RESEARCH INSTRUMENTS FOR THE DIAGNOSIS AND

TREATMENT OF PATIENTS WITH ERECTILE DYSFUNCTION

RAYMOND C. ROSEN, STANLEY E. ALTHOF,

AND

FRANOIS GIULIANO

ABSTRACT
As the incidence and prevalence of erectile dysfunction (ED) increase, healthcare providers will require
robust, accurate, and efficient tools for appropriately diagnosing and treating patients with ED. Moreover,
clinicians will need effective follow-up tools that assess treatment efficacy and satisfaction, to help patients
meet their expectations for successful treatment of ED. We provide a summary of some of the most
commonly used instruments for the diagnosis and assessment of ED treatment efficacy that will be referred
to in this supplement. UROLOGY 68 (Suppl 3A): 616, 2006. 2006 Elsevier Inc.

nstruments based on patient self-report, such as

self-administered questionnaires, event logs,
and patient diaries, have become widely accepted
and are frequently used tools for the diagnosis of
erectile dysfunction (ED) and the assessment of
ED treatment efficacy.1 Early tools that were used
to explore the pathophysiology of ED included penile plethysmography, Doppler sonography, color
duplex Doppler ultrasound, dynamic infusion cavernosometry and cavernosography, and nocturnal
penile tumescence monitoring (RigiScan; Dacomed Corporation, Minneapolis, MN), with or
without visual sexual stimulation. These techniques may have helped one to discern the cause of
ED, and perhaps to identify underlying vascular
health issues, but they required specialized equipment and personnel, some were invasive, and most
were costly. Patient-reported assessments of erectile function (EF) offer several advantages over instruments that use physiologic measures: They are
not invasive, are easy to use, are cost-effective, and
have favorable reliability and validity, the latter of
which has been established through formal psychometric validation, which remains the hallmark
From the Robert Wood Johnson Medical School, Piscataway, New
Jersey, USA (RCR); Center for Marital and Sexual Health of
South Florida, West Palm Beach, Florida, USA (SEA); and Hpital de Bictre, Cedex, France (FG).
Raymond C. Rosen is a paid consultant to, and study investigator funded by, Pfizer Inc. Stanley E. Althof and Franois Giuliano are paid consultants to, meeting participants and lecturers
for, and study investigators partially funded by, Pfizer Inc.
Reprint requests: Raymond C. Rosen, PhD, Department of Psychiatry, Center for Sexual and Marital Health, UMDNJRobert
Wood Johnson Medical School, 125 Old Chemistry Building, Piscataway, NJ 08854-5635. E-mail: rosen@umdnj.edu.
2006 ELSEVIER INC.
6

ALL RIGHTS RESERVED

of questionnaire development. Validated measures

have convincingly demonstrated not only the functional outcomes but also the emotional and social
consequences of ED and the benefits of effective
ED treatment. Patient-kept diaries and event logs
can be readily used outside of clinical research;
entries in diaries and logs in clinical practice settings can provide information on everyday sexual
activity. This review explains the most common
patient-centered instruments of EF and satisfaction that have been used in the studies discussed in
this supplement to promote a clear understanding
of the methods of clinical trials and data that they
have provided.
INTERNATIONAL INDEX OF ERECTILE
FUNCTION
During the early course of clinical development of
sildenafil citrate (Viagra; Pfizer Inc, New York, NY),
few easy-to-use tools were available for measuring
ED in clinical studies. In recognition of this need, and
in response to the National Institutes of Health (NIH)
Consensus Conference recommendation for improved methods of assessing ED treatment outcomes,2 Pfizer Inc developed an initial version of the
International Index of Erectile Function (IIEF) questionnaire, which was successfully used in early phase
2 trials. With the help of an international panel of
experts, who further refined and validated the questionnaire, the final version of the IIEF was generated.3 The IIEF is the most commonly used instrument in clinical trials of ED treatment. The validity,
reliability, specificity, and responsiveness of this
questionnaire have been well established through rig0090-4295/06/$32.00
doi:10.1016/j.urology.2006.05.046

TABLE I. International Index of Erectile Function questionnaire*

Q1: How often were you able to get an erection during sexual activity?
0 No sexual activity; 1 Almost never/never; 2 A few times (much less than half the time); 3 Sometimes
(about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q2: When you had erections with sexual stimulation, how often were your erections hard enough for penetration?
0 No sexual activity; 1 Almost never/never; 2 A few times (much less than half the time); 3 Sometimes
(about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q3: When you attempted sexual intercourse, how often were you able to penetrate (enter) your partner?
0 Did not attempt intercourse; 1 Almost never/never; 2 A few times (much less than half the time); 3
Sometimes (about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q4: During sexual intercourse, how often were you able to maintain your erection after you had penetrated
(entered) your partner?
0 Did not attempt intercourse; 1 Almost never/never; 2 A few times (much less than half the time); 3
Sometimes (about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q5: During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?
0 Did not attempt intercourse; 1 Extremely difficult; 2 Very difficult; 3 Difficult; 4 Slightly difficult;
5 Not difficult
Q6: How many times have you attempted sexual intercourse?
0 No attempts; 1 1 to 2 attempts; 2 3 to 4 attempts; 3 5 to 6 attempts; 4 7 to 10 attempts; 5
11 attempts
Q7: When you attempted sexual intercourse, how often was it satisfactory for you?
0 Did not attempt intercourse; 1 Almost never/never; 2 A few times (much less than half the time); 3
Sometimes (about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q8: How much have you enjoyed sexual intercourse?
0 No intercourse; 1 No enjoyment; 2 Not very enjoyable; 3 Fairly enjoyable; 4 Highly enjoyable;
5 Very highly enjoyable
Q9: When you had sexual stimulation or intercourse, how often did you ejaculate?
0 No sexual stimulation/intercourse; 1 Almost never/never; 2 A few times (much less than half the time);
3 Sometimes (about half the time); 4 Most times (much more than half the time); 5 Almost
always/always
Q10: When you had sexual stimulation or intercourse, how often did you have the feeling of orgasm or climax?
0 No sexual stimulation/intercourse; 1 Almost never/never; 2 A few times (much less than half the time);
3 Sometimes (about half the time); 4 Most times (much more than half the time); 5 Almost
always/always
Q11: How often have you felt sexual desire?
1 Almost never/never; 2 A few times (much less than half the time); 3 Sometimes (about half the time);
4 Most times (much more than half the time); 5 Almost always/always
Q12: How would you rate your level of sexual desire?
1 Very low/none at all; 2 Low; 3 Moderate; 4 High; 5 Very high
Q13: How satisfied have you been with your overall sex life?
1 Very dissatisfied; 2 Moderately dissatisfied; 3 About equally satisfied and dissatisfied; 4 Moderately
satisfied; 5 Very satisfied
Q14: How satisfied have you been with your sexual relationship with your partner?
1 Very dissatisfied; 2 Moderately dissatisfied; 3 About equally satisfied and dissatisfied; 4 Moderately
satisfied; 5 Very satisfied
Q15: How do your rate your confidence that you could get and keep an erection?
1 Very low; 2 Low; 3 Moderate; 4 High; 5 Very high
*All questions are preceded by the phrase Over the past 4 weeks. . . .

orous psychometric testing, and this instrument has

become the gold standard for evaluating the efficacy of therapeutic intervention in clinical trials of
patients with ED.4 The IIEF is brief and reliable and
can be used cross-culturally; it is sensitive enough to
reflect changes in EF produced by ED treatment and
yet is not unduly cumbersome.
The IIEF has been validated in 32 languages.4 It
contains 15 items that are divided into 5 unique
domains: Erectile Function (question [Q]1 to Q5
and Q15), Intercourse Satisfaction (Q6 to Q8), OrUROLOGY 68 (Supplement 3A), September 2006

gasmic Function (Q9 to Q10), Sexual Desire (Q11

to Q12), and Overall Satisfaction (Q13 to Q14)
(Table I). Subjects are instructed to respond to
each item on the basis of their sexual experiences
over the previous 4 weeks. Q1 to Q10 are scored on
a 6-point Likert-type scale; a response option of
0 signifies a complete lack of sexual activity. Q11
to Q15 are scored on a 5-point scale. Lower scores
on the IIEF indicate more severe ED.
The IIEF has been used as a measure of treatment
efficacy throughout the sildenafil clinical trial pro7

TABLE II. Sexual Health Inventory for Men (SHIM)

Over the past 6 months:
1. How do you rate your confidence
that you could get and keep an
erection?

