Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine dipstick test | Diagnostic Test | A sample of urine will be tested using a Mission Urinalysis Reagent Strip. |
|
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects are all healthy volunteers, who are primarily family, friends, or acquaintances of study investigators.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tony Zitek, MD | Nova Southeastern University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendall Regional Medical Center | Miami | Florida | 33175 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11018165 | Background | 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. | |
| 4866351 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. |
| FG001 | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. |
| BG001 | Asymptomatic Female Volunteers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Posted | Count of Participants | Participants | The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine. |
|
During urine specimen collection and survey completion (about 5 minutes)
No adverse events were expected given the nature of the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tony Zitek | Kendall Regional Medical Center | 305-480-6602 | zitek10@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2019 | Jun 1, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| 10951726 | Background | Nicolle LE. Asymptomatic bacteriuria in institutionalized elderly people: evidence and practice. CMAJ. 2000 Aug 8;163(3):285-6. No abstract available. |
| 25841289 | Background | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Incidental Hematuria | A urine sample with any blood on urine dipstick test will be considered to have "incidental hematuria" | Not Posted | The urine is tested immediately, and results are available two minutes after placing the reagent strip in the urine. | Participants |
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | 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: A sample of urine will be tested using a Mission Urinalysis Reagent Strip. | 0 | 104 | 0 | 104 | 0 | 104 |
Not provided
Not provided