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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Sysmex UF-5000 for urethritis detection?

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 high negative predictive value of 96%, meaning it is good at confirming when someone does not have the condition. ^{1 2 3 4 5}

Is the Sysmex UF-5000 safe for use in humans?

The research articles focus on the Sysmex UF-5000's ability to quickly diagnose urinary tract infections, but they do not provide specific safety data for its use in humans. ^{6 7 8 9 10}

How does the Sysmex UF-5000 treatment for urethritis differ from other treatments?

The Sysmex UF-5000 is unique because it uses advanced flow cytometry to quickly analyze urine samples for signs of urethritis, such as bacteria and white blood cells, providing rapid results compared to traditional methods that rely on microscopic examination or culture tests. ^{1 2 3 11 12}

What is the purpose of this trial?

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.

Research Team

Stephen J Jordan, MD

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Experimental evaluation of the Sysmex UF-1000i for ruling out non-gonococcal urethritis]. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Evaluating the utility of the A.F. Genital System test for pathogen diagnosis in acute male urethritis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Performance evaluation of automated urine microscopy as a rapid, non-invasive approach for the diagnosis of non-gonococcal urethritis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of a direct immunofluorescence test for diagnosing gonorrhoea. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of the early morning smear investigation. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The diagnostic value of rapid urine test platform UF-5000 for suspected urinary tract infection at the emergency department. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Field evaluation of a second-generation cytometer UF-100 in diagnosis of acute urinary tract infections in adult patients. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Validation and Search of the Ideal Cut-Off of the Sysmex UF-1000i® Flow Cytometer for the Diagnosis of Urinary Tract Infection in a Tertiary Hospital in Spain. [2020]

9. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of Sysmex UF-5000 flow cytometer flag BACT-info for Gram discrimination in urinary tract infection]. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Combination of UC-3500 and UF-5000 as a quick and effective method to exclude bacterial urinary tract infection. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Microscopy of Gram-stained urethral smear in the diagnosis of urethritis: Which threshold value should be selected? [2019]

12. Denmark pubmed.ncbi.nlm.nih.gov

Urethritis associated with Chlamydia trachomatis: comparison of leukocyte esterase dipstick test of first-voided urine and methylene blue-stained urethral smear as predictors of chlamydial infection. [2019]