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0022-5347/05/1742-0662/0 Vol.

174, 662– 667, August 2005


THE JOURNAL OF UROLOGY® Printed in U.S.A.
Copyright © 2005 by AMERICAN UROLOGICAL ASSOCIATION DOI: 10.1097/01.ju.0000165389.73148.d1

Outcomes/Epidemiology/Socioeconomics

HEALTH ISSUES OF MEN: PREVALENCE AND CORRELATES OF


ERECTILE DYSFUNCTION
R. SHABSIGH,*,† M. A. PERELMAN,‡ D. C. LOCKHART,§ T. F. LUE㛳 AND G. A. BRODERICK¶
From the Department of Urology, Columbia University (RS) and Department of Psychiatry, Reproductive Medicine and Urology, New York
Weill Cornell Medical Center (MAP), New York, New York, Eli Lilly and Co. (DCL), Indianapolis, Indiana, Department of Urology,
University of California-San Francisco (TFL), San Francisco, California, and Department of Urology, Mayo Clinic College of Medicine
(GAB), Jacksonville, Florida

ABSTRACT

Purpose: The Cross-National Survey on Men’s Health Issues was a population based, interna-
tional survey of men using the health care systems of participating countries. The prevalence of
erectile dysfunction (ED) and its correlation with patient age, overall health and comorbidities
were assessed.
Materials and Methods: Men who were 20 to 75 years old in the United States, Germany,
United Kingdom, France, Italy and Spain were recruited to participate in the study. During visits
to physician offices participants completed a screening questionnaire about their overall health,
and problems with prostate, urination and penile erection. Men who reported ED completed a
followup questionnaire.
Results: A cohort of 28,691 men completed the screening questionnaire and provided their age.
Respondents in the oldest age group (70 to 75 years) were at 14-fold higher relative risk for ED
than respondents in the youngest age group (20 to 29 years). ED correlated positively with poor
overall health, and prostate and urinary problems. The prevalence of comorbid conditions
increased with ED severity. Only a small percent of men with ED (2% to 8%) were using nitrates
for comorbid cardiac disorders. Approximately 10% to 20% of men were on ␤-blockers.
Conclusions: The results of this survey are consistent with those of other population based
reports showing a high correlation between ED prevalence and patient age, and ED and lower
urinary tract symptoms. The prevalence of comorbidities, such as vascular conditions, increased
with ED severity, which may indicate that ED is a prognostic marker of overall health and an
important medical condition.
KEY WORDS: impotence, penis, questionnaires, age distribution, comorbidity

