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BE Technologies Mobile Uroflowmetry Validation Study

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ClinicalTrials.gov Identifier: NCT04599283
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Urology of Virginia
Information provided by (Responsible Party):
BE Technologies Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Device: MenHealth Uroflowmeter Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of MenHealth Mobile Uroflowmetry Application
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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

 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 Name: MenHealth Mobile Uroflowmeter
Active Comparator: 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.
 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 Name: MenHealth Mobile Uroflowmeter


Outcome Measures
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Primary Outcome Measures :
  1. MenHealth Uroflowmetry application performance [ Time Frame: 2 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599283


Contacts
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Contact: Laurie Jackson (757) 452 3586 research@urologyofva.net

Locations
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United States, Virginia
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Laurie Jackson    757-452-3586    research@urologyofva.net   
Sponsors and Collaborators
BE Technologies Inc
Urology of Virginia
Investigators
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Principal Investigator: Roger Schultz, MD Urology of Virginia
More Information
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Responsible Party: BE Technologies Inc
ClinicalTrials.gov Identifier: NCT04599283    
Other Study ID Numbers: 00041138
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
 Urination Disorders
Urologic Diseases
Urological Manifestations
Urinary Bladder Diseases