Sprite study

INTERVENTION: 1. Group A Serenoa repens 320mg, selenium and lycopene (Profluss ®) 1 tablet per day for 6 months. 2. Group B Tadalafil® 5mg 1 tablet a day for 6 months CONDITION: Benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) ; Urological and Genital Diseases ; Hyperplasia of prostate PRIMARY OUTCOME: 1. Mean change of international prostate symptom score (IPSS) and peak flow in patients treated with Profluss® or Tadalafil® 5mg. The study is designed as non‐inferiority study with a 95% power and an equivalence margin of 0.5 for IPSS and of 0.8 for the peak flow.; 2. IPSS quality of life (QoL) questionnaire; 3. Maximum urinary flow rate (Qmax uroflowmetry); 4. International Index of Erectile Function (IIEF‐5) score SECONDARY OUTCOME: Mean changes of post‐void residual (PVR) volume in patients treated with Profluss® or Tadalafil® 5 mg at enrollment (visit 0), one month (visit 1), at 3 months (visit 2), at 6 months (visit 3) INCLUSION CRITERIA: 1. Age between 50 and 75 2. Digital rectal examination negative for prostate cancer 3. Prostate specific antigen (PSA) <4ng/ml 4. IPSS =12 5. PVR <100 ml 6. Peak flow between 4 and 15ml/s