BE Technologies Mobile Uroflowmetry Validation Study

Overactive Bladder Clinical Trial

Official title: Validation of MenHealth Mobile Uroflowmetry Application

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• 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 Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge
• Urinary Obstruction

• NCT number: NCT04599283
• Study type: Interventional
• Source: BE Technologies Inc
• Status: Completed
• Phase: N/A
• Start date: August 18, 2020
• Completion date: February 25, 2021