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[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)].
Аннотация на английскомСтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Pushkar D Yu, Bernikov A N, Shvedov A M, Dubov S V
Аннотация
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 (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 (-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.
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 (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 (-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.