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The Correlation Between Erectile Function and Patient Satisfaction
Blackwell Science, LtdOxford, UKJSMJournal of Sexual Medicine1743-6095Journal of Sexual Medicine 200542472476Original ArticleErectile Function and SatisfactionTeloken et al.
472
The Correlation Between Erectile Function and Patient Satisfaction Patrick Teloken, MS,* Rolando Valenzuela,† Marilyn Parker, MD,† and John Mulhall, MD‡ *Fundação Faculdade Federal de Ciências Médicas de Porto Alegre, Porto Alegre, Brazil; †Department of Urology, Loyola University Medical Center, Maywood, IL, USA; ‡Weill Medical College of Cornell University, Department of Urology, New York, NY, USA DOI: 10.1111/j.1743-6109.2005.00164.x
ABSTRACT
Introduction. The International Index of Erectile Function (IIEF) has become the gold standard inventory for the assessment of sexual function in drug trials and in clinical research. Normalization of the erectile function domain (EFD) score, an end of treatment score of 26 or higher, is an end-point that is currently being used routinely in drug trials. It has been our experience that some men with scores less that 26 on a sexual pharmaceutical are content with their sexual function. We undertook this study to define what proportion of men with EFD scores <26 are satisfied with their therapeutic response. Methods. 100 consecutive patients who had presented to a sexual health clinic and who had used sildenafil citrate on at least 4 occasions completed the IIEF pertaining to their sildenafil response. They were also asked questions, pertaining to their ability to have sexual intercourse (Q1), their satisfaction with their erectogenic medication (Q2), the ability of the medication to improve erectile rigidity (Q3), and the ability of the medication to improve their ability to have sexual intercourse (Q4). Patients were subcategorized into 4 groups based on treatment IIEF scores (≥26, 22–25, 18–21, and 11–17). The IIEF scores were compared to the responses to the global assessment questions. Main Outcome Measures. The mean patient age was 58 ± 22 years. For Q1 and Q2, for each subcategory, there was a significant difference in the percentage of men answering definitely, somewhat, or not at all. In the group with EFD scores 22–25, 67% agreed at least somewhat with Q1 and 66% with Q2. In this group 84% and 78% responded in the affirmative to Q3 and Q4, respectively. No patient with an EFD score <22 definitely agreed with Q1 or Q2. Conclusions. These data indicate that a significant proportion of patients with EFD scores 21–25 can have sexual relations that are satisfactory and that they are satisfied with their erectogenic medication. Teloken P, Valenzuela R, Parker M, and Mulhall J. The correlation between erectile function and patient satisfaction. J Sex Med 2007;4:472–476. Key Words. Psychological Assessment of Sexual Dysfunction; Diagnostic Testing; Oral Vasoactive Agents
Introduction
he International Index of Erectile Function (IIEF) has become the gold standard inventory for the assessment of sexual function in drug trials and in clinical research [1,2]. This validated instrument has five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The IIEF meets psychometric criteria for test reliability and validity, has a high degree of sensitivity and specificity, and correlates well with other measures of treatment outcome [2].
T
J Sex Med 2007;4:472–476
The erectile function domain (EFD) of the IIEF was evaluated using data from four clinical trials of sildenafil, totalizing 1,151 men. The optimal cutoff score was 25 with men scoring less than or equal to 25 classified as having erectile dysfunction (ED) and those scoring above 25 as not having ED (sensitivity 0.97, specificity 0.88). It was also shown to be useful in classifying ED severity into categories with substantial agreement shown between these predicted and “true” classes (weighted kappa 0.80): no ED (EFD score 26–30), mild (EFD score 18–25), moderate (EFD score 11–17), and severe (EFD score 6–10). © 2005 International Society for Sexual Medicine
473
Erectile Function and Satisfaction It is believed that a one-point improvement in each of the six questions in the EFD and a sixpoint improvement in the whole EFD are clinically meaningful. Normalization of the EFD score (i.e., an end of treatment score of 26 or higher) is an end-point that is currently being used routinely in drug trials. It has been our experience that some men with scores less that 26 on a sexual pharmaceutical are content with their sexual function. We undertook this study to define what proportion of men with EFD scores <26 are satisfied with their therapeutic response. Methods
Patient Population One hundred consecutive patients presenting with ED to a single sexual health clinic who had used sildenafil citrate on at least four occasions prospectively completed the IIEF pertaining to their sildenafil response. Demographic data were obtained from their medical record. International Index of Erectile Function The IIEF instrument is a highly validated inventory that has been used extensively in the evaluation of erectile function, particularly in response to pharmacotherapy. The questionnaire has 15 questions, questions 1–5 and 15 are organized into an EFD, which is scored 6–30. The questions ask about sexual function in frequency terms, and each is scored on a five-point Likert scale, 5 indicating “always or almost always” and 1 “never or almost never.” A score ≥26 indicates the absence of ED and a score ≤10 defines severe ED. Patients completed the IIEF during a follow-up visit after at least four attempts at intercourse using sildenafil citrate at 100 mg. Global Assessment Questions In addition to completing the IIEF, patients were also asked to complete four global assessment questions. Question 1 (Q1) posed patients with the statement “I can have sex whenever I want”; Question 2 (Q2) posed the statement “I am satisfied with my erection drug.” For these two questions patients where asked “How much do you agree with the statement” and had “definitely,” “somewhat,” and “not at all” as possible answers. Questions 3 and 4 (Q3 and Q4) asked simple “yes” or “no” response questions; Q3 asked “has the medication improved your ability to get an erection?” and Q4 “has the medication improved your ability to have sexual intercourse?” Patients were subcat-
egorized into four groups based on treatment IIEF scores (≥26, 22–25, 18–21, and 11–17) and comparisons were made in responses to Q1–4 and the IIEF subcategories.
