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Completed

NCT Number: NCT04055675

Urinalysis Results in Healthy Individuals

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kendall Regional Medical Center

Miami, Florida, 33175, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine dipstick test

Diagnostic Test

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

Primary outcomes

  1. False Positive Urine

    Time frame: 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 outcomes

  1. Incidental Hematuria

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Kendall Healthcare Group, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 14, 2019
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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