Single-dose/day versus extended antibiotic prophylaxis for elective urological surgery: a prospective randomized controlled trial

Background Excess and prolonged antibiotic use for perioperative prophylaxis is a very common clinical practice. This overuse is largely driven by ingrained protocols rooted in fear of postoperative infection, despite limited evidence supporting extended prophylaxis. The objective was to evaluate whether extending antibiotic prophylaxis beyond the immediate perioperative period provides additional protection against postoperative symptomatic urinary tract infection (UTI) in patients undergoing elective urological surgery. Methods This open-label, randomized controlled trial included patients scheduled for elective urological surgery from March 2024 to September 2025. The patients were randomized 1:1 to either single-dose or extended perioperative prophylaxis. The primary endpoint was symptomatic urinary tract infection (sUTI) within 30 days of surgery. Secondary endpoints included one-week sUTI rate, asymptomatic bacteriuria at 7 and 30 days, 30-day hospital readmission, antibiotic escalation, length of stay and subgroup analyses by age, co-morbidity, surgical approach, and procedure type. The trial was prospectively registered with the Clinical Trials Registry of India (CTRI/2024/03/063953). Findings A total of 334 patients completed follow-up and were included in the analysis (single-dose group: n=169; extended-prophylaxis group: n=165). The 30-day sUTI rate was 7.1% (12/169) in single versus 5.5% (9/165) in extended prophylaxis groups (Absolute risk difference 1.6%, 95% CI: −3.6% to 6.8%; p=0.536). All secondary outcome parameters were comparable between the groups with no statistically significant difference. No patient in either group developed septic shock or infection-related mortality. Interpretation As a test of difference, without implying equivalence or non-inferiority, there was no statistically significant difference in postoperative symptomatic UTI incidence between single-dose and extended antibiotic prophylaxis for elective urological surgery. Funding None.