Serenoa repens, lycopene and selenium vs. tamsulosin for the treatment of lower urinary tract symptoms (LUTS)/ Benign prostatic hyperplasia (BPH)

INTERVENTION: Participants were randomized with a 1:1:1 ratio into three treatment arms each consisting of 75 patients: group A (Ser 320 mg, Ly and Se ( Profluss ®) 1 tablet per day for 1 year), group B (tamsulosin 0.4 mg 1 tablet a day for 1 year), group C (Ser 320 mg , Ly and Se ( Profluss ®) 1 tablet per day for 1 year + tamsulosin 0.4 mg 1 tablet per day for 1 year. CONDITION: Benign prostatic hyperplasia (BPH) / lower urinary tract symptoms (LUTS) ; Urological and Genital Diseases ; Benign prostatic hyperplasia (BPH) PRIMARY OUTCOME: Reduction of IPSS (= 3 points from baseline), a percentage reduction of IPSS (IPSS%) = 25%, increase of Qmax (= 30% from the baseline) and the reduction of PVR in patients treated with SeR, Ly and Se (Profluss ®) + tamsulosin compared to those treated with SeR, Ly and Se (Profluss®) or tamsulosin monotherapies after 1 year SECONDARY OUTCOME: Secondary endpoints of the study were considered the change in erectile function (assessed by the International Index of Erectile Function‐5 questionnaire), prostate volume, serum PSA and QoL at 1 year INCLUSION CRITERIA: 1. Age between 55 and 80 years old 2. Digital rectal examination negative for prostate cancer 3. Prostate‐specific antigen (PSA) = 4 ng / ml, International Prostate Symptom Score (IPSS) = 12, prostate volume = 60 cc (assessed by suprapubic ultrasound), Qmax = 15 ml / s, post ‐void residual urine <150 ml.