Combination therapy for benign prostate hyperplasia-related urinary symptoms

Introduction. Non-neurogenic lower urinary tract symptoms (LUTS) are a serious polyetiologic problem in the male population. The side effects of the medication agents used to treat LUTS significantly reduce treatment compliance. According to the literature data, the frequency of refusal for the proposed treatment during the year varies from 20 to 80%. Several studies have shown the benefits of herbal medicine for LUTS concerning the fewer side effects and increased adherence to treatment. However, to obtain a high-level recommendation base, clinical trials are required.Purpose of the study. To evaluate the effectiveness of Gardaprost® in LUTS combination therapy.Materials and methods. The study included 57 men aged 60 – 70 years with diagnosed medium- or large-volume benign prostatic hyperplasia (BPH) and moderate-to-severe LUTS according to I-PSS, morphologically excluded prostate cancer, without urinary infection signs. The patients were randomized into two follow-up groups. Tamsulosin 0.4 mg q.d. was prescribed to patients in the control group. Patients of the main group received Gardaprost® 0.4 mg q.d. in addition to Tamsulosin. The follow-up period in both groups was one-year. The statistical analysis includes data from 56 men. To evaluate therapy at the screening visit and on days 180 and 360, I-PSS, urination diary, IIEF-5, urinalysis, prostate-specific antigen, uroflowmetry, ultrasound were analyzed. Paired t-test and one-way ANOVA test were used to determine intergroup differences in normally distributed variables. For variables with a distribution other than normal, Friedman's two-way ANOVA for related samples was used. Events with a probability greater than 95% were considered statistically significant.Results. At the time of inclusion in the study, the groups were comparable concerning the control parameters. In the main group, there was a more pronounced positive dynamics in the I-PSS score, maximum urine flow rate, and post-void residual urine volume, which corresponded to 7.9 ± 2.1 points, 18.0 ± 7.3 ml/sec, 23.6 ± 13.6 ml vs 19.7 ± 7.2 points, 10 ± 3.5 ml/sec, 65.9 ± 33.2 ml in the main and control groups, respectively (p < 0.001). Additionally, in the main observation group, a decrease in prostate volume was recorded by 18.8% (p < 0.001) was recorded.Conclusion. We have obtained encouraging long-term results from the use of Gardaprost® in combination therapy of moderate-to-severe LUTS caused by medium- and large-volume BPH.