Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men

Status: Completed
Location: See location...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Acute urethritis (inflammation of the male urethra) affects millions of men in the United States each year. Effective management of STIs is complicated by asymptomatic infections, as men often delay seeking care until symptoms become severe. Yet, even men without symptoms can show measurable evidence of urethritis. Therefore, a cheap, simple, and non-invasive point-of-care (POC) test, providing results within 30 minutes, could significantly enhance STI management by facilitating early diagnosis and treatment. A new diagnostic method, urine flow cytometry, has shown potential in hospital settings for accurately detecting inflammation by counting white blood cells (infection-fighting cells) in urine samples. The Sysmex UF-5000 flow cytometer, a state-of-the-art device, may offer a non-invasive, cost-effective, and accurate method to diagnose urethritis compared to traditional Gram stains and urinalysis, potentially extending its use beyond specialized clinics. This study aims to determine the efficacy and precision of the Sysmex UF-5000 analyzer in diagnosing urethritis using first-catch urine samples. Additionally, the study seeks to evaluate whether urine collected using the 10 mL Colli-Pee device provides greater accuracy and precision compared to the standard urine cup (30-60 mL) when used with urine flow cytometry and LE urinalysis.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Men aged 18 to 50.

• No urethral symptoms (discharge, dysuria)

Locations
United States
Indiana
Indiana University
Indianapolis
Time Frame
Start Date: 2025-04-09
Completion Date: 2025-05-07
Participants
Target number of participants: 20
Treatments
Active_comparator: Colli-Pee collection followed by standard-of-care urine collection cup
Participants with an odd birth year will collect urine using the Colli-Pee device during Week 1 and with the standard-of care urine cup during Week 2.
Active_comparator: Standard-of-care urine collection followed by Colli-Pee collection
Participants with an even birth year will collect urine using the standard-of-care urine cup during Week 1 and with the Colli-Pee device during Week 2.
Related Therapeutic Areas
Sponsors
Leads: Indiana University

This content was sourced from clinicaltrials.gov

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