Self-esteem, confidence and relationship satisfaction in men with erectile dysfunction: a randomized, parallel-group, double-blind, placebo-controlled study of sildenafil in Mexico

Abstract

Erectile dysfunction (ED) negatively impacts self-esteem and relationship satisfaction. The Self-Esteem and Relationship (SEAR) questionnaire is a validated, ED-specific, patient-reported instrument that specifically addresses self-esteem and relationship issues within the context of ED. Effective ED treatment with sildenafil in a double-blind, placebo-controlled clinical trial conducted in Brazil, Mexico, Australia and Japan showed pooled cross-cultural improvements in self-esteem, confidence and relationship satisfaction. This report focuses on the results from the subgroup of men from nine Mexican centers who participated in the multinational study. A total of 95 men aged X18 years with clinically diagnosed ED and currently in a stable relationship were randomized to placebo (n ¼ 47) or sildenafil (n ¼ 48). The SEAR results for Mexican men showed that sildenafil treatment led to significant improvements in self-esteem, confidence and relationship satisfaction. These data support an earlier study showing that Latin American men taking sildenafil have similar safety and efficacy profiles compared to non-Latin counterparts.

A Systematic Review of the Psychosocial Outcomes Associated with Erectile Dysfunction: Does the Impact of Erectile Dysfunction Extend Beyond a Man's Inability to Have Sex?

“…There were 28 single‐ or double‐blind, placebo‐controlled, parallel‐group trials [9,16,20–45], one treatment‐controlled, parallel group trial [46], and three open‐label trials [15,47,48]. In addition, there were five pooled analyses of RCT data [14,49–52] and three secondary or subgroup analyses of RCT data [53–55].…”

“…All publications reported that men had ED for at least 6 months (where relevant), and most men had ED for at least 3 years (Tables and ). Disease duration was not reported as an eligibility criterion for 24 of the 40 publications [9,14,21,23,25–33,41,43,44,47–49,51–55]. The mean age of men with ED varied from 45 to 62 years [21,26], and most had ED of mixed or organic etiology [9,14,15,20–22,24–29,32–41,44,46–48,50–53,55,71].…”

“…Baseline scores for psychosocial measures for men with ED before PDE5 inhibitor treatment were reported in 29 publications. SEAR scores were reported in 15 publications (Table ) and were a primary outcome measure in 9 publications [9,14,28,32,33,47,49,54,55]. Other outcome measures were reported in 16 publications (Table ).…”

Pharmacotherapy for Erectile Dysfunction

“…There is clear evidence that sildenafil is efficacious in the treatment of the broad population of men with erectile dysfunction when taken on demand at a doses of 25, 50, and 100 mg. There are multiple level 1 studies with consistent outcomes [20–43]. The overall grade of recommendation is grade A.…”

“…Although side effects do occur with sildenafil (most notably headache, flushing, indigestion, nasal congestion, and occasional visual changes), providing that the drug is used in line with the labeling recommendations, there is no convincing evidence in the literature of any significant safety issue, including cardiovascular, visual, and aural safety [20–74] (Consistent level 1 studies, Overall grade of recommendation is grade A).…”