BE Technologies Mobile Uroflowmetry Validation Study

Validation of MenHealth Mobile Uroflowmetry Application

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Lower Urinary Tract Symptoms; Urinary Incontinence, Urge; Overactive Bladder Syndrome; BPH; Urinary Obstruction; BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms; BPH Without Urinary Obstruction; BPH Without Urinary Obstruction With Other Lower Urinary Tract Symptoms
• Intervention / Treatment: Device: MenHealth Uroflowmeter

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Symptomatic; You have to be a male patient.; You must have a smartphone (iPhone or Android).; 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: 1. Frequent or urgent need to urinate 2. Increased frequency of urination at night (nocturia) 3. Difficulty starting urination 4. Weak urine stream or a stream that stops and starts 5. Dribbling at the end of urination 6. Inability to completely empty the bladder 7. Experience urge incontinence - the involuntary loss of urine immediately following an urgent need to urinate	Device: MenHealth Uroflowmeter; 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 Names: MenHealth Mobile Uroflowmeter
ACTIVE_COMPARATOR: Asymptmatic; You have to be a male patient.; You must have a smartphone (iPhone or Android).; 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.	Device: MenHealth Uroflowmeter; 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 Names: MenHealth Mobile Uroflowmeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MenHealth Uroflowmetry application performance	To validate the performance of MenHealth Uroflowmetry application by measuring maximum flow, average flow, and voided volume obtained by MenHealth Uroflowmetry application and comparing this data with corresponding data obtained by a standard office Uroflowmeter. Every individual Uroflowmetry test contains these three parameters ( maximum flow, voided volume, and average flow) as an outcome measure.	2 weeks

Collaborators and Investigators

• Sponsor: BE Technologies Inc
• Collaborators: Urology of Virginia
• Investigators: Principal Investigator: Roger Schultz, MD, Urology of Virginia

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 18, 2020
• Primary Completion (ACTUAL): February 25, 2021
• Study Completion (ACTUAL): February 25, 2021

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Lower Urinary Tract Symptoms; Urinary Incontinence, Urge
• Other Study ID Numbers: 00041138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes