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Keywords:

  • Erectile Dysfunction;
  • Health-Related Characteristics;
  • Health-Related Quality of Life;
  • PDE5 Inhibitors

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

Introduction

Data suggest that ED is still an underdiagnosed and undertreated condition. In addition, it seems that men with ED are unsatisfied about their relationship with their physician and with the available drugs.

Aim

The study aims to identify health-related characteristics and unmet needs of patients suffering from erectile dysfunction (ED) in big 5 European Union (EU) nations (France, Germany, Italy, Spain, and UK).

Methods

Data were collected from the 2011 5EU National Health and Wellness-Survey on a population of 28,511 adult men (mean age: 47.18; SD 16.07) and was focused on men (5,184) who self-reported ED in the past 6 months. In addition, the quality of life (QoL) and work productivity/activity were explored.

Main Outcome Measures

Health-related QoL (HRQoL) and work productivity were measured with SF-12v2 and WPAI validated psychometric tools.

Results

One in every 20 young men (age 18–39) across 5EU experienced ED in the past 6 months. About half of men (2,702/5,184; [52%]) with ED across all ages did not discuss their condition with their physician. Interestingly, among those men who did discuss their condition with their physician, 68% (1,668/2,465) do not currently use medication. These findings were more evident in the age group of 18–39 years. Only 48% (2,465/5,184) had a closer relationship with their physician, suggesting that this quality of relationship may be unsatisfactory. Compared with controls, ED patients have a significantly higher intrapsychic and relational psychopathological comorbid burden and relevant decreasing in HRQoL, with a significantly higher impairment on work productivity/activity.

Conclusion

Data suggest that there is a need for a new therapeutic paradigm in ED treatment which images the achievement of a new alliance between physician and patient. Hence, alternative drug delivery strategies may reduce the psychological and social impact of this disease. Jannini EA, Sternbach N, Limoncin E, Ciocca G, Gravina GL, Tripodi F, Petruccelli I, Keijzer S, Isherwood G, Wiedemann B, and Simonelli C. Health-related characteristics and unmet needs of men with erectile dysfunction: A survey in five European countries. J Sex Med 2014;11:40–50.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

Although definitions of erectile dysfunction (ED) still do not find a complete agreement, it is estimated that this condition affects 16–45% of men [1–3], with the risk and severity of ED increasing with age [2–5]. In particular, a general overview [6] shows that the prevalence of ED in subjects aged 40 to 49 years ranges between 2% and 9%, while the general population of men aged 60 to 69 years shows a rather high rate of 20–40%.

Literature evidences show that ED is a potential harbinger of cardiovascular disease [7,8], with penile flow evaluation as a specific modality to identify both ED patients with present cardiovascular status and those with high risk to develop a cardiovascular disease [9].

The association of ED with underlying conditions such as diabetes, hypertension and dyslipidemia [2,10,11], obesity [12], impaired fasting glucose [13], depression [14], and smoking [15] has also been evidenced. Finally, ED can have a negative effect on general [13,14] and sexual quality of life [9] (QoL). Interestingly, literature [9] indicates a correlative finding between hypoactive sexual desire disorder (HSDD) and cardiovascular risk. This correlation maintains its statistical value even after adjusting analysis for patient's desire, Framingham risk score, and testosterone levels. If one or more common ethiopathogenic factors, between HSDD and cardiovascular risk, exists, it is a matter of debate. Difficulties in building social relationships and defensive psychological mechanisms have been taken into account [9].

Despite the prevalence of ED and its link with many healthcare problems [3,16,17], it remains underrecognized, underdiagnosed, and undertreated [18,19]. Awareness of ED has increased since the advent of oral phosphodiesterase type 5 (PDE5) inhibitor treatments [1,3,20]. However, although the great majority of men consider ED a problem able to result in a general impairment of the QoL, there may be a subpopulation of subjects with ED who may not consider it to be a serious problem or are too embarrassed to speak to their physician [17,21–24]. Moreover, many physicians are reluctant to initiate discussions about sexual health with their patients [21,25]. Although several large-scale surveys of ED have been conducted, these have primarily studied middle-aged men and/or specific aspects of ED [4,19,26,27]. Few studies have gathered detailed data from the same sample of men, across a broad age range, on prevalence rates, demographic and lifestyle characteristics, healthcare resource utilization, and PDE5 inhibitor use [2,28,29].

This article reports findings provided by men aged ≥18 years as part of a general population survey conducted across five EU nations (France, Germany, Italy, Spain, and UK).

Aims

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

The current study goals were to establish the health-related characteristics and unmet needs of men with ED, the impact of ED on men's well-being, and rates of ED treatment across different age groups. Specifically, the healthcare resource attitudes among men with ED were investigated.

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

Data were collected from the National Health and Wellness Survey (NHWS), a cross-sectional survey representative of the total male and female adult populations in each 5EU market that captures information directly from respondents (Kantar Health, February 2012. NHWS, 2011 [EU Big 5]. Princeton, NJ). In brief, the survey sample was drawn from the Internet panel maintained by Lightspeed Research and its partner organizations, stratified according to age and gender in each country. To ensure a representative sample, particularly in the older population (>65), online recruitment was supported by computer-assisted web interviews (CAWIs), where respondents were recruited by telephone and had the choice to complete the interview on the phone as well, or were e-mailed a link to the survey to complete on their own. This search strategy has been well documented in literature [30,31]. NHWS has been conducted in 5EU since 2000 and data presented in this manuscript were collected from male respondents between September and December 2011. All NHWS respondents were recruited from either an online panel or a telephone database. Internet panels, such as Lightspeed Research, use a variety of methods to recruit and build their panels including, but not limited to, banner ads on websites, search engines, and social media. All protocols and informed consent procedures were approved by the Essex Institutes' Institutional Review Board. Invitations to participate were sent to adults aged ≥18 years in France, Germany, Italy, Spain, and UK. Respondents received a small incentive to participate in the survey. Panelists received their incentive in the form of points which can be collected and exchanged for small gifts; CAWI respondents received a monetary amount (20–25 Euros) that was mailed after completion of the survey was verified. All respondents provided their informed consent. All information was based on medical diagnosis and self-reported by participants. However, no attempt was made to validate respondents' answers with their medical records or through discussion with their physician. The first survey screen contained basic information about the study and clarified issues related to informed consent. Participants who agreed to participate in NHWS received detailed information on the aim and the level of commitment to which they would be agreeing. Prospective participants were asked to confirm that they were of legal age (18 years of age) and that they agreed to participate in the study. Respondents are only identified through a unique ID in the dataset. NHWS respondents are classified as having a specific disease if they self-reported having received a physician's diagnosis or if they are taking medication(s) for the specific disease in question. Inclusion criteria for the sample included in this manuscript are mean age 18 years old or older and had difficulty achieving/maintaining an erection in the past 6 months. Invitation to survey was sent to 331,674 participants and 16.9% (56,156/33,1674) of them agreed to take part in the survey. However, we excluded 2,676 participants (4.7%; 2,676/56,156) as they dropped out of the interview during the screening, 4,273 (7.6%; 4,273/56,156) because they refused informed consent, 69 (0.1%; 69/56,156) were under 18 years of age, 17,039 (30.3%; 17,039/56,156) because overquota, and 3,588 (6.4%; 3,588/56,156) dropped out during the main interview. The remaining 28,511 have been included in the final analysis.

Main Outcome Measures

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

The sociodemographic characteristics, the presence of ED in the past 6 months, and the health-related characteristics with patients' unmet needs were investigated, with nonstandardized questionnaire reported in Appendix 1.

