Evaluation of the efficiency of two-stage therapy with Vitaprost® (suppositories → tablets) in patients with chronic prostatitis and lower urinary tract symptoms after failure of previous therapy: results of a prospective non-interventional real-world study (LEVITATE)

Pushkar D.Yu., Bernikov A.N., Shvedov A.M., Dubov S.V.

1) Russian University of Medicine, Moscow, Russia; 2) S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, Moscow, Russia

Aim. To evaluate the clinical efficiency and safety of a two-stage treatment regimen with Vitaprost® (rectal suppositories followed by change to the tablet form) in patients with chronic prostatitis (CP) and lower urinary tract symptoms (LUTS) after failure of previous therapy in real-world clinical practice. Materials and methods. A prospective non-interventional study, LEVITATE (Long-term Evidence for VITAprost in Treatment of prostatE diseases), was carried out. The analysis included 30 men with CP and LUTS (mean age 36.1±4.6 years) after ineffective previous therapy. Patients received Vitaprost® suppositories for 30 days followed by 30 days of tablet therapy. Patients were also followed for 90 days. Assessments were performed at four visits using the NIH-CPSI, IPSS, and SF-36 questionnaires, transrectal ultrasound, and uroflowmetry. Statistical analysis was performed using the Friedman test. Results. The total NIH-CPSI score decreased from 12.8±1.3 to 8.6±0.9 (Δ−4.2; p<0.0001). Improvement in prostate structure on transrectal ultrasound was observed in most patients; the proportion of fibrotic changes decreased from 46.7% to 16.7%. Prostate size decreased from 26.1±8.4 to 24.1±6.8 mm (Δ-2,0; p<0.0001). Improvement in voiding parameters and quality of life was also noted. No adverse events were recorded. Conclusion. Two-stage therapy with Vitaprost® is effective in patients with CP and LUTS after failure of previous treatment, providing a significant reduction in symptoms, improvement in the morphological and functional state of the prostate and voiding parameters, with high adherence and a favorable safety profile.

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About the Authors

Corresponding author: A.N. Bernikov – Ph.D., Associate Professor of the Department of Urology, Russian University of Medicine; Urologist of the Highest Qualification Category; Oncologist, S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center; Moscow, Russia; e-mail: bernikov@mac.com

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