Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
Status:
Completed
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
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.