Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.
Urologic Diseases
About this trial
This is an interventional health services research trial for Urologic Diseases
Eligibility Criteria
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
Sites / Locations
- Indiana UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Other
Cohort 1a: in-person clinical assessment of LUTS/BPH
Cohort 1b: virtual (telehealth) clinical assessment of LUTS/BPH
Cohort 2: Validation Cohort
COHORT 1a: Subjects randomized to undergo in-person initial clinical workup of Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH) and in-person clinical follow-up after 3 months of clinical intervention. In-person clinical workup at both the initial and Month 3 follow-up timepoint includes International Prostate Symptom Score (IPSS), and standard of care uroflowmetry, post void residual (PVR), and urinalysis (UA) assessments.
COHORT 1b: Subjects randomized to undergo virtual initial clinical workup of Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH) and virtual clinical follow-up after 3 months of clinical intervention. Virtual clinical workup at both the initial and Month 3 follow-up timepoint includes at home completion of International Prostate Symptom Score (IPSS), at home uroflowmetry assessment through use of the Stream Dx device, at home assessment of post void residual (PVR) through use of the DFree device, and at home urinalysis (UA) through use of the TestCard device.
COHORT 2: Non-randomized subjects who will attend a single, clinically scheduled, in-person follow-up appointment to directly compare the standard of care assessments/devices to the experimental assessments/devices. Prior to the in-person appointment, patients will complete at home uroflowmetry assessment through use of the Stream Dx device. At the in-person appointment, the clinic staff will perform standard of care uroflowmetry, post void residual (PVR), and urinalysis (UA). At this visit, clinic staff will also obtain PVR measurements through use of the DFree device and urinalysis through the TestCard device.