The health-related quality of life (HRQoL) was explored using the Short-Form Health Survey, version 2.0 (SF-12v2) [32] questionnaire composed of 12 validated questions that are scored to provide an index of respondents' mental health, physical health, and overall HRQoL. The individual components of the SF-12v2 scale include measures of physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, and role limitations due to emotional problems and effects on mental health.

Work productivity and effects on daily activities were evaluated using the validated Work Productivity and Activity Impairment questionnaire (WPAI) [33]. The WPAI yields four types of scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on-the-job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and activity impairment. WPAI outcomes are expressed as percentages, with higher numbers indicating greater impairment and lower productivity. Overall work productivity loss, absenteeism, and presenteeism are evaluated for the working population, while activity impairment is calculated for all respondents.

Statistical Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

Data were summarized descriptively and group data were analyzed using t-tests for two groups and one-way anova test for more than two groups. The T-statistic was calculated from NHWS data and compared with critical values of a T-distribution. Significance was determined if the number calculated from NHWS data was greater than the critical values of a T-distribution. Chi-squared tests were used to test for differences between categorical variables. To assess the physical and mental well-being of respondents in each subgroup, SF-12v2 scores for each subgroup were compared with those of the general population, and the therapeutic category average. In order to estimate the actual incidence in the total population across the five surveyed countries, results were projected according to known population incidences for key subgroups from the International Data Base of the US Census Bureau, and the Organisation for Economic Co-operation and Development, with age as weighting variables. P values <0.05 were considered statistically significant. All statistical analyses were performed using the SPSS statistical analysis software package version 10.0 (SPSS Inc., Chicago, IL, USA).

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

Demographics, Lifestyle Characteristics, and ED Prevalence

Of the 28,511 male respondents of the 2011 5EU NHWS, 5,184 men met the criteria for self-reported ED during the past 6 months (Figure 1), indicating a prevalence of ED equal to 17% (corresponding to 21.7 million men across 5EU). Of these men, 1,420 (29%; corresponding to a projected estimate of 6.2 million men across 5EU) reported mild ED; 1,648 (33%; corresponding to a projected 7.1 million men across 5EU) reported moderate ED, and 2,116 (39%; corresponding to a projected 8.4 million men across 5EU) reported severe ED (Figure 1). The mean age of participants was 47.18 (SD 16.07). On average, men with ED were older than men without ED (P < 0.01). When stratified for age groups, a significant age-related trend with respect to ED was documented (P < 0.001). Interestingly, the incidence and severity of ED increased with age although a significant proportion of young men experienced ED (P < 0.0001; Table 1, Figure 1). Compared with their counterparts without ED, men with ED led a less healthy lifestyle. They exercised less (P < 0.05) and were more likely to be obese (P < 0.05) (Table 1). Among all men age 18 and older, about one half (53%) of the men were married, 26% were single, 5% divorced, and 2% separated (Table 1). A significant difference was found between responders with ED with respect to responders without ED across different age ranges in terms of mean body mass index, overweight, marital status, and lifestyle characteristics (Table 1). Interestingly, among men aged 18–59 years, there was a higher proportion of smokers in the ED group, compared with the non-ED group (P < 0.05), while among men aged ≥60 years, there was a higher proportion of men using alcohol in the ED group, compared with the non-ED group (P < 0.05). Men with ED reported more physical and psychological comorbidities than men without ED, across all age groups (Table 2). In particular, men with ED were more likely to have cardiovascular and metabolic conditions and mood and sleep disorders. In comparison with men experiencing ED and having a high household income, men with ED and with low household income showed increased rates of diabetes (P < 0.05), alcoholism (P < 0.05), anxiety (P < 0.05), depression (P < 0.05), insomnia (P < 0.05), sleep difficulties (P < 0.05), and pain (P < 0.05; Table 2).

figure

Figure 1. This figure shows the percentage of men meeting the criteria for self-reported erectile dysfunction (ED) during the past 6 months (Item “In the past six months, have you had difficulty achieving/maintaining an erection?”). *4% of men are not included in this analysis due to responses of Decline to Answer/Not Applicable. **1% of men are not included in this analysis due to responses of Decline to Answer. ***Less than 1% of men are not included in this analysis due to responses of Decline to Answer.