Erectile dysfunction (ED) was defined by a National Insti- ditions, certain medications, obesity and life-style behaviors, eg
tutes of Health consensus panel as the inability to achieve or alcohol and tobacco use.5 The Massachusetts Male Aging Study,
maintain an erection sufficient for satisfactory sexual perfor- which was the first large-scale, population based study of ED,
mance.1, 2 Worldwide estimates of ED prevalence are 2% in men indicated that ED prevalence correlated highly with age.6 This
younger than 40 years to 86% in men 80 years or older.3 The study also showed that ED correlated with other factors inde-
large variation in reported prevalence rates reflects differences pendent of age, such as heart disease, hypertension, diabetes
in methodology, ED definitions, regional and cultural percep- and low high density lipoprotein cholesterol.
tions of ED, study participant age and the extent of concomitant In a large, nationally represented claims database covering
medical conditions.3, 4 ED risk factors are aging, comorbid con- 51 health plans and 28 million lives from 1995 through 2002
in the United States Seftel et al found that hypertension,
Submitted for publication October 26, 2004. hyperlipidemia, diabetes and depression were prevalent in
Supported by a research grant from Lilly ICOS LLC, Bothell,
Washington and Indianapolis, Indiana. men with ED, suggesting that ED shares common etiological
* Correspondence and requests for reprints: College of Physicians risk factors with these comorbidities.7 Esposito et al reported
and Surgeons, Columbia University, Atchley Pavilion, Room 1123, that life-style changes, such as weight loss and increased
161 Fort Washington Ave., New York, New York 10032 (telephone:
212-305-0123; FAX: 212-305-0106; e-mail: RS66@columbia.edu). physical activity, were associated with improved sexual func-
† Financial interest and/or other relationship with Pfizer, AMS, tion in about a third of the men with ED.8
Solvay, Lilly ICOS, Bayer/GlaxoSmithKline, Genix and Johnson & Many diseases associated with ED appear to affect the
Johnson. vascular system, eg atherosclerosis, hypertension, lipid dis-
‡ Financial interest and/or other relationship with Alza, Pfizer,
Bayer/GlaxoSmithKline, Johnson & Johnson, Lilly ICOS, Sanofi- orders, myocardial infarction, cerebrovascular accidents, pe-
Aventis, Schering-Plough, OMP, Palatin and Proctor & Gamble. ripheral vascular disease and diabetes mellitus.5, 6 The erec-
§ Financial interest and/or other relationship with Eli Lilly. tile response involves a complex interaction between
㛳 Financial interest and/or other relationship with Pfizer, Bayer/ neurological, vascular, hormonal and cognitive processes. Ac-
GlaxoSmithKline, Lilly ICOS, NexMed and Genix.
¶ Financial interest and/or other relationship with Eli Lilly, cordingly disorders that impair processes common to those
Ortho-Urology, Pfizer, Mentor, AMS and Bayer/GlaxoSmithKline. that underlie the erectile mechanism, eg neural transmis-
662
HEALTH ISSUES OF MEN WITH ERECTILE DYSFUNCTION 663
sion, blood flow or smooth muscle response, may be predicted cord injury, ongoing feelings of depression and ongoing feel-
to have a role in ED.5 Recently considerable attention has ings of anxiety.
been given to the correlation between lower urinary tract Participants were recruited in 3 phases. In phase 1 men
symptoms (LUTS) and ED.9⫺11 LUTS, frequently caused by who presented to physicians in general practice, family prac-
benign prostatic hyperplasia, is an aggregate of related void- tice or general internal medicine were asked to complete the
ing symptoms, including urinary frequency, urgency, noctu- screening questionnaire while in the waiting room of the
ria and slow stream. Although the pathophysiological link physician office. Phase 1 questionnaires were used to esti-
between LUTS and ED is not understood, findings in several mate the overall prevalence of ED in this population of men.
studies suggest that LUTS is a risk factor for ED indepen- In this phase it was necessary for men to provide their names
dent of age and other comorbidities.9, 11 and addresses to be sent the followup questionnaire. The
The Cross-National Survey on Men’s Health Issues was a followup questionnaire was then mailed to current or former
population based, international survey of men that asked respondents with ED who indicated a willingness to complete
about their health issues. The objectives of the survey were to this more detailed questionnaire. However, many initial par-
investigate the prevalence of ED, evaluate treatment seeking ticipants were reluctant to provide contact information on a
behaviors in these men, assess their attitudes toward the survey of such a personal nature. Consequently in study
condition and identify the barriers and motivators to seeking phase 2 men with self-reported ED based on the screening
treatment for ED. The study was unique, in that it primarily questionnaire were asked to complete the followup question-
measured the prevalence of ED in men who use health care naire while in the physician office, which permitted them to
systems. complete the questionnaire anonymously.
The treatment seeking behaviors of men with ED have Although phase 1 and 2 recruitment procedures were gen-
been reported previously12 and the results of this report erally effective, recruiting men with ED through general
confirm other population based reports showing that only a practitioners proved to be more difficult than anticipated in 4
minority of men with ED seek treatment. Common barriers of the 6 countries. Therefore, phase 3 was initiated, during
are the belief that the condition would resolve without treat- which men in Germany, Italy and Spain were recruited from
ment (primarily younger men) and the perception that ED is urologist offices, while men in France were recruited on the
a normal part of aging (primarily older men). This report street. Overall 51% of followup questionnaires were collected
focuses on the association of ED with age, overall health and in phase 1, 18% were collected in phase 2 and 31% were
comorbidities, such as hypertension, hyperlipidemia, diabe- collected in phase 3. Questionnaires with fewer than 50% of
tes, depression and LUTS. the questions answered were not included in the evaluation.
Approximately 8% of the questionnaires were not evaluable.
The OR was calculated to assess the prevalence of ED by
MATERIALS AND METHODS
age, overall health, and prostate and urinary problems. All
significance testing was performed at the 95% CI. Data on
Men 20 to 75 years old were recruited to participate in the each respondent were weighted as the reciprocal of the num-
Cross-National Survey on Men’s Health Issues. The sample ber of times in the previous 12 months that the respondent
population was unique, in that it comprised a subset of men had reported visiting the physician office where he was re-
using the health care systems of participating countries. The cruited. This weighting scheme was used to adjust for the
survey used a common method to examine the epidemiology fact that men who more frequently visited the office of their
of ED across 6 countries. Recruitment was geographically physician were more likely to be recruited into the survey.
distributed, representing 22 regions in the United States, 4
in Germany, 6 in the United Kingdom, 11 in France, 16 in RESULTS
Italy and 7 in Spain.13 The survey was done from March to
September 2000 by a medical marketing research firm in A total of 28,691 men completed the screening question-
accordance with the code of conduct of the Council of Amer- naire (the section on ED) and provided their age in phase 1
ican Survey Research Organizations, and the European So- (table 1). The overall prevalence of self-reported ED across all
ciety of Opinion and Marketing Research. age groups in this sample was 19%. Rates were lower in
The survey was done in 2 stages. In stage 1 a short screen- Spain (12%) and France (13%) than in the United States,
ing questionnaire designed to mask the intent of investiga- Germany, Italy and the United Kingdom (19% to 25%) (fig.
tors to learn about ED sought general information about 1). The number of men who reported previous or current ED
participant perceptions of their overall health (excellent, increased with age in all countries surveyed.12 ED was re-
good, fair or poor), prostate problems, difficulty controlling ported by fewer than 10% of men younger than 40 years
urination and ED. The ED status of participants was deter- across all countries. In men 70 to 75 years old the prevalence
mined based on their responses to the item, difficulty getting was 39% to 73%.
or keeping an erection. Possible responses were 1—never had Figure 2 shows respondent ratings of overall health and
it, 2— had it before but not now, 3— have it now sometimes LUTS. The prevalence of urinary problems was 7% to 12%
across the 6 countries. Prostate problems were slightly more
and 4 — have it now always. Participants who selected re-
frequent at 8% to 16%. The rate of self-reported fair to poor
sponse 2 were classified as former ED individuals and those
who selected responses 3 or 4 were classified as current ED
individuals. Participants who selected response 1 did not
report ED and, therefore, they were not evaluated further. TABLE 1. Respondents
In stage 2 a followup questionnaire based on the Interna- No. Questionnaire
tional Index of Erectile Function (IIEF)14 was used to confirm Screening* Followup†
ED in men from stage 1 and examine the association of ED
United States 6,474 866
with other comorbid conditions in men who were classified as France 3,852 417
current or former ED individuals according to their re- Germany 3,289 395
sponses to the screening questionnaire. Based on the findings Italy 5,400 382
of previous studies5, 6, 15 the comorbidities assessed in this Spain 5,054 380
United Kingdom 4,622 391
survey were high blood pressure (hypertension), hardening of
the arteries (atherosclerosis), heart trouble, including an- Totals 28,691 2,831
gina, heart attack or heart surgery, high cholesterol, diabe- * Completed the ED section and provided information on age.
† Excluding questionnaires with fewer than 50% of questions answered.
tes, enlarged prostate (not cancer), prostate cancer, spinal
664 HEALTH ISSUES OF MEN WITH ERECTILE DYSFUNCTION

