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

Primary Purpose

Urologic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stream Dx
DFree
TestCard
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Urologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Other

Arm Label

Cohort 1a: in-person clinical assessment of LUTS/BPH

Cohort 1b: virtual (telehealth) clinical assessment of LUTS/BPH

Cohort 2: Validation Cohort

Arm Description

COHORT 1a: Subjects randomized to undergo in-person initial clinical workup of Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH) and in-person clinical follow-up after 3 months of clinical intervention. In-person clinical workup at both the initial and Month 3 follow-up timepoint includes International Prostate Symptom Score (IPSS), and standard of care uroflowmetry, post void residual (PVR), and urinalysis (UA) assessments.

COHORT 1b: Subjects randomized to undergo virtual initial clinical workup of Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH) and virtual clinical follow-up after 3 months of clinical intervention. Virtual clinical workup at both the initial and Month 3 follow-up timepoint includes at home completion of International Prostate Symptom Score (IPSS), at home uroflowmetry assessment through use of the Stream Dx device, at home assessment of post void residual (PVR) through use of the DFree device, and at home urinalysis (UA) through use of the TestCard device.

COHORT 2: Non-randomized subjects who will attend a single, clinically scheduled, in-person follow-up appointment to directly compare the standard of care assessments/devices to the experimental assessments/devices. Prior to the in-person appointment, patients will complete at home uroflowmetry assessment through use of the Stream Dx device. At the in-person appointment, the clinic staff will perform standard of care uroflowmetry, post void residual (PVR), and urinalysis (UA). At this visit, clinic staff will also obtain PVR measurements through use of the DFree device and urinalysis through the TestCard device.

