Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04599283
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2020-10-12
Brief Title:
BE Technologies Mobile Uroflowmetry Validation Study
Sponsor:
BE Technologies Inc
Organization:
BE Technologies Inc
Study Overview
Official Title:
Validation of MenHealth Mobile Uroflowmetry Application
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients natural environment without the need for an in-office visit A patients 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 subjects office uroflow test
About 60 subjects will participate in this study The 60 subjects will comprise two groups Group 1Symptomatic 45 subjects and Group 2Asymptomatic 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
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 patients natural environment without the need for an in-office visit A patients 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 subjects office uroflow test
About 60 subjects will participate in this study The 60 subjects will comprise two groups Group 1Symptomatic 45 subjects and Group 2Asymptomatic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None