Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
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.
Padma-Nathan
H
H
Department of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
McCullough
A R
AR
Levine
L A
LA
Lipshultz
L I
LI
Siegel
R
R
Montorsi
F
F
Giuliano
F
F
Brock
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D003624:Darkness; D007172:Erectile Dysfunction / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000494:pharmacology*; D011182:Postoperative Care; D011467:Prostate / Q000294:innervation* / Q000601:surgery*; D011468:Prostatectomy / Q000379:methods*; D011687:Purines / Q000009:adverse effects / Q000494:pharmacology; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000009:adverse effects / Q000494:pharmacology*
D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate