Preventing Urinary Tract Infection Post-Surgery

Study Overview
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Brief Summary
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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 powder capsules or placebo powder capsules. 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.

Detailed Description
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Cranberry products prevent bacteria that cause UTI, especially Escherichia coli, from adhering to bladder cell wall thus preventing infection. Adherence of type 1 pili is inhibited by the fructose and of p pili by the proanthocyanidins present in cranberry.

Official Title
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Phase II Efficacy of Cranberry Powder in Preventing Catheter-associated Urinary Tract Infection Post Elective Gynecological Surgery

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: Cranberry powder capsules
* Drug: Placebo powder capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting at the gynecology clinic for a pre-operatory visit Ability to give informed consent Willing to take cranberry capsules for up to 6 weeks 18 of age or older Exclusion Criteria: Pregnancy History of nephrolithiasis History of allergy to cranberry Patient on anticoagulant medicine to be re-started during the 4-6 weeks after surgery Less than 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cranberry powder capsules<br>TheraCran® cranberry: based upon proanthocyanidin content, the four cranberry capsules are equivalent to two 8-ounce servings of cranberry juice. Participants were directed to take two capsules by mouth twice each day (once in the morning and once in the evening) starting at time of discharge for 4-6 weeks, or until their return for their post-operative doctor's visit. Participants were instructed to drink an 8 oz glass of water while taking the capsule with or without food. | Drug: Cranberry powder capsules<br>* 2 cranberry powder capsules twice a day<br>* Other names: TheraCran;|
| Placebo Comparator: Placebo capsules<br>Placebo: participants were directed to take two capsules by mouth twice each day (once in the morning and once in the evening) starting at time of discharge for 4-6 weeks, or until their return for their post-operative doctor's visit. Participants were instructed to drink an 8 oz glass of water while taking the capsule with or without food. | Drug: Placebo powder capsules<br>* 2 placebo capsules twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Clinically-diagnosed and Treated UTI's. | The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records. | From surgery to post-op visit, approximately 6 weeks post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystitis, pyelonephritis, bladder infection, kidney infection