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Virtual vs In-Person Treatment for Lower Urinary Tract Symptoms

N/A

Recruiting

Led By Marcelino Rivera, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing the accuracy of uroflowmetry devices at home vs. in the doctor's office, as well as patient satisfaction with virtual visits for lower urinary tract symptoms.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-invasive testing equipment rather than medication, traditional side effects are not a concern. However, there may be discomfort or inconvenience associated with using the devices as per their design.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

International Prostate Symptom Score (IPSS) Baseline

International Prostate Symptom Score (IPSS) Change

Post Void Residual (PVR) Baseline

+5 more

Secondary outcome measures

Urology Satisfaction with Outpatient Service (SWOPS) 3 months

Urology Satisfaction with Outpatient Service (SWOPS) baseline

Other outcome measures

DFree Device Validation

Stream Dx Device Validation

TestCard Device Validation

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2: Validation CohortExperimental Treatment3 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/BPHExperimental Treatment3 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/BPHActive Control1 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,101 Total Patients Enrolled

Marcelino Rivera, MDPrincipal InvestigatorIndiana University School of Medicine

1 Previous Clinical Trials

Media Library

DFree Clinical Trial Eligibility Overview. Trial Name: NCT05508165 — N/A

Urological Diseases Research Study Groups: Cohort 2: Validation Cohort, Cohort 1a: in-person clinical assessment of LUTS/BPH, Cohort 1b: virtual (telehealth) clinical assessment of LUTS/BPH

Urological Diseases Clinical Trial 2023: DFree Highlights & Side Effects. Trial Name: NCT05508165 — N/A

DFree 2023 Treatment Timeline for Medical Study. Trial Name: NCT05508165 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this clinical trial currently available to eligible subjects?

"According to the details available on clinicaltrials.gov, this particular trial has stopped actively seeking participants; it was posted on August 30th 2022 and updated lastly on August 19th 2022. However, 59 other medical studies are currently recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Marcelino Rivera 2022. "Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05508165.