Clinical trial NCT05508165: Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urologic Diseases
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: This study is being done to improve the availability of telehealth urology visits. In this study, investigators will compare the usefulness of data collected by three home devices to understand the amount of urine released from the body, how empty the bladder gets after urinating, and if there is an infection present in the bladder. These will be compared to being at home versus in the doctor's office. Additionally, the study will determine how satisfied patients are 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 standard clinical practices and demonstrate the ability of these devices to provide useful information in the home setting. The study involves two cohorts. Cohort 1 are new patients who will be randomized to either telehealth visits or in office visits. If randomized to the telehealth group, the patients will use various devices to perform a standard workup at home. If randomized to the clinic visit, similar tests will be performed in the office. Cohort 2 are existing patients who will use one of the devices at home, but will also complete similar in-office tests in order to compare device accuracy.

Screening will be performed prior to patient's first scheduled visit based on chief complaints of urinary retention, BPH, or LUTS. Patients will be initially identified by study personnel or qualified research coordinator when the patient is identified to have qualifying issues through reviewing medical records of patients. Patient will be contacted by phone by the study personnel. If the patients are interested, the patients will be screened for inclusion criteria.

Eligibility 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

Primary outcomes:
measure: International Prostate Symptom Score (IPSS) Baseline
timeFrame: Baseline
measure: International Prostate Symptom Score (IPSS) Change
timeFrame: 3 months
measure: Uroflowmetry Baseline
timeFrame: Baseline
measure: Uroflowmetry Change
timeFrame: 3 months
measure: Post Void Residual (PVR) Baseline
timeFrame: Baseline
measure: Post Void Residual (PVR) Change
timeFrame: Baseline and 3 months
measure: Urinalysis (UA) Baseline
timeFrame: Baseline
measure: Urinalysis (UA) 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Urology Satisfaction with Outpatient Service (SWOPS) baseline
timeFrame: Baseline
measure: Urology Satisfaction with Outpatient Service (SWOPS) 3 months
timeFrame: 3 months
Other outcomes:
measure: Stream Dx Device Validation
timeFrame: Baseline
measure: DFree Device Validation
timeFrame: Baseline
measure: TestCard Device Validation
timeFrame: Baseline
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Marcelino Rivera, MD
role: PRINCIPAL_INVESTIGATOR
References: