Virtual vs In-Person Treatment for Lower Urinary Tract Symptoms

Overseen By Stephanie Woffard, MSM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Visually impaired, Hearing impaired, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marcelino Rivera, MD

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

This trial is for men over 18 years old who are either new or established patients with lower urinary tract symptoms (LUTS), possibly due to prostatic enlargement, or urinary retention. It's not suitable for those under 18, unable to consent, have sensory impairments, need an in-person exam for other conditions, or have allergies to ultrasound gel.

Inclusion Criteria

Male

You are a new patient referred for urinary retention, enlarged prostate, or lower urinary tract symptoms.

You have been diagnosed with urinary retention, enlarged prostate, or lower urinary tract symptoms.

Exclusion Criteria

Inability to provide informed consent

Concomitant condition requiring in-person exam or evaluation

You have trouble seeing or hearing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual or in-person)

Baseline Assessment

Participants undergo baseline assessments including uroflowmetry, post void residual, and urinalysis using either in-clinic or at-home devices

1 week

1 visit (in-person or virtual)

Treatment

Participants receive either virtual or in-person clinical workup and treatment for Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH)

3 months

Multiple visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up assessments at 3 months

3 months

1 visit (in-person or virtual)

Treatment Details

Interventions

• DFree
• Stream Dx
• TestCard

Trial Overview The study compares the effectiveness of at-home uroflowmetry devices—TestCard, Stream Dx, DFree—with standard clinical practices. It aims to determine if these devices can accurately measure urine flow at home and assess patient satisfaction with virtual versus in-person visits.

Participant Groups

Group I: Cohort 2: Validation Cohort Experimental Treatment 3 Interventions

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.

Group II: Cohort 1b: virtual (telehealth) clinical assessment of LUTS/BPH Experimental Treatment 3 Interventions

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.

Group III: Cohort 1a: in-person clinical assessment of LUTS/BPH Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+