Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients

The Cleveland Clinic52 enrolled

Overview

The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Catheter-Associated Urinary Tract Infection

Interventions

BactrimDRUG

Bactrim DS BID for 3 days

PlaceboOTHER

Corn starch capsules

Eligibility

Sex: FEMALEMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Requires catheterization \>24h hours following incontinence or pelvic reconstructive surgery Exclusion Criteria: * Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization * Allergy to sulfonamides or trimethoprim * Non-English speaking * Pregnancy * Breast feeding * Severe renal impairment (creatinine clearance \<30) * Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Number of Participants With Urinary Tract Infection

Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as \>100,000 colony forming units/mL

Time frame: 7 days following catheter removal

Data from ClinicalTrials.gov

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