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

H. Padma-Nathan, A. R. McCullough, L. A. Levine, L. I. Lipshultz, R. Siegel, F. Montorsi, F. Giuliano, G. Brock

Research output: Contribution to journalArticle

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 ≥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.

Original languageEnglish
Pages (from-to)479-486
Number of pages8
JournalInternational Journal of Impotence Research
Volume20
Issue number5
DOIs
Publication statusPublished - Sep 2008

Keywords

  • Erectile dysfunction
  • Prostatectomy
  • Sildenafil citrate

ASJC Scopus subject areas

  • Urology

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