The CARE-UTI Study (The Urinary Track Infections study)
a multinational e-mail/web-based study
Copyright ©2002, CARE-UTI

For women, much is known about the risk factors, presentation, and treatment of urinary tract infections. While men get urinary tract symptoms also, the state of knowledge is much less about their risk factors and clinical presentation. Unfortunately, much of the clinical examination is not efficient at identifying which women have urinary tract infection. The baseline prevalence of asymptomatic bacteriuria is so high among women, that the clinical examination is not particularly useful for stratifying patients into those more or less likely to have a culture-proven urinary tract infection. This information may not generalize at all to men.

Among men with an array of symptoms that prompt consideration of a urinary tract infection (non-chlamydial), what are the risk factors, symptoms, and examination findings that make a culture-proven infection more, or less, likely.

• Investigators will be invited to join using the Internet
• Investigators can be from primary, secondary or tertiary care settings
• The Internet will be used to enroll in the study and to complete data collection
• Each investigator group will have responsibility for obtaining local ethics approval and proof of this must be forwarded to the study-coordinating Centre on request
• A dipstick urinalysis (that includes the presence of nitrates and leukocyte esterase) and routine urine cultures should be sent on every patient enrolled in the study (because of the expense, chlamydial cultures will not be requested)
• Each investigator should enroll at least 6 patients
• A second investigator will not repeat the clinical examination to avoid multiple rectal examinations
• Clinical exam may be done before or after the urinalysis, but the examiner should be unaware of the results

Patients must be men who have:

• Discomfort on urination
• Difficulty urinating
• Chills or fever (with no obvious extra-urinary tract source)
• Age >= 70 with new (<4weeks) confusion/altered mental status
• Investigators can be from primary, secondary or tertiary care settings
• The Internet will be used to enroll in the study and to complete data collection

Exclusion criteria:

• Indwelling urinary catheter
• Antibiotics within the past week

See attached data collection sheet

Urinalysis (must use method that assays for nitrates and leukocyte esterase). Investigators should submit the name of their laboratory's dipstick brand to the Coordinating Centre.

Urine culture for bacteria. Chlamydia cultures will not be performed.

Sensitivity, specificity, and LRs for each of the findings will be assessed. A multivariate analysis will also be done to look for combinations of findings that might be useful. If a model is found, bootstrap regression to assess the confidence limits of the model will be assessed.

Enrollment to continue until we have enrolled 100 patients with UTI or at least 1 year.

• First analyses and drafts will be sent to participating investigators
• After the investigators are satisfied with the manuscript and the analysis, it will be submitted to a journal by mutual agreement with the authors and will include a line stating "On behalf of the Mens' Urinary Tract Infection study group"
• All investigators and methodologist will be included and will be listed in descending order by the number of patients they enroll.

Submitted by Ken Goldberg and David Simel, Durham, NC USA

* Any comments or concerns about this protocol, please email carestudy@rogers.com.