Do Cranberry Juice Capsules Reduce the Risk of Urinary Tract Infections in Patients With Indwelling Urinary Catheters Following Urogynecologic Surgery?
Conditions: Urinary Tract Infections
Sponsor: TriHealth Inc.

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RESEARCH PROTOCOL 
 
Date 
11-04-16 
Title 
Do cranberry juice capsules reduce the risk of urinary tract infections 
in patients with indwelling urinary catheters following 
urogynecologic surgery? 
Principal Investigator 
Rachel N. Pauls, MD 
Sub-Investigators 
Abigail Shatkin-Margolis, MD; Jenna Warehime, MD; Steven D. 
Kleeman, MD; Catrina C. Crisp, MD, MSc; Jennifer Yeung, DO; 
Benjamin Smith, MD 
Research Specialist 
Eunsun Yook, MS 
Department 
Department of OB/Gyn, Division of Urogynecology and 
Reconstructive Pelvic Surgery 
Hatton # 
16-087 
 
 
Purpose of Study 
• The incidence of urinary tract infection (UTI) in women undergoing pelvic floor 
gynecologic surgery is high, ranging from 10-64% (Falagas, Athanasiou, Iavazzo, 
Tokas, & Antsaklis, 2008). A recent randomized trial showed that cranberry juice 
capsules significantly reduced the incidence of UTI in patients undergoing elective 
gynecologic surgery (19% vs 38%; odds ratio 0.38 with confidence interval 0.19-0.79) 
(Foxman, Cronenwett, Spino, Berger, & Morgan, 2015).   
• Cincinnati Urogynecology Associates, TriHealth Inc incorporated this clinical regimen 
into their standard practice in early 2016. Currently, all patients who undergo pelvic 
floor gynecologic surgery and are discharged from the hospital with an indwelling 
urinary catheter postoperatively are prescribed cranberry juice capsules to reduce 
the risk of UTI.  
• The purpose of this study is to determine if the addition of cranberry juice capsules 
to our discharge medication regimen for patients discharged home with an 
indwelling urinary catheter following pelvic floor gynecology surgery reduced the 
incidence of UTI. 
o Primary Aim:  To determine the incidence of UTI in patients who were 
discharged home with an indwelling urinary catheter following pelvic floor 
gynecologic surgery in those who were prescribed cranberry juice capsules 
compared to those who were not. 
o Secondary Aim:  To determine potential risk factors for postoperative UTI, other 
than urinary catheter use, such as certain demographic and perioperative factors 
including the following:  
▪ Age, race, BMI, tobacco use, medical comorbidities, type of surgery 
performed, type of anesthesia, intraoperative intravenous fluid 
administration, estimated blood loss, and duration of catheter use. 
 

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Hypothesis or Research Question  
• We hypothesize that the addition of cranberry juice capsules reduced the incidence 
of UTI in patients discharged home with an indwelling urinary catheter following 
pelvic floor gynecologic surgery, compared to patients that had similar treatment 
without cranberry capsules.   
• We further hypothesize that the addition of cranberry juice capsules reduced the 
duration of catheter use for those patients requiring postoperative catheterization 
following pelvic floor gynecologic surgery. 
 
Background  
Urinary tract infections (UTI) continue to be one of the most common healthcare-associated 
infections encountered today (Magill et al., 2012). The majority of these healthcare-associated 
UTIs are attributed to the use of urinary catheters (Hooton et al., 2010). Unfortunately, urinary 
catheter use is often unavoidable—as in the setting of postoperative urinary retention (POUR). 
Generally speaking, POUR can be characterized by any impairment in bladder emptying 
following surgery (Geller, 2014). Previous research has illustrated that POUR is a particularly 
common issue following urogynecologic surgery, with incidence rates of 1.4-43% (Dorflinger & 
Monga, 2001; Hakvoort, Elberink, Vollebregt, Ploeg, & Emanuel, 2004; Partoll, 2002). This 
means that a substantial number of patients will be discharged from the hospital with urinary 
catheters, putting them at substantially increased risk of developing a postoperative UTI. From 
an internal review of previously completed studies, approximately 54% and 25% of patients are 
discharged with a catheter following pelvic reconstructive surgery and suburethral sling 
procedures, respectively (Crisp et al., 2016). 
 