Outcomes

Primary Outcome Measures

International Prostate Symptom Score (IPSS) Baseline
The IPSS assesses prostate related symptoms and their frequency of occurrence through seven questions, scored on a 6 point scale, from 0 (not at all) to 5 (always). Total symptom-related scores range from 1-7 (mild), 8-19 (moderate), and 20-35 (severe). The IPSS also assess quality of life due to urinary symptoms with a single question, scored on a 7 point scale (0 = delighted; 6 = terrible). The IPSS will be administered at the initial visit (baseline) for Cohorts 1a and 1b. Baseline scores will be compared between the two groups to evaluate for equivalency.
International Prostate Symptom Score (IPSS) Change
The IPSS assesses prostate related symptoms and their frequency of occurrence through seven questions, scored on a 6 point scale, from 0 (not at all) to 5 (always). Total symptom-related scores range from 1-7 (mild), 8-19 (moderate), and 20-35 (severe). The IPSS also assess quality of life due to urinary symptoms with a single question, scored on a 7 point scale (0 = delighted; 6 = terrible). The IPSS will be administered at the initial visit (baseline) and Month 3 for Cohorts 1a and 1b. The amount of IPSS score reduction at the time of 3 month follow up will be compared between both groups to evaluate for equivalency.
Uroflowmetry Baseline
Uroflowmetry measures the flow of urine as milliliters (ml) of urine passed per second(s). Typical scores range between 5 and 20 ml/s, with a lower score indicating possible obstruction, enlarged prostate or weak bladder and a higher score indicating good flow. Cohort 1a will undergo in-person uroflowmetry per standard clinical assessment at Baseline. Standard clinical assessment includes measurement of a single void during the in-person clinic visit by urinating once into the uroflowmetry device (a urinal with calibrated sensors to measure flow). Cohort 1b will undergo uroflowmetry through at-home use of the Stream Dx device (also a urinal with calibrated sensors to measure flow), which includes measuring all voids performed at home during a 5 day period prior to Baseline (initial virtual visit). Baseline uroflowmetry assessment results for Cohorts 1a and 1b will be evaluated for equivalency.
Uroflowmetry Change
Uroflowmetry measures the flow of urine as milliliters (ml) of urine passed per second(s). Typical scores range between 5 and 20 ml/s, with a lower score indicating possible obstruction, enlarged prostate or weak bladder and a higher score indicating good flow. Cohort 1a will undergo in-person uroflowmetry per standard clinical assessment at Baseline and Month 3. Standard clinical assessment includes measurement of a single void during the in-person clinic visit by urinating once into the uroflowmetry device. Cohort 1b will undergo uroflowmetry through at-home use of the Stream Dx device (also a urinal with calibrated sensors to measure flow), which includes measuring all voids performed at home during a 5 day period prior to Baseline (initial virtual visit) and again during a 5 day period prior to the Month 3 follow up visit. Increase in average flow at 3 months on uroflowmetry for Cohorts 1a and 1b will be evaluated for equivalency.
Post Void Residual (PVR) Baseline
Post Void Residual is the amount of urine remaining in the bladder after voiding. Typical scores range between 0 and 150 mL, with a higher score indicating incomplete bladder emptying. Cohort 1a will undergo in-person PVR assessment per clinical standards once at Baseline. This includes measurement of a single PVR volume during the clinical in-person visit using a calibrated ultrasound based bladder scanner that is placed on the patient's lower abdomen for 5 seconds. Cohort 1b will undergo PVR assessment through at-home use of the DFree device, a wearable bladder scanner. Participants will wear this device for an entire day during which will collect PVR measurements after each void during that period prior to the Baseline visit (initial virtual visit). PVR results for Cohorts 1a and 1b at baseline will be evaluated for equivalency.
Post Void Residual (PVR) Change
Post Void Residual is the amount of urine remaining in the bladder after voiding. Typical scores range between 0 and 150 mL, with a higher score indicating incomplete bladder emptying. Cohort 1a will undergo in-person PVR assessment per clinical standards once at Baseline and Month 3 . This includes measurement of a single PVR volume during the clinical in-person visit using a calibrated ultrasound based bladder scanner that is placed on the patient's lower abdomen for 5 seconds. Cohort 1b will undergo PVR assessment through at-home use of the DFree device, a wearable bladder scanner. Participants will wear this device for an entire day during which will collect PVR measurements after each void during that period prior to the Baseline (initial virtual visit) and Month 3 virtual visit. Reduction in PVR between each group at the time of 3 month follow up will be evaluated for equivalency.
Urinalysis (UA) Baseline
Urinalysis (UA) the urine for infection (UTI) or diabetes. Recorded outcomes will be possible UTI (any positive leukocyte esterase, nitrites, or blood) and possible diabetes (any positive glucose, ketones, or proteins). Cohort 1a will undergo a UA assessment per standard clinical assessment once at the initial visit (baseline). This includes dipping a urine sample with a test strip which is read by a machine during the clinic in-person visit. Cohort 1b will undergo a UA assessment per standard clinical assessment once at the first virtual visit (baseline). Using the Testcard phone app, the patient will collect a urine sample at home, and dip a test strip into the urine which is then analyzed by the mobile app. UA results for Cohorts 1a and 1b will be evaluated for equivalency between the two groups at baseline. Any positive results (UTI or diabetes) will undergo confirmatory lab testing per standard of care.
Urinalysis (UA) 3 Months
Urinalysis (UA) the urine for infection (UTI) or diabetes. Recorded outcomes will be possible UTI (any positive leukocyte esterase, nitrites, or blood) and possible diabetes (any positive glucose, ketones, or proteins). Cohort 1a will undergo a UA assessment per standard clinical assessment once at Month 3 follow up. This includes dipping a urine sample with a test strip which is read by a machine during the clinic in-person visit. Cohort 1b will undergo a UA assessment per standard clinical assessment once at the Month 3 follow up. Using the Testcard phone app, the patient will collect a urine sample at home, and dip a test strip into the urine which is then analyzed by the mobile app. UA results for Cohorts 1a and 1b will be evaluated for equivalency between the two groups at 3 month follow up. Any positive results (UTI or diabetes) will undergo confirmatory lab testing per standard of care.

Secondary Outcome Measures

Urology Satisfaction with Outpatient Service (SWOPS) baseline
Patient satisfaction in Cohorts 1a and 1b will be measured with the validated Satisfaction with Outpatient Service (SWOPS) questionnaire following their initial visit (baseline). The questionnaire assesses the patient's satisfaction with their visit across 13 topics. The investigators will test non-inferiority in SWOPS scores between patients in the virtual group and in-clinic group at the initial visit. There is no defined scale or score that would suggest a better or worse outcome, rather the percent response of "Yes, definitely", "Yes, to some extent", and "No" to each of the 13 questions will be compared between the two groups for equivalency and thus the non-inferiority statistical approach was chosen.
Urology Satisfaction with Outpatient Service (SWOPS) 3 months
Patient satisfaction in Cohorts 1a and 1b will be measured with the validated Satisfaction with Outpatient Service (SWOPS) questionnaire following their 3 month follow up. The questionnaire assesses the patient's satisfaction with their visit across 13 topics. The investigators will test non-inferiority in SWOPS scores between patients in the virtual group and in-clinic group at the initial visit. There is no defined scale or score that would suggest a better or worse outcome, rather the percent response of "Yes, definitely", "Yes, to some extent", and "No" to each of the 13 questions will be compared between the two groups for equivalency and thus the non-inferiority statistical approach was chosen.