1 Very low

0 No sexual
2. When you had erections with
activity
sexual stimulation, how often
were your erections hard enough
for penetration?

2 Low

3 Moderate

4 High

5 Very high

1 (Almost never/ 2 (A few times, ie, much 3 (Sometimes, ie, about 4 (Most times, ie, much 5 (Almost always/
half the time)
more than half the
always)
never)
less than half the
time)
time)

UROLOGY 68 (Supplement 3A), September 2006

3. During sexual intercourse, how

often were you able to maintain
your erection after you had
penetrated (entered) your
partner?

0 (Did not attempt 1 (Almost never/ 2 (A few times, ie, much 3 (Sometimes, ie, about 4 (Most times, ie, much 5 (Almost always/
intercourse)
never)
less than half the
half the time)
more than half the
always)
time)
time)

4. During sexual intercourse, how

difficult was it to maintain your
erection to completion of
intercourse?

0 (Did not attempt 1 (Extremely

intercourse)
difficult)

5. When you attempted sexual

intercourse, how often was it
satisfactory for you?

0 (Did not attempt 1 (Almost never/ 2 (A few times, ie, much 3 (Sometimes, ie, about 4 (Most times, ie, much 5 (Almost always/
intercourse)
never)
less than half the
half the time)
more than half the
always)
time)
time)

2 (Very difficult)

3 (Difficult)

Total Score*
*Add the numbers corresponding to questions 15. If your score is 21 or less, you may be showing signs of erectile dysfunction and may want to speak with your doctor.

4 (Slightly difficult)

5 (Not difficult)

gram. It is now considered the gold standard

among patient-centered measures of ED and is universally accepted by regulatory agencies and scientific journals. Notably, the IIEF is a highly versatile
instrument that has been used successfully, regardless of the cause of ED57 or associated comorbidities,8 11 cultural background,1219 or therapeutic
interventions.20 23
The IIEF was not designed to evaluate sexual
dysfunctions other than ED. For instance, it was
not designed to provide a detailed classification of
orgasmic and sexual desire disorders. Although the
IIEF is multidimensional, it should be used when
assessment of EF outcome is the primary goal.
Moreover, the IIEF assesses a patients sexual experience only during the previous 4 weeks. A single administration of the IIEF cannot provide the
depth of information that a patients comprehensive medical history can yield, but the instrument
may be administered an unlimited number of
times. Finally, a patients IIEF score can be influenced by factors other than EF. For example, low
IIEF scores may reflect a lack of opportunity for
sexual activity (a rare occurrence, according to the
design of most ED studies), extremely low sexual
desire, or partner sexual dysfunctions, such as hypoactive sexual desire disorder, rather than male
sexual dysfunction.
SEXUAL HEALTH INVENTORY FOR MEN
Whereas the IIEF is the gold standard measure
for the assessment of EF and is a crucial tool in
clinical research, it is not ideal for use in clinical
practice because of its length. Therefore, a 5-item
abridged version of the IIEF, the Sexual Health
Inventory for Men (SHIM), also known as the IIEF5,24,25 was developed and is commonly used in
clinical practice settings as an efficient and accurate screening tool to identify the presence and
severity level of ED (Table II).
The SHIM was generated through an analysis of
pooled IIEF data from patients who were enrolled
in 4 multicenter, double-blind, placebo-controlled
phase 3 clinical trials of sildenafil.24,25 Healthy men
with no history of ED were recruited separately
from a community outpatient center as control
subjects. Items were chosen for the SHIM in accordance with the Classification and Regression Trees
(CART) software ranking system (Salford Systems,
San Diego, CA) and on close adherence to the NIH
Consensus Conference definition of ED. Questions
included in the SHIM address erection firmness
(IIEF Q2), maintenance frequency (IIEF Q4),
maintenance ability (IIEF Q5), erection confidence (IIEF Q15), and intercourse satisfaction
(IIEF Q7); all of these directly reflect the NIH definition of ED. Patients are instructed to complete
UROLOGY 68 (Supplement 3A), September 2006

