Urinalysis Results in Healthy Individuals

Asymptomatic Bacteriuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055675
• Other study ID #: 2019-356 Non-NSU Health
• Status: Completed
• Start date: July 3, 2019
• Est. completion date: January 2, 2020

Study information

• Verified date: June 2020
• Source: Kendall Healthcare Group, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Asymptomatic Bacteriuria
• Asymptomatic Pyuria
• Bacteriuria

Intervention

Diagnostic Test:
• Urine dipstick test
A sample of urine will be tested using a Mission Urinalysis Reagent Strip.

Locations

Country	Name	City	State
United States	Kendall Regional Medical Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kendall Healthcare Group, Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Nicolle LE. Asymptomatic bacteriuria in institutionalized elderly people: evidence and practice. CMAJ. 2000 Aug 8;163(3):285-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.