Prulifloxacin vs Phosphomycin: Prophylaxis in patients with recurrent UTI. Preliminary results of a randomized multi-centre study

Introduction & Objectives To compare the efficacy of Prulifloxacin vs. Phosphomycin in reducing the number of urinary tract infection (UTI) episodes during and after prophylaxis. Material & Methods From January 2009 to July 2010, 115 consecutive patients were enrolled in this randomized multi-centre trial. Inclusion criteria were female gender, age over 18 years, no allergies or counter-indications to the drugs to be prescribed, urine culture responsiveness to drugs at patient recruitment, history of UTI with at least three episodes in the previous year or two in the past six months. Exclusion criteria were pregnancy and lack of tolerability of prescribed drugs. Patients with recurrent UTI who were referred to our outpatient clinics, were prospectively randomised by a computer generated sequence to Prulifloxacin (1 tablet/week for 12 weeks – group A) and Phosphomycin (1 cachet/week for 12 weeks – group B). Follow-up: Check-ups were scheduled at the following time-points: 2 weeks, 1 and 3 months from the beginning of the study and 3, 6, and 12 months after suspension of therapy. Primary outcome was negative urine culture. X2 , Friedman and Mann-Whitney tests were applied for data analysis. Results 86/115 (74.78%) patients with a minimum follow-up of 12 months were included in this analysis: 41 patients in group A and 45 in group B. During follow-up 7/41 patients (group A) and 4/45 (group B) were lost. Table 1 summarizes the study results. The frequency of UTIs was reduced significantly (p<0.0001) in patients who received 3-months antibiotic prophylaxis. When the Prulifloxacin and Phosphomycin prophylactic schedules were compared no significant differences were found in efficacy i.e. reduction of the number of urinary tract infection episodes during and after prophylaxis, in adverse effects or in specific drug resistance after therapy. Conclusions We found that both drugs provided an adequate prophylactic regimen in patients with recurrent UTI. The patient satisfaction with both of them was very high, but no difference in efficacy was recorded between them.