DFree for Urologic Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Indiana University, Indianapolis, IN
Urologic Diseases+1 More
DFree - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Urologic Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 2 Secondary · Reporting Duration: 3 months

3 months
International Prostate Symptom Score (IPSS) Change
International Prostate Symptom Score (IPSS) Reduction
Urinalysis (UA) 3 Months
Uroflowmetry Change
Uroflowmetry Improvement
Urology Satisfaction with Outpatient Service (SWOPS) 3 months
Baseline
DFree Device Validation
International Prostate Symptom Score (IPSS) Baseline
Post Void Residual (PVR) Baseline
Stream Dx Device Validation
TestCard Device Validation
Urinalysis (UA) Baseline
Uroflowmetry Baseline
Urology Satisfaction with Outpatient Service (SWOPS) baseline
Baseline and 3 months
Post Void Residual (PVR) Change
Post Void Residual (PVR) Reduction

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Cohort 1a: in-person clinical assessment of LUTS/BPH
1 of 2
Cohort 1b: virtual (telehealth) clinical assessment of LUTS/BPH
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: DFree · No Placebo Group · N/A

Cohort 1b: virtual (telehealth) clinical assessment of LUTS/BPHExperimental Group · 3 Interventions: TestCard, Stream Dx, DFree · Intervention Types: Device, Device, Device
Cohort 1a: in-person clinical assessment of LUTS/BPHNoIntervention Group · 1 Intervention: Cohort 1a: in-person clinical assessment of LUTS/BPH · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
Closest Location: Indiana University · Indianapolis, IN
Photo of Indiana University 1Photo of Indiana University 2Photo of Indiana University 3
1992First Recorded Clinical Trial
1 TrialsResearching Urologic Diseases
416 CompletedClinical Trials

Who is running the clinical trial?

Indiana UniversityLead Sponsor
858 Previous Clinical Trials
543,522 Total Patients Enrolled
Marcelino Rivera, MDPrincipal InvestigatorIndiana University School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years old.
You have a diagnosis of urinary retention, BPH, or LUTS.
You are male.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.