Evaluation of perioperative prophylaxis with fosfomycin tromethamine in ureteroscopic stone removal: an investigator-driven prospective, multicenter, randomized, controlled study.

PURPOSE: To compare efficacy, safety, and cost-effectiveness of fosfomycin tromethamine with other standard-of-care antibiotics in patients undergoing ureteroscopic lithotripsy. METHODS: This study was a prospective, multicenter, randomized, controlled trial. Eligible patients scheduled for ureteroscopic lithotripsy were randomly assigned to receive either fosfomycin (fosfomycin group, N = 101 patients) or standard-of-care antibiotic therapy as prophylaxis (control group, N = 115 patients). The incidence of infectious complications and adverse events was analyzed between the two groups, as well as the cost-benefit analysis. RESULTS: The incidence of infections following lithotripsy was 3.0% in the fosfomycin group and 6.1% in the control group (p > 0.05). Only asymptomatic bacteriuria was reported in fosfomycin group. In the control group was reported asymptomatic bacteriuria (3.5%), fever (0.9%), bacteremia (0.9%), and genitourinary infection (0.9%). The rate of adverse events was very low, with no adverse event reported in the fosfomycin group and only one in the control group (forearm phlebitis). The average cost per patient of antibiotic therapy with fosfomycin was 151.45 ± 8.62 yuan (22.7 ± 1.3 USD), significantly lower compared to the average cost per patient of antibiotics used in the control group 305.10 ± 245.95 yuan (45.7 ± 36.9 USD; p < 0.001). CONCLUSIONS: Two oral doses of 3 g fosfomycin tromethamine showed good efficacy and safety and low cost in perioperative prophylaxis of infections following ureteroscopic stone removal.

Systemic inflammatory response syndrome after percutaneous nephrolithotomy: an assessment of risk factors.

OBJECTIVES: To analyze the risk factors for systemic inflammatory response syndrome (SIRS) after percutaneous nephrolithotomy (PCNL) and to quantitatively predict the probability of SIRS after PCNL. METHODS: Medical records on 209 patients who underwent PCNL were retrospectively analyzed. The chi2 test, the t-test and a logistic regression model were used to identify key risk factors of SIRS after PCNL. A predictive equation was then formulated to assess the risk of SIRS according to the results from the logistic model. Subsequently, the accuracy of the equation by calculating sensitivity, specificity, overall correct percentage, and positive and negative predictive values was tested. RESULTS: The incidence of SIRS after PCNL was 23.4%. The key risk factors for SIRS following PCNL were: the number of tracts, receipt of a blood transfusion, stone size, and presence of pyelocaliectasis. Other factors added no independent risk to the development of SIRS. The calculated values for sensitivity, specificity, overall percentage correct, positive predictive value and negative predictive value were 44.9%, 95.0%, 83.3%, 73.3%, and 84.9%, respectively. CONCLUSIONS: Number of tracts, receipt of a blood transfusion, stone size and presence of pyelocaliectasis are identified as the key risk factors for SIRS after PCNL. The predictive equation allows for an individualized and quantitative assessment of the probability of SIRS after PCNL.