Relevance of the Urine Bacterial Culture Performed Before TransUrethral Resection of the Bladder for Post-operative Febrile Urinary Tract Infections Prevention: a Non-inferiority Randomized Controlled Trial

Transurethral resection of the bladder (TURB) is a routinely performed surgery in urology (65,000/y in France). Its primary indication is the management of bladder cancer for diagnostic, prognostic, and therapeutic purposes. Currently, both French and European guidelines recommend screening for asymptomatic bacteriuria (ABU) using a urine culture (UC) before TURB. If the UC is positive, antibiotic treatment must be initiated 48 hours before surgery and continued for a maximum of 7 days after the procedure. Theoretically, the purpose of preoperative ABU screening before TURB is to reduce the rate of post-operative urinary tract infections (UTIs). However, there is currently a lack of high-level studies justifying this approach, despite its being a recommended practice. The literature estimates the rate of post-TURB UTIs to be between 2% and 3.7%. In a recent French multicentre retrospective study, the rate of postoperative febrile UTI was 2.3%. This study did not find a significant association between positive pre-operative UC and a post-operative febrile UTI. Moreover, these post-TURB infections are generally of moderate severity (Grade 2 of Clavien-Dindo classification) and do not progress to sepsis. The rate of severe infections is estimated between 0.3% and 0.74%, and no study has yet demonstrated the link between the presence of a positive preoperative UC and an increased risk of postoperative infection. The causality between preoperative UC and postoperative UTIs remains unestablished. According to the TOCUS study, approximately one-third of patients exhibit ABU before undergoing urological surgery, translating to approximately 20,000 patients annually in France. Despite the relatively low rate of post-TURB UTIs and their mild severity, guidelines mandate antibiotic treatment for these patients. Antibiotic resistance is now a daily concern for clinicians and countries alike. A prominent 2014 WHO report emphasized the consequences of antibiotic resistance, including its impact on morbidity, mortality, and societal costs. The risk of entering a post-antibiotic era by 2050 could become a reality if strong measures are not taken immediately. Therefore, we propose a non- inferiority randomized controlled trial to investigate the impact of not performing pre-operative UC before TURB on the incidence of post-TURB febrile UTIs.

• Proportion of patients with postponed TURB surgery [Time frame: Between the pre-operative consultation and date of TURB surgery, up to 60 days]
• Time to surgery (in days), defined by the number of days between the pre-operative consultation and the date of TURB surgery [Time frame: Between the pre-operative consultation and the date of TURB surgery, up to 60 days]
• The hospital length of stay [Time frame: Between TURB surgery and day 30 after TURB surgery]
• Proportion of patients with hospital readmission or postoperative complications [Time frame: Within 30 days following the TURB surgery]
• Proportion of patients with hospital readmission linked to the urinary surgical procedure [Time frame: Within 30 days following the TURB surgery]
• Proportion of patients with systemic UTI among patients with hospital readmission [Time frame: Within 30 days following the TURB surgery]
• Proportion of patients with pre-operative antibiotic prescription for preoperative colonization before the TURB surgery [Time frame: Between Visit 0 (pre-operative consultation) and Visit 1(TURB surgery)]
• Proportion of patients with post-operative antibiotic prescription [Time frame: Within 30 days following the TURB surgery]
• Time to post-TURB infection diagnosis [Time frame: Between the TURB surgery and the infection diagnosis date (truncated at day 30)]
• Overall survival time [Time frame: Between TURB surgery and the date of death (censored at day 30)]