Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial

The Cleveland Clinic1 site in 1 country52 target enrollmentApril 2010

ConditionsCatheter-Associated Urinary Tract Infection

InterventionsBactrim Placebo

DrugsBactrim

Overview

Phase: Not Applicable
Intervention: Bactrim
Conditions: Catheter-Associated Urinary Tract Infection
Sponsor: The Cleveland Clinic
Enrollment: 52
Locations: 1
Primary Endpoint: Number of Participants With Urinary Tract Infection
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

August 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The Cleveland Clinic

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Drug

Intervention: Bactrim

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants With Urinary Tract Infection

Time Frame: 7 days following catheter removal

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