Virtual vs In-Person Treatment for Lower Urinary Tract Symptoms
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates whether at-home tests for lower urinary tract symptoms, such as difficulty urinating, are as effective as those conducted in a doctor's office. It also examines whether participants prefer at-home testing and virtual visits over clinic visits. The study uses devices like DFree, Stream Dx, and TestCard at home to measure urine flow and residual urine. Men experiencing urinary issues, such as retention or an enlarged prostate, and who are open to virtual visits, may be suitable candidates for this trial. As an unphased trial, it explores convenient at-home testing options that could enhance the healthcare experience.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these devices are safe for home use?
Research has shown that devices like DFree, Stream Dx, and TestCard are generally safe. These tools are being tested to help people track urinary symptoms easily from home. Although these specific devices haven't been widely used at home yet, similar tools have been well-received in clinics.
This trial aims to determine if these devices can be safely and effectively used at home. While specific data on side effects for these devices is not available, their inclusion in a research study suggests a promising level of safety.
Typically, when a treatment reaches the stage of testing with real patients, it has passed initial safety checks. So, while these devices are new for home use, past experience with similar technology suggests they are likely safe to try.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the potential of virtual treatment options for managing Lower Urinary Tract Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH). Unlike traditional in-person care, which typically involves frequent clinic visits for assessments, this trial evaluates the effectiveness of remote monitoring tools like DFree, Stream Dx, and TestCard. These devices allow patients to conduct important tests like uroflowmetry, post-void residual measurements, and urinalysis from the comfort of their homes, potentially increasing convenience and accessibility. The trial aims to determine if these virtual options can match or even surpass the diagnostic accuracy and patient satisfaction of standard in-person treatments.
What evidence suggests that these devices are effective for measuring lower urinary tract symptoms?
Research has shown that telehealth can effectively manage lower urinary tract symptoms (LUTS). In this trial, participants in the virtual treatment arm will use devices like DFree, Stream Dx, and TestCard for at-home assessments. Studies have found these devices provide results as accurate as those obtained in a doctor's office. The International Prostate Symptom Score (IPSS), a key tool for evaluating LUTS, will also be used in the virtual arm, showing that symptoms can improve over time. Additionally, telehealth has increased patient satisfaction, making it a promising option for those with LUTS. Overall, these devices appear reliable for monitoring and assessing symptoms at home.26789
Who Is on the Research Team?
Marcelino Rivera, MD
Principal Investigator
Indiana University School of Medicine
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including uroflowmetry, post void residual, and urinalysis using either in-clinic or at-home devices
Treatment
Participants receive either virtual or in-person clinical workup and treatment for Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including follow-up assessments at 3 months
What Are the Treatments Tested in This Trial?
Interventions
- DFree
- Stream Dx
- TestCard
Trial Overview
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Citations
Validation of a Visual Prostate Symptom Score in Men With ...
There was significantly less alteration in responses using the VPSS, suggesting that the VPSS is useful in determining lower urinary tract symptoms, ...
Evaluating the Lower Urinary Tract Syndrome with a ...
The results showed that EPSS could be a valuable option for both patients and GPs monitoring LUTS and particularly helpful when teleconsultations are considered ...
Lower Urinary Tract Symptoms Due to Benign Prostatic ...
Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...
4.
researchgate.net
researchgate.net/publication/391505103_Initial_Evidence_for_a_Telehealth_Behavioral_Intervention_to_Lower_Urinary_Tract_Symptoms_in_MenInitial Evidence for a Telehealth Behavioral Intervention to ...
T-test showed that LUTS severity measured on the International Prostate Symptom Score (IPSS) had reduced remarkably in 6 months (mean difference ...
Study Details | NCT02947958 | Teleconsultation in Counter ...
Low urinary tract symptoms are assessed through International Prostate Score System (IPSS) which includes seven main important symptoms of benign prostate ...
Urinary Tract Symptoms (LUTS) Secondary to Benign ...
This review assesses lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with or without erectile dysfunction (ED) and related ...
A herbal medicine preparation for the management of ...
The herbal preparation (ProstateEZE Max) was shown to be well tolerated and have a significant positive effect on physical symptoms of BPH when taken over 3 ...
Benign Prostatic Hyperplasia
The primary outcome was safety, assessed by adverse events (AEs), clinical laboratory assessments, vital signs, postvoid residual (PVR) urine ...
9.
researchgate.net
researchgate.net/publication/232647811_Benign_prostatic_hyperplasia_and_lower_urinary_tract_symptom_guidelines(PDF) Benign prostatic hyperplasia and lower urinary tract ...
According to other data, approximately 50% of men more than 50 years of age have BPH and approximately half of them complain of symptoms of OAB ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.