Clinical trial NCT01346774: Preventing Urinary Tract Infection Post-Surgery
Official title: Phase II Efficacy of Cranberry Powder in Preventing Catheter-associated Urinary Tract Infection Post Elective Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infection
Keywords: cystitis
pyelonephritis
bladder infection
kidney infection
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Michigan
First posted: 2011-05-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Participants With Clinically-diagnosed and Treated UTI's.
timeFrame: From surgery to post-op visit, approximately 6 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Urogynecology Clinic; University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Betsy Foxman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.