A double-blind, randomized, placebo-controlled, multicenter trial to evaluate the efficacy and safety of systemic enzyme therapy as part of comprehensive treatment in patients with exacerbation of chronic recurrent cystitis. Preliminary results

BACKGROUND: According to the current classification of urinary tract infections, recurrent chronic cystitis may be categorized as either uncomplicated or complicated lower urinary tract infection and is characterized by at least two exacerbations within six months or three exacerbations within one year. In the new classification proposed by the European Association of Urology in 2025, recurrent cystitis is defined as a localized urinary tract infection with or without risk factors and without signs or symptoms of a systemic inflammatory response. Given the lack of consensus in the scientific data on the treatment and prevention of recurrent urinary tract infections, we conducted a phase IV clinical trial using combination therapy for uncomplicated recurrent cystitis without risk factors.

AIM: The work aimed to evaluate the efficacy and safety of Wobenzym compared with placebo as part of combination therapy in patients with exacerbation of chronic recurrent uncomplicated cystitis.

METHODS: The study enrolled 638 female patients aged 20–49 years with chronic uncomplicated recurrent cystitis without risk factors, who were randomized into two groups: 320 women in group I (Wobenzym), and 318 women in group II (placebo). Comparative analysis showed no statistically significant differences between the groups (p > 0.05). Treatment lasted 12 weeks, with 5 tablets of the study drug or placebo taken 3 times daily, at least 30 minutes before or 2 hours after meals, swallowed whole with 200 mL of water. Concomitant therapy included fosfomycin trometamol 3 g (granules) for 2 days in accordance with the drug’s prescribing information. To assess efficacy and safety, each patient was scheduled for 7 visits over 219 days.

RESULTS: In the study drug group, recurrent exacerbation of chronic recurrent uncomplicated cystitis occurred in 12.50% of patients (95% CI 9.32–16.57), compared with 24.53% in the placebo group (95% CI 20.12–29.54), p = 0.00014. Among patients with recurrence of the infectious-inflammatory process, 29 adverse events of only mild severity were recorded: 4 in the Wobenzym group and 25 in the placebo group.

CONCLUSION: Wobenzym is a safe and effective component of combination therapy for urinary tract infection, which significantly reduces the recurrence rate.