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

Indiana University

Status: Enrolling

Conditions: Urologic Diseases

Treatments: Device: Stream Dx; Device: DFree; Device: TestCard

Study type: Interventional

Funder types: Other

Identifiers

NCT05508165

IndianaU 12530

Details and patient eligibility

About

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.

Full 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-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 standard clinical practices and demonstrate the ability of these devices to provide useful information in the home setting. The study involves two cohorts. Cohort 1 are new patients who will be randomized to either telehealth visits or in office visits. If randomized to the telehealth group, the patients will use various devices to perform a standard workup at home. If randomized to the clinic visit, similar tests will be performed in the office. Cohort 2 are existing patients who will use one of the devices at home, but will also complete similar in-office tests in order to compare device accuracy.

Screening will be performed prior to patient's first scheduled visit based on chief complaints of urinary retention, BPH, or LUTS. Patients will be initially identified by study personnel or qualified research coordinator when the patient is identified to have qualifying issues through reviewing medical records of patients. Patient will be contacted by phone by the study personnel. If the patients are interested, the patients will be screened for inclusion criteria.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Cohort 1a: in-person clinical assessment of LUTS/BPH

No Intervention group

Description:

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: virtual (telehealth) clinical assessment of LUTS/BPH

Experimental group

Description:

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.

Treatment:

Device: TestCard

Device: DFree

Device: Stream Dx

Cohort 2: Validation Cohort

Other group

Description:

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.

Treatment:

Device: TestCard

Device: DFree

Device: Stream Dx