Urinalysis Results in Healthy Individuals
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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"
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kendall Regional Medical Center | Miami | Florida | United States | 33175 |
Sponsors and Collaborators
- Kendall Healthcare Group, Ltd.
Investigators
- Study Director: Tony Zitek, MD, Nova Southeastern University
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- Nicolle LE. Asymptomatic bacteriuria in institutionalized elderly people: evidence and practice. CMAJ. 2000 Aug 8;163(3):285-6.
- 2019-356 Non-NSU Health
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers |
|---|---|---|
| Arm/Group Description | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. |
| Period Title: Overall Study | ||
| STARTED | 96 | 104 |
| COMPLETED | 96 | 104 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | Total |
|---|---|---|---|
| Arm/Group Description | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. | Total of all reporting groups |
| Overall Participants | 96 | 104 | 200 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
46.2
(21.7)
|
53.7
(23.6)
|
50.1
(23.0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
104
100%
|
104
52%
|
| Male |
96
100%
|
0
0%
|
96
48%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
6
6.3%
|
4
3.8%
|
10
5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
4
4.2%
|
4
3.8%
|
8
4%
|
| White |
86
89.6%
|
96
92.3%
|
182
91%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
96
100%
|
104
100%
|
200
100%
|
Outcome Measures
| Title | False Positive Urine |
|---|---|
| Description | A urine sample with at least 1+ leukocytes or positive nitrites on urine dipstick test will be considered a "false positive urine". |
| Time Frame | The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers |
|---|---|---|
| Arm/Group Description | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. |
| Measure Participants | 96 | 104 |
| Count of Participants [Participants] |
6
6.3%
|
40
38.5%
|
| Title | Incidental Hematuria |
|---|---|
| Description | A urine sample with any blood on urine dipstick test will be considered to have "incidental hematuria" |
| Time Frame | The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | During urine specimen collection and survey completion (about 5 minutes) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | No adverse events were expected given the nature of the study. | |||
| Arm/Group Title | Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | ||
| Arm/Group Description | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. | ||
All Cause Mortality |
||||
| Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/96 (0%) | 0/104 (0%) | ||
Serious Adverse Events |
||||
| Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/96 (0%) | 0/104 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Asymptomatic Male Volunteers | Asymptomatic Female Volunteers | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/96 (0%) | 0/104 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Tony Zitek |
|---|---|
| Organization | Kendall Regional Medical Center |
| Phone | 305-480-6602 |
| zitek10@gmail.com |
- 2019-356 Non-NSU Health