Clinical trial NCT04055675: Urinalysis Results in Healthy Individuals
Official title: The Frequency of Leukocytes and Nitrites in the Urine of Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asymptomatic Bacteriuria
Asymptomatic Pyuria
Lead sponsor: Kendall Healthcare Group, Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are all healthy volunteers, who are primarily family, friends, or acquaintances of study investigators.

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.

Eligibility criteria: 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

Primary outcomes:
measure: False Positive Urine
timeFrame: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.
Secondary outcomes:
measure: Incidental Hematuria
timeFrame: The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Tony Zitek, MD
role: STUDY_DIRECTOR
References:
citation: Hooton TM, Scholes D, Stapleton AE, Roberts PL, Winter C, Gupta K, Samadpour M, Stamm WE. A prospective study of asymptomatic bacteriuria in sexually active young women. N Engl J Med. 2000 Oct 5;343(14):992-7. doi: 10.1056/NEJM200010053431402.
citation: Kunin CM, McCormack RC. An epidemiologic study of bacteriuria and blood pressure among nuns and working women. N Engl J Med. 1968 Mar 21;278(12):635-42. doi: 10.1056/NEJM196803212781201. No abstract available.
citation: Nicolle LE. Asymptomatic bacteriuria in institutionalized elderly people: evidence and practice. CMAJ. 2000 Aug 8;163(3):285-6. No abstract available.
citation: Frazee BW, Enriquez K, Ng V, Alter H. Abnormal urinalysis results are common, regardless of specimen collection technique, in women without urinary tract infections. J Emerg Med. 2015 Jun;48(6):706-11. doi: 10.1016/j.jemermed.2015.02.020. Epub 2015 Apr 1.