Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension
Abstract
AIMS: 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 = 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 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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 189 participants or records.
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