UrethritisNCT06951009
Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men
A study testing Colli-Pee, Urinalysis and Sysmex UP-5000 in people with Urethritis and Healthy Men Age 18-50 With no Urethral Symptoms, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urethritis, Healthy Men Age 18-50 With no Urethral Symptoms
- What is being tested?
- Colli-Pee, Urinalysis and Sysmex UP-5000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to 7 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 18 to 50.
- No urethral symptoms (discharge, dysuria)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Acute urethritis (i.e., inflammation of the male urethra) affects millions of men within the United States annually. In young sexually active men, urethritis is most commonly caused by the sexually transmitted infections (STI) Neisseria gonorrhoeae (GC, causes gonorrhea) and Chlamydia trachomatis (CT, causes chlamydia), but can also be caused by a lengthening list of known and emerging pathogens that cause "nongonococcal urethritis" (NGU). STI management has proven challenging due to the prevalence of asymptomatic infections and because men often fail to seek STI care until they experience pronounced symptoms. However, even without urethral symptoms, most men with a urethral STI have measurable evidence of urethritis. Thus, a cheap, simple, and non-invasive point of care (POC) test (i.e., results available within 30 minutes) that accurately detects urethritis could be a game changer in STI management as asymptomatic infections could be detected and treated, potentially decreasing the risk of spreading STIs to sexual partners.
Currently, the only widely used POC test available for diagnosis of urethritis in men in the US is Gram stain microscopy of a urethral swab smear. This approach has been shown to be highly effective for identifying men who have urethritis and has 95% sensitivity for diagnosing GC in symptomatic men [4]. Although the urethral swab remains the gold standard test to diagnose urethritis at the POC, it is rarely used outside of specialized STI clinics given its many limitations, which include: (1) it often elicits severe pain, and in rare cases can permanently damage the urethra; (2) it requires specialized instrumentation (an inverted microscope with a 1000x objective) and Gram stain reagents; (3) it must also be administered and interpreted by trained personnel that have different inter-operator accuracy in reporting results, and (4) anxiety associated with this procedure is a common reason men cite for delaying STI care and failing to return for follow-up visits. In many other clinical settings, POC screening for STIs would be highly desirable, for example during annual wellness exams of high-risk male adolescents; screening with specific STI nucleic acid amplification tests (NAATs) is not cost-effective in low-risk populations and the urethral swab procedure is unacceptable in these populations. As an alternative approach, a few investigators have evaluated Leukocyte esterase (LE) testing as part of a routine urinalysis using first-catch urine to diagnose urethritis, but the low sensitivity and specificity of this approach has limited its use to resource-limited settings.
Flow cytometry is routinely used in clinical settings to identify populations of cells (e.g., neutrophils, red blood cells for whole blood counts) from blood and urine. Modern flow cytometers are highly automated, rapid, and inexpensive to run, which makes them an optimal assay for screening for urethritis by detecting elevated neutrophils in asymptomatic men. Interestingly, several recent publications have shown that flow cytometric analysis of urine can be used to diagnose urethritis with comparable sensitivity and specificity to the urethral Gram stain smear. However, most of these studies did not use state-of-the-art flow cytometers, did not calibrate Gram stain to flow cytometric results directly, and did not diagnose the sensitivity/specificity of this approach for detection of a broad section of urethral STI. The investigators hypothesize that the state-of-the-art flow cytometer analyzer, Sysmex UF-5000, may be able to similarly provide a non-invasive and cost-effective approach for urethritis diagnosis in men using first-catch urine when compared to Gram stain and urinalysis. A prior version, the Sysmex UF-1000i, has been shown to be promising in detection of urinary tract infections, but has not yet been studied in STIs. The UF-5000 could be a powerful screening approach for urethral STI that could be employed in a broad range of clinical settings, not just specialized STI clinics. Separately, if urine flow cytometry could be optimized to yield similar sensitivity to the Gram stain smear, the investigators suspect this approach would rapidly replace the Gram stain smear in clinical practice which in turn would improve patient capture and retention.
