The potential for enhancing the efficacy of treatment for exacerbations of chronic recurrent uncomplicated cystitis in women: preliminary results from a randomized multicenter clinical trial

BACKGROUND: Chronic recurrent cystitis is a significant problem for women, affecting both patients and healthcare providers due to the challenges in its treatment. This condition crucially reduces the quality of life for patients, causing physical and emotional distress, while leading to decreased social and sexual functioning, self-esteem, and work capacity. It is worth noting that the ineffectiveness of standard antibiotic regimens is frequently associated with antimicrobial resistance, contributing to recurrent infections. Currently, there is an ongoing global effort to develop alternative or adjuvant antibiotic treatments for this condition. AIM: The aim of this placebo-controlled study was to evaluate the efficacy and safety of using Wobenzym in combination with standard therapy in patients with acute exacerbations of chronic recurrent uncomplicated cystitis. METHODS: A double-blind randomized placebo-controlled multicenter clinical trial was conducted. All patients received standard therapy for exacerbations of chronic recurrent cystitis, which included 3 g fosfomycin orally for 2 days. As adjuvant therapy, the women received Wobenzym or placebo, 5 tablets 3 times daily for 12 weeks. Each patient was scheduled for 7 visits over a 219-day period. RESULTS: In total, 642 women aged 20–49 years underwent primary screening for exacerbation of chronic recurrent cystitis. Of these, 640 individuals were randomly assigned to two representative comparison groups: Wobenzym (n = 320) and placebo (n = 320). In the Wobenzym group, repeated exacerbations of chronic recurrent uncomplicated cystitis were observed in 12.50% (95% confidence interval 9.32–16.57) of patients compared to the placebo group, where 24.53% (95% confidence interval 20.12–29.54) of patients had exacerbations (p = 0.00014). Among patients with recurrent infectious inflammatory process, 29 mild adverse events were recorded: 4 in the Wobenzym group and 25 in the placebo group. CONCLUSION: Preliminary data obtained demonstrate the high efficacy and safety of oral enzyme combination therapy as an adjuvant treatment for chronic recurrent cystitis. Given the frequency of relapses, demographic significance of complications, and the specific course of infectious and inflammatory conditions, Wobenzym may become an important component in the treatment of genitourinary infections.