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

<i>Purpose</i>: 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). <i>Materials and methods</i>: Men aged &gt; 45 years with LUTS/BPH were randomly assigned to receive sildenafil 25 mg qd (<i>n = </i>42), bid (<i>n = </i>41), 50 mg qd (<i>n = </i>38) or placebo (<i>n = </i>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. <i>Results</i>: 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) (<i>p = </i>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, <i>p = </i>0.027). Quality of life score was improved in all treatment groups. <i>Q</i>_max and PVR did not change significantly in all groups. All regimens were well tolerated. <i>Conclusions</i>: 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.