the SHIM according to their sexual experiences

over the previous 6 months. Lower scores are indicative of more severe ED, and a lack of sexual
activity is represented by a response of 0.
The grading of SHIM for diagnosis of the presence and severity of ED came from its original validation: normal EF (no ED) 22 to 25, mild ED
17 to 21, mild-to-moderate ED 12 to 16, moderate ED 8 to 11, and severe ED 1 to 7 (5 to 7 if
subject did not have the opportunity to engage in
sexual activity and intercourse). In a separate validation study that was based on an independent
body of clinical trials of sildenafil,24 SHIM scores
correlated strongly and as expected with patient
self-assessments of ED severity, both before and
after treatment, and with scores on the Erectile
Dysfunction Inventory of Treatment Satisfaction
(EDITS, see below). The SHIM, however, was
found to have better reliability than a 1-item selfassessment of ED severity.24 Limitations of the
SHIM are similar to those of the IIEF: Low scores
on the SHIM do not distinguish between ED and
minimal sexual desire, lack of opportunity for sexual activity, or partner sexual dysfunctions. Thus,
clinicians should include patient interviews to rule
out these possibilities in patients with low SHIM
scores. The SHIM was designed primarily to diagnose the presence and severity of ED in clinical
practice, or as part of inclusion criteria in a clinical
trial. A 5-year review on the SHIM revealed that it
is a useful, quick, and inexpensive tool that can be
used to complement clinical judgment for the diagnosis, treatment, and management of ED.26
ERECTILE FUNCTION DOMAIN
OF THE INTERNATIONAL INDEX OF
ERECTILE FUNCTION
The EF domain of the IIEF consists of 6
itemsQ1 to Q5 and Q15 (Table III)that are
sensitive to ED treatment.3,4 It is used in clinical
research settings, in which the focus is on the measurement of EF and treatment efficacy. Scores on
the IIEF EF domain are commonly used as a primary or secondary clinical end point in trials of ED
therapies. Similar to responses to questions on the
IIEF, responses to IIEF EF domain questions refer
to the previous 4 weeks. Individual items on the
IIEF EF domain address erection frequency, hardness, penetration ability, frequency of maintained
erections, ability to maintain erections, and confidence in ability to achieve and maintain an erection.
Although this is not its primary purpose, the IIEF
EF domain is a valuable tool that can be used to
efficiently and conveniently diagnose ED and to
classify ED severity,27,28 thereby fulfilling an important need recognized by the NIH Consensus
9

Conference. The cutoff score for the diagnosis of

ED and the classification system of ED severity
were determined through analysis of baseline data
of patients from 4 pivotal multicenter, doubleblind, placebo-controlled, phase 3 clinical trials of
sildenafil with the use of CART statistical software.28 Further validation was obtained in an independent investigation in which patient scores on
the IIEF EF domain were correlated strongly with
their own self-assessment of ED severity, both at
baseline and after 12 weeks of treatment with sildenafil.27 Similar to the SHIM, the IIEF EF domain
was found to have better reliability than a 1-item
self-assessment of ED severity,27 and like its parent
instrument, the IIEF EF domain is versatile
enough to be used cross-culturally, in patients with
ED of diverse causes, and with a variety of therapeutic interventions.
The IIEF EF domain has a maximum possible
total score of 30. Although the IIEF EF domain was
designed to measure treatment efficacy, this score
can also be used to determine ED severity: normal
EF (no ED) 26, mild ED 22 to 25, mild-tomoderate ED 17 to 21, moderate ED 11 to 16,
and severe ED 10.28 It should be noted, however,
that a perfect score of 30the upper bound for
healthy men without EDis unlikely. In a study of
109 healthy men without ED, the mean IIEF EF
domain score was only 85% of the maximum possible score, and mean scores on individual questions ranged from 4.13 to 4.45.13 Many investigators believe that a change in EF domain score of 4
is clinically significant; the difference between the
midpoint of adjacent ED severity categories is
slightly 4 points. However, the mean change in
EF domain scores after treatment with sildenafil is
generally much greater than 4 points. In a review of
11 double-blind, placebo-controlled clinical trials
of sildenafil, the pooled mean change in EF domain
scores was roughly 10 points for patients taking
sildenafil, independent of baseline patient characteristics.29
As with IIEF and SHIM, the IIEF EF domain is
widely accepted as a valid measure of EF. It is
efficient, convenient, and versatile. Although it
is an excellent tool for assessing the outcomes of
ED intervention, limitations of the IIEF EF domain are similar to those of the IIEF. The IIEF EF
domain does not assess other sexual disorders, it
does not provide information regarding the
causes of EDbe they organic or psychogenic in
nature or related to underlying health issues (eg,
depression, diabetes mellitus, cardiovascular
disease)and it does not provide the same level
of detail as is given in a patients complete medical and sexual history. Additionally, although
low scores indicate the presence of ED, they may
also represent non-ED factors, such as a lack of
10

