NCT01346774

Preventing Urinary Tract Infection Post-Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Betsy Foxman · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Cranberry powder capsules	2 cranberry powder capsules twice a day
DRUG	Placebo powder capsules	2 placebo capsules twice a day

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-05-01
• Completion: 2013-10-01
• First posted: 2011-05-03
• Last updated: 2015-06-10
• Results posted: 2015-06-10

Locations

1 site across 1 country: United States