health was progressively positive with respondents who re-


ported poor health at 5-fold higher risk for ED than respon-
dents reporting excellent health. Respondents with prostate
and urinary symptoms were at 2-fold greater risk for ED
than those without these symptoms.
Additional information about comorbidities was collected
from responses on the followup questionnaire. The followup
questionnaire was sent to the 4,622 subjects in phase 1 of the
study, of whom 1,577 returned a completed questionnaire,
yielding an overall return rate of 34%. Followup question-
naires were completed by 564 men in phase 2 and by 952 in
phase 3. Of the 3,093 followup questionnaires obtained in the
3 phases 2,831 (92%) were evaluable, ie more than 50% of the
questions were answered. Table 1 shows the distribution of
evaluable followup questionnaires by country.
Table 3 lists select demographic, life-style and medical
characteristics in respondents with evaluable followup ques-
FIG. 1. Percent of men with previous or current ED by country. tionnaires. Of men who were classified with ED based on the
Data include men who completed screening questionnaire at primary
care physician/general practitioner offices only. IIEF mean age was similar in all countries (51 to 58 years)
and the majority of men were married or living with a part-
ner (73% to 80%). The percent of respondents on nitrates was
low across participants in all countries surveyed (2% to 8%),
whereas the use of ␤-blockers was 10% to 22%. The percent of
smokers in the study population was higher in Italy, France,
Spain and Germany (37% to 54%) than in the United States
(22%) or United Kingdom (18%).
The most frequently reported comorbidities in men with
ED across all countries surveyed were high blood pressure
and high cholesterol at about 20% for each in France and
Spain to more than 40% for each in the United States (table
4). In Italy the rate of high blood pressure in respondents also
exceeded 40%. An enlarged prostate unrelated to cancer was
another frequent comorbidity, affecting at least 20% of men
in the United States, Germany and Italy. Men in the United
Kingdom and Italy reported the highest levels of ongoing
feelings of anxiety (28% and 30%), whereas men in the
United States and United Kingdom reported the highest
rates of depression (17% and 18%, respectively). Diabetes
was most frequent in Italy (20%), whereas cardiovascular
disease was highest in the United States and United King-
FIG. 2. Prevalence of fair or poor overall health and LUTS (pros- dom (each 18%).
tate and urinary problems) in screened men by country. Data include
men who completed screening questionnaires at primary care phy- The prevalence of ED comorbidities was associated with ED
sician/general practitioner offices only. severity and with age. The assessment of correlations between
comorbidities and ED severity was based on the IIEF scale.12
Some men in the study sample did not have ED, as evaluated by
overall health was higher in Germany, Spain, Italy and the the IIEF definition, although all respondents had ED as deter-
United Kingdom (28% to 36%) than in France (20%) and mined by self-report. Table 5 shows that the prevalence of all
the United States (14%). ED was significantly associated comorbidities tended to increase with ED severity. A similar
with age, overall health and LUTS (table 2). The prevalence correlation between comorbidity and ED severity was observed
of ED progressively increased with advancing age with re- when severity was assessed by self-report (data not shown).
spondents in the oldest age group at 14-fold higher relative Table 6 shows that the occurrence rates of most comorbidities
risk for ED than respondents in the youngest age group. increased with age. High blood pressure and high cholesterol
Similarly the correlation between ED and increasingly poor were rare (less than 15% of respondents) until men were in the
fifth decade of life. In the 70 to 75-year-old group almost half of
the men reported high blood pressure and more than 40%
reported high cholesterol. Comorbid anxiety, depression or spi-
TABLE 2. Association of ED with age, overall health and LUTS nal cord injury did not appear to correlate with age.
Variable OR 95% CI
Age:
DISCUSSION
30–39 1.4 1.1–1.7
40–49 2.5 2.0–3.2 The Cross-National Survey on Men’s Health Issues is dif-
50–59 5.0 4.1–6.3
60–69 9.1 7.3–11.4
ferent from other population based epidemiological surveys,
70–75 14.0 10.9–18.2 in that it primarily measures ED prevalence in men who use
Overall health: health care systems. Current or former individuals with ED
Good 2.0 1.8–2.5 comprised 19% of the population in this study, which is
Fair 3.0 2.5–3.6
Poor 5.1 3.8–6.5
consistent with reports in other population based surveys,3, 4
Problems: yielding an overall worldwide ED prevalence rate of 19%. Age
Prostate 2.0 1.8–2.5 was the primary variable that correlated with ED in this
Urinary 2.1 1.9–2.7 study. Respondents in the oldest age group (70 to 75 years)
The reference response for each variable was age—20 to 29 years, overall were at 14-fold higher relative risk for ED than respondents
health— excellent, prostate problems—none and urinary problems—none.
in the youngest age group (20 to 29 years). Across the 6
HEALTH ISSUES OF MEN WITH ERECTILE DYSFUNCTION 665

