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BE Technologies Mobile Uroflowmetry Validation Study

NCT04599283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-03-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Urology of Virginia

    collaborator OTHER

  • BE Technologies Inc

    lead INDUSTRY

Principal Investigators

  • Roger Schultz, MD · Urology of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2021-02-25
Completion
2021-02-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599283 on ClinicalTrials.gov