Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)

Inclusion Criteria

• •Male patient
• •Between 45 and 85 years old.
• •Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months
• •I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2)
• •Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2)
• •I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits,
• •5 mL/s ≤ maximum urinary flow rate \< 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary)
• •Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2)
• •Serum total PSA at randomisation visit (visit 2) :
• •* 4 ng/mL
• •* 10 ng/mL and Prostate Specific Antigen (free) / Prostate Specific Antigen (total) ≥ 25% or negative prostate biopsy within the past 6 months prior to selection visit.
• •Patient able to understand and sign the informed consent and understand and fill in self-questionnaires