Daily use of sildenafil 50mg at night effectively ameliorates nocturia in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: an exploratory multicenter, double-blind, randomized, placebo-controlled study

摘要

Purpose: To compare the efficacy and safety of sildenafil 25mg qd, 25mg bid or 50mg qd - on treating lower urinary tract symptoms with benign prostatic hyperplasia (LUTS/BPH).Materials and methods: Men aged>45 years with LUTS/BPH were randomly assigned to receive sildenafil 25mg qd (n=42), bid (n=41), 50mg qd (n=38) or placebo (n=41) for 8 weeks. Changes from baseline in International Prostate Symptom Score (I-PSS), maximum urinary flow rate (Qmax) and postvoid residual urine volume (PVR) were assessed at week 4 and week 8.Results: Sildenafil 25mg qd (-7.35.8) and 25mg bid (-7.0 +/- 5.7) exhibited significant improvements of I-PSS compared to placebo (-5.2 +/- 6.4) (p=0.020, 0.025, respectively). In particular, voiding domain was more affected than storage domain. Only sildenafil 50mg qd improved nocturia significantly (versus placebo, p=0.027). Quality of life score was improved in all treatment groups. Q(max) and PVR did not change significantly in all groups. All regimens were well tolerated.Conclusions: Sildenafil 25mg qd, 25mg bid and 50mg qd are safe and effective to improve LUTS/BPH in long term, along with coexisting ED. In particular, nocturia is most well-controlled by 50mg qd.