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. (3rd April 2017)

• Record Type: Journal Article
• Authors: Ko, Woo Jin; Han, Hyun Ho; Ham, Won Sik; Lee, Hae Won
• Is Part Of: Aging male. Volume 20:Number 2(2017:Jun.)
• Page Start: 81
• Page End: 88
• Publication Date: 2017-04-03
• Subjects: Benign prostatic hyperplasia -- erectile dysfunction -- lower urinary tract symptom -- nitric oxide pathway -- nocturia -- phosphodiesterase 5 inhibitor; Aging -- Periodicals; Men -- Periodicals; Gerontology -- Periodicals; Men -- Health and hygiene -- Periodicals; Aging -- periodicals; Geriatric -- periodicals; Men -- periodicals; Aged -- periodicals; Aged, 80 and over -- periodicals; 612.67
• DOI: 10.1080/13685538.2016.1204290
• Languages: English
• ISSNs: 1368-5538

Abstract

Abstract: 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.