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Preventing Urinary Tract Infection Post-Surgery (PUPS)

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cranberry powder capsules
Placebo powder capsules
Sponsored by
Betsy Foxman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection focused on measuring cystitis, pyelonephritis, bladder infection, kidney infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urogynecology Clinic; University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cranberry powder capsules

Placebo capsules

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2011
Last Updated
May 26, 2015
Sponsor
Betsy Foxman
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01346774
Brief Title
Preventing Urinary Tract Infection Post-Surgery
Acronym
PUPS
Official Title
Phase II Efficacy of Cranberry Powder in Preventing Catheter-associated Urinary Tract Infection Post Elective Gynecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Betsy Foxman
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
cystitis, pyelonephritis, bladder infection, kidney infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cranberry powder capsules
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Cranberry powder capsules
Other Intervention Name(s)
TheraCran
Intervention Description
2 cranberry powder capsules twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo powder capsules
Intervention Description
2 placebo capsules twice a day
Primary Outcome Measure Information:
Title
Participants With Clinically-diagnosed and Treated UTI's.
Description
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.
Time Frame
From surgery to post-op visit, approximately 6 weeks post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting at the gynecology clinic for a pre-operatory visit Ability to give informed consent Willing to take cranberry capsules for up to 6 weeks 18 of age or older Exclusion Criteria: Pregnancy History of nephrolithiasis History of allergy to cranberry Patient on anticoagulant medicine to be re-started during the 4-6 weeks after surgery Less than 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betsy Foxman, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urogynecology Clinic; University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25882919
Citation
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.
Results Reference
result
PubMed Identifier
31540834
Citation
Manohar J, Hatt S, DeMarzo BB, Blostein F, Cronenwett AEW, Wu J, Lee KH, Foxman B. Profiles of the bacterial community in short-term indwelling urinary catheters by duration of catheterization and subsequent urinary tract infection. Am J Infect Control. 2020 Feb;48(2):178-183. doi: 10.1016/j.ajic.2019.08.005. Epub 2019 Sep 17.
Results Reference
derived

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Preventing Urinary Tract Infection Post-Surgery

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