Clinical Outcomes of Single-Dose Flomoxef Prophylaxis for Transrectal Prostate Biopsy: A Single-Center Study of 834 Cases.

OBJECTIVES: Prostate biopsy remains essential for the diagnosis of prostate cancer. Although the transperineal approach is increasingly favored, transrectal prostate biopsy (TRPB) continues to be performed in many institutions. In our institution, single-dose flomoxef (FMOX) was introduced as a prophylactic antibiotic in response to increasing resistance to levofloxacin (LVFX). This study evaluated the effectiveness and microbiological validity of FMOX using real-world clinical data. METHODS: This retrospective single-center study included 834 patients who underwent TRPB under single-dose intravenous FMOX (1 g) between 2015 and 2024. The clinical outcomes were acute prostatitis and sepsis within 4 weeks after biopsy. Post-biopsy bacteriuria was evaluated as an exploratory microbiological outcome. Pathogen distribution was described among patients with identified organisms, and factors associated with post-biopsy bacteriuria were evaluated using univariable analysis and multivariable logistic regressions. RESULTS: Among 834 patients, prostatitis occurred in 0.5% of patients; no cases of sepsis were observed. Post-biopsy bacteriuria was observed in 6.5% of patients. Among 31 cases with identified pathogens, Enterococcus faecalis was the most common (54.8%), whereas Escherichia coli accounted for 12.9% of cases. Multivariable analysis identified prostate volume, International Prostate Symptom Score, and constipation as independent risk factors for post-biopsy bacteriuria. CONCLUSIONS: Single-dose FMOX prophylaxis was associated with low rates of acute prostatitis and no cases of sepsis after TRPB. However, the absence of a comparator group and limitations in bacteriuria and culture assessment preclude definitive conclusions regarding its efficacy or microbiological impact. Further prospective comparative studies are needed to clarify the role of FMOX in TRPB prophylaxis.