Preventing Urinary Tract Infection Post-Surgery

NCT01346774 | Completed Phase 2 Results DMC

• 2 other identifiers: R21DK085290HUM00041108
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

cystitis; pyelonephritis; bladder infection; kidney infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cranberry powder capsules

EXPERIMENTAL

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

Placebo capsules

PLACEBO COMPARATOR

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

Interventions

Cranberry powder capsules DRUG

2 cranberry powder capsules twice a day

Also known as: TheraCran

Cranberry powder capsules

Placebo powder capsules DRUG

2 placebo capsules twice a day

Placebo capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Betsy Foxman: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Michigan: collaborator

Study Sites (1)

Urogynecology Clinic; University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

Related Publications (4)

• 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.

  PMID: 25882919 RESULT

• Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

  PMID: 37947276 DERIVED

• Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

  PMID: 37068952 DERIVED

• 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.

  PMID: 31540834 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Cystitis; Pyelonephritis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Nephritis, Interstitial; Nephritis; Kidney Diseases; Pyelitis

Results Point of Contact

• Title: Betsy Foxman, Hunein F. and Hilda Maassab Professor of Epidemiology
• Organization: University of Michigan

bfoxman@umich.edu

734-764-5487

Study Officials

• Betsy Foxman, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hunein F & Hilda Maassab Professor of Epidemiology

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 3, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-05

Locations

US (1)