Preventing Urinary Tract Infection Post-Surgery (PUPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Betsy Foxman, University of Michigan
ClinicalTrials.gov Identifier:
NCT01346774
First received: April 29, 2011
Last updated: November 15, 2013
Last verified: November 2013

April 29, 2011
November 15, 2013
June 2011
May 2013   (final data collection date for primary outcome measure)
urinary tract infection [ Time Frame: within first 6 weeks post surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01346774 on ClinicalTrials.gov Archive Site
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Preventing Urinary Tract Infection Post-Surgery
Phase II Efficacy of Cranberry Powder in Preventing Catheter-associated Urinary Tract Infection Post Elective Gynecological Surgery

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 capsules or placebo. 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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Urinary Tract Infection
Drug: Cranberry powder
2 cranberry powder capsules twice a day
Other Name: TheraCran
  • Experimental: Cranberry capsules
    Intervention: Drug: Cranberry powder
  • Placebo Comparator: Placebo
    Intervention: Drug: Cranberry powder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2013
May 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01346774
R21DK085290
Yes
Betsy Foxman, University of Michigan
University of Michigan
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University of Michigan
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP