Phase 2
N=160
Preventing Urinary Tract Infection Post-Surgery
Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01346774 ↗Enrolled (actual)
160
Serious AEs
5.0%
Results posted
Jun 2015
Primary outcome: Primary: Participants With Clinically-diagnosed and Treated UTI's. — 15; 30 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cranberry powder capsules (Drug); Placebo powder capsules (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Betsy Foxman
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Clinically-diagnosed and Treated UTI's. |
15; 30 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01346774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.