Preventing Urinary Tract Infection Post-Surgery (PUPS)

Betsy Foxman

Status and phase: Completed; Phase 2

Conditions: Urinary Tract Infection

Treatments: Drug: Cranberry powder capsules; Drug: Placebo powder capsules

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01346774

R21DK085290 (U.S. NIH Grant/Contract)

HUM00041108 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Cranberry powder capsules

Experimental group

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.

Treatment:

Drug: Cranberry powder capsules

Placebo capsules

Placebo Comparator group

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.

Treatment:

Drug: Placebo powder capsules