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Table 1. Demographic characteristics and lifestyle factors of respondents with or without ED, stratified by age and household income
 Total EU big 5 male population (age 18+)AgeAgeAgeHousehold income—lowHousehold income—mediumHousehold income—high
18–39 years40–59 years≥60 years
No EDEDNo EDEDNo EDEDNo EDEDNo EDEDNo EDED
n =28,5118,7505088,3421,7365,0902,9405,3961,35710,0672,5374,235935
  1. *Statistically significant difference at 95% confidence interval level between respondents with ED vs. without ED, within each age-range category.

  2. BMI = body mass index; ED = erectile dysfunction; NA = not assessed

Age, mean years47.229.530.7*48.450.7*67.067.9*NANANANANANA
BMI, mean kg/m226.625.026.2*27.028.7*27.128.0*26.128.3*26.328.1*26.327.7*
Overweight (BMI ≥25 and <30), %41303045435049364141464350
Obese (BMI ≥30), %181018*1932*1926*173116271523
Marital status, %
Married53272961*577577*NANANANANANA
Single, never married26535116165*3NANANANANANA
Divorced512*711*87NANANANANANA
Separated213*3433NANANANANANA
Lifestyle
Alcohol use, % Yes82848283838082*787984838888
Current smoker, % Yes262738*3038*17*16323226242122
Days exercised in past month, mean number6.77.1*6.36.4*5.17.3*6.76.4*5.26.9*6.27.7*6.8
Table 2. Comorbidity burden reported by at least 5% of any subgroup of respondents with or without ED, stratified by age and household income (%)
 Total populationAgeHousehold income
18–39 years40–59 years≥60 yearsLowMediumHigh
n =28,511No EDEDNo EDEDNo EDEDNo EDEDNo EDEDNo EDED
8,7505088,3421,7365,0902,9405,3961,35710,0672,5374,235935
  1. Multiple responses possible.

  2. Statistically significant difference at 95% confidence interval level between: *respondents with ED vs. without ED; and respondents with ED of stated income vs. those having low, medium, or §high income

  3. Household income: low ≤€20,000 or <£20,000; medium = €20,000–50,000 or £20,000–40,000; high ≥€50,000 or >£40,000 for respondents in France, Germany, Italy, and Spain, or UK, respectively.

  4. ED = erectile dysfunction

Comorbidities ever experienced
Cardiovascular conditions
Angina44547*58*59§47§35
Unstable angina/chest pains325*37*46*49§36§36
Arrhythmia42248*710*483948
Atherosclerosis10112*25*141413
Heart attack301*25*69*272726
High cholesterol1759*1830*2535*133115301633
Hypertension19510*1733*3245*133316381839
Intermittent claudication212*26*37*28§2615
Infections
Shingles3233346*343536
Ulcers (active/peptic stomach or duodenal213*25*34*25§24§23
Metabolic disorders
Diabetes (type 1 or 2)824*617*1423*622§619617
Thyroid condition324*25*35*252425
Neurological and psychiatric disorders
Alcoholism4310*411*24*512§3626
Respiratory conditions
Chronic bronchitis32336*45*462625
Chronic obstructive pulmonary disease201*13*34*25§1312
Other
Arthritis/arthrosis927*815*1520*923§615715
Dry eye547*46*56474657
Overactive bladder (dry)212*13*35*151425
Overactive bladder (wet)103*14*24*151313
Prostate cancer201*02*37*041515
Psoriasis547*57*56575668
Comorbidities experienced in the last 12 months
Allergies
Dermatitis235*3312*322322
Eczema4463423*454344
Food allergies348*3422443334
Hay fever1013141111771081081313
Nasal allergies91110987887109§87
Skin allergies5710*56*33655544
Gastrointestinal disorders
Chronic constipation21.173.37*1.434.33*1.894.43*25§2513
Diarrhea (frequent)5611*49*23*59§4535
Gastroesophageal reflux disease/acid reflux536*610*69*5951058
Heartburn212027*2332*1720*2127§21242123
Irritable bowel syndrome437*46*34*373545
Infections
Fungal infections of the skin/athlete's foot326*3434*353444
Nail fungus524*58*711*48510510
Metabolic disorders
Gout201*25*46*27§2524
Neurological and psychiatric disorders
Anxiety121327*1327*611*1523§1117816
Depression111027*1128*59*1428§815§713
Generalized anxiety disorder227*26*12*25§2413
Headache323744*3743*18183434§32283529
Insomnia141327*1428*915*1526§12201117
Migraine141720161867151215121210
Pain232127*2536*2024*2536§22272125
Panic disorder228*26*01*36§1312
Restless legs syndrome326*38*25*38§2625
Sleep difficulties201832*2140*1522*2234§18281728
Social anxiety disorder3310*310*13*510§2524
Respiratory conditions
Asthma57857*3468§5455
Other
Gingivitis337*35*2334§35§22

