Urinalysis Results in Healthy Individuals

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

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.

Study Overview

• Status: Completed
• Conditions: Asymptomatic Bacteriuria; Asymptomatic Pyuria
• Intervention / Treatment: Diagnostic test: Urine dipstick test

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33175
      • Kendall Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects are all healthy volunteers, who are primarily family, friends, or acquaintances of study investigators.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Urine dipstick test; A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
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.	Diagnostic test: Urine dipstick test; A sample of urine will be tested using a Mission Urinalysis Reagent Strip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidental Hematuria	A urine sample with any blood on urine dipstick test will be considered to have "incidental hematuria"	The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine.

Collaborators and Investigators

• Sponsor: Kendall Healthcare Group, Ltd.
• Investigators: Study Director: Tony Zitek, MD, Nova Southeastern University

Publications and helpful links

General Publications

• 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.
• 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.
• Nicolle LE. Asymptomatic bacteriuria in institutionalized elderly people: evidence and practice. CMAJ. 2000 Aug 8;163(3):285-6. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): January 2, 2020

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria
• Other Study ID Numbers: 2019-356 Non-NSU Health

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No