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

International Prostate Symptom Score (IPSS) Baseline

The IPSS assesses prostate related symptoms and their frequency of occurrence through seven questions, scored on a 6 point scale, from 0 (not at all) to 5 (always). Total symptom-related scores range from 1-7 (mild), 8-19 (moderate), and 20-35 (severe). The IPSS also assess quality of life due to urinary symptoms with a single question, scored on a 7 point scale (0 = delighted; 6 = terrible). The IPSS will be administered at the initial visit (baseline) for Cohorts 1a and 1b. Baseline scores will be compared between the two groups to evaluate for equivalency.

International Prostate Symptom Score (IPSS) Change

The IPSS assesses prostate related symptoms and their frequency of occurrence through seven questions, scored on a 6 point scale, from 0 (not at all) to 5 (always). Total symptom-related scores range from 1-7 (mild), 8-19 (moderate), and 20-35 (severe). The IPSS also assess quality of life due to urinary symptoms with a single question, scored on a 7 point scale (0 = delighted; 6 = terrible). The IPSS will be administered at the initial visit (baseline) and Month 3 for Cohorts 1a and 1b. The amount of IPSS score reduction at the time of 3 month follow up will be compared between both groups to evaluate for equivalency.

Uroflowmetry Baseline

Uroflowmetry measures the flow of urine as milliliters (ml) of urine passed per second(s). Typical scores range between 5 and 20 ml/s, with a lower score indicating possible obstruction, enlarged prostate or weak bladder and a higher score indicating good flow. Cohort 1a will undergo in-person uroflowmetry per standard clinical assessment at Baseline. Standard clinical assessment includes measurement of a single void during the in-person clinic visit by urinating once into the uroflowmetry device (a urinal with calibrated sensors to measure flow). Cohort 1b will undergo uroflowmetry through at-home use of the Stream Dx device (also a urinal with calibrated sensors to measure flow), which includes measuring all voids performed at home during a 5 day period prior to Baseline (initial virtual visit). Baseline uroflowmetry assessment results for Cohorts 1a and 1b will be evaluated for equivalency.

Uroflowmetry Change

Uroflowmetry measures the flow of urine as milliliters (ml) of urine passed per second(s). Typical scores range between 5 and 20 ml/s, with a lower score indicating possible obstruction, enlarged prostate or weak bladder and a higher score indicating good flow. Cohort 1a will undergo in-person uroflowmetry per standard clinical assessment at Baseline and Month 3. Standard clinical assessment includes measurement of a single void during the in-person clinic visit by urinating once into the uroflowmetry device. Cohort 1b will undergo uroflowmetry through at-home use of the Stream Dx device (also a urinal with calibrated sensors to measure flow), which includes measuring all voids performed at home during a 5 day period prior to Baseline (initial virtual visit) and again during a 5 day period prior to the Month 3 follow up visit. Increase in average flow at 3 months on uroflowmetry for Cohorts 1a and 1b will be evaluated for equivalency.

Urology Satisfaction with Outpatient Service (SWOPS) baseline

Patient satisfaction in Cohorts 1a and 1b will be measured with the validated Satisfaction with Outpatient Service (SWOPS) questionnaire following their initial visit (baseline). The questionnaire assesses the patient's satisfaction with their visit across 13 topics. The investigators will test non-inferiority in SWOPS scores between patients in the virtual group and in-clinic group at the initial visit. There is no defined scale or score that would suggest a better or worse outcome, rather the percent response of "Yes, definitely", "Yes, to some extent", and "No" to each of the 13 questions will be compared between the two groups for equivalency and thus the non-inferiority statistical approach was chosen.

Urology Satisfaction with Outpatient Service (SWOPS) 3 months

Patient satisfaction in Cohorts 1a and 1b will be measured with the validated Satisfaction with Outpatient Service (SWOPS) questionnaire following their 3 month follow up. The questionnaire assesses the patient's satisfaction with their visit across 13 topics. The investigators will test non-inferiority in SWOPS scores between patients in the virtual group and in-clinic group at the initial visit. There is no defined scale or score that would suggest a better or worse outcome, rather the percent response of "Yes, definitely", "Yes, to some extent", and "No" to each of the 13 questions will be compared between the two groups for equivalency and thus the non-inferiority statistical approach was chosen.

Stream Dx Device Validation

Cohort 2 will be asked to complete at home uroflowmetry assessment through use of the Stream Dx device for 5 days, starting 3 weeks prior to a single in-person clinical appointment to establish the baseline for that patient. During the in-person clinical appointment, Cohort 2 will also undergo standard uroflowmetry measurement by urinating once into the uroflowmetry device in the clinic (a urinal with calibrated sensors to measure flow). The baseline Stream Dx results including average and maximum flow rate in mL/s and volume voided in mL will be compared to those obtained by the in-person clinic performed uroflowmetry.

DFree Device Validation

Once at a single in-person clinical appointment, Cohort 2 will be asked to undergo a baseline assessment of post-void residual by both the standard clinic bladder scanner and the DFree device. Clinical staff will perform both the bladder scanner and DFree measurements. Baseline results between the assessment methods will be compared.

TestCard Device Validation

Once at a single in-person clinical appointment, Cohort 2 will be asked to undergo a baseline urinalysis assessment by both standard in clinic urinalysis dip stick and through the TestCard mobile app analysis. Clinical staff will perform both the standard and TestCard assessment on a single urine sample. Baseline results between the assessment methods will be compared. Recorded outcomes will be possible UTI (any positive leukocyte esterase, nitrites, or blood) and possible diabetes (any positive glucose, ketones, or proteins) and any positive results (UTI or diabetes) will undergo confirmatory lab testing per standard of care.