The investigators will recruit healthy men aged 18 to 50 who, after consenting to participate, will be assigned to start collecting a urine specimen three times week (typically, Monday, Wednesday, and Friday) for two weeks.
The device used to collect urine will be either a Colli-Pee or a standard-of-care 60 ml sterile urine cup. 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.
- Being tested
- Colli-Pee, standard of care 60 mL urine cup, Urinalysis, Sysmex UP-5000
- Medical subject headings
- Urethritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colli-PeeDevice
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.
standard of care 60 mL urine cupDevice
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.
UrinalysisDiagnostic test
Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000Diagnostic test
Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Colli-Pee; Device: standard of care 60 mL urine cup; Diagnostic Test: Urinalysis; Diagnostic Test: Sysmex UP-5000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start9 Apr 2025
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UrethritisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Jordan, Indiana University
- Investigators
- Stephen J Jordan, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951009
- Sponsor's protocol ID
- 26774
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2025
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Information and specimens collected for this study may be used for other research studies or shared with other researchers who are conducting their own research studies. This may include sharing with researchers outside Indiana University and sharing with private companies. It may also include making the information available in public and private databases of research data so that other researchers can use the information to answer research questions. If study staff share information or specimens in this way, they will remove information that could identify the subject(s), such as name and contact information, before any information or specimens are shared. Due to privacy concerns, IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men
- ClinicalTrials.gov ID
- NCT06951009
- Acronym / sponsor ID
- 26774
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute urethritis (i.e., inflammation of the male urethra) affects millions of men within the United States annually. In young sexually active men, urethritis is most commonly caused by the sexually transmitted infections (STI) Neisseria gonorrhoeae (GC, causes gonorrhea) and Chlamydia trachomatis (CT, causes chlamydia), but can also be caused by a lengthening list of known and emerging pathogens that cause "nongonococcal urethritis" (NGU). STI management has proven challenging due to the prevalence of asymptomatic infections and because men often fail to seek STI care until they experience pronounced symptoms. However, even without urethral symptoms, most men with a urethral STI have measurable evidence of urethritis. Thus, a cheap, simple, and non-invasive point of care (POC) test (i.e., results available within 30 minutes) that accurately detects urethritis could be a game changer in STI management as asymptomatic infections could be detected and treated, potentially decreasing the risk of spreading STIs to sexual partners.
Currently, the only widely used POC test available for diagnosis of urethritis in men in the US is Gram stain microscopy of a urethral swab smear. This approach has been shown to be highly effective for identifying men who have urethritis and has 95% sensitivity for diagnosing GC in symptomatic men [4]. Although the urethral swab remains the gold standard test to diagnose urethritis at the POC, it is rarely used outside of specialized STI clinics given its many limitations, which include: (1) it often elicits severe pain, and in rare cases can permanently damage the urethra; (2) it requires specialized instrumentation (an inverted microscope with a 1000x objective) and Gram stain reagents; (3) it must also be administered and interpreted by trained personnel that have different inter-operator accuracy in reporting results, and (4) anxiety associated with this procedure is a common reason men cite for delaying STI care and failing to return for follow-up visits. In many other clinical settings, POC screening for STIs would be highly desirable, for example during annual wellness exams of high-risk male adolescents; screening with specific STI nucleic acid amplification tests (NAATs) is not cost-effective in low-risk populations and the urethral swab procedure is unacceptable in these populations. As an alternative approach, a few investigators have evaluated Leukocyte esterase (LE) testing as part of a routine urinalysis using first-catch urine to diagnose urethritis, but the low sensitivity and specificity of this approach has limited its use to resource-limited settings.
