Preventing Urinary Tract Infection Post-Surgery

Urinary Tract Infection Clinical Trial

— PUPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346774
• Other study ID #: R21DK085290
• Secondary ID: HUM00041108R21DK
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2011
• Last updated: May 26, 2015
• Start date: June 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Cranberry powder capsules
2 cranberry powder capsules twice a day
• Placebo powder capsules
2 placebo capsules twice a day

Locations

Country	Name	City	State
United States	Urogynecology Clinic; University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Betsy Foxman	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Foxman B, Cronenwett AE, Spino C, Berger MB, Morgan DM. Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial. Am J Obstet Gynecol. 2015 Aug;213(2):194.e1-8. doi: 10.1016/j.ajog.2015.04.003. Epub 2015 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No