Recruiting

Virtual vs. In-Person

Sponsor:

Indiana University

Code:

NCT05508165

Conditions

Urologic Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Stream Dx

DFree

TestCard

Study Details

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.

Conditions

Urologic Diseases

Study ID

NCT05508165

Start date

Aug 30, 2022

Status verified date

Mar, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: 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.

other: 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.

Interventions

Stream Dx

home uroflowmetry device

DFree

at home wearable bladder scanner

TestCard

mobile urinalysis reader

Primary outcome measure

  • International Prostate Symptom Score (IPSS) Baseline [ Time Frame: Baseline ]
  • International Prostate Symptom Score (IPSS) Change [ Time Frame: 3 months ]
  • Uroflowmetry Baseline [ Time Frame: Baseline ]
  • Uroflowmetry Change [ Time Frame: 3 months ]
  • Post Void Residual (PVR) Baseline [ Time Frame: Baseline ]
  • Post Void Residual (PVR) Change [ Time Frame: Baseline and 3 months ]
  • Urinalysis (UA) Baseline [ Time Frame: Baseline ]
  • Urinalysis (UA) 3 Months [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Stephanie Woffard, MSM

(317) 695-7585sdwillia@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Stephanie Wofford, MSM

317-695-7585sdwillia@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Mar 13, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-03-13.