Self-Esteem, Confidence and Relationship Satisfaction of Men With Erectile Dysfunction Treated With Sildenafil Citrate: A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled Study in the United States

Harvard University, Cambridge, Massachusetts, United States
The Journal of Urology (Impact Factor: 4.47). 03/2006; 175(3 Pt 1):1058-62. DOI: 10.1016/S0022-5347(05)00418-0
Source: PubMed


We assessed the change in confidence, relationships and self-esteem, and its correlation with erectile function in men with ED treated with sildenafil citrate in the first United States based, double-blind, placebo controlled, randomized trial assessed by the validated SEAR.
This 12-week flexible dose (25, 50 or 100 mg) trial determined change scores from baseline to end of treatment for the 5 SEAR components (Sexual Relationship domain, Confidence domain, Self-Esteem subscale [prespecified as the primary end point], Overall Relationship subscale and Overall score), and their correlations with the IIEF and event log data, as well as correlations between SEAR components and a general efficacy question at the end of treatment.
Compared with the placebo group (125 patients, mean age +/- SD 55 +/- 13 years, mean years ED 3.8 +/- 4.2), the sildenafil group (128 patients, mean age +/- SD 56 +/- 12, mean years ED 4.6 +/- 4.3) had significantly greater improvements in all 5 SEAR components (p < 0.0001) and all sexual function measures. SEAR component scores showed significant correlations with IIEF Erectile Function domain scores (r range 0.34 to 0.69, p < 0.0001), other IIEF domain scores (p < 0.0001), percentage of successful intercourse attempts (p < 0.0001) and frequency of erection that allowed satisfactory intercourse (p < 0.0001).
In this study of men with ED, sildenafil produced substantial improvements in self-esteem, confidence and relationship satisfaction as measured by SEAR scores, which showed moderate to high positive correlations with IIEF scores.

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    • "The present study and previous clinical trials also demonstrated significant correlations between treatment satisfaction on the EDITS (and psychosocial variables on the SEAR) and other self-reported efficacy data (eg, IIEF, SEP; Cappelleri et al, 2005; Althof et al, 2006b; O&apos;Leary et al, 2006; Steidle et al, 2006). Prior clinical trials also demonstrated that effective ED management with PDE5 inhibitors and more invasive therapies (ie, intracavernosal injection therapy) led to resumption of spontaneous waking (and nocturnal) erections, even after treatment had been discontinued (Montorsi et al, 1997; Brock et al, 2001; Mulhall et al, 2005; Aversa et al, 2007). "
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