opportunity for sexual activity, low sexual desire, or partner sexual dysfunction.
ERECTION HARDNESS GRADING SCALE
Because erection hardness is a key component of
erectile function, the Erection Hardness Grading
Scale (EHGS) has been used in many clinical trials
of sildenafil as a supplement to other measures,12,13,30 32 often as part of a sexual activity
event log (Table IV), and may also be of use in
clinical practice. The EHGS, which has not been
validated by formal psychometric testing, is a specific, self-reported measure that classifies erection
hardness on a simple 4-point scale: grade 1 indicates an increase in penis size, but no hardness;
grade 2 indicates a slightly hard erection, but not
hard enough for penetration; grade 3 indicates an
erection that is hard enough for penetration, but
not fully hard; and grade 4 indicates a fully hard
and rigid erection. This measure is clinically relevant as a potentially important source of patient
satisfaction with erection hardness, EF, sexual experiences, and ED.3,3234 The association between
improved erection hardness, sexual relationship
satisfaction, and treatment satisfaction suggests
that achieving a grade 4 erection should be the
optimal goal of ED treatment.
SELF-ESTEEM AND RELATIONSHIP
QUESTIONNAIRE
Although the aforementioned scales were designed
to primarily measure erectile function and hardness,
the validated Self-Esteem and Relationship (SEAR)
questionnaire was developed specifically to measure
the impact of ED on mens self-esteem, confidence,
and relationship satisfaction (Table V).35 Items on
the SEAR were generated by a thorough literature
review of ED and psychosocial instruments, and
through input received from focus groups composed
of patients with ED, their partners, and physicians.
From this process, 86 items were initially created.
This number was reduced by removing items that
were redundant, ambiguous, or poorly worded, or
that had poor measurement capability, as identified
by item-to-total correlation, factor analysis, and item
level discriminant validity tests. After further revisions were made, validation of the resulting 14-item
SEAR was achieved in 98 patients with ED and
healthy age-matched controls.35 The 14-item SEAR
contains 5 components: the Sexual Relationship domain (Q1 to Q8), the Confidence domain (Q9 to
Q14), a Self-Esteem subscale (Q9 to Q12), an Overall
Relationship Satisfaction subscale (Q13 to Q14), and
an Overall score (Q1 to Q14). Response options for
items on the SEAR are almost always/always, most
times, sometimes, a few times, and almost
never/never. Responses are scored on a 5-point LikUROLOGY 68 (Supplement 3A), September 2006

TABLE III. Erectile Function (EF) domain of the International Index of Erectile Function
(IIEF) questionnaire*
Q1: How often were you able to get an erection during sexual activity?
0 No sexual activity; 1 Almost never/never; 2 A few times (much less than half the time); 3 Sometimes
(about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q2: When you had erections with sexual stimulation, how often were your erections hard enough for penetration?
0 No sexual activity; 1 Almost never/never; 2 A few times (much less than half the time); 3 Sometimes
(about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q3: When you attempted sexual intercourse, how often were you able to penetrate (enter) your partner?
0 Did not attempt intercourse; 1 Almost never/never; 2 A few times (much less than half the time); 3
Sometimes (about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q4: During sexual intercourse, how often were you able to maintain your erection after you had penetrated
(entered) your partner?
0 Did not attempt intercourse; 1 Almost never/never; 2 A few times (much less than half the time); 3
Sometimes (about half the time); 4 Most times (much more than half the time); 5 Almost always/always
Q5: During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?
0 Did not attempt intercourse; 1 Extremely difficult; 2 Very difficult; 3 Difficult; 4 Slightly difficult; 5
Not difficult
Q15: How do you rate your confidence that you could get and keep an erection?
1 Very low; 2 Low; 3 Moderate; 4 High; 5 Very high
*All questions are preceded by the phrase Over the past 4 weeks . . . .

TABLE IV. Erection Hardness Grading Scale (EHGS)

Grade

Definition of Erection Hardness

1
2

Increase in size of penis, but no hardness (rigidity)

Increase in size and slight increase in hardness (rigidity), but
insufficient for sexual intercourse
Increase in hardness (rigidity) sufficient for sexual intercourse,
but not fully hard (rigid)
Fully hard (rigid) erection

3
4

ert scale. For most items, the response almost never/

never is assigned a score of 1 and almost always/
always is assigned a score of 5, with other items
falling in between. Q8 and Q11, however, are reversescored, such that almost never/never is scored as 5
and almost always/always is scored as 1. Thus,
higher scores represent more favorable responses for
all items. The items of the entire SEAR and items
specific to each domain and subscale are summed
and transformed to a 100-point scale (0 least favorable to 100 most favorable).
Analyses of SEAR data have revealed that improvement in SEAR scores selectively discerns treatment
responders35; the questionnaire has been shown to
possess convergent validity, divergent validity, discriminant validity, internal consistency reliability,
and testretest reproducibility. The sensitivity of the
SEAR to ED treatment was verified through demonstration that scores on all domains and subscales, as
well as overall SEAR score, are significantly improved
after 10 weeks of successful treatment with flexibledose sildenafil.36 Changes in patient scores on all 5
components of the SEAR questionnaire are significantly correlated with changes in scores on the IIEF
EF domain following sildenafil treatment. Three silUROLOGY 68 (Supplement 3A), September 2006

denafil clinical trials, 2 of which are double-blind placebo-controlled studies,36 38 suggest that the SEAR
questionnaire is responsive, sensitive, and robust,
and that it appears to be an excellent instrument for
use in detecting changes related to sexual relationship satisfaction, confidence, and particularly self-esteem after successful treatment.
ERECTILE DYSFUNCTION INVENTORY OF
TREATMENT SATISFACTION
Patients who have been given currently available
treatments for ED, including oral phosphodiesterase-5 inhibitors and intracavernosal injections, report high levels of efficacy in clinical trials.39,40
However, refill rates in general practice are approximately 60%,41 43 suggesting that efficacy alone is
not the only contributing factor in ED treatment
adherence. Thus, the EDITS was designed to provide a psychometrically valid instrument to be
used in measuring patient satisfaction with ED
treatment.44 The first step in the development of
the EDITS was to identify features of ED treatment
that are important to patients.45 Candidate items
were generated on the basis of diagnostic criteria
11

TABLE V. Self-Esteem and Relationship (SEAR) questionnaire

1. Sexual Relationship
domain

2. Confidence domain

2a. Self-Esteem subscale

2b. Overall Relationship

subscale

During the Past 4 Weeks:

1. I felt relaxed about initiating sex with my partner
2. I felt confident that during sex, my erection would last
long enough
3. I was satisfied with my sexual performance
4. I felt that sex could be spontaneous
5. I was likely to initiate sex
6. I felt confident about performing sexually
7. I was satisfied with our sex life
8. My partner was unhappy with the quality of our sexual
relations*
9. I had good self-esteem
10. I felt like a whole man
11. I was inclined to feel that I am a failure*
12. I felt confident
13. My partner was satisfied with our relationship in general
14. I was satisfied with our relationship in general
Response options:
1 Almost never/never
2 A few times (much less than half the time)
3 Sometimes (about half the time)
4 Most times (much more than half the time)
5 Almost always/always

*Questions 8 and 11 are reverse-scored, so that a higher score indicates a more favorable response for all 14 items.

for ED, a review of treatment satisfaction instruments for other therapies, and clinical experiences
of patients with ED and their partners.44 The 29
identified items were subsequently reviewed by 2
independent experts, and modifications were
made in accordance with their recommendations.
The appropriateness and the value of each item for
assessing ED treatment satisfaction were evaluated
by a content validity panel composed of 5 mental
health professionals and 5 urologistsall experts
in the treatment of ED. These items were then administered to 28 patients and their partners to examine testretest reproducibility, internal consistency, and correlation between a patients response
for each item and his partners estimation of the
patients response. Items were included in the final
EDITS questionnaire if they met the following criteria: 70% of the content validity panel concurred
that the item was both relevant and important to
ED treatment satisfaction; a response range of 4
(of the possible 5) was observed in patients; the
testretest reproducibility coefficient was 0.70;
and the correlation between patient and partner
responses was positive and significant.44 A total of
11 items met all inclusion criteria and collectively
constitute the EDITS questionnaire (Table VI). Individual questions on the EDITS are scored on a
5-point scale, from 0 to 4, with higher scores indicating greater treatment satisfaction; an EDITS Index score can be derived by multiplying the mean
score of all items by 25, resulting in a treatment
12

