A prospective observational comparative multicenter clinical study assessing the efficiency and safety of pidotimod for treatment and prevention of exacerbations of uncomplicated chronic recurrent cystitis in women

Rasner P.I., Shulzhenko A.E., Kotov S.V., Zheltikova E.A., Zuykova I.N., Shchubelko R.V., Pulbere S.A., Polovinko A.L.

1) Russian University of Medicine, Ministry of Health of the Russian Federation, Moscow, Russia; 2) Institute of Immunology, FMBA of Russia, Moscow, Russia; 3) Pirogov Russian National Research Medical University (Pirogov University), Ministry of Health of Russia, Moscow, Russia; 4) N.I. Pirogov City Clinical Hospital No. 1, Moscow Healthcare Department, Moscow, Russia; 5) I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia, Moscow, Russia

Introduction. Rising antimicrobial resistance combined with a high recurrence rate of chronic cystitis in women necessitates the search for additional non-antimicrobial approaches to treatment and prevention. Aim. To evaluate the efficiency and safety of pidotimod immunotherapy for treatment and prevention of exacerbations of uncomplicated chronic recurrent cystitis in women. Materials and methods. This prospective observational study was carried out in 2023–2024 at clinical centers in 21 cities across Russia. A total of 401 women with chronic recurrent cystitis during an exacerbation were enrolled and assigned to two groups. The study group (n=361) received standard antibacterial therapy combined with pidotimod 800 mg twice daily for 14 days, followed by maintenance pidotimod 800 mg once daily for 60 days. The control group (n=40) received antibacterial therapy only. The primary endpoint was the change in recurrence rate by month 6; secondary endpoints included time to first recurrence, changes in urinary immunological markers, and safety in the immunotherapy group. Results. Pidotimod significantly reduced the total number of chronic recurrent cystitis recurrences compared with the control group over 6 months of follow-up (p<0.0001). The recurrence-free interval was longer in the immunotherapy group (101.3 days vs 74.2 days; p=0.02). Normalization of the pro-/anti-inflammatory cytokine balance with increased urinary IFN-γ and sIgA suggests an immunomodulatory effect of pidotimod and activation of local immune response. Adverse events during pidotimod therapy were reported in 3.2% of cases and did not require treatment discontinuation. Conclusion. Adding pidotimod to standard antibacterial therapy in women with chronic recurrent cystitis reduces recurrence frequency, prolongs remission, and improves local immunological parameters, with a favorable safety profile.

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About the Authors

Corresponding author: Rasner Petr Ilyich – Ph.D., MD, Professor, Chief Physician, N.A. Semashko Clinical Center, Research and Education Institute of Clinical Medicine, Russian University of Medicine, Ministry of Health of the Russian Federation, Moscow, Russia; e-mail: dr.rasner@gmail.com

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