MP53-19\u2003A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL (RCT) REGARDING ANTIMICROBIAL PROPHYLAXIS IN TRANSURETHRAL RESECTION OF THE PROSTATE (TURP): AN INTERIM ANALYSIS OF THE PROPHYLAXIS001-TRIAL

Abstract

INTRODUCTION AND OBJECTIVES: Microbial resistance is an increasing problem in healthcare and antibiotic use should be minimized whenever possible. The guidelines recommend antimicrobial prophylaxis (AMP) in TURP but are mainly based on dated literature. Our study was set up to investigate the current value of AMP in a prospective, multi-centered randomized controlled-trial (RCT). METHODS: After approval by the ethical committee (B243201733480) a prospective RCT was initiated in 5 hospitals starting from 17 September 2017 to compare AMP vs control in TURP. A power analysis was performed (alpha 0.05 and power 80%) and an inclusion of 556 patients is scheduled in a 1:1 randomization. Exclusion criteria for the study are a pre-operative catheter or pre-operative pyuria > 100 white blood-cells/µL (WBC). Primary endpoint are uncomplicated (< 38.5°C) or complicated (>38.5°C or urosepsis) post-operative urinary tract infection (UTI). Secondary endpoints are post-operative bacteriuria (>105 micro-organisms) at time of hospital discharge and after 4 weeks at the follow-up consultation. RESULTS: 304 patients are already included since 17 September 2017. Mean pre-op age was 69.8, mean PSA 5 ng/mL and mean prostate volume 55 g. 24/304 (8.2%) Patients have DM-2, 44/304 (14.5%) had a pre-operative cystoscopy and 21/304 (6.5%) urodynamics. Mean operating time 48.9 minutes for a mean resected prostate volume of 26.4 g. Pathology showed active prostatitis in 22/304 (7.2%), chronic prostatitis in 15/304 (4.9%), malignancy in 53/304 (17.4%) and benign prostate hyperplasia in 233/304 (76.7%) patients. Mean catheter time was 2.2d and mean hospitalization stay 2.4d. 14/304 (4.6%) Patients had a post-operative UTI. Logistic regression could not show a significant difference in favor of AMP (4.3% vs. 4.7% ; p 0.9) in developing UTI in general or complicated UTI (2.2% vs. 3.4% ; p 0.52). A statistical, non-significant decrease in bacteriuria at time of hospital discharge (5.2% vs. 12.5% ; p 0.57) or at the follow-up consultation (6.3% vs. 15% ; p 0.4) was observed. CONCLUSIONS: Our preliminary results shows no significant difference in post-operative UTI in favor of AMP in TURP, meaning we can safely continue our study. A slight but statistical not-significant decrease in post-operative bacteriuria at time of hospital discharge and at the follow-up consultation after 4 weeks is observed. Further data collecting and analysis is needed to confirm our preliminary findings. Source of Funding: none