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
Indiana University
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.
Description
This study is being done to improve the availability of telehealth urology visits. In this study, investigators will compare the usefulness of data collected by three home devices to understand the amount of urine released from the body, how empty the bladder gets after urinating, and if there is an infection present in the bladder. These will be compared to being at home versus in the doctor's office. Additionally, the study will determine how satisfied patients are when completing a virtual visit for lower urinary tract symptoms (LUTS), related to prostatic enlargement, compared to an in-per…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria * ≥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 Criteria * \<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
Interventions
- DeviceStream Dx
home uroflowmetry device
- DeviceDFree
at home wearable bladder scanner
- DeviceTestCard
mobile urinalysis reader
Location
- Indiana UniversityIndianapolis, Indiana