Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension.
OBJECTIVE
To evaluate once-daily 100-mg sildenafil for the treatment of erectile dysfunction (ED) in men with ED and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).


METHODS
This was a 12-week, randomised, double-blind, placebo-controlled (DBPC) trial, with an 8-week open-label (OL) extension, in men > or = 45 years of age who scored < or = 25 on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and > or = 12 on the International Prostate Symptom Score.


RESULTS
At DBPC end of treatment (EOT), the sildenafil group (n = 189, vs. placebo, n = 180) had improved EF (IIEF), improved emotional well-being [Self-Esteem And Relationship questionnaire (SEAR)], and greater treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction) (p < 0.0001). At OL EOT, IIEF and SEAR scores improved slightly in the group previously randomised to sildenafil (n = 168), but much more in the group previously randomised to placebo (N = 155), such that total improvement over the 20-week trial was comparable between the groups. Erections at baseline were hard enough for penetration on approximately half of occasions and lasted long enough for successful intercourse on less than one quarter of occasions, increasing at sildenafil DBPC and OL EOT to approximately 90% (penetration) and 80% (intercourse success) vs. 61% (penetration) and 39% (intercourse success) for DBPC placebo. At sildenafil DBPC and OL EOT, > or = 90% of men were taking sildenafil 100 mg. Sildenafil was generally well tolerated.


CONCLUSIONS
In this trial of men with ED and BPH-associated LUTS, sildenafil treatment for ED was efficacious, effective and generally well tolerated.
McVary
K T
KT
Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, IL 60611-3008, USA. k-mcvary@northwestern.edu
Kaufman
J
J
Young
J M
JM
Tseng
L-J
LJ
D000368:Aged; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications; D053448:Prostatism / Q000150:complications / Q000188:drug therapy*; D011687:Purines / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D012649:Self Concept; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate