Background
An increase of infections after transrectal prostate biopsy (PB), related to an increasing number of patients with ciprofloxacin-resistant rectal flora, necessitates the exploration of alternatives for the traditionally standard used empirical prophylaxis with ciprofloxacin. We compared infectious complication rates after transrectal PB using empirical ciprofloxacin prophylaxis versus culture-based prophylaxis.
Methods
In this non-blinded, randomized trial, between April 4, 2018 to July 30, 2021, we enrolled 1538 patients from 11 Dutch hospitals undergoing transrectal PB. After rectal swab collection, patients were 1:1 randomized to receive empirical prophylaxis with oral ciprofloxacin (control group; CG), or culture-based prophylaxis (intervention group; IG). Primary outcome was any infectious complication within seven days post-biopsy. Secondary outcomes were infectious complications within 30 days, and bacteremia and bacteriuria within seven and 30 days post-biopsy. For primary outcome analysis, the Chi-square test stratified for hospital was used. Trial registration number: NCT03228108.
Results
Data from 1288 patients (83.7%) were available for analysis (CG: 652 and IG: 636). Infection rates within seven days post-biopsy were 4.3% (n = 28) (CG) and 2.5% (n = 16) (IG) (p-value: 0.08; reduction: -1.8%; 95% CI -0.004 to 0.040). Ciprofloxacin-resistant bacteria were detected in 15.2% (n = 1288). In the CG, the presence of ciprofloxacin-resistant rectal flora resulted in a 6.2 fold higher risk of early post-biopsy infection.
Conclusions
Our study supports the use of culture-based prophylaxis to reduce infectious complications after transrectal PB. Despite adequate prophylaxis, post-biopsy infections can still occur. Therefore, culture-based prophylaxis must be weighed against other strategies that could reduce post-biopsy infections.