At present time several preclinical and clinical study have demonstrated the safety and efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction. However, the link between clinical outcomes (symptoms scores), functional activity (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern (molecular analyses), has not been previously investigated. Aim of present study is 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
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).
Time frame: 12 weeks
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.
Time frame: 12 weeks
Volumetric change of the prostate
Prostate volume as assessed by transrectal ultrasound
Time frame: 12 weeks
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.
Time frame: 12 weeks
Variation in genic expression of prostatic inflammation markers
BPH-associated prostate inflammation, fibrosis, and hypoxia will be measured by immunohistochemical and quantitative RT-PCR (qRT-PCR) analyses of inflammatory-, fibrosis- and hypoxia-related markers.
Time frame: 12 weeks
Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate)
CRP measured on serum and ESR measured on blood drawn at baseline and after 12 weeks
Time frame: 12 weeks
Improvement in metabolic profile
Metabolic parameters will be evaluated (glycaemia, insulinemia, total cholesterol, HDL, triglycerides, HbA1c, mean arterial pressure, waist circumference, body mass index)
Time frame: 12 weeks
Variation in seminal plasma IL-8 (interleukin-8) levels
Seminal IL-8, a chemokine involved in male genital tract infection/inflammation, will be evaluated.
Time frame: 12 weeks
Improvement in erectile function
Erectile function will be assessed by using the International Index of Erectile Function-5 (IIEF-5) score.
Time frame: 12 weeks
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