Urinalysis Results in Healthy Individuals

Completed

Conditions: Asymptomatic Pyuria
Asymptomatic Bacteriuria

Interventions: Diagnostic Test: Urine dipstick test

Registration Number: NCT04055675

Lead Sponsor: Kendall Healthcare Group, Ltd.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asymptomatic Female Volunteers	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.
Asymptomatic Male Volunteers	Urine dipstick test	These are subjects over the age of 18 who have no acute symptoms, volunteered to provide a urine sample, and are male.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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"