Healthcare Resource Use, Attitudes and Approaches to Healthcare, and Medication Use in Men with ED

Compared with men aged 18–39 years, men aged ≥60 years reported a closer relationship with their physician (older group: 55%; 1,617/2,940; younger group: 35%; 177/508; P = 0.0069); were more informed of the side effects of medicines (older group: 57%; 1,676/2,940; younger group: 40%; 203/508; P = 0.0236), and were more willing to take long-term medication to prevent potential future health problems (older group: 71%; 2,087/2,940; younger group: 40%; 203/508; P < 0.0001). Although men in the older age group reported more adherent attitudes in taking their medications with respect to their younger counterparts, they would prefer the medications to be combined into fewer pills (older group: 48%; 1,411/2,940; younger group: 38%; 193/508; P = 0.1986). Less than half of men with self-reported ED (48%; 2,465/5,184) had discussed their condition with their physician. Among these men, only 32% (788/2,465) were currently using ED medication. Both in younger (age ≤50 years) and older (age >50 years) men, most prescriptions were issued by primary care physicians, general practitioners or internists (57% and 64%, respectively), or urologists (29% in group aged ≤50 years and 28% in group aged ≤50 years, respectively). Among the subgroup who had consulted a physician about their ED but were not currently using an ED treatment and never had used medications in the past (739 men), nearly three quarters (72%, 534/739) had never been recommended a prescription treatment by their physician. This occurrence was highest in the middle-aged group (40–59 years, 81%, 170/213), followed by the oldest age group (≥60 years, 68%, 340/487) (P = 0.0516) and lowest in the younger age group (18–39 years, 64%, 24/39). A significant higher proportion (P < 0.01) of men older than 60 years (54% [1,580/2,940]) with ED discussed their condition with their physician with respect to younger respondents (28% [141/508] and 43% [744/1,736] of men with ED aged 18–39 and 40–59 years, respectively). Men with severe ED who were not taking medication for their condition had higher prevalence of high cholesterol (37%; 320/837), anxiety (20%; 168/837), depression (21%; 182/837), pain (36%; 314/837), sleep difficulties (32%; 282/837), and insomnia (23%; 184/837), than those who were taking ED medication (high cholesterol [28%; 108/363]; anxiety [20%; 71/363]; depression [20%; 76/363]; pain [31%; 127/363]; sleep difficulties [31%; 116/363], and insomnia [24%; 87/363]). Interestingly, men with ED were more likely to have a lower HRQoL and have higher work and activity impairment due to health than men without ED across all age-range categories (Table 3). The demographic profiles and HRQoL assessments of men using sildenafil, tadalafil, or vardenafil were similar. Tadalafil use was reported by the greatest proportion of respondents (47%), followed by sildenafil (32%) and vardenafil (19%) use. Tadalafil appeared to be used by men reporting less severe ED, whereas vardenafil tended to be used by men reporting more severe ED. On average, PDE5 inhibitors were used for 4 days per month over a period of 35.8 months. Overall, 43% of users were extremely or very satisfied with their medication. Tadalafil had the highest satisfaction rates (47% extremely/very satisfied), very close to that of film-coated vardenafil (44%) and then sildenafil (35%). Tadalafil was the PDE5 inhibitor most often specifically requested by patients (36%), followed by vardenafil (33%) and sildenafil (32%).

