Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stream Dx, DFree, TestCard.
- Who it may be relevant to
- Registry conditions: Urologic Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Stream Dx
home uroflowmetry device - Device DFree
at home wearable bladder scanner - Device TestCard
mobile urinalysis reader
Primary outcome measures
- International Prostate Symptom Score (IPSS) Baseline [Time frame: Baseline]
- International Prostate Symptom Score (IPSS) Change [Time frame: 3 months]
- Uroflowmetry Baseline [Time frame: Baseline]
- Uroflowmetry Change [Time frame: 3 months]
- Post Void Residual (PVR) Baseline [Time frame: Baseline]
- Post Void Residual (PVR) Change [Time frame: Baseline and 3 months]
- Urinalysis (UA) Baseline [Time frame: Baseline]
- Urinalysis (UA) 3 Months [Time frame: 3 months]
Secondary outcome measures (2)
- Urology Satisfaction with Outpatient Service (SWOPS) baseline [Time frame: Baseline]
- Urology Satisfaction with Outpatient Service (SWOPS) 3 months [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Indiana University — Indianapolis
Identifiers
NCT: NCT05508165 · IndianaU 12530