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

NCT06951009 | Completed FDA Device

• 1 other identifier: 26774
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Detection of white blood cells in single sample

  Participants will provide urine samples on three days during each week of participation, for a total of 2 weeks. Urine samples collected in standard of care urine cups and Colli-Pee devices will be compared for white blood cells (WBC) per microliter, as detected by the Sysmex UP-5000. The UF5000 results will be the continuous variable of "WBCs per microliter" of urine.

  Three days during Week 1 and three days during Week 2

• Detection of leukocyte esterase (LE) in single sample

  Participants will provide urine samples on three days during each week of participation, for a total of 2 weeks. Urine samples collected in standard of care urine cups and Colli-Pee devices will be compared for leukocyte esterase as detected by urinalysis. For the urinalysis, the categorical results will be "neg", "1+", "2+", "3+", and "4+" leukocyte esterase.

  Three days during Week 1 and three days during Week 2

• Detection of white blood cells in repeat sampling

  Participants will provide urine samples on three days during each week of participation, for a total of 2 weeks. Urine samples collected in standard of care urine cups and Colli-Pee devices will be compared for white blood cells (WBC) per microliter, as detected by the Sysmex UP-5000. The UF5000 results will be the continuous variable of "WBCs per microliter" of urine. The average of 3 sample collections will be evaluated.

  Three days during Week 1 and three days during Week 2

• Detection of leukocyte esterase (LE) in repeat sampling

  Participants will provide urine samples on three days during each week of participation, for a total of 2 weeks. Urine samples collected in standard of care urine cups and Colli-Pee devices will be compared for leukocyte esterase as detected by urinalysis. For the urinalysis, the categorical results will be "neg", "1+", "2+", "3+", and "4+" leukocyte esterase. The average of 3 sample collections will be evaluated.

  Three days during Week 1 and three days during Week 2

• Detection of white blood cells over time

  Participants will provide urine samples on three days during each week of participation, for a total of 2 weeks. Urine samples collected in standard of care urine cups and Colli-Pee devices will be compared for white blood cells (WBC) per microliter, as detected by the Sysmex UP-5000. The UF5000 results will be the continuous variable of "WBCs per microliter" of urine. Specimens will be compared at 0 hours, 1 hour, 2 hours, 4 hours and 8 hours.

  Three days during Week 1 and three days during Week 2

• Detection of leukocyte esterase (LE) over time

  Participants will provide urine samples on three days during each week of participation, for a total of 2 weeks. Urine samples collected in standard of care urine cups and Colli-Pee devices will be compared for leukocyte esterase as detected by urinalysis. For the urinalysis, the categorical results will be "neg", "1+", "2+", "3+", and "4+" leukocyte esterase. Specimens will be compared at 0 hours, 1 hour, 2 hours, 4 hours and 8 hours.

  Three days during Week 1 and three days during Week 2

Study Arms (2)

Colli-Pee collection followed by standard-of-care urine collection cup

ACTIVE COMPARATOR

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.

Device: Colli-Pee; Device: standard of care 60 mL urine cup; Diagnostic Test: Urinalysis; Diagnostic Test: Sysmex UP-5000

Standard-of-care urine collection followed by Colli-Pee collection

ACTIVE COMPARATOR

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.

Device: Colli-Pee; Device: standard of care 60 mL urine cup; Diagnostic Test: Urinalysis; Diagnostic Test: Sysmex UP-5000

Interventions

Colli-Pee DEVICE

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.

Colli-Pee collection followed by standard-of-care urine collection cup; Standard-of-care urine collection followed by Colli-Pee collection

standard of care 60 mL urine cup DEVICE

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.

Colli-Pee collection followed by standard-of-care urine collection cup; Standard-of-care urine collection followed by Colli-Pee collection

Urinalysis DIAGNOSTIC_TEST

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

Colli-Pee collection followed by standard-of-care urine collection cup; Standard-of-care urine collection followed by Colli-Pee collection

Sysmex UP-5000 DIAGNOSTIC_TEST

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

Colli-Pee collection followed by standard-of-care urine collection cup; Standard-of-care urine collection followed by Colli-Pee collection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: assigned male at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men aged 18 to 50.
• No urethral symptoms (discharge, dysuria)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Urethritis

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Stephen J Jordan, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants with an odd birth year will use the Colli-Pee during the first week; even birth year participants will use the Colli-Pee during the second week. Participants with an odd birth year will use the standard-of-care 60 mL urine cup during the second week; even birth year participants will use the urine cup during the first week.

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 30, 2025
• Study Start: April 9, 2025
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)