OBJECTIVE: To assess the efficacy and safety of a new medical device (MD; a capsule whose main component is a cross-linked protein) in the prevention of uncomplicated cystitis recurrences. METHODS:Adult women with acute cystitis symptoms and a ciprofloxacin-susceptible isolate in urine culture were included in a randomized, double-blind clinical trial. Patients were treated with ciprofloxacin 500 mg/day and 1 capsule/day or matched placebo for 5 days, 1 capsule/day or placebo for 15 additional days, and 2 additional cycles of 1 capsule/day or placebo for 15 days on months 1 and 2 after initial treatment. RESULTS:No recurrence was observed after the first month of follow-up in the MD-treated group. In addition, symptomatic recurrence was reduced by 19.4% compared with placebo after 6 months. CONCLUSIONS: The new MD can help prevent the recurrence of uncomplicated cystitis as well as help to reduce antibiotic use in management of urinary tract infection in women.
RCT Entities:
OBJECTIVE: To assess the efficacy and safety of a new medical device (MD; a capsule whose main component is a cross-linked protein) in the prevention of uncomplicated cystitis recurrences. METHODS: Adult women with acute cystitis symptoms and a ciprofloxacin-susceptible isolate in urine culture were included in a randomized, double-blind clinical trial. Patients were treated with ciprofloxacin 500 mg/day and 1 capsule/day or matched placebo for 5 days, 1 capsule/day or placebo for 15 additional days, and 2 additional cycles of 1 capsule/day or placebo for 15 days on months 1 and 2 after initial treatment. RESULTS: No recurrence was observed after the first month of follow-up in the MD-treated group. In addition, symptomatic recurrence was reduced by 19.4% compared with placebo after 6 months. CONCLUSIONS: The new MD can help prevent the recurrence of uncomplicated cystitis as well as help to reduce antibiotic use in management of urinary tract infection in women.