BE Technologies Mobile Uroflowmetry Validation Study

NCT ID: NCT04599283

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2021-02-25

Brief 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Symptomatic

1. You have to be a male patient.

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

3. 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

Group Type: ACTIVE_COMPARATOR

MenHealth Uroflowmeter

Intervention Type: DEVICE

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.

Asymptmatic

1. You have to be a male patient.

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

3. 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.

Group Type: ACTIVE_COMPARATOR

MenHealth Uroflowmeter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

MenHealth Mobile Uroflowmeter

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Urology of Virginia

OTHER

Sponsor Role: collaborator

BE Technologies Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Schultz, MD

Role: PRINCIPAL_INVESTIGATOR

Urology of Virginia

Locations

Urology of Virginia

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

00041138

Identifier Type: -

Identifier Source: org_study_id