Virtual vs In-Person Treatment for Lower Urinary Tract Symptoms

Overseen By Stephanie Woffard, MSM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Visually impaired, Hearing impaired, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

60 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

Male

You are a new patient referred for urinary retention, enlarged prostate, or lower urinary tract symptoms.

You have been diagnosed with urinary retention, enlarged prostate, or lower urinary tract symptoms.

Exclusion Criteria

Inability to provide informed consent

Concomitant condition requiring in-person exam or evaluation

You have trouble seeing or hearing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual or in-person)

Baseline Assessment

Participants undergo baseline assessments including uroflowmetry, post void residual, and urinalysis using either in-clinic or at-home devices

1 week

1 visit (in-person or virtual)

Treatment

Participants receive either virtual or in-person clinical workup and treatment for Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH)

3 months

Multiple visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up assessments at 3 months

3 months

1 visit (in-person or virtual)

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?

Group I: Cohort 2: Validation Cohort Experimental Treatment 3 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/BPH Experimental Treatment 3 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/BPH Active Control 1 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4551494/

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, ...

2. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.848923/full

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06051383

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_Men

Initial 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02947958

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3888888/

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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0965229913000253

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 ...

8. auajournals.org auajournals.org/doi/pdf/10.1097/01.JU.0001109832.07222.c5

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 ...