satisfaction score out of a maximum possible 100

points. Patients who score 50 on the EDITS Index are considered satisfied with treatment.
Comparisons of EDITS scores in open-label
studies and double-blind, placebo-controlled trials
have demonstrated that the EDITS is responsive to
ED treatment,39,40,46 48 and that the EDITS is appropriate for use with an array of therapeutic interventions in patients with a wide variety of ED causes.49,50 Scores on the EDITS indicate satisfaction
with treatment, which may be an important factor
in a patients decision to continue using ED therapy. However, this has never been formally studied, and further studies would be needed to substantiate this.
OTHER MEASURES
SEXUAL ACTIVITY EVENT LOGS
Clinical trials of patients with ED frequently use
the above-reviewed questionnaires in conjunction
with event logs and diaries of sexual activity,1 in
which patients record their sexual experiences as
they occur. Event logs specifically used in Pfizersponsored studies throughout the sildenafil clinical trial program are shown in Table VII. Patients
use these logs to record important details of their
experience as soon as possible after each occurrence of sexual activity throughout the study.
Event logs such as these capture the frequency of
events related to sexual activity, but they may not
UROLOGY 68 (Supplement 3A), September 2006

TABLE VI. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire

1. Overall, how satisfied are you with this treatment?
Very satisfied
Somewhat satisfied
Neither satisfied nor dissatisfied
Somewhat dissatisfied
Very dissatisfied
2. During the past 4 weeks, to what degree has the treatment met your expectations?
Completely
Considerably
Halfway
A little
Not at all
3. How likely are you to continue using this treatment?
Very likely
Moderately likely
Neither likely nor unlikely
Moderately unlikely
Very unlikely
4. During the past 4 weeks, how easy was it for you to use this treatment?
Very easy
Moderately easy
Neither easy nor difficult
Moderately difficult
Very difficult
5. During the past 4 weeks, how satisfied have you been with how quickly the treatment works?
Very satisfied
Somewhat satisfied
Neither satisfied nor dissatisfied
Somewhat dissatisfied
Very dissatisfied
6. During the past 4 weeks, how satisfied have you been with how long the treatment lasts?
Very satisfied
Somewhat satisfied
Neither satisfied nor dissatisfied
Somewhat dissatisfied
Very dissatisfied
7. How confident has this treatment made you feel about your ability to engage in sexual activity?
Very confident
Somewhat confident
It has had no impact
Somewhat less confident
Very much less confident
8. Overall, how satisfied do you believe your partner is with the effects of this treatment?
Very satisfied
Somewhat satisfied
Neither satisfied nor dissatisfied
Somewhat dissatisfied
Very dissatisfied
9. How does your partner feel about your continuing to use this treatment?
My partner absolutely wants me to continue
My partner generally prefers me to continue
My partner has no opinion
My partner generally prefers me to stop
My partner absolutely wants me to stop
10. How natural did the process of achieving an erection feel when you used this treatment over the past 4 weeks?
Very natural
Somewhat natural
Neither natural nor unnatural
Somewhat unnatural
Very unnatural
11. Compared with before you had an erection problem, how would you rate the naturalness of your erection when
you used this treatment over the past 4 weeks in terms of hardness?
A lot harder than before I had an erection problem
Somewhat harder than before I had an erection problem
The same hardness as before I had an erection problem
Somewhat less hard than before I had an erection problem
A lot less hard than before I had an erection problem