Flow cytometry is routinely used in clinical settings to identify populations of cells (e.g., neutrophils, red blood cells for whole blood counts) from blood and urine. Modern flow cytometers are highly automated, rapid, and inexpensive to run, which makes them an optimal assay for screening for urethritis by detecting elevated neutrophils in asymptomatic men. Interestingly, several recent publications have shown that flow cytometric analysis of urine can be used to diagnose urethritis with comparable sensitivity and specificity to the urethral Gram stain smear. However, most of these studies did not use state-of-the-art flow cytometers, did not calibrate Gram stain to flow cytometric results directly, and did not diagnose the sensitivity/specificity of this approach for detection of a broad section of urethral STI. The investigators hypothesize that the state-of-the-art flow cytometer analyzer, Sysmex UF-5000, may be able to similarly provide a non-invasive and cost-effective approach for urethritis diagnosis in men using first-catch urine when compared to Gram stain and urinalysis. A prior version, the Sysmex UF-1000i, has been shown to be promising in detection of urinary tract infections, but has not yet been studied in STIs. The UF-5000 could be a powerful screening approach for urethral STI that could be employed in a broad range of clinical settings, not just specialized STI clinics. Separately, if urine flow cytometry could be optimized to yield similar sensitivity to the Gram stain smear, the investigators suspect this approach would rapidly replace the Gram stain smear in clinical practice which in turn would improve patient capture and retention.
The investigators will recruit healthy men aged 18 to 50 who, after consenting to participate, will be assigned to start collecting a urine specimen three times week (typically, Monday, Wednesday, and Friday) for two weeks.
The device used to collect urine will be either a Colli-Pee or a standard-of-care 60 ml sterile urine cup. 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Colli-Pee collection followed by standard-of-care urine collection cup | Active comparator | Device: Colli-Pee, Device: standard of care 60 mL urine cup, Diagnostic Test: Urinalysis, Diagnostic Test: Sysmex UP-5000Participants 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. |
| Standard-of-care urine collection followed by Colli-Pee collection | Active comparator | Device: Colli-Pee, Device: standard of care 60 mL urine cup, Diagnostic Test: Urinalysis, Diagnostic Test: Sysmex UP-5000Participants 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 may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men aged 18 to 50.
- No urethral symptoms (discharge, dysuria)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colli-PeeThe 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 | 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 cupParticipants 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. | Device | Colli-Pee collection followed by standard-of-care urine collection cup, Standard-of-care urine collection followed by Colli-Pee collection |
| UrinalysisParticipant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE). | Diagnostic test | Colli-Pee collection followed by standard-of-care urine collection cup, Standard-of-care urine collection followed by Colli-Pee collection |
| Sysmex UP-5000Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter. | Diagnostic test | Colli-Pee collection followed by standard-of-care urine collection cup, Standard-of-care urine collection followed by Colli-Pee collection |
Primary outcome
Median Urinary White Blood Cell Count (WBCs/uL) by Collection Device (Urine Cup vs Colli-Pee)
Time frame: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2
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.
Proportion of Urine Samples Positive for Leukocyte Esterase (≥1+) by Collection Device (Urine Cup vs Colli-Pee)
Time frame: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2
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.
Within-Subject Coefficient of Variation of Urinary White Blood Cell Counts by Collection Device
Time frame: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2
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.
Proportion of Urine Samples Positive for Leukocyte Esterase (≥1+) by Time Point and Collection Device
Time frame: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2
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.
Detection of White Blood Cells Over Time
Time frame: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2
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.
Detection of Leukocyte Esterase (LE) Over Time
Time frame: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Information and specimens collected for this study may be used for other research studies or shared with other researchers who are conducting their own research studies. This may include sharing with researchers outside Indiana University and sharing with private companies. It may also include making the information available in public and private databases of research data so that other researchers can use the information to answer research questions. If study staff share information or specimens in this way, they will remove information that could identify the subject(s), such as name and contact information, before any information or specimens are shared. Due to privacy concerns, IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Jordan, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colli-Pee, Urinalysis and Sysmex UP-5000 in people with Urethritis and Healthy Men Age 18-50 With no Urethral Symptoms, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Urinary White Blood Cell Count (WBCs/uL) by Collection Device (Urine Cup vs Colli-Pee) (time frame: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.