TABLE 3. Subject characteristics


United States France Germany Italy Spain United Kingdom
No. subjects 866 417 395 374 370 389
Mean age 58.4 50.7 53.5 55.4 50.7 56.9
No. marital status: 860 411 391 381 378 388
% Single, never married 7 12 10 12 15 7
% Married or living together 80 77 73 74 75 80
% Widower 2 2 3 6 3 2
% Divorced or separated 12 10 14 8 7 11
No. sexual partner: 857 406 378 378 372 386
% Yes 86 92 85 91 86 87
% No 15 8 15 9 14 13
No. nitrates (%) 846 (6) 405 (2) 378 (4) 356 (3) 378 (3) 370 (8)
No. ␤-blockers (%) 842 (22) 401 (11) 384 (17) 363 (13) 376 (10) 374 (20)
No. smoking status: 856 409 393 380 374 380
% Smoker 22 50 37 54 45 18
% Nonsmoker 78 50 63 46 55 82
Respondents who completed an evaluable followup questionnaire.

TABLE 4. Subjects with comorbidities by country


% Respondents
United States France Germany Italy Spain United Kingdom

No. subjects 856 407 388 380 377 382


High blood pressure 43 20 29 42 21 33
High cholesterol 43 19 35 31 20 20
Enlarged prostate, not Ca 20 6 25 32 18 7
Heart trouble, including angina 18 8 14 8 5 18
Ongoing anxiety feelings 17 20 7 30 14 28
Diabetes 17 6 11 20 6 15
Ongoing depression feelings 17 6 9 12 6 18
Heart attack or heart surgery 17 7 8 6 4 16
Hardening of arteries 7 6 11 13 6 5
Spinal cord injury 3 10 1 2 9 5
Prostate Ca 2 2 1 3 1 1
Respondents with ED who completed an evaluable followup questionnaire.

TABLE 5. Subjects with comorbidities by ED severity


% ED Severity
None Mild Mild/Moderate Moderate Severe

No. subjects 355 849 718 344 196


High blood pressure 24 25 32 42 39
High cholesterol 20 25 27 35 38
Enlarged prostate, not Ca 10 16 16 23 26
Heart trouble, including angina 3 7 10 16 34
Ongoing anxiety feelings 13 15 18 19 18
Diabetes 11 8 11 16 24
Ongoing depression feelings 8 8 12 12 12
Heart attack or heart surgery 4 7 8 13 29
Hardening of arteries 3 6 7 10 13
Spinal cord injury 3 5 5 3 5
Prostate Ca 0 1 1 1 0
Respondents with ED who completed an evaluable followup questionnaire and severity assessed by IIEF.13

countries ED prevalence rates increased from 4% to 6% in hypertension and a history of pelvic operations. Similarly the
men younger than 40 years to 39% to 73% in respondents 70 results of the Multinational Survey of the Aging Male-7, done
to 75 years old. These findings are consistent with those of in approximately 14,000 men in the United States and in 6
another population based study.3 European countries (United Kingdom, France, Germany, The
Information on the screening questionnaire allowed us to Netherlands, Italy and Spain), showed that ED was strongly
assess the correlation between self-reported ED and overall associated with LUTS severity independent of age and vas-
health. The results of the analysis showed a significant pos- cular related comorbidities (p ⬍0.001).9
itive correlation between ED and increasingly poor health The followup questionnaire that was completed by men
with respondents reporting poor health at 5-fold higher risk who reported ED included several items related to demo-
for ED than respondents reporting excellent health. graphics, comorbidities and medication use. The most fre-
The results of the screening analysis also showed a signif- quently reported comorbidities in this sample population of
icant association between ED and LUTS, which is consistent men in the health care system were hypertension and hyper-
with findings in other studies. For example, the results of the lipidemia. However, the prevalence of comorbidities varied
Cologne Male Survey of 8,000 men in Germany revealed that among countries. Fewer men in France and Spain reported
the prevalence of LUTS was approximately 72% in men with comorbid high blood pressure, high cholesterol or heart trou-
ED vs 38% in men without ED (OR 2.11).11 Multivariate ble than in the other countries. In the United Kingdom fewer
analyses showed that the association of LUTS with ED was men reported high cholesterol, while in Italy fewer men re-
independent of age and other comorbidities, such as diabetes, ported heart trouble. Diabetes was cited by a large number of
666 HEALTH ISSUES OF MEN WITH ERECTILE DYSFUNCTION

