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    Int J Impot Res. 2008 Sep-Oct;20(5):479-86. Epub 2008 Jul 24.

    Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy.

    Padma-Nathan H, McCullough AR, Levine LA, Lipshultz LI, Siegel R, Montorsi F, Giuliano F, Brock G; Study Group.

    Collaborators (12)

    Andrianne R, Bell D, Broderick G, Carrier S, Cuzin B, Deeths HJ, Hellstrom W, Herschorn S, Lewis RW, Rosen RC, Shabsigh R, Stricker P.

    Source

    Department of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

    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.

    PMID:
    18650827
    [PubMed - indexed for MEDLINE]

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