Double-blinded placebo-controlled study on men with lower urinary tract symptoms secondary to prostatic hyperplasia (LUTS-BPH) to assess changes in pressure flow study (PFS) and in molecular profile of prostatic tissue and to correlate this parameters with modifications of symptoms scores (IPSS) after 12 weeks treatment with tadalafil

INTERVENTION: Trade Name: Cialis Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596‐29‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: lower urinary tract symptoms/benign prostatic hyperplasia ; MedDRA version: 17.1 Level: PT Classification code 10071289 Term: Lower urinary tract symptoms System Organ Class: 10038359 ‐ Renal and urinary disorders ; MedDRA version: 17.1 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 ‐ Reproductive system and breast disorders Therapeutic area: Diseases [C] ‐ Male diseases of the urinary and reproductive systems [C12] PRIMARY OUTCOME: Main Objective: To assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers. Primary end point(s): Improvement of LUTS/BPH symptoms; BPH‐associated inflammatory symptoms will be assessed by using the National Institute of Health Chronic Prostatitis Symptom Index (NIH‐CPSI). BPH‐associated LUTS will be assessed by using International Prostate Symptom Score (IPSS).; Secondary Objective: Improvement of pressure flow study (PFS) parameters; Volumetric change of the prostate ; Change in prostate inhomogeneity and in the number of prostatic macrocalcifications ; BPH‐associated prostate inhomogeneity and presence of micro‐calcifications will be assessed by using male genital tract male genital tract colour‐Doppler ultrasonography.; Variation in genic expression of prostatic inflammation markers; BPH‐associated prostate inflammation, fibrosis, and hypoxia will be measured by immunohistochemical and quantitative RT‐PCR analyses of inflammatory‐, fibrosis‐ and hypoxia‐related markers.; Variation in serum inflammation markers CRP (C‐reactive protein) and ESR (Erythrocyte Sedimentation Rate; Improvement in metabolic profile; Metabolic parameters will be evaluated (glycaemia, insulinemia, total cholesterol, HDL, triglycerides, HbA1c, mean arterial pressure, waist circumference, body mass index); Variation in seminal plasma IL‐8 levels ; Improvement in erectile function; ; Timepoint(s) of evaluation of this end point: 12 weeks SECONDARY OUTCOME: Secondary end point(s): Improvement of pressure flow study (PFS) parameters; Maximum flow rate (Qmax), average flow rate (Qave), voided volume (Vcomp), post void residual volume (PVR) will be evaluated. An abdominal ultrasound immediately after voiding for uroflowmetry will be performed in order to determine the PVR.; Volumetric change of the prostate ; Change in prostate inhomogeneity and in the number of prostatic macrocalcifications ; BPH‐associated prostate inhomogeneity Timepoint(s) of evaluation of this end point: 12 weeks INCLUSION CRITERIA: adult male subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia; treatment with alpha‐blockers (Tamsulosin 0.4 mg/die) being capable of giving informed consent. 18 Years and older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26