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

Purpose: To compare the efficacy and safety of sildenafil 25?mg qd, 25?mg bid or 50?mg 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 25?mg qd (n?=?42), bid (n?=?41), 50?mg 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 25?mg qd (-7.3?±?5.8) and 25?mg 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 50?mg 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 25?mg qd, 25?mg bid and 50?mg qd are safe and effective to improve LUTS/BPH in long term, along with coexisting ED. In particular, nocturia is most well-controlled by 50?mg qd.