The incidence of UTI has been estimated to be 3-4% per year for women in the general 
population (Foxman, 2014). However, for women undergoing urogynecologic surgery, the 
incidence of UTI is significantly greater, ranging from 10-64% (Falagas et al., 2008). As alluded to 
above, this increased incidence is likely related to postoperative urinary catheter use. Other risk 
factors for postoperative UTI have been postulated including age, menopausal status, history of 
recurrent UTIs, duration of catheter use, and increased distance between the urethra and anus 
(Foxman et al., 2015; Sutkin et al., 2010).  
 
Previously, there has been much focus on the use of antibiotics to reduce the incidence of UTI 
in patients with indwelling urinary catheters. According to the most recent Cochrane Review, 
there remains limited evidence to indicate that receiving prophylactic antibiotics reduces the 
rate of bacteriuria and other signs of infection in surgical patients who undergo bladder 
drainage for greater than 24 hours postoperatively (Lusardi, Lipp, & Shaw, 2013). More 
recently, the focus of UTI prevention has turned to cranberry capsules.  
 
Cranberry products are a potential nonantimicrobial method for UTI prevention, as cranberry 
proanthocyanidins have been shown to inhibit the adherence of P-fimbriated Escherichia coli to 
uroepithelial cells (Howell, Vorsa, Der Marderosian, & Foo, 1998). Because E coli is the culprit 
behind most UTIs, cranberry products remain an appealing UTI prevention strategy. However, 

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the evidence continues to be conflicting (Jepson, Williams, & Craig, 2012; Juthani-Mehta et al., 
2016).  
 
A recent randomized trial published in a high-impact journal showed that cranberry juice 
capsules significantly reduced the incidence of UTI in patients undergoing elective gynecologic 
surgery (19% vs 38%; odds ratio 0.38 with confidence interval 0.19-0.79) (Foxman et al., 2015). 
As a result of this new data, Cincinnati Urogynecology Associates, TriHealth Inc incorporated 
cranberry capsules into their standard practice as of March 2016. This change was made in an 
effort to reduce the incidence of UTI in patients requiring urinary catheterization following 
urogynecologic surgery. Currently, all patients who undergo urogynecologic surgery and are 
discharged from the hospital with an indwelling urinary catheter postoperatively are prescribed 
cranberry juice capsules, in addition to the standard discharge medication regimen.  
 
However, the use of cranberry capsules has not been consistently shown to improve these 
outcomes in other subgroups of patients at risk (Juthani-Mehta et al., 2016).  Furthermore, 
compliance and actual use of the capsules is uncertain, since patients may elect not to fill the 
prescription or fail to take the medication appropriately.   
 
We aim to determine if the addition of cranberry juice capsules to the discharge medication 
regimen for patients discharged home with an indwelling urinary catheter following pelvic floor 
gynecology surgery significantly reduced the incidence of UTI, compared to a separate cohort 
that did not have cranberry prescribed. Given recent publications, our hypothesis is that the 
addition of cranberry juice capsules did reduce the risk of UTI. If we determine that cranberry 
capsules did in fact reduce the incidence of UTI in our study population, we can feel confident 
in continuing to incorporate this prevention method in our standard practice.  
 
 
Research Plan 
• Study Design  
o Retrospective chart review 
 
• Setting for the study 
o The retrospective chart review will be performed on TriHealth EPIC platform at 
one of the various clinical locations.  
 
• Participants 
o Study population:  All women 18 years of age or older, who underwent pelvic 
floor gynecologic surgery (for the indication of pelvic organ prolapse or stress 
urinary incontinence) performed by a physician at Cincinnati Urogynecology 
Associates, TriHealth Inc between April 2015 and September 2015, and April 
2016 and September 2016, who required indwelling urinary catheter use upon 
discharge from the hospital. 
o A chart review will be performed on all patients who underwent pelvic floor 
gynecologic surgery performed by a physician at Cincinnati Urogynecology 

