (maximum flow, average flow, and voided volume) and a flow curve. All test results are saved in an automated voiding diary.
Other intervention name(s): MenHealth Mobile Uroflowmeter
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic