ANAHEIM, Calif.—Sildenafil taken  daily improves lower urinary tract symptoms (LUTS) secondary to BPH similar to alpha blockers and 5-α-reductase inhibitors, a new trial indicates.


Lead investigator Kevin T. McVary, MD, professor of urology at the Feinberg School of Medicine at Northwestern University in Chicago, said he believes the agents may help relax smooth muscle cells in the bladder wall and dilate small blood vessels in pelvis and in the prostate and relieve LUTS. 

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The 12-week double-blind, placebo-controlled study enrolled 369 men aged 45 and older who had ED and moderate or severe lower urinary tract symptoms (LUTS) associated with BPH. Their mean age was 60.8 years; the mean duration of ED and BPH was 5.6 and 4.8 years, respectively. Sildenafil 50 mg or matching placebo was taken daily. Sildenafil was titrated to 100 mg after 14 days with the op-tion of returning to 50 mg.


Among the subjects, 34% had BPH before ED, 45% had ED before BPH, and 21% had ED and BPH diagnosed at the same time. After 12 weeks of treatment with sildenafil, the 186 men with severe LUTS (International Prostate Symptom Score [IPSS] of 20 or greater) had greater improvements in IPSS compared with those on placebo (-8.6 vs. -2.4) than the 155 men with moderate LUTS (IPSS of less than 20) at baseline (-3.6 vs. -1.7).  More men taking sildenafil than placebo improved from having severe LUTS at baseline to having mild LUTS (16% vs. 4%) or moderate LUTS (57% vs. 36%) at the end of treatment.


Improvements in ED domain scores correlated with improvement in IPSS, but there were no significant differences between groups in maximum urinary flow rate (Qmax) across LUTS severity categories.


“We certainly saw LUTS improvement without changing the flow rate,” Dr. McVary said. “The magnitude of the change was comparable to all the other drugs that we have come to know and use over the past 20 years [alpha blockers and 5-α-reductase inhibitors]. I see PDE-5 inhibitors

as a potentially new class of medications for LUTS.”


Study findings were presented here at the American Urological Association annual meeting.