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Associates, TriHealth Inc between April 2015 and September 2015, and April 
2016 and September 2016 to determine which patients required discharge with 
an indwelling urinary catheter. 
o The charts of those patients who required catheterization postoperatively will be 
reviewed further and will make up our study population of interest. 
o Inclusion criteria 
▪ Adults 18 years of age or older 
▪ Underwent pelvic floor gynecologic surgery (for the indication of pelvic 
organ prolapse or stress urinary incontinence) performed by a physician 
at Cincinnati Urogynecology Associates, TriHealth Inc between April 2015 
and September 2015, and April 2016 and September 2016 
▪ Required indwelling urinary catheterization upon discharge from the 
hospital postoperatively 
o Exclusion criteria 
▪ Intraoperative bladder injury, fistula repair, urethral diverticulectomy, or 
any other need for prolonged catheterization 
▪ Complications in the 2 weeks following surgery requiring reoperation and 
subsequent catheter use 
▪ Allergy to cranberry or its components 
▪ Failure to present for both the two-week and six-week postoperative 
office visit 
o Sample size 
▪ Cranberry juice capsules were incorporated into the standard practice of 
Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016. 
We plan to review six months of data from similar time frames of 2015 
and 2016. This will allow us to capture a similar number of patients in the 
exposure (cranberry juice capsules, 2016) and no exposure (no cranberry 
juice capsules, 2015) groups. 
▪ Given the fact that Cincinnati Urogynecology Associates, TriHealth Inc 
typically performs 400 surgeries annually, we estimate that reviewing a 
total of 12 months of data will result in accessing approximately 400 
charts. 
 
• Data Collection 
o Independent variables:  cranberry juice capsules prescribed as part of discharge 
medication regimen 
o Dependent variables:  UTI as defined by documentation of positive urine culture 
or treatment by an involved provider, with documentation in the Epic chart 
within 6 weeks postoperative. 
o Each chart will be reviewed and the following data will be collected or 
extrapolated: 
▪ General demographic data – Name, date of birth, age, race, weight, 
height, BMI, parity, tobacco use, medical comorbidities, date of surgery, 
surgery performed,  date of discharge, intraoperative and postoperative 

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complications, type of anesthesia, intraoperative intravenous fluid 
administration, estimated blood loss, discharge medications, 
postoperative urine cultures, prescribed UTI treatment, duration of 
catheter use, and any postoperative complications or readmissions 
(fever, ileus, hematoma, transfusion) 
 
• Intervention or experimental aspect of the study 
o No intervention will occur as part of this study.  
o There are no potential risks to the study population by any aspect of the study. 
 
• Statistical Analysis 
o The primary outcome is the incidence of UTI in patients who were discharged 
home with an indwelling urinary catheter after pelvic floor gynecologic surgery. 
To compare the primary outcome between two groups with/without cranberry 
capsules, the odds ratio and corresponding confidence interval will be utilized. 
Descriptive statistics will be generated for demographic information such as age, 
race, BMI, Parity etc. The independent samples t-tests or Mann-Whitney U test 
will be employed for continuous variables and the Fisher’s exact or Pearson Chi-
square tests for categorical variables to test any significant difference between 
two groups. Logistic regression will be implemented to determine potential risk 
factors for postoperative UTI.  
 
Ethical Considerations 
• Informed consent  
o Since this is a retrospective study, waivers of Informed consent and 
Authorization will  be requested. 
• Privacy information 
o Extensive efforts will be made to ensure and maintain participant 
confidentiality. All identifying information will be maintained in a secure area 
at all times. All communication between staff members regarding participant 
data will occur via the Subject ID number only. However, identifying 
information will be retained in the original/source documents. 
o The Excel spreadsheet will be stored on a password protected, encrypted 
TriHealth computer for ten years following study closure, and then purged. 
 
Cost/Budget 
• This study will incur no cost to the institution, the participants, or the investigators. 
 
Estimated Period of Time to Complete Study 

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When will study begin? 
January 2017 
Protocol Development 
Completed 
2 weeks 
Admin Review Time 
2 weeks 
IRB Approval 
3 weeks 
Data collection 
4 weeks 
Data analysis 
2 weeks 
Presentation development 
(if applicable) 
2 weeks 
Manuscript Development 
(if applicable) 
4 weeks 
Journal submission process 
(if applicable) 
4 weeks 
Study closure 
2 weeks 
 
• When and how will results be disseminated? 
o The results will be disseminated by way of an oral or poster presentation at a 
national meeting, and with publication in a high-impact journal. 
 
 
 
References 
 
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