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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

 Woo Jin Ko  ;  Hyun Ho Han  ;  Won Sik Ham  ;  Hae Won Lee 
 Aging Male, Vol.20(2) : 81-88, 2017 
Journal Title
 Aging Male 
Issue Date
Aged ; Analysis of Variance ; Double-Blind Method ; Erectile Dysfunction/complications ; Erectile Dysfunction/drug therapy ; Humans ; Male ; Middle Aged ; Nocturia/complications ; Nocturia/drug therapy* ; Nocturia/psychology ; Phosphodiesterase 5 Inhibitors/administration & dosage* ; Prostatic Hyperplasia/complications* ; Quality of Life ; Sildenafil Citrate/administration & dosage* ; Urination
Benign prostatic hyperplasia ; erectile dysfunction ; lower urinary tract symptom ; nitric oxide pathway ; nocturia ; phosphodiesterase 5 inhibitor
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. Qmax 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.
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1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Han, Hyun Ho(한현호) ORCID logo https://orcid.org/0000-0002-6268-0860
Ham, Won Sik(함원식) ORCID logo https://orcid.org/0000-0003-2246-8838
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