Trial Outcomes & Findings for Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men (NCT NCT06951009)
NCT ID: NCT06951009
Last Updated: 2026-08-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2
Results posted on
2026-08-17
Participant Flow
Participant milestones
| Measure |
Colli-Pee Collection Followed by Standard-of-care Urine Collection Cup
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
Standard-of-care Urine Collection Followed by Colli-Pee Collection
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men
Baseline characteristics by cohort
| Measure |
Colli-Pee Collection Followed by Standard-of-care Urine Collection Cup
n=9 Participants
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
Standard-of-care Urine Collection Followed by Colli-Pee Collection
n=11 Participants
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=51 Participants
|
11 Participants
n=51 Participants
|
20 Participants
n=102 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=51 Participants
|
11 Participants
n=51 Participants
|
20 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
3 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=51 Participants
|
10 Participants
n=51 Participants
|
17 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=102 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=51 Participants
|
7 Participants
n=51 Participants
|
14 Participants
n=102 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=51 Participants
|
2 Participants
n=51 Participants
|
3 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
PRIMARY outcome
Timeframe: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2Urinary 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.
Outcome measures
| Measure |
Urine Cup Collection of Urine
n=60 urine samples
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
Colli-Pee Collection of Urine
n=60 urine samples
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
|---|---|---|
|
Median Urinary White Blood Cell Count (WBCs/uL) by Collection Device (Urine Cup vs Colli-Pee)
|
1.800 WBCs/ul urine
Interval 0.858 to 3.55
|
3.950 WBCs/ul urine
Interval 2.117 to 7.45
|
PRIMARY outcome
Timeframe: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2Urinary 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.
Outcome measures
| Measure |
Urine Cup Collection of Urine
n=60 urine samples
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
Colli-Pee Collection of Urine
n=60 urine samples
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
|---|---|---|
|
Proportion of Urine Samples Positive for Leukocyte Esterase (≥1+) by Collection Device (Urine Cup vs Colli-Pee)
|
0 urine samples
|
0 urine samples
|
PRIMARY outcome
Timeframe: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2Participants 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.
Outcome measures
| Measure |
Urine Cup Collection of Urine
n=60 urine samples
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
Colli-Pee Collection of Urine
n=60 urine samples
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
|---|---|---|
|
Within-Subject Coefficient of Variation of Urinary White Blood Cell Counts by Collection Device
|
28.4 Coefficient of variation
Interval 24.2 to 51.0
|
38.4 Coefficient of variation
Interval 23.4 to 53.8
|
PRIMARY outcome
Timeframe: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2Urinary 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.
Outcome measures
| Measure |
Urine Cup Collection of Urine
n=60 urine samples
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
Colli-Pee Collection of Urine
n=60 urine samples
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.
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.
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.
Urinalysis: Participant samples will be analyzed by urinalysis to evaluate for leukocyte esterase (LE).
Sysmex UP-5000: Participant samples will be analyzed by the Sysmex UP-5000 to evaluate for white blood cells (WBCs) per microliter.
|
|---|---|---|
|
Proportion of Urine Samples Positive for Leukocyte Esterase (≥1+) by Time Point and Collection Device
Time point 1
|
0 urine samples
|
0 urine samples
|
|
Proportion of Urine Samples Positive for Leukocyte Esterase (≥1+) by Time Point and Collection Device
Time point 2
|
0 urine samples
|
0 urine samples
|
|
Proportion of Urine Samples Positive for Leukocyte Esterase (≥1+) by Time Point and Collection Device
Time point 3
|
0 urine samples
|
0 urine samples
|
PRIMARY outcome
Timeframe: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2Population: No participants were analyzed for this outcome. Prior to implementation of the planned serial time-course assessment, a limited feasibility evaluation indicated that urinary WBC concentrations were insufficient for meaningful evaluation of WBC stability over time. Consequently, the serial measurement protocol was not implemented in the study population, no outcome-specific dataset was generated, and no participants underwent the planned 0-, 1-, 2-, 4-, and 8-hour assessment.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Monday, Wednesday, and Friday during Week 1 and Monday, Wednesday, and Friday during Week 2Population: This outcome was not analyzed because leukocyte esterase was negative in all samples, and the planned serial measurements at 0, 1, 2, 4, and 8 hours were not conducted
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.
Outcome measures
Outcome data not reported
Adverse Events
Urine Cup Collection of Urine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colli-Pee Collection of Urine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place