Efficacy of antibiotic prophylaxis in patients undergoing cystoscopy: a randomized clinical trial
Abstract
OBJECTIVE: To establish the efficacy of antibiotic prophylaxis prior to cystoscopy in outpatients in decreasing the incidence of post-procedure urinary tract infection.
STUDY DESIGN AND SETTING: A randomized clinical trial in patients (men and women) older than 18 who underwent cystoscopy for any non-urgent indication. The intervention was Levofloxacin 500 mg single dose, and the control was placebo 500 mg single dose made with similar characteristics. The primary outcome was urinary tract infection (UTI) measured 3-10 days after the procedure. It was performed as per protocol analysis.
RESULTS: Hundred and thirty-eight patients in each study arm completed the trial. The incidence of UTI in the intervention group was 0.7% and in the placebo group was 3% (p = 0.17), and no significant differences were found. The incidence of asymptomatic bacteriuria in the intervention group was 5.8% and in the control group was 14.5% (p = 0.01).
CONCLUSIONS: No significant differences were found in the use of prophylactic antibiotic compared to placebo to reduce the incidence of UTI in patients who undergo cystoscopy as an outpatient procedure with sterile urine demonstrated by urine culture.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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