RecruitingNot ApplicableNCT05508165

Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.

IRB: #12530 Prospective, Randomized Study to Assess Clinical Outcomes and Patient Satisfaction of Virtual vs. In-Person Workup and Treatment of Lower Urinary Tract Symptoms


Sponsor

Indiana University

Enrollment

60 participants

Start Date

Aug 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to compare usefulness of data collected in uroflowmetry, a test that measures the amount of urine released from the body, at home versus in the doctor's office. Additionally, investigators are assessing patient satisfaction when completing a virtual visit for lower urinary tract symptoms (LUTS), related to prostatic enlargement, compared to an in person visit. The three devices being investigated have not been used in the home setting to make urinary measurements as is typically done in clinic. The goal is to test the effectiveness and accuracy of these devices compared to our standard clinical practices and demonstrate their ability to provide useful information in the home setting.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • ≥18 years of age
  • New patient referral for urinary retention, BPH, or LUTS (Cohort 1)
  • Established patient for urinary retention, BPH, or LUTS (Cohort 2)
  • Male

Exclusion Criteria5

  • <18 years of age
  • Inability to provide informed consent
  • Visually or hearing impaired
  • Concomitant condition requiring in-person exam or evaluation
  • History of allergic reaction or issues with ultrasound gel

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Interventions

DEVICEStream Dx

home uroflowmetry device

DEVICEDFree

at home wearable bladder scanner

DEVICETestCard

mobile urinalysis reader


Locations(1)

Indiana University

Indianapolis, Indiana, United States

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NCT05508165


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