Sysmex UF-5000 for Urethritis Detection

Overseen By Paul A Sparks

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Genital surgery, Urethral abnormalities, Gonorrhea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for diagnosing urethritis, an inflammation of the male urethra that often goes unnoticed until it worsens. The Sysmex UF-5000 device quickly and accurately detects inflammation by counting white blood cells in urine samples. The study compares the accuracy of urine collected with a special device called Colli-Pee against a standard urine cup. Men aged 18 to 50, without symptoms like discharge or painful urination, can participate if they haven’t had a recent sexually transmitted infection. As an unphased trial, this study offers participants the chance to contribute to innovative diagnostic research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Sysmex UF-5000 device is safe for urethritis detection?

Research has shown that the Sysmex UF-5000 reliably diagnoses conditions like urinary tract infections (UTIs) by counting white blood cells in urine to detect inflammation. However, specific safety information for the Sysmex UF-5000 itself is limited.

This tool is non-invasive, meaning it doesn't involve surgery or entering the body, which generally enhances safety. Hospitals have already used it to help identify infections. Since the Sysmex UF-5000 primarily analyzes urine samples, the physical risks are low. Its use in medical settings indicates it is well-tolerated by patients.

In summary, while direct safety data is lacking, the Sysmex UF-5000's successful hospital use and non-intrusive nature suggest it is safe for diagnosing urethritis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a new technique for detecting urethritis using the Sysmex UF-5000, a sophisticated urine analyzer. Unlike traditional methods that often rely on manual microscopy, which can be time-consuming and subjective, the Sysmex UF-5000 offers automation and precision. This technology can potentially streamline the diagnostic process, making it faster and more accurate. Additionally, the trial is comparing two urine collection methods, which could lead to insights on optimizing sample collection for better results.

What evidence suggests that the Sysmex UF-5000 is effective for diagnosing urethritis?

Research has shown that the Sysmex UF-5000 is a promising tool for diagnosing urethritis. It counts white blood cells in urine, which are linked to inflammation. A similar device, the Sysmex UF-1000i, was 84% effective in detecting non-gonococcal urethritis, suggesting the UF-5000 might also perform well. The device accurately rules out bacterial urinary tract infections. Its non-invasive, quick, and cost-effective features make it a strong option for early STI detection and management. Participants in this trial will use different urine collection methods to evaluate the Sysmex UF-5000's effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephen J Jordan, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for healthy men who may be at risk of urethritis or asymptomatic bacteriuria. Participants should not currently have any urinary tract infections, and they must be willing to provide urine samples using different collection methods.

Inclusion Criteria

I am a man between 18 and 50 years old.

I do not have any symptoms like pain during urination or discharge.

Exclusion Criteria

Testing positive for gonorrhea and chlamydia

Diagnosis of a sexually transmitted infection within the last year

I cannot provide morning urine samples three times a week for two weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants collect urine samples three times a week for two weeks using either the Colli-Pee device or standard urine cup

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sysmex UF-5000

Trial Overview The study is testing the Sysmex UF-5000 flow cytometer's ability to diagnose urethritis in men by analyzing their urine. It compares the accuracy of this device with traditional tests and checks if a new collection method (Colli-Pee) is more effective than standard cups.

How Is the Trial Designed?

Group I: Colli-Pee collection followed by standard-of-care urine collection cup Active Control 4 Interventions

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.

Group II: Standard-of-care urine collection followed by Colli-Pee collection Active Control 4 Interventions

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06951009

Establishing Baseline Sysmex UF-5000 Flow Cytometer ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11619479/

Performance of UF-5000 in rapidly screening out urinary ... This study aimed to evaluate the performance of UF-5000 in excluding bacterial urinary tract infection (UTI) and detecting the presence of Gram-negative ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0304286

Sysmex UF-5000 as a screening tool for bacterial urinary tract ... The consistency rate for GP/GN is 85.2%, and the sensitivity is 11.8%,compared to individual bacterial infections, UF-5000 is less effective at ...

4. withpower.com withpower.com/trial/phase-urethritis-3-2025-9d816

Sysmex UF-5000 for Urethritis Detection · Info for Participants The Sysmex UF-1000i, a similar device to the Sysmex UF-5000, showed high effectiveness in ruling out non-gonococcal urethritis with a sensitivity of 84% and a ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0009898118302651

Evaluation of the new Sysmex UF-5000 fluorescence flow ... Results: UF-5000 showed a very good performance in the screening process. Carryover and cross-contamination was negligible. 797 samples were culture ...

6. sysmex.com sysmex.com/en-us/lab-solutions/urinalysis/un-series/uf-5000

UF-5000™ Fully Automated Urine Particle Analyzer Find Technical Data Sheets (TDS) and Safety Data Sheets (SDS). Careers. Our ... An intuitive data management program to quickly analyze urinalysis test results.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38865329/

Sysmex UF-5000 as a screening tool for bacterial urinary ... We have evaluated for the first time the performance of the Sysmex UF-5000 flow cytometer as a screening tool for UTIs in children.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0281118

Accuracy of the Sysmex UF-5000 analyzer for urinary tract ... The Sysmex UF-5000 analyzer was used to determine urine white blood cell (WBC) and bacteria simultaneously. A chemical strip was used to assess ...