Infections of the genitourinary ract account for ~ 40% of all hospital- acquired infections;of these, 80% are related to urinary tract instrumentation and catheterization. Catheter associated urinary tract infection (CAUTI) is a common complication of patients undergoing gynecologic surgery, with 10-27% of gynecologic surgery patients developing a UTI in the post operatory period - despite prophylactic antibiotic therapy. Further, UTI pathogens are increasingly resistant to antibiotics. Most CAUTI prevention strategies have focused on modifying the catheter, improving hygiene associated with catheter insertion, and using prophylactic antibiotics. Cranberry products provide an alternative;they inhibit adherence of E. coli and other gram-negative bacteria to uroepithelial cells, (and likely of gram positive bacteria as well), and are known to reduce UTI incidence among non-catheterized populations. Thus, cranberry potentially provides alternative means for preventing CAUTI that also would reduce prophylactic and therapeutic antibiotic use. To date, the use of cranberry products for the prevention of UTI among catheterized post operator gynecological patients remains an unexplored potential intervention. We propose a randomized, double blind, placebo-controlled pilot clinical trial of 200 surgical gynecological patients. Our overall goal is to determine the effect of taking cranberry capsules on reducing the rate of post operatory CAUTI among surgical gynecological patients. This pilot study will have 2 arms: 1) Cranberry capsules equivalent to 8 oz of cranberry juice (CJ) twice a day 2) Placebo capsules twice a day. The results of this study will help us to increase our understanding the effect of cranberry on reducing the prevalence of post gynecologic surgery CAUTI, aiming for a large scale clinical trial in the future.

Public Health Relevance

Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (CAUTI) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery, Cranberry products, provide alternative means for preventing CAUTI and could result in decreased use of antimicrobials. In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to take either cranberry capsules or placebo. The low risk of harm associated with using cranberry to reduce UTI coupled with its potential benefit makes it a desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot /feasibility study will prepare us for the conduct of a large scale clinical trial.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21DK085290-01
Application #
7771620
Study Section
Special Emphasis Panel (ZRG1-DKUS-G (51))
Program Officer
Bavendam, Tamara G
Project Start
2010-09-01
Project End
2012-06-30
Budget Start
2010-09-01
Budget End
2011-06-30
Support Year
1
Fiscal Year
2010
Total Cost
$193,125
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Foxman, Betsy; Cronenwett, Anna E W; Spino, Cathie et al. (2015) Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial. Am J Obstet Gynecol 213:194.e1-8
Marschall, Jonas; Piccirillo, Marilyn L; Foxman, Betsy et al. (2013) Patient characteristics but not virulence factors discriminate between asymptomatic and symptomatic E. coli bacteriuria in the hospital. BMC Infect Dis 13:213
Foxman, Betsy; Buxton, Miatta (2013) Alternative approaches to conventional treatment of acute uncomplicated urinary tract infection in women. Curr Infect Dis Rep 15:124-9
Marschall, Jonas; Zhang, Lixin; Foxman, Betsy et al. (2012) Both host and pathogen factors predispose to Escherichia coli urinary-source bacteremia in hospitalized patients. Clin Infect Dis 54:1692-8