Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.
M
Marcelino Rivera
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
N/A
60 participants needed
1 Location
Brief description of study
This study is being done to compare usefulness of data collected in uroflowmetry, a test thatures 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 tovisit.
The three devices being investigated have not been used in the home setting to make urinaryurements as is typically done in clinic. The goal is to test the effectiveness anduracy of these devices compared to our standard clinical practices and demonstrate theirbility to provide useful information in the home setting.
Detailed description of study
This study is being done to improve the availability of telehealth urology visits. In thisudy, 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 howd 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 isypically done in clinic. The goal is to test the effectiveness and accuracy of these devicesd to standard clinical practices and demonstrate the ability of these devices tovide useful information in the home setting. The study involves two cohorts. Cohort 1 arew patients who will be randomized to either telehealth visits or in office visits. Ifdomized to the telehealth group, the patients will use various devices to perform adard workup at home. If randomized to the clinic visit, similar tests will be performedhe 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 chiefurinary retention, BPH, or LUTS. Patients will be initially identified by studyqualified research coordinator when the patient is identified to have qualifyingues through reviewing medical records of patients. Patient will be contacted by phone byhe study personnel. If the patients are interested, the patients will be screened forusion criteria.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Urologic Diseases
-
Age: 18 Years
-
Gender: All
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
Updated on
01 Aug 2024.
Study ID: IndianaU 12530
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