Comparing patient satisfaction of virtual and in-person visits for urinary symptoms
IRB: #12530 Prospective, Randomized Study to Assess Clinical Outcomes and Patient Satisfaction of Virtual vs. In-Person Workup and Treatment of Lower Urinary Tract Symptoms
This study is testing whether patients with urinary symptoms are happier with virtual visits or in-person appointments while also trying out new home devices for measuring urine output.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05508165 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of three home devices for measuring urinary output compared to traditional in-office assessments. It will assess patient satisfaction with telehealth visits for lower urinary tract symptoms (LUTS) related to prostatic enlargement versus in-person consultations. The study involves two cohorts: new patients randomized to either telehealth or in-office visits, and existing patients using home devices alongside in-office tests. The goal is to determine the accuracy of these devices and improve telehealth accessibility in urology.
Who should consider this trial
Good fit: Ideal candidates include male patients aged 18 and older with urinary retention, benign prostatic hyperplasia (BPH), or LUTS.
Not a fit: Patients under 18, those unable to provide informed consent, or with conditions requiring in-person evaluation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient access to urological care and improve satisfaction with telehealth services.
How similar studies have performed: Other studies have shown promising results in telehealth approaches for urological assessments, suggesting potential success for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Indianapolis, Indiana
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Marcelino Rivera, MD — Indiana University
- Study coordinator: Stephanie Woffard, MSM
- Email: sdwillia@iu.edu
- Phone: (317) 695-7585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.