Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Stream Dx
  home uroflowmetry device
• Устройство DFree
  at home wearable bladder scanner
• Устройство TestCard
  mobile urinalysis reader

Первичные конечные точки

• International Prostate Symptom Score (IPSS) Baseline [Срок оценки: Baseline]
• International Prostate Symptom Score (IPSS) Change [Срок оценки: 3 months]
• Uroflowmetry Baseline [Срок оценки: Baseline]
• Uroflowmetry Change [Срок оценки: 3 months]
• Post Void Residual (PVR) Baseline [Срок оценки: Baseline]
• Post Void Residual (PVR) Change [Срок оценки: Baseline and 3 months]
• Urinalysis (UA) Baseline [Срок оценки: Baseline]
• Urinalysis (UA) 3 Months [Срок оценки: 3 months]

Вторичные конечные точки (2)

• Urology Satisfaction with Outpatient Service (SWOPS) baseline [Срок оценки: Baseline]
• Urology Satisfaction with Outpatient Service (SWOPS) 3 months [Срок оценки: 3 months]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• <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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Indiana University — Indianapolis

Идентификаторы

NCT: NCT05508165 · IndianaU 12530

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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