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

NCT06951009 | Completed Results 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)

• Median Urinary White Blood Cell Count (WBCs/uL) by Collection Device (Urine Cup vs Colli-Pee)

  Urinary white blood cell (WBC) counts (cells/µL) will be measured using a Sysmex UF-5000 urine flow cytometer. Each participant will provide urine samples on three separate days during each of two weeks, with samples collected using both a standard urine cup and a Colli-Pee device. WBC counts will be summarized using the median (and interquartile range) and compared between collection methods.

  Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2

• Proportion of Urine Samples Positive for Leukocyte Esterase (≥1+) by Collection Device (Urine Cup vs Colli-Pee)

  Urinary leukocyte esterase will be assessed by standard urinalysis (dipstick). Each participant will provide urine samples on three separate days during each of two weeks, with samples collected using both a standard urine cup and a Colli-Pee device. Leukocyte esterase results will be recorded as an ordinal categorical variable with levels: negative, 1+, 2+, 3+, and 4+, and compared between collection methods.

  Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2

• Within-Subject Coefficient of Variation of Urinary White Blood Cell Counts by Collection Device

  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 cell (WBC) concentration (WBCs/µL), as measured by the Sysmex UF-5000. Day-to-day variability will be quantified as the within-subject coefficient of variation (CV%) across the three sample collections for each collection method. Results are summarized as the median (interquartile range) CV% across participants.

  Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2

• Proportion of Urine Samples Positive for Leukocyte Esterase (≥1+) by Time Point and Collection Device

  Urinary leukocyte esterase will be assessed by standard urinalysis (dipstick). Each participant will provide urine samples on three separate days during each of two weeks, with samples collected using both a standard urine cup and a Colli-Pee device. Leukocyte esterase results will be dichotomized as positive (≥1+) or negative. The outcome is the proportion of urine samples with a positive leukocyte esterase result at each collection visit for each collection device.

  Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday 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.

  Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday 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.

  Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday 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

Results Point of Contact

• Title: Dr. Stephen Jordan
• Organization: Indiana University

jordansj@iu.edu

317-274-8110

Study Officials

• Stephen J Jordan, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 17, 2026
• Results First Posted: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)