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ABSTRACTBackground:The quality of life consequences of erectile dysfunction (ED) include depression, anxiety, and loss of self-esteem. The Self-Esteem And Relationship (SEAR) questionnaire is a validated, patient-administered, psychometric instrument specific to ED.Objective:To determine correlations between erectile function (EF), intercourse success, and emotional well-being measured with the SEAR questionnaire in men treated with sildenafil citrate for ED and stratified by age (< 50 years, 50–65 years, and > 65 years).Research design and methods:This was an open-label, flexible-dose trial of sildenafil (25, 50 and 100 mg) administered for 10 weeks to 382 men with ED (mean ± SD age, 55 ± 13 years; mean ED duration, 4 years), which was conducted at 62 centers in the United States.Main outcome measures:Analysis (by intent-to-treat, n= 368) of the change from baseline to the week‐10 endpoint in the SEAR questionnaire Self-Esteem subscale, the intercourse success rate (percent of occasions at which an erection that lasted long enough for successful intercourse was achieved), and their correlation.Results:For the overall population, there was mean ± SD improvement ( p< 0.0001, paired t‐tests) in the Self-Esteem subscale (56 ± 25 to 79 ± 22) and intercourse success rate (21 ± 30% to 70 ± 36%), which showed positive correlation ( p< 0.0001). Secondary outcomes (i.e., EF domain of the International Index of Erectile Function; event log frequency of erection hard enough for sexual intercourse and of ejaculation/orgasm) also improved ( p< 0.0001) and correlated positively with the SEAR Self-Esteem subscale and Sexual Relationship domain ( p< 0.05 for all correlations). All 10 correlations were positive ( p< 0.05) in men aged 50 to 65 years, eight were positive in men aged > 65 years, and six were positive in men aged < 50 years. The most common treatment-related adverse events were mild-to-moderate headache (12% of patients), vasodilatation (7%), and rhinitis (4%).Conclusions:Men treated with sildenafil for ED demonstrated improved erectile function and an increased intercourse success rate, which correlated positively with improvement in SEAR measures of self-esteem and sexual relationship. |