Full Information

First Posted
May 2, 2022
Last Updated
June 30, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05508165
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1a: in-person clinical assessment of LUTS/BPH
Arm Type
No Intervention
Arm Description
COHORT 1a: Subjects randomized to undergo in-person initial clinical workup of Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH) and in-person clinical follow-up after 3 months of clinical intervention. In-person clinical workup at both the initial and Month 3 follow-up timepoint includes International Prostate Symptom Score (IPSS), and standard of care uroflowmetry, post void residual (PVR), and urinalysis (UA) assessments.
Arm Title
Cohort 1b: virtual (telehealth) clinical assessment of LUTS/BPH
Arm Type
Experimental
Arm Description
COHORT 1b: Subjects randomized to undergo virtual initial clinical workup of Lower Urinary Tract Symptoms (LUTS) / Benign Prostatic Hyperplasia (BPH) and virtual clinical follow-up after 3 months of clinical intervention. Virtual clinical workup at both the initial and Month 3 follow-up timepoint includes at home completion of International Prostate Symptom Score (IPSS), at home uroflowmetry assessment through use of the Stream Dx device, at home assessment of post void residual (PVR) through use of the DFree device, and at home urinalysis (UA) through use of the TestCard device.
Arm Title
Cohort 2: Validation Cohort
Arm Type
Other
Arm Description
COHORT 2: Non-randomized subjects who will attend a single, clinically scheduled, in-person follow-up appointment to directly compare the standard of care assessments/devices to the experimental assessments/devices. Prior to the in-person appointment, patients will complete at home uroflowmetry assessment through use of the Stream Dx device. At the in-person appointment, the clinic staff will perform standard of care uroflowmetry, post void residual (PVR), and urinalysis (UA). At this visit, clinic staff will also obtain PVR measurements through use of the DFree device and urinalysis through the TestCard device.
Intervention Type
Device
Intervention Name(s)
Stream Dx
Intervention Description
home uroflowmetry device
Intervention Type
Device
Intervention Name(s)
DFree
Intervention Description
at home wearable bladder scanner
Intervention Type
Device
Intervention Name(s)
TestCard
Intervention Description
mobile urinalysis reader
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS) Baseline
Description
The IPSS assesses prostate related symptoms and their frequency of occurrence through seven questions, scored on a 6 point scale, from 0 (not at all) to 5 (always). Total symptom-related scores range from 1-7 (mild), 8-19 (moderate), and 20-35 (severe). The IPSS also assess quality of life due to urinary symptoms with a single question, scored on a 7 point scale (0 = delighted; 6 = terrible). The IPSS will be administered at the initial visit (baseline) for Cohorts 1a and 1b. Baseline scores will be compared between the two groups to evaluate for equivalency.
Time Frame
Baseline
Title
International Prostate Symptom Score (IPSS) Change
Description
The IPSS assesses prostate related symptoms and their frequency of occurrence through seven questions, scored on a 6 point scale, from 0 (not at all) to 5 (always). Total symptom-related scores range from 1-7 (mild), 8-19 (moderate), and 20-35 (severe). The IPSS also assess quality of life due to urinary symptoms with a single question, scored on a 7 point scale (0 = delighted; 6 = terrible). The IPSS will be administered at the initial visit (baseline) and Month 3 for Cohorts 1a and 1b. The amount of IPSS score reduction at the time of 3 month follow up will be compared between both groups to evaluate for equivalency.
Time Frame
3 months
Title
Uroflowmetry Baseline
Description
Uroflowmetry measures the flow of urine as milliliters (ml) of urine passed per second(s). Typical scores range between 5 and 20 ml/s, with a lower score indicating possible obstruction, enlarged prostate or weak bladder and a higher score indicating good flow. Cohort 1a will undergo in-person uroflowmetry per standard clinical assessment at Baseline. Standard clinical assessment includes measurement of a single void during the in-person clinic visit by urinating once into the uroflowmetry device (a urinal with calibrated sensors to measure flow). Cohort 1b will undergo uroflowmetry through at-home use of the Stream Dx device (also a urinal with calibrated sensors to measure flow), which includes measuring all voids performed at home during a 5 day period prior to Baseline (initial virtual visit). Baseline uroflowmetry assessment results for Cohorts 1a and 1b will be evaluated for equivalency.
Time Frame
Baseline
Title
Uroflowmetry Change
Description
Uroflowmetry measures the flow of urine as milliliters (ml) of urine passed per second(s). Typical scores range between 5 and 20 ml/s, with a lower score indicating possible obstruction, enlarged prostate or weak bladder and a higher score indicating good flow. Cohort 1a will undergo in-person uroflowmetry per standard clinical assessment at Baseline and Month 3. Standard clinical assessment includes measurement of a single void during the in-person clinic visit by urinating once into the uroflowmetry device. Cohort 1b will undergo uroflowmetry through at-home use of the Stream Dx device (also a urinal with calibrated sensors to measure flow), which includes measuring all voids performed at home during a 5 day period prior to Baseline (initial virtual visit) and again during a 5 day period prior to the Month 3 follow up visit. Increase in average flow at 3 months on uroflowmetry for Cohorts 1a and 1b will be evaluated for equivalency.
Time Frame
3 months
Title
Post Void Residual (PVR) Baseline
Description
Post Void Residual is the amount of urine remaining in the bladder after voiding. Typical scores range between 0 and 150 mL, with a higher score indicating incomplete bladder emptying. Cohort 1a will undergo in-person PVR assessment per clinical standards once at Baseline. This includes measurement of a single PVR volume during the clinical in-person visit using a calibrated ultrasound based bladder scanner that is placed on the patient's lower abdomen for 5 seconds. Cohort 1b will undergo PVR assessment through at-home use of the DFree device, a wearable bladder scanner. Participants will wear this device for an entire day during which will collect PVR measurements after each void during that period prior to the Baseline visit (initial virtual visit). PVR results for Cohorts 1a and 1b at baseline will be evaluated for equivalency.
Time Frame
Baseline
Title
Post Void Residual (PVR) Change
