Asymptomatic Bacteriuria, Asymptomatic Pyuria
Conditions
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
A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| False Positive Urine | The 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
| Measure | Time frame | Description |
|---|---|---|
| Incidental Hematuria | The 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
| Arm | Count |
|---|---|
| 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 |
| Total | 200 |
Baseline characteristics
| Characteristic | Asymptomatic Male Volunteers | Total | Asymptomatic Female Volunteers |
|---|---|---|---|
| Age, Continuous | 46.2 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 86 Participants | 182 Participants | 96 Participants |
| Region of Enrollment United States | 96 participants | 200 participants | 104 participants |
| Sex: Female, Male Female | 0 Participants | 104 Participants | 104 Participants |
| Sex: Female, Male Male | 96 Participants | 96 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 104 |
| other Total, other adverse events | 0 / 96 | 0 / 104 |
| serious Total, serious adverse events | 0 / 96 | 0 / 104 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asymptomatic Male Volunteers | False Positive Urine | 6 Participants |
| Asymptomatic Female Volunteers | False Positive Urine | 40 Participants |
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.