Men with mild erectile dysfunction benefit from sildenafil treatment
Abstract
INTRODUCTION: Sildenafil treatment has not been evaluated in a double-blind, placebo-controlled (DBPC) trial specific to men with mild erectile dysfunction (ED), defined by a 22-25 score on the International Index of Erectile Function-erectile function domain (IIEF-EF).
AIM: To assess sildenafil efficacy in sexually dissatisfied men with mild ED.
MAIN OUTCOME MEASURES: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), IIEF, Quality of Erection Questionnaire (QEQ), Erection Hardness Score (EHS 4=completely hard/fully rigid), general efficacy questions (GEQs), event log questions (hardness sufficient for penetration, duration sufficient for successful intercourse, ejaculation/orgasm, and second erection within 24 hours), and analog scales (erection firmness, reliability, and maintenance, and general sexual performance).
METHODS: Eight-week DBPC flexible-dose (25, 50, or 100 mg) trial with 6-week, open-label (OL) extension.
RESULTS: One hundred and seventy-six men were randomized (mean±standard deviation: age, 50±12 year; ED duration, 3.5±3.2 year). Most had organic or mixed ED. For sildenafil vs. placebo, 66% vs. 89% titrated to 100 mg and efficacy at DBPC end was better, including the EDITS Index score (least squares mean [standard error], 80.3 [2.3] vs. 62.1 [2.5]; P50 in 89% vs. 63%; P=0.0001); no ED (IIEF-EF ≥26 in 58% vs. 39%; P50), 77% had no ED, and ≥89% were GEQ responders; mean scores on IIEF domains, the QEQ, and analog scales were >80% of the…
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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.
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