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

NCT ID: NCT05508165

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2026-12-30

Brief Summary

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.

Detailed 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.

Conditions

Urologic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cohort 1b: virtual (telehealth) clinical assessment of LUTS/BPH

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 Type: EXPERIMENTAL

Stream Dx

Intervention Type: DEVICE

home uroflowmetry device

DFree

Intervention Type: DEVICE

at home wearable bladder scanner

TestCard

Intervention Type: DEVICE

mobile urinalysis reader

Cohort 2: Validation Cohort

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 Type: OTHER

Stream Dx

Intervention Type: DEVICE

home uroflowmetry device

DFree

Intervention Type: DEVICE

at home wearable bladder scanner

TestCard

Intervention Type: DEVICE

mobile urinalysis reader

Interventions

Stream Dx

home uroflowmetry device

Intervention Type: DEVICE

DFree

at home wearable bladder scanner

Intervention Type: DEVICE

TestCard

mobile urinalysis reader

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Marcelino Rivera

Assistant Professor, IU Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelino Rivera, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie Woffard, MSM

Role: CONTACT

sdwillia@iu.edu

(317) 695-7585

Facility Contacts

Stephanie Wofford, MSM

Role: primary

sdwillia@iu.edu

317-695-7585

Other Identifiers

IndianaU 12530

Identifier Type: -

Identifier Source: org_study_id