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Aging Male. 2017 Jun;20(2):81-88. doi: 10.1080/13685538.2016.1204290. Epub 2017 Feb 21.

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.

Author information

1
a Department of Urology , National Health Insurance Service Ilsan Hospital, Yonsei University College of Medicine , Goyang , Korea.
2
b Department of Urology , Yonsei University College of Medicine , Seoul , Korea , and.
3
c Department of Urology , Dongguk University Ilsan Hospital , Goyang , Korea.

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. 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.

KEYWORDS:

Benign prostatic hyperplasia; erectile dysfunction; lower urinary tract symptom; nitric oxide pathway; nocturia; phosphodiesterase 5 inhibitor

PMID:
28590828
DOI:
10.1080/13685538.2016.1204290
[Indexed for MEDLINE]

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