Antimicrobial Prophylaxis in Transurethral Resection of the Prostate: Results of a Randomized Trial

Abstract

Purpose: To determine whether omitting antimicrobial prophylaxis (AMP) in TURP is safe in patients undergoing TURP without pre-operative pyuria and a pre-operative catheter. Materials and Methods: A multi-centered randomized controlled trial (RCT) from 17-09-2017 until 31-12-2019 in 5 hospitals. Patients with pyuria (>100 white blood cells (WBC)/mL)) and a pre-operative, indwelling catheter were excluded. Post-operative fever was defined as a body temperature ≥ 38.3°C. A non-inferiority design with a 6% noninferiority margin and null hypothesis (H0) that the infection risk is at least 6% higher in the experimental (E) than in the control (C) group; H0: C (AMP-group) − E (no AMP-group) ≥ Δ (6% noninferiority margin). A multivariable, logistic regression was performed regarding post-TURP fever and AMP with co-variates: (clot-)retention and operating time. The R Project® for statistical computing was used and a p value of 0.05 was considered as statistically significant. Results: 474 Patients were included for multivariable analysis and 211/474 (44.5%) received AMP vs 263/474 (55.5%) patients without AMP. Antibiotics were fluoroquinolones in 140/211 (66.4%), cephazolin in 58/211 (27.5%) and amikacin in 13/211 (6.2%) patients. Fever occurred in 9/211 (4.4%) patients with AMP vs 13/263 (4.9%) without AMP (p 0.8, risk difference (RD) 0.006 (95% CI [-0.003; 0.06], relative risk (RR) 1.16)). We were able to exclude a meaningful increase in harm associated with omitting AMP (p 0.4; Adjusted RD 0.016 (95% CI [-0.02, 0.05])). Conclusions: Our data demonstrate the safety of omitting AMP in patients undergoing TURP without pre-operative pyuria and a pre-operative, indwelling catheter.