TABLE 6. Subjects with comorbidities by age


% Age Group
20–29 30–39 40–49 50–59 60–69 70–75

No. subjects 75 252 482 751 837 370


High blood pressure 4 9 17 37 45 49
High cholesterol 1 12 27 32 38 42
Enlarged prostate, not Ca 0 2 3 18 31 35
Heart trouble, including angina 0 2 3 11 19 31
Ongoing anxiety feelings 15 20 22 20 19 15
Diabetes 1 4 7 14 19 20
Ongoing depression feelings 9 16 12 15 10 10
Heart attack or heart surgery 1 0 3 10 16 24
Hardening of arteries 0 0 3 6 12 18
Spinal cord injury 4 3 6 6 4 4
Prostate Ca 0 0 0 1 2 6
Respondents with ED who completed an evaluable followup questionnaire.

men as a frequent comorbidity. These findings are consistent Conversely the presence of ED should alert practitioners to
with reports of other population based surveys.6, 7, 15–17 In the likelihood of common comorbidities. Many of these con-
the Massachusetts Male Aging Study total serum cholesterol ditions, eg hypertension, hyperlipidemia and diabetes, are
did not correlate with ED prevalence but high density li- frequently silent or have nonspecific symptoms. The greater
poprotein cholesterol inversely correlated with ED.6 The the severity of ED, the greater the likelihood that 1 of these
prevalence of ED comorbidities in our survey increased with conditions is present. Therefore, treating ED becomes an
increasing ED severity when severity was based on IIEF or opportunity for clinicians to detect these serious comorbid
self-report. Except for anxiety, depression and spinal cord diseases and perhaps motivate patients to improve their
injury comorbidity rates increased with age. self-care.19, 20
Some epidemiological differences among countries may Men with comorbid conditions, such as vascular diseases
have been secondary to demographic differences among sam- and LUTS, should be screened for ED and men with ED
ple groups. For example, men in the United States who should be screened for comorbid conditions commonly seen in
participated in the survey were older and more educated, and patients with ED. The results of this and similar surveys will
had higher incomes than men in other countries.12 These improve the identification, disease management and treat-
demographic differences could have affected the number and ment paradigms for ED. Practitioners and educators will
types of comorbid conditions reported in the study. A detailed make a significant contribution to male health by paying
discussion of cross-national differences has been presented attention to sexual health in diagnosis and treatment.
previously.12, 18
Approximately 10% to 20% of men with ED in this study CONCLUSIONS
were on ␤-blockers. Compared with the general public the
relatively high percent of ␤-blocker users in this study, espe- The Cross-National Survey on Men’s Health Issues is a
cially in the United States, probably resulted from the high population based epidemiological survey of men who use the
rate of comorbid hypertension in men with ED.7 Further- health care system. Consistent with other population based
more, because survey participants were recruited from reports, this study shows a high correlation between ED
within the health care system, they were more likely to be prevalence and age, and an association of ED with comor-
receiving treatment for comorbid hypertension than similar bidities such as vascular diseases and LUTS. ED severity is
men not in the health care system. Only a small percent of also a prognostic marker of important medical conditions.
men with ED (2% to 8%) were using nitrates for comorbid This strong association provides an opportunity for optimiz-
cardiac disorders, which is important because many men ing patient care by screening men for overall health and
with ED receive phosphodiesterase type 5 inhibitors as first comorbid conditions when the diagnosis of ED is made. Like-
line therapy and this class of agents is contraindicated with wise practitioners have an opportunity to overcome barriers
nitrate use. to the discussion and treatment of ED by inquiring about the
As in all epidemiological studies, biases were inherent in possibility of ED in middle-aged and older men who present
the survey methodology and data analyses. Analyses per- with vascular diseases or LUTS. In this sense ED may be
formed on the data were post hoc and exploratory. As ex- considered the portal to male health.
pected, given the sensitivity of the subject matter and the
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