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BE Technologies Mobile Uroflowmetry Validation Study

Primary Purpose

BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, BPH Without Urinary Obstruction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MenHealth Uroflowmeter
Sponsored by
BE Technologies Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for BPH

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Urology of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Symptomatic

Asymptmatic

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2020
Last Updated
March 1, 2021
Sponsor
BE Technologies Inc
Collaborators
Urology of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04599283
Brief Title
BE Technologies Mobile Uroflowmetry Validation Study
Official Title
Validation of MenHealth Mobile Uroflowmetry Application
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BE Technologies Inc
Collaborators
Urology of Virginia

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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: Evaluate for expected post surgical improvement in flow or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic
Arm Type
Active Comparator
Arm Description
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
Arm Title
Asymptmatic
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MenHealth Uroflowmeter
Other Intervention Name(s)
MenHealth Mobile Uroflowmeter
Intervention Description
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.
Primary Outcome Measure Information:
Title
MenHealth Uroflowmetry application performance
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Schultz, MD
Organizational Affiliation
Urology of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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BE Technologies Mobile Uroflowmetry Validation Study

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