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

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.

Conditions

• Urethritis
• Healthy Men Age 18-50 With no Urethral Symptoms

Interventions

DEVICE

Colli-Pee

The Colli-Pee device is a first void urine self-sampling device. Participants will collect urine samples with this device three times during one week of study participation. Urine sample collection with this device will occur either in Week 1 or Week 2 of study participation, depending on the Participant's Arm assignment.

DEVICE

standard of care 60 mL urine cup

Participants will collect clean catch urine samples with this device three times during one week of study participation. Urine sample collection with this device will occur either in Week 1 or Week 2 of study participation, depending on the Participant's Arm assignment.

DIAGNOSTIC_TEST

Urinalysis

Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).

DIAGNOSTIC_TEST

Sysmex UP-5000

Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.

Sponsors & Collaborators

• Indiana University

  lead OTHER

Principal Investigators

• Stephen J Jordan, MD · Indiana University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-09

Primary Completion

2025-05-07

Completion

2025-05-07

FDA Device

Yes

Countries

• United States

Study Locations