Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
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| Abstract |
Four weeks after bilateral nerve-sparing radical retropubic prostatectomy, men with normal erectile function before surgery were randomized to double-blind sildenafil (50 or 100 mg) or placebo nightly for 36 weeks, followed by an 8-week drug-free period before assessment of erectile function. Enrollment was prematurely ceased and only 76 men completed because, assuming a placebo response rate similar to the published literature (for example, 34% in meta-analysis), the 25% response at blinded interim review suggested a lack of treatment effect. On the contrary, spontaneous erectile function (a combined score of >or=8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to 'Were erections good enough for satisfactory sexual activity?') occurred in only 4% of the placebo group (n=1 of 25) versus 27% (n=14 of 51, P=0.0156, Fisher's exact test) of the sildenafil group. Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections.
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| Authors | H Padma-Nathan, A R McCullough, L A Levine, L I Lipshultz, R Siegel, F Montorsi, F Giuliano, G Brock, Study Group |
| Journal | International journal of impotence research (Int J Impot Res) 2008 Sep-Oct Vol. 20 Issue 5 Pg. 479-86 ISSN: 1476-5489 [Electronic] England |
| PMID | 18650827 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't) |
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