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Urinalysis Results in Healthy Individuals

The Frequency of Leukocytes and Nitrites in the Urine of Healthy Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04055675
Enrollment
200
Registered
2019-08-14
Start date
2019-07-03
Completion date
2020-01-02
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Bacteriuria, Asymptomatic Pyuria

Brief summary

This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals.

Detailed description

The urinalysis (UA) is one of the most commonly utilized tests in the emergency department (ED). In some busy EDs, a UA is routinely ordered by protocol on patients with abdominal pain, and in elderly patients, a UA is often ordered for a variety of chief complaints including dizziness and altered mental status. When these patients, who often do not specifically have symptoms of a urinary tract infection, have a urinalysis demonstrating pyuria or bacteria, it may be interpreted as an atypical presentation of a UTI. However, it is possible that these patients do not have urinary tract infections, but have baseline pyuria or bacteriuria. One prior study found that 5% of sexually active healthy women 18-40 have asymptomatic bacteriuria \[1\], and the rate of asymptomatic bacteriuria increases with age, such that it is present in 8-10% of women from 70-80 years of age \[2\]. Moreover, one prior article stated that 30-50% of residents of long term nursing facilities have positive urine cultures at any given time \[3\]. The above statistics come from the results of urine cultures. In the ED, the decision to treat or not treat a patient for a UTI is not made based upon culture results, but upon a urinalysis (microscopic or dipstick). Only one prior study has looked at the frequency of abnormal urinalyses in healthy individuals, and it found that over a third of asymptomatic women had at least 1+ leukocytes in their urine \[4\]. This is evidence that a substantial number of people who do not have symptomatic UTIs have UAs that could be interpreted as UTIs. If these results could be replicated and expanded to include a wider group of individuals (males, elderly patients, various races, etc.), it would provide valuable information about how we can better interpret and utilize the results of a UA. Thus, the investigators propose a prospective study to assess the frequency of abnormal UAs in a wide variety of individuals without acute symptoms. Urine samples will be obtained from adults with no acute symptoms, and performed urine dipsticks to assess the frequency of leukocytes or nitrites in the urine. Patients will be divided into groups to determine if there are certain factors (gender, age, or medical history) that increase the chance of having leukocytes or nitrites in the urine.

Interventions

DIAGNOSTIC_TESTUrine dipstick test

A sample of urine will be tested using a Mission Urinalysis Reagent Strip.

Sponsors

Kendall Healthcare Group, Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \> 18 years * Able to spontaneously provide a urine sample

Exclusion criteria

* Any acute symptoms (including but not limited to vaginal bleeding, vaginal discharge, abdominal pain, back pain, dysuria, hematuria, and fever) * Pregnancy * Prisoner status * Antibiotics within 72 hours * Urologic procedure within a week

Design outcomes

Primary

MeasureTime frameDescription
False Positive UrineThe urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a false positive urine.

Secondary

MeasureTime frameDescription
Incidental HematuriaThe urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.A urine sample with any blood on urine dipstick test will be considered to have incidental hematuria

Countries

United States

Participant flow

Participants by arm

ArmCount
Asymptomatic Male Volunteers
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male. Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
96
Asymptomatic Female Volunteers
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female. Urine dipstick test: A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
104
Total200

Baseline characteristics

CharacteristicAsymptomatic Male VolunteersTotalAsymptomatic Female Volunteers
Age, Continuous46.2 years
STANDARD_DEVIATION 21.7
50.1 years
STANDARD_DEVIATION 23
53.7 years
STANDARD_DEVIATION 23.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants10 Participants4 Participants
Race (NIH/OMB)
Black or African American
4 Participants8 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
86 Participants182 Participants96 Participants
Region of Enrollment
United States
96 participants200 participants104 participants
Sex: Female, Male
Female
0 Participants104 Participants104 Participants
Sex: Female, Male
Male
96 Participants96 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 960 / 104
other
Total, other adverse events
0 / 960 / 104
serious
Total, serious adverse events
0 / 960 / 104

Outcome results

Primary

False Positive Urine

A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a false positive urine.

Time frame: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Asymptomatic Male VolunteersFalse Positive Urine6 Participants
Asymptomatic Female VolunteersFalse Positive Urine40 Participants
Secondary

Incidental Hematuria

A urine sample with any blood on urine dipstick test will be considered to have incidental hematuria

Time frame: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026