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Preventing Urinary Tract Infection Post-Surgery (PUPS)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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

April 29, 2011
May 26, 2015
June 2011
May 2013   (final data collection date for primary outcome measure)
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.
urinary tract infection [ Time Frame: within first 6 weeks post surgery ] [ Designated as safety issue: No ]
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 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.
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.
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 capsules
    2 cranberry powder capsules twice a day
    Other Name: TheraCran
  • Drug: Placebo powder capsules
    2 placebo capsules twice a day
  • 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.

    Intervention: Drug: Cranberry powder capsules
  • 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.
    Intervention: Drug: Placebo powder capsules
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.

*   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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01346774
R21DK085290, HUM00041108, R21DK085290
Yes
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Betsy Foxman, University of Michigan
Betsy Foxman
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Michigan
Principal Investigator: Betsy Foxman, PhD University of Michigan
University of Michigan
May 2015

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