Preventing Urinary Tract Infection Post-Surgery

Phase 2

Completed

• Conditions: Urinary Tract Infection
• Interventions: Drug: Placebo powder capsules; Drug: Cranberry powder capsules

• Registration Number: NCT01346774
• Lead Sponsor: Betsy Foxman

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Study Start: 2011-06
• Primary Completion: 2013-05
• Study Completion: 2013-10
• Results First Submitted: 2015-04-28
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-26
• Last Update Submitted: 2015-05-26
• Results First Posted: 2015-06-10
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Presenting at the gynecology clinic for a pre-operatory visit
2. Ability to give informed consent
3. Willing to take cranberry capsules for up to 6 weeks
4. 18 of age or older

Exclusion Criteria

1. Pregnancy
2. History of nephrolithiasis
3. History of allergy to cranberry
4. Patient on anticoagulant medicine to be re-started during the 4-6 weeks after surgery
5. Less than 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo capsules	Placebo powder capsules	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.
Cranberry powder capsules	Cranberry powder capsules	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.

Primary Outcome Measures

Name	Time	Method
Participants With Clinically-diagnosed and Treated UTI's.	From surgery to post-op visit, approximately 6 weeks post surgery	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.

Trial Locations

Locations (1)

Urogynecology Clinic; University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States