Urinalysis Results in Healthy Individuals

NCT ID: NCT04055675

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2020-01-02

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.

Conditions

Asymptomatic Bacteriuria; Asymptomatic Pyuria

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Urine dipstick test

Intervention Type: DIAGNOSTIC_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.

Urine dipstick test

Intervention Type: DIAGNOSTIC_TEST

A sample of urine will be tested using a Mission Urinalysis Reagent Strip.

Interventions

Urine dipstick test

A sample of urine will be tested using a Mission Urinalysis Reagent Strip.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kendall Healthcare Group, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tony Zitek, MD

Role: STUDY_DIRECTOR

Nova Southeastern University

Locations

Kendall Regional Medical Center

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11018165 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4866351 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10951726 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25841289 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-356 Non-NSU Health

Identifier Type: -

Identifier Source: org_study_id