Description
Post Void Residual is the amount of urine remaining in the bladder after voiding. Typical scores range between 0 and 150 mL, with a higher score indicating incomplete bladder emptying. Cohort 1a will undergo in-person PVR assessment per clinical standards once at Baseline and Month 3 . This includes measurement of a single PVR volume during the clinical in-person visit using a calibrated ultrasound based bladder scanner that is placed on the patient's lower abdomen for 5 seconds. Cohort 1b will undergo PVR assessment through at-home use of the DFree device, a wearable bladder scanner. Participants will wear this device for an entire day during which will collect PVR measurements after each void during that period prior to the Baseline (initial virtual visit) and Month 3 virtual visit. Reduction in PVR between each group at the time of 3 month follow up will be evaluated for equivalency.
Time Frame
Baseline and 3 months
Title
Urinalysis (UA) Baseline
Description
Urinalysis (UA) the urine for infection (UTI) or diabetes. Recorded outcomes will be possible UTI (any positive leukocyte esterase, nitrites, or blood) and possible diabetes (any positive glucose, ketones, or proteins). Cohort 1a will undergo a UA assessment per standard clinical assessment once at the initial visit (baseline). This includes dipping a urine sample with a test strip which is read by a machine during the clinic in-person visit. Cohort 1b will undergo a UA assessment per standard clinical assessment once at the first virtual visit (baseline). Using the Testcard phone app, the patient will collect a urine sample at home, and dip a test strip into the urine which is then analyzed by the mobile app. UA results for Cohorts 1a and 1b will be evaluated for equivalency between the two groups at baseline. Any positive results (UTI or diabetes) will undergo confirmatory lab testing per standard of care.
Time Frame
Baseline
Title
Urinalysis (UA) 3 Months
Description
Urinalysis (UA) the urine for infection (UTI) or diabetes. Recorded outcomes will be possible UTI (any positive leukocyte esterase, nitrites, or blood) and possible diabetes (any positive glucose, ketones, or proteins). Cohort 1a will undergo a UA assessment per standard clinical assessment once at Month 3 follow up. This includes dipping a urine sample with a test strip which is read by a machine during the clinic in-person visit. Cohort 1b will undergo a UA assessment per standard clinical assessment once at the Month 3 follow up. Using the Testcard phone app, the patient will collect a urine sample at home, and dip a test strip into the urine which is then analyzed by the mobile app. UA results for Cohorts 1a and 1b will be evaluated for equivalency between the two groups at 3 month follow up. Any positive results (UTI or diabetes) will undergo confirmatory lab testing per standard of care.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Urology Satisfaction with Outpatient Service (SWOPS) baseline
Description
Patient satisfaction in Cohorts 1a and 1b will be measured with the validated Satisfaction with Outpatient Service (SWOPS) questionnaire following their initial visit (baseline). The questionnaire assesses the patient's satisfaction with their visit across 13 topics. The investigators will test non-inferiority in SWOPS scores between patients in the virtual group and in-clinic group at the initial visit. There is no defined scale or score that would suggest a better or worse outcome, rather the percent response of "Yes, definitely", "Yes, to some extent", and "No" to each of the 13 questions will be compared between the two groups for equivalency and thus the non-inferiority statistical approach was chosen.
Time Frame
Baseline
Title
Urology Satisfaction with Outpatient Service (SWOPS) 3 months
Description
Patient satisfaction in Cohorts 1a and 1b will be measured with the validated Satisfaction with Outpatient Service (SWOPS) questionnaire following their 3 month follow up. The questionnaire assesses the patient's satisfaction with their visit across 13 topics. The investigators will test non-inferiority in SWOPS scores between patients in the virtual group and in-clinic group at the initial visit. There is no defined scale or score that would suggest a better or worse outcome, rather the percent response of "Yes, definitely", "Yes, to some extent", and "No" to each of the 13 questions will be compared between the two groups for equivalency and thus the non-inferiority statistical approach was chosen.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Stream Dx Device Validation
Description
Cohort 2 will be asked to complete at home uroflowmetry assessment through use of the Stream Dx device for 5 days, starting 3 weeks prior to a single in-person clinical appointment to establish the baseline for that patient. During the in-person clinical appointment, Cohort 2 will also undergo standard uroflowmetry measurement by urinating once into the uroflowmetry device in the clinic (a urinal with calibrated sensors to measure flow). The baseline Stream Dx results including average and maximum flow rate in mL/s and volume voided in mL will be compared to those obtained by the in-person clinic performed uroflowmetry.
Time Frame
Baseline
Title
DFree Device Validation
Description
Once at a single in-person clinical appointment, Cohort 2 will be asked to undergo a baseline assessment of post-void residual by both the standard clinic bladder scanner and the DFree device. Clinical staff will perform both the bladder scanner and DFree measurements. Baseline results between the assessment methods will be compared.
Time Frame
Baseline
Title
TestCard Device Validation
Description
Once at a single in-person clinical appointment, Cohort 2 will be asked to undergo a baseline urinalysis assessment by both standard in clinic urinalysis dip stick and through the TestCard mobile app analysis. Clinical staff will perform both the standard and TestCard assessment on a single urine sample. Baseline results between the assessment methods will be compared. Recorded outcomes will be possible UTI (any positive leukocyte esterase, nitrites, or blood) and possible diabetes (any positive glucose, ketones, or proteins) and any positive results (UTI or diabetes) will undergo confirmatory lab testing per standard of care.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Woffard, MSM
Phone
(317) 695-7585
Email
sdwillia@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelino Rivera, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Wofford, MSM
Phone
317-695-7585
Email
sdwillia@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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