UROLOGY 68 (Supplement 3A), September 2006

13

TABLE VII. Event Log of Sexual Activity

1a. Was the study medication taken?
Yes No
1b. If Yes, please indicate number of tablets taken: ____
2. Did you have any sexual stimulation?
Yes No
3. Did you get an erection that was hard enough for sexual intercourse?
Yes No
4. Did you attempt sexual intercourse?
Yes No
If the answer to Question 4 is Yes, please answer Questions 5, 6, 7, and 8.
5. Was your erection hard enough to penetrate your partner?
Yes No
6. Did your erection last long enough to have successful intercourse?
Yes No
7. Did you have successful sexual intercourse?
Yes No (erection was not hard enough or did not last long enough)
No (other reasons)
8. Did you ejaculate and/or have an orgasm?
Yes No
9. Did you get a second erection hard enough to attempt sexual intercourse within 24 hours of taking this dose of
Viagra*?
Yes No
*Sildenafil nitrate; Pfizer Inc, New York, NY.

capture subjective data as well as the other research

instruments reviewed earlier do. These logs are
typically used to record information on dosage,
timing, hardness of erections achieved, and intercourse attempts and successes; they can gather
complementary and supplementary insights regarding patients erections and sexual intercourse
experiences. Event logs have demonstrated treatment sensitivity, as demonstrated by open-label
studies and double-blind, placebo-controlled trials
of sildenafil.7,12,13,30 Efficacy measures of this type
are advantageous in that they do not rely on patients memories of their experiences over an extended period, and they can capture data on successful sexual intercourse attempts, in addition to
data on erectile hardness and function.
GLOBAL ASSESSMENT QUESTIONS
Many clinical studies have included global assessment questions (GAQs)also referred to as
Global Efficacy Questions or a Global Efficacy Assessmentas simple, qualitative measures that
support the results of ED treatment efficacy conveyed by the instruments reviewed above. Patient
responses to GAQs are collected at the end point of
the trial and correlate well with IIEF and SHIM
scores. Typically, GAQs are variants of the following simple questions: Compared with having no
treatment at all for your ED, did the treatment improve your erection? Did the treatment improve
your ability to have sexual intercourse? and How
often did you get an erection that allowed you to
14

engage in satisfactory sexual intercourse? GAQs

contribute to a comprehensive assessment of ED
treatment and management.
DISCUSSION
The patient-reported instruments reviewed in
this article have had a substantial impact on ED
clinical research and treatment, and they represent
a considerable complement to physiologic measures that assess erectile function. They are efficient, convenient, cost-effective, and psychometrically soundin other words, they reliably measure
what they are supposed to measure. Notably, their
use has expanded beyond pharmaceutical industrysponsored trials to independent research and
clinical practice, and they have helped move the
field of sexual medicine forward.
The IIEF has become the most commonly used
and most trusted instrument in ED research. The
IIEF EF domain provides a focused measure of EF,
as well as a classification system for ED severity.
The SHIM is a valuable diagnostic instrument used
worldwide that has facilitated the diagnosis and
treatment of ED in clinical practice settings. This is
important not only because ED has a negative impact on mens self-esteem and sexual relationships35,51,52 but also because ED shares risk factors
with several serious medical conditions, including
cardiovascular disease, hypertension, diabetes,
dyslipidemia, and depression, and may thus facilitate the identification of serious medical conditions that can otherwise remain undiagnosed.53,54
UROLOGY 68 (Supplement 3A), September 2006

The SEAR questionnaire specifically evaluates

the effects of ED on mens self-esteem, confidence,
and relationship satisfaction, and it has become a
useful tool for capturing psychosocial indicators
related to ED and its treatment. The EDITS is the
primary tool for the assessment of patient satisfaction with ED treatment. Similar scoring methods
and easily transformed scores on these measures
make it possible to assess correlations of treatment
efficacy with changes in emotional well-being and
treatment satisfaction (see the article by Montorsi
et al.55 in this supplement).
Patient event logs and diaries are valuable research tools for the collection of specific information about individual sexual experiences that do
not rely on patient memories across extensive periods and that do record data related to a key treatment outcome for ED, namely, successful sexual
intercourse attempts. GAQs are simple, qualitative
measures of patient judgments of treatment efficacy that help to provide a well-rounded assessment. The EHGS provides information on self-assessed erection hardnessa key attribute of
patient satisfaction.
We acknowledge that other instruments are
available and that many have been used in clinical
trials and independent investigations of ED. However, a detailed description of all available research
instruments related to sexual dysfunction is beyond the scope of this review.
CONCLUSIONS
Instruments cited in this article have played a
large role in furthering our understanding of ED,
its impact on men and their partners, and the treatment and management of ED. These instruments
have been used in many of the studies discussed
elsewhere in this supplement.5557
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