An observational study in Asymptomatic Bacteriuria and Asymptomatic Pyuria, sponsored by Kendall Healthcare Group, Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-18.
Sponsored by Kendall Healthcare Group, Ltd. · Observational
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
Browse Bacteriuria studies →Kendall Healthcare Group, Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects are all healthy volunteers, who are primarily family, friends, or acquaintances of study investigators.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.
Diagnostic Test: Urine dipstick test
These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are female.
Diagnostic Test: Urine dipstick test
A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
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.
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.
| Milestone | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers |
|---|---|---|
| Started | 96 | 104 |
| Completed | 96 | 104 |
| Not completed | 0 | 0 |
A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a "false positive urine".
| Participants | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers |
|---|---|---|
| False Positive Urine | 6 | 40 |
A urine sample with any blood on urine dipstick test will be considered to have "incidental hematuria"
Results for this outcome have not been posted.
Collected over During urine specimen collection and survey completion (about 5 minutes). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asymptomatic Male Volunteers | 0/96 (0%) | 0/96 (0%) | 0/96 (0%) |
| Asymptomatic Female Volunteers | 0/104 (0%) | 0/104 (0%) | 0/104 (0%) |
| Age, Continuous(years) | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | Total |
|---|---|---|---|
| Mean | 46.2 ± 21.7 | 53.7 ± 23.6 | 50.1 ± 23.0 |
| Sex: Female, Male(Participants) | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | Total |
|---|---|---|---|
| Female | 0 | 104 | 104 |
| Male | 96 | 0 | 96 |
| Race (NIH/OMB)(Participants) | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 86 | 96 | 182 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | Total |
|---|---|---|---|
| United States | 96 | 104 | 200 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2019 to primary completion in Dec 2019, 5 months.
Results were first posted in Jun 2020, 5 months after primary completion.
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Kendall Healthcare Group, Ltd.