Prophylactic chemotherapy with fosfomycin trometamol during transurethral surgery and urological manoeuvres. Results of a multicentre study.

The aim of the present open prospective study is to evaluate the efficacy and safety profile of fosfomycin trometamol in the chemoprophylaxis of urinary tract infections following transurethral diagnostic and/or therapeutic manoeuvres. 712 patients were enrolled in 72 urological surgical centres. All the enrolled patients received an initial dose of fosfomycin trometamol (Monuril sachet containing 3 g of active drug in powder) 3 h before and a second dose 24 h after the transurethral manoeuvres. Clinical and microbiological examinations were carried out before the intervention, and then on the second and seventh days after the manoeuvres. 94 patients with positive baseline tests were excluded from the microbiological follow-up for non-compliance with the main inclusion criteria. Out of 618 patients with sterile urine or with bacteriuria less than 10(5) ml on baseline screening, 20 (3.2%) developed UTI on the second day and 22 (3.6%) on the seventh day after treatment. Clinical follow-up is in agreement with these microbiological data. Overall, a total of 24 side effects were observed (3.3%), 16 of which were associated with Monuril treatment. The results of this open study agree with the preliminary observations in the controlled studies.