BE Technologies Mobile Uroflowmetry Validation Study

NCT04599283 | Completed FDA Device

• 1 other identifier: 00041138
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Symptomatic

ACTIVE COMPARATOR

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

Asymptmatic

ACTIVE COMPARATOR

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

Interventions

MenHealth Uroflowmeter 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.

Also known as: MenHealth Mobile Uroflowmeter

Asymptmatic; Symptomatic

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Male younger than 18 or older than 90
• Female

Sponsors & Collaborators

• BE Technologies Inc: lead
• Urology of Virginia: collaborator

Study Sites (1)

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders

Study Officials

• Roger Schultz, MD

  Urology of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 22, 2020
• Study Start: August 18, 2020
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)