Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients
Not Applicable
Terminated
- Conditions
- Catheter-Associated Urinary Tract Infection
- Interventions
- Other: Placebo
- Registration Number
- NCT01108757
- Lead Sponsor
- The Cleveland Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 52
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Drug Bactrim -
- Primary Outcome Measures
Name Time Method Number of Participants With Urinary Tract Infection 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States