Table 3. Quality of life and impact on work and activity by population subgroup
 Total populationAgeRespondents with severe ED
18–39 years40–59 years≥60 yearsNo ED treatment usedED treatment used
No EDEDNo EDEDNo EDED
n =28,5118,7505088,3421,7365,0902,940837363
  1. *Statistically significant difference at 95% confidence interval level between respondents with ED vs. without ED, within each age-range category.

  2. Absenteeism, work time missed during the previous 7 days; presenteeism, impairment while working.

  3. ED = erectile dysfunction; SF-12v2 = 12-item Short-Form Health Survey, version 2.0 questionnaire; WPAI = Work Productivity and Activity Impairment questionnaire

SF-12v2, mean score
Mental domain47.846.3*39.748.3*42.952.0*49.946.848.2
Physical domain49.252.6*49.459.6*44.447.3*44.344.144.6
WPAI, mean %
Absenteeism5.25.011.6*4.46.9*4.46.16.58.9
Presenteeism15.515.830.3*13.419.4*10.517.1*18.024.3
Work productivity loss18.818.935.4*16.523.9*14.121.0*24.831.9
Activity impairment22.319.535.3*19.334.4*21.228.3*29.934.6

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

The current study using data from the NHWS considered multiple aspects of ED and included a subgroup of men aged 18–39 years, an age group so far not included in similar studies. Based on population projections, 21.7 million men in France, Germany, Italy, Spain, and the UK may experience ED. In addition to well-established underlying conditions, such as diabetes and hypertension, ED was associated with neurological and psychiatric comorbidities, decreased HRQoL, and impaired work productivity and activity. Half of all men with self-reported ED had not discussed their condition with their physician. Among those who had spoken to a physician, two thirds were not currently using PDE5 inhibitor therapy. In this survey of adult men across 5EU, 17% of respondents self-reported experiencing ED in the past 6 months. Published estimates of ED prevalence in Europe range from 8% to 48% [2,3,5,17,19,34,35]. Differences in survey approach and sample population account for some of the variations in estimated prevalence [3,35,36]; nevertheless, the rate in this survey falls well within the expected range, with the prevalence and severity of ED positively associated with age [2–5,17,35–37]. Interestingly, this study showed that 5% of men aged between 18 and 39 years (an age group that is seldom included in ED studies) had experienced ED in the past 6 months and therefore these findings confirm that a significant proportion of young men suffer from ED. Across all ages, men with ED reported a less healthy lifestyle and a higher comorbidity burden than men without ED. The associations of ED with cardiovascular disease, depression, diabetes, obesity, physical inactivity, and smoking are well documented [2,10,12,14,16,17,37,38]. In these subjects, neurological and psychiatric disorders were also prevalent among men with ED. As highlighted by Corona et al. [39,40], not only psychiatric disorders are associated with relational problems, but also free-floating anxiety symptoms are more pronounced in patients affirming to have difficulties in maintaining erection [39,40].

One of the most interesting findings drawn from this survey is that despite advances in ED treatment and widespread awareness of this condition, ED is still underdiagnosed and undertreated. In addition, a critical point remains the difficulty to individualize subjects not satisfying criteria for the diagnosis of ED [41], who may be diagnosed as affected by subclinical erectile dysfunction (SED).

In this study, more than half of the respondents have not discussed the condition with their physician, although men who were older or had more severe ED were more likely to consult their physician for advice [1,2,19,21–24,26–28,42]. Rates of help-seeking behavior appear to have changed little, despite greater public and physician awareness, perhaps in part due to the poor physician–patient relationship reported by the respondents in this survey. Even when men discussed their ED with a physician, the physician seldom recommended a therapy and treatment rates were low. These data are not surprising as the MALES study found similar results [2]. Mental and physical domains of HRQoL were both impaired in men with ED. Compared with those without ED, men with ED were frequently absent from work, and their general activity and work productivity were more affected by health problems [17,43,44]. These data have important implications as we found that men with ED also reported impaired HRQoL and work productivity. On the contrary, as shown in the current survey, men with severe ED who currently use PDE5 inhibitors have improved health and report lower impairment in HRQoL. Therefore, to provide the best care for their patients, physicians should proactively initiate discussions about sexual health when a man presents in the office for any reason, and discuss the range of treatment options. However, this survey also clearly demonstrates that there is the need to improve the degree of satisfaction regarding ED treatments. Although men taking a PDE5 inhibitor for their ED reported a certain degree of satisfaction with treatment (35%, 47%, and 44% of users were extremely or very satisfied with sildenafil, tadalafil, or vardenafil, respectively), about one half of patients show some levels of treatment dissatisfaction as already documented in other studies [27,28,45,46]. Interestingly, the average use of PDE5 inhibitors was lower than once per week. This supports the evidence that, in real life, despite questionable patients' preference, on-demand use may better fit both men's and couples' needs compared with chronic use. Furthermore, although our survey was not specifically aimed at investigating the patient's preference with respect to orodispersible tablet (ODT) formulation, literature suggests that difficulty in swallowing tablets and capsules may configure a negative factor in medication compliance [47,48]. Thus, the development of alternative drug delivery strategies such as ODTs has been promoted. In this regard, the use of this specific formulation is associated with improved medication compliance compared with traditional tablet formulations [49], and in some measure vardenafil ODT may present a potential opportunity for physicians to open up dialogue and maintaining therapeutic relationship as an essential foundation for ensuring patient compliance. This study has several potential limitations. The main limit is that this survey was not a longitudinal study, and no conclusions can be drawn about the relationship between any identified associations. Although distinguished literature indicates that single-question self-report accurately identifies subjects with clinically diagnosed ED when compared with International Index of Erectile Function [50], the ascertaining of ED without this tool is a significant limitation. However, the peculiarity of our survey was not to conduct a study on the prevalence of ED but to investigate the unmet needs of men with ED from the participants' point of view. Other aspects such as information regarding patients' hormonal data were not reported, making it impossible to evaluate any correlation with important clinical characteristics. In addition, the respondents were not asked whether they were concerned by ED, which may influence their help-seeking behavior including the presence of a stable relationship. However, previous studies have successfully used similar single-question approaches, and this may be preferable to longer questionnaires that have lower response rates [36]. While prevalence rates may vary according to the questionnaire used, health-related associations appear to be consistent [35,36]. Finally, the dropout/exclusion rate we reported could be interpreted as hugely large and could configure itself as a main limitation. However, we believe that the dropout/exclusion rate that we report is the result of a conservative approach in the selection of participants and the potential resulting bias has been largely overcome by the huge number of subjects studied.

Conclusions

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

The results of the current study from NHWS confirm that ED is still underdiagnosed and undertreated across Europe. In addition, men whose medical condition does not satisfy criteria for ED diagnosis are still not individualized and classified [41] as affected by SED. Many men with ED appear dissatisfied with their physician relationship and with the treatments available at the time of the survey (when the new vardenafil orodispersible was only available for a short time). New therapies that overcome some of the limitations of current treatments (e.g., those offering greater discretion or flexibility) may help to reduce the stigma that is often associated with ED, and encourage uptake of and continuation with therapy. Taken together, these data suggest that there is a need for a new therapeutic paradigm in ED management. Recognition and treatment of ED should be part of a multifactorial healthcare approach, enabling early diagnosis of underlying and comorbid conditions and leading to improved patient health and HRQoL.

Conflict of Interest: Emmanuele A. Jannini has relevant financial activity with Bayer, Besins, Ibsa, Janssen, Lilly, Menarini and Pfizer.

Statement of Authorship

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

Category 1

  • (a)
    Conception and Design
    Sylvia Keijzer; Britta Wiedemann
  • (b)
    Acquisition of Data
    Nikoletta Sternbach; Gina Isherwood
  • (c)
    Analysis and Interpretation of Data
    Nikoletta Sternbach; Gina Isherwood; Giovanni Luca Gravina; Emmanuele A. Jannini; Erika Limoncin; Giacomo Ciocca

Category 2

  • (a)
    Drafting the Article
    Giovanni Luca Gravina; Erika Limoncin; Giacomo Ciocca; Francesca Tripodi; Irene Petruccelli
  • (b)
    Revising It for Intellectual Content
    Emmanuele A. Jannini; Chiara Simonelli

Category 3

  • (a)
    Final Approval of the Completed Article
    Emmanuele A. Jannini; Chiara Simonelli; Nikoletta Sternbach; Erika Limoncin; Giacomo Ciocca; Giovanni Luca Gravina; Francesca Tripodi; Irene Petruccelli; Sylvia Keijzer; Gina Isherwood; Britta Wiedemann

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

Appendix I

  1. Top of page
  2. Abstract
  3. Introduction
  4. Aims
  5. Methods
  6. Main Outcome Measures
  7. Statistical Methods
  8. Results
  9. Discussion
  10. Conclusions
  11. Statement of Authorship
  12. References
  13. Appendix I

This section includes nonstandardized items utilized for the detention of information regarding sociodemographic characteristics, erectile dysfunction (ED), and health-related characteristics with patients' unmet needs.

Sociodemographic Characteristics

Sociodemographic information was determined by asking participants: What is your year of birth?; What is your marital status?; How many children under the age of 18 live in your household?; What is the size of the typical alcoholic beverage you drink?; Do you currently smoke cigarettes?; How many days in the past month did you exercise vigorously for at least 20 minutes for the purpose of improving or maintaining your health, with the purpose of losing weight, or for enjoyment?; Which of the following income categories best describes your total 2010 household income before taxes? Low, medium, and high household income was defined as follows: <€20,000; from €20,000 to €50,000 and >€50,000, for subjects living in France, Spain, Germany, and Italy, respectively. In UK, low, medium, and high household income was defined as follow: <£20,000; from £20,000 to £40,000: ≥£40,000.

ED

The self-reported presence of ED was evaluated using the question: In the past 6 months, have you had difficulty achieving/maintaining an erection? Participants were asked to rate their response using a Likert scale, with 1 corresponding to “not at all” and 5 to “a great deal.” Respondents had the option to select response choice 6 corresponding to “decline to answer” or 7 to “not applicable.” Respondents were classified into four groups according to their response: no ED (score = 1 or 2 corresponding to the past 6 months or did not report ED in the past 12 months), mild ED (score = 3), moderate ED (score = 4), or severe ED (score = 5).

Health-Related Characteristics and Unmet Needs

Information was determined by asking participants: Have you ever spoken with your doctor about erectile dysfunction?; Are you currently taking a prescription medication for your erectile dysfunction?; Who prescribes your erectile dysfunction medication?; Have you ever used a prescription medication to treat erectile dysfunction?; Has your doctor ever recommended a prescription medication to treat erectile dysfunction? (Please indicate which of the following prescription medications you currently use to treat erectile dysfunction); How many years and/or months have you been using these prescription medication(s)?; How many days did you use these prescription medication(s) in the past month?; Did you request this specific brand from your doctor?; How satisfied are you with these prescription medication(s)?