Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men
Investigating Techniques for Urethritis Diagnosis in Men
Stephen Jordan
Primary Investigator
Brief description of study
The research team hypothesizes that the state-of-the-art flow cytometer analyzer, the Sysmex UF-5000, may be able to similarly provide a non-invasive and cost-effective approach for urethritis diagnosis in men using first-catch urine when compared to Gram stain and urinalysis. A cheap, simple, and non-invasive point of care test (i.e., results available within 30 minutes) that accurately detects urethritis could be a game changer in STI management as asymptomatic infections could be detected and treated, potentially decreasing the risk of spreading STIs to sexual partners. Additionally, we hypothesize that the Colli-pee device increases accuracy and precision of the urine flow cytometry compared to a standard-of-care urine cup. The importance of this study is that we will understand whether the Colli-Pee or standard-of-care urine cup is the optimal device for collecting urine for measuring neutrophils using the non-invasive Sysmex urethral flow cytometer or LE by urinalysis. We will also be able to know which analysis method and collection device is the most precise across different collection days and how quickly the urine results (WBCs/uL or LE) change over time. This knowledge may help us assess the potential of the Sysmex UF-5000 to replace the Gram stain in the future.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
Participants will complete a brief questionnaire, be tested for four different sexually transmitted infections, and provide 6 urine specimens (3 morning urine specimens per week, typically Mon, Wed, and Fri) over the course of two weeks.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy
-
Age: 18 years - 50 years
-
Gender: Male
Inclusion Criteria
- Men aged 18 to 50
No urethral symptoms (discharge, dysuria)
Exclusion Criteria
History of genital surgery or known urethral abnormalities
Testing positive for gonorrhea and chlamydia
Diagnosis of a sexually transmitted infection within the last year.
Not available to collect a urine specimen in the morning 3x/week for 2 weeks
This study investigates the effectiveness of a state-of-the-art flow cytometer analyzer, the Sysmex UF-5000, in diagnosing urethritis in men using first-catch urine. Urethritis is an inflammation of the urethra, often caused by infection, and can lead to symptoms like pain or discharge. The study aims to determine if this method can be a non-invasive and cost-effective alternative to traditional Gram stain and urinalysis methods.
Participants will complete a brief questionnaire and be tested for four sexually transmitted infections. They will provide six urine specimens over two weeks, specifically three morning specimens per week. The study will compare the accuracy of urine samples collected with the Colli-Pee device versus a standard urine cup, assessing which method yields more precise results in measuring neutrophils, a type of white blood cell, in the urine.
- Who can participate: Men aged 18 to 50 without urethral symptoms like discharge or pain can participate. They must not have a history of genital surgery, known urethral abnormalities, or a recent STI diagnosis.
- Study details: Participants will provide urine samples and complete a questionnaire. A placebo is not used in this study.
- Study timelines and visits: The study will last 2 weeks. The study requires 6 visits.
