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Introduction Men may choose to bypass the healthcare system to obtain a phosphodiesterase type 5 inhibitor (PDE5i). Aim Evaluate the characteristics and purchasing patterns of men obtaining a PDE5i without prior healthcare professional (HCP) interaction. Main Outcome Measures Prior HCP interaction, defined as having a prescription for any PDE5i, having a PDE5i sample from a physician, or buying the PDE5i in a retail pharmacy; and erectile dysfunction (ED, the Massachusetts Male Aging Study single-item question) were assessed. A multivariate regression analysis determined predictive factors for PDE5i purchase without prior HCP interaction. Methods A Web-based observational study was conducted in the United Kingdom, Germany, and Italy. Results Of the 11,899 participants, 1,252 (10.5% [95% CI, 10.0–11.1%]) reported PDE5i use in the last 6 months. PDE5is were obtained without prior HCP interaction by 403 users (32.3% [95% CI, 29.6–34.8%]); 65.5% of them had ED. Overall prevalence of men using PDE5is without HCP interaction was 3.0% (95% CI, 2.6–3.5%), 4.1% (95% CI, 3.5–4.6%), and 2.8% (95% CI, 2.1–3.5%) for men aged 18–34, 35–50, and >50 years, respectively (P = 0.0045). Predictive factors for obtaining a PDE5i without prior HCP interaction were embarrassment to speak to a physician (P = 0.0009) and the perception that this would be the cheapest way to get the medicine (P = 0.03). Conclusions Based on these findings, it can be estimated that approximately 6 million men in Europe might currently bypass the healthcare system to obtain a PDE5i. In addition to the risks associated with use of PDE5is from uncontrolled sources, because most of these men have ED, they also miss the opportunity for important health information or medical follow-up. HCPs should actively address ED and offer treatment to discourage men from seeking uncontrolled sources of ED medicines.

Introduction Erectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self-esteem. Aim In men with ED, to use the validated Self-Esteem and Relationship (SEAR) questionnaire to evaluate changes in self-esteem associated with sildenafil treatment of ED and to assess changes dependent on concomitant comorbid conditions. Methods This was a 14-week, international, randomized, parallel-group, double-blind, flexible-dose (25, 50, or 100 mg), placebo-controlled study of sildenafil in men aged ≥18 years with a clinical diagnosis of ED (score ≤ 21 on the Sexual Health Inventory for Men). Main Outcome Measures The primary outcome was the change in the SEAR Self-Esteem subscale score from baseline to the end of treatment. Secondary outcomes were the change in SEAR component scores stratified by ED comorbidity, the change in the International Index of Erectile Function (IIEF) domain scores and in the intercourse success rate, and the response to the global efficacy assessment and to the global satisfaction assessment. Results A total of 841 patients were included in the intent-to-treat efficacy analysis (559 sildenafil, 282 placebo). Patients randomized to sildenafil had significantly greater change scores from baseline to the end of treatment on all components of the SEAR and all domains of the IIEF (P < 0.0001) compared with placebo. This finding was also consistent for all SEAR components when stratified by each ED comorbidity. In the sildenafil group, the improvement in the mean Self-Esteem subscale score correlated with improvements in the mean Erectile Function domain score (r = 0.6338, P < 0.0001). Conclusions The physiologic and emotional benefits of sildenafil in the treatment of ED were confirmed, overall and in men with comorbid hypertension, hyperlipidemia, benign prostatic hypertrophy, and/or depression. Using both the IIEF and the SEAR questionnaires provides a more complete assessment of ED.

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