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
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.
Available from: Antonio Aversa
- "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'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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ABSTRACT: Previous studies established the efficacy of once-daily tadalafil for men with erectile dysfunction. However, no trial has focused on the effects of such treatment on men without previous experience using oral phosphodiesterase type 5 (PDE5) inhibitors. Subjects were randomized (2:1) to once-daily tadalafil 5 mg (with possible down-titration to 2.5 mg; n = 146) or placebo (n = 69) for 12 weeks. Among 215 subjects (mean age = 52 years), once-daily tadalafil treatment resulted in 61.7% of study participants reporting their ability to achieve and maintain erections being much better or very much better (vs. 21.7% on placebo; P < .001). Tadalafil significantly improved treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS; P < .001 vs. placebo at endpoint) and psychosocial outcomes on the Self-Esteem and Relationship (SEAR) questionnaire (least-squares mean difference in SEAR total score change from baseline = 11.8 [95% CI = 5.4-18.2; P < .001 vs. placebo]). Subjects receiving once-daily tadalafil also experienced a higher proportion of daily self-reported spontaneous morning erections at endpoint (58.7%) compared to placebo (42.2%; P < .001 for the between-treatment difference in changes from baseline). However, no significant differences in parameters of endothelial dysfunction (including biomarkers and peripheral arterial tonometric measures) or nocturnal erections as recorded by the nocturnal electrobioimpedance volumetric assessment were observed between treatment groups. Tadalafil was well tolerated; adverse events included back pain, headache, and dyspepsia. These findings may contribute to a more comprehensive understanding of once-daily tadalafil's effects on PDE5-inhibitor-naive men.
Available from: acponline.org
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ABSTRACT: Descripción: El American College of Physicians desarrolló estas guías clínicas para presentar la evidencia disponible sobre la evaluación hormonal y el tratamiento farmacológico de la disfunción eréctil. Las terapéutica farmacológica actual incluye a los inhibidores de la 5-fosfodiesterasa (PDE-5) como el sildenafil, vardenafil, tadalafil, mirodenafil y udenafil, así como el tratamiento hormonal. Métodos: La literatura publicada sobre este tema fue identificada usando MEDLINE (1966 a mayo del 2007), EMBASE (1980 a la semana 22 del 2007), el Registro Central de Estudios Controlados Cochrane (segunda trimestre del 2007), PsycINFO (1985 a junio del 2007), AMED (1985 a junio del 2007), y SCOPUS (2006). La búsqueda bibligráfica fue actualizada buscando artículos en MEDLINE y EMBASE publicados entre mayo 2007 y abril 2009. Las búsquedas se limitaron a publicaciones en idioma inglés. Esta guía clínica establece el nivel de evidencia y el grado de recomendación utilizando el sistema de graduación de las guías clínicas del American College of Physicians.
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ABSTRACT: Existing medical treatments for men diagnosed with prostate cancer have a number of distressing side effects, which can include
erectile dysfunction, leakage of urine with orgasm, dry ejaculation, penile shrinkage, loss of libido and responsiveness
to sexual visual cues, urinary incontinence, bowel dysfunction and rectal bleeding, hot flashes, weight gain, fatigue, loss
of muscle mass, pain, and physical impairment [1, 2]. Symptoms can occur immediately after treatment or may not develop until
2–5 years following treatment . These symptoms can be troubling for men because they can compromise masculinity, self-esteem,
sexual confidence, responsivity to sexual cues, sexual fantasies, sexual desire, the ability to engage in sexual activity,
and subsequently increase psychological distress [2 4–7]. Sexual dysfunction can be a particularly difficult stressor. Although
approximately half of men diagnosed and treated for prostate cancer use erectile aids to partially or completely restore erectile
functioning [8, 9], the majority of men do not continue to use and/or are not satisfied with these aids [9–11]. Ultimately,
many men never achieve the same level of or satisfaction with sexual activity as they experienced before the cancer , and
the disruptions to sexual activity compromise men’s quality of life [7, 12].
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