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NCT Number: NCT01346774

Preventing Urinary Tract Infection Post-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.

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Key information

Conditions

Urinary Tract Infection Cystitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pyelitis Pyelonephritis Urinary Bladder Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Urogynecology Clinic; University of Michigan

Ann Arbor, Michigan, 48103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry powder capsules

Drug

2 cranberry powder capsules twice a day

Other names: TheraCran

Placebo powder capsules

Drug

2 placebo capsules twice a day

Primary outcomes

  1. Participants With Clinically-diagnosed and Treated UTI's.

    Time frame: From surgery to post-op visit, approximately 6 weeks post surgery

    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.

Sponsors and collaborators

Lead sponsor

Betsy Foxman

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Michigan

Registry information

Official study title

Phase II Efficacy of Cranberry Powder in Preventing Catheter-associated Urinary Tract Infection Post Elective Gynecological Surgery

Acronym: PUPS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 3, 2011
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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