Introduction and hypothesis: This multicentre, randomised, non-blinded, parallel group study is designed to assess the null hypothesis that a 3-month prophylactic schedule with fosfomycin is not inferior to prulifloxacin in reducing the number of urinary tract infection episodes during and after prophylaxis in female patients with recurrent urinary tract infections (rUTIs).
Methods: One hundred and fifty-two patients with rUTIs who were candidates for prophylaxis therapy were enrolled and randomised to prulifloxacin (group 1) or fosfomycin (group 2). The prophylaxis regimen included a single dose of fosfomycin (one 3-g cachet) per week, or a single dose (600 mg) of prulifloxacin (one tablet) a week for 12 weeks. The inclusion criteria were female patients over 18 years, urine culture responsiveness to drugs at patient recruitment and history of rUTI. Exclusion criteria were pregnancy and counter-indications to this drug therapy. Patients were prospectively randomised. Check-ups were scheduled at 2 weeks, 1 month and 3 months from the beginning of the study and 3, 6, and 12 months after suspension of the therapy. The primary end-points were the reduction of the number of UTIs (negative urine culture) during and after prophylaxis.
Results: Final data analysis included 67 patients in group 1 and 57 in group 2. Nine out of 76 patients (group 1) and 19 out of 76 (group 2) dropped out. UTI episodes were significantly reduced in number compared with before prophylaxis (p < 0.0001) at all study end-points in both groups. No significant differences were found in disease-free duration, as achieved by the two therapy groups (log-rank test; p = 0.41), in the reduction of UTI episodes during and after prophylaxis, in the adverse effects or improved quality of life.
Conclusions: Both drugs provided adequate prophylaxis in patients with rUTIs, with no difference in efficacy.