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

DEVICE

Stream Dx

home uroflowmetry device

DEVICE

DFree

at home wearable bladder scanner

DEVICE

TestCard

mobile urinalysis reader

International Prostate Symptom Score (IPSS) Baseline

Time frame: 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

Time frame: 3 months

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

Time frame: 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

Time frame: 3 months

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.

Post Void Residual (PVR) Baseline

Time frame: Baseline

Post Void Residual is the amount of urine remaining in the bladder after voiding. Typical scores range between 0 and 150 mL, with a higher score indicating incomplete bladder emptying. Cohort 1a will undergo in-person PVR assessment per clinical standards once at Baseline. This includes measurement of a single PVR volume during the clinical in-person visit using a calibrated ultrasound based bladder scanner that is placed on the patient's lower abdomen for 5 seconds. Cohort 1b will undergo PVR assessment through at-home use of the DFree device, a wearable bladder scanner. Participants will wear this device for an entire day during which will collect PVR measurements after each void during that period prior to the Baseline visit (initial virtual visit). PVR results for Cohorts 1a and 1b at baseline will be evaluated for equivalency.

Post Void Residual (PVR) Change

Time frame: Baseline and 3 months

Post Void Residual is the amount of urine remaining in the bladder after voiding. Typical scores range between 0 and 150 mL, with a higher score indicating incomplete bladder emptying. Cohort 1a will undergo in-person PVR assessment per clinical standards once at Baseline and Month 3 . This includes measurement of a single PVR volume during the clinical in-person visit using a calibrated ultrasound based bladder scanner that is placed on the patient's lower abdomen for 5 seconds. Cohort 1b will undergo PVR assessment through at-home use of the DFree device, a wearable bladder scanner. Participants will wear this device for an entire day during which will collect PVR measurements after each void during that period prior to the Baseline (initial virtual visit) and Month 3 virtual visit. Reduction in PVR between each group at the time of 3 month follow up will be evaluated for equivalency.

Urinalysis (UA) Baseline

Time frame: Baseline

Urinalysis (UA) the urine for infection (UTI) or diabetes. Recorded outcomes will be possible UTI (any positive leukocyte esterase, nitrites, or blood) and possible diabetes (any positive glucose, ketones, or proteins). Cohort 1a will undergo a UA assessment per standard clinical assessment once at the initial visit (baseline). This includes dipping a urine sample with a test strip which is read by a machine during the clinic in-person visit. Cohort 1b will undergo a UA assessment per standard clinical assessment once at the first virtual visit (baseline). Using the Testcard phone app, the patient will collect a urine sample at home, and dip a test strip into the urine which is then analyzed by the mobile app. UA results for Cohorts 1a and 1b will be evaluated for equivalency between the two groups at baseline. Any positive results (UTI or diabetes) will undergo confirmatory lab testing per standard of care.

Urinalysis (UA) 3 Months

Time frame: 3 months

Urinalysis (UA) the urine for infection (UTI) or diabetes. Recorded outcomes will be possible UTI (any positive leukocyte esterase, nitrites, or blood) and possible diabetes (any positive glucose, ketones, or proteins). Cohort 1a will undergo a UA assessment per standard clinical assessment once at Month 3 follow up. This includes dipping a urine sample with a test strip which is read by a machine during the clinic in-person visit. Cohort 1b will undergo a UA assessment per standard clinical assessment once at the Month 3 follow up. Using the Testcard phone app, the patient will collect a urine sample at home, and dip a test strip into the urine which is then analyzed by the mobile app. UA results for Cohorts 1a and 1b will be evaluated for equivalency between the two groups at 3 month follow up. Any positive results (UTI or diabetes) will undergo confirmatory lab testing per standard of care.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.