Study design, materials and methods
To confirm the accuracy of the MenHealth uroflowmetry application, a validation trial using a standard medical office urinary flowmeter (Laborie UROCAP II) as a reference was conducted. Two males, age 36 and 58, provided a total of 50 voids with measurement of uroflow and voided volume: 22 tests using UROCAP II and 28 tests using MenHealth application. The average maximum flow rate and average voided volume were calculated and their ranges were determined.
Results of the validation trial are presented in the table below.
Comparisons of average maximum flow and of average voided volume and their ranges demonstrated no significant statistical differentiation between the MenHealth audio uroflowmetry and Laborie UROCAP II.
In a separate validation trial, 31 independent testers evaluated the MenHealth Application. Of the participants, 91% rated the application easy or very easy to use, while 56% would test their urine flow every week or several times a week, and 77% would conduct self testing once per month or more often (Figure 1).
In addition, 84% of testers responded that they would purchase the application if a physician recommended it, and all the testers responded that they would definitely use the app if cost were covered by their insurance.
Interpretation of results
This audio uroflowmetry application can convert any toilet into a mobile uroflowmeter. Men found the device generally easy or very easy to use. There is no need for office staff or user to empty a dirty collection device, nor is there a need for the user to aim into a funnel. The flow curves and voided volumes obtained by the application are similar to those from a standard uroflowmeter, confirming the accuracy of the measurements.
In addition, the application may be used at home to obtain multiple uroflowmetry events, allowing for potentially more accurate diagnoses than can be obtained from a single office-based test. The application stores each event which can be reviewed in diary or graphic form.
The use of multiple uroflow events, and varying voided volumes throughout the day should allow the urologist to more accurately determine the presence or absence of normal versus abnormal uroflowmetry parameters, permitting more accurate diagnoses and more appropriate treatment for male voiding dysfunction,.
The MenHealth application is non-contact, hygienic, free from the need for cleaning between uses, and user-friendly. Equivalence with standard uroflowmetry has been established. This novel technology can be used by men at home for self- assessment. Graphic recording of the uroflow curves, especially with multiple data points, should aid the physicians’ evaluation of voiding dysfunction.