Preventing Urinary Tract Infection Post-Surgery (PUPS)

This study has been completed.
Sponsor:
Collaborators:
University of Michigan
Information provided by (Responsible Party):
Betsy Foxman, University of Michigan
ClinicalTrials.gov Identifier:
NCT01346774
First received: April 29, 2011
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Drug: Cranberry powder capsules
Drug: Placebo powder capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase II Efficacy of Cranberry Powder in Preventing Catheter-associated Urinary Tract Infection Post Elective Gynecological Surgery

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Participants With Clinically-diagnosed and Treated UTI's. [ Time Frame: From surgery to post-op visit, approximately 6 weeks post surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 200
Study Start Date: June 2011
Study Completion Date: October 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Cranberry powder capsules
2 cranberry powder capsules twice a day
Other Name: TheraCran
Placebo Comparator: Placebo 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.
Drug: Placebo powder capsules
2 placebo capsules twice a day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346774

Locations
United States, Michigan
Urogynecology Clinic; University of Michigan
Ann Arbor, Michigan, United States, 48103
Sponsors and Collaborators
Betsy Foxman
University of Michigan
Investigators
Principal Investigator: Betsy Foxman, PhD University of Michigan
  More Information

Publications:
Responsible Party: Betsy Foxman, Hunein F & Hilda Maassab Professor of Epidemiology, University of Michigan
ClinicalTrials.gov Identifier: NCT01346774     History of Changes
Other Study ID Numbers: R21DK085290, HUM00041108, R21DK085290
Study First Received: April 29, 2011
Results First Received: April 28, 2015
Last Updated: May 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
cystitis
pyelonephritis
bladder infection
kidney infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on August 02, 2015