Statistical Analysis Comparisons were made using analysis of variance (ANOVA; SPSS, Chicago, IL, USA). Results
Patient Population The mean patient age was 58 ± 22 years. The mean duration of ED was 2.2 ± 4.2 years. The mean number of vascular risk factors was 2.5 ± 2.1. There were 10 patients in the 11–17 group (10%), 32 in 18–21 (32%), 36 in 22–25 (36%), and 22 in ≥26 groups (22%). The mean EFD scores at baseline and on sildenafil were 16.5 ± 7 and 21.8 ± 8.1. The mean number of sildenafil doses used at the time of completion of the questionnaires was 6.5 ± 5.4 (4–13). Global Assessment Question Outcomes For Q1 and Q2, for each subcategory, there was a significant difference in the percentage of men answering “definitely,” “somewhat,” or “not at all” (Figures 1 and 2). No patient with an EFD score <22 definitely agreed with Q1 or Q2. In the 11– 17 group 10% of patients answered “somewhat” to both Q1 and Q2. In the 18–21 group, 13% and 18% answered “somewhat” to Q1 and Q2, respectively. In the 22–25 group, 28% of patients answered “definitely” to both Q1 and Q2, while 39% and 38% answered “somewhat” to these questions. In the ≥26 EFD score group 77% and 76% answered “definitely” to Q1 and Q2, respectively, while 18% and 16% answered only “somewhat” to these questions.
Figure 1 Percentage of answers to Question 1 stratified by erectile function domain (EFD) score.
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Figure 2 Percentage of answers to Question 2 stratified by erectile function domain (EFD) score.
Figure 4 Percentage of answers to Question 4 stratified by erectile function domain (EFD) score.
In the 11–17 group 22% and 6% answered “yes” to Q3 and Q4, respectively. In the 18–21 group 42% and 28% answered “yes” to Q3 and Q4. In the 22–25 group 84% and 78% answered “yes” to Q3 and Q4, while 92% and 84% answered “yes” to Q3 and Q4 in the ≥26 group (Figures 3 and 4). No statistically significant difference existed between Q3 responses for 22–25 and ≥26 groups. The difference for Q4 was significant between the two groups (P = 0.035).
clinical research, and few clinical trials have been performed since the approval of sildenafil citrate, in which the IIEF has not been used as a primary efficacy end-point. One of the frequently cited endpoints in contemporary trials is termed “normalization of the EFD score.” A score of 26 or greater on the EFD is deemed to represent “no ED.” However, some have suggested that such an endpoint may be overly rigorous as some men with scores less than this are satisfied with their sexual function. Indeed, it has been our clinical impression that erectogenic pharmacotherapy responders with scores above 20 but less than 26 have a significant likelihood of proclaiming satisfaction with their drug, whether it is oral, intraurethral, or intracavernosal. To the best of our knowledge there has been no study to date to define satisfaction levels of men at various EFD score levels. While the global assessment questions that were used in this study have not been formally validated, Q3 and Q4 are routinely used in ED drug trials; indeed, Q3, “has the medication improved your ability to get an erection?” is a major end-point in many of these trials [8]. These questions were chosen in an attempt to define the likelihood of patients continuing treatment. Given the fact that men are largely interested in using an erectogenic drug that permits them to have a reproducibly rigid and durable erection, in other words, they need to have restoration of sexual confidence, posing them with the statement “I can have sex whenever I want (with my erection drug)” (Q1) and “I am satisfied with my erection drug” (Q2) and asking for their level of agreement with these are reasonable measures of this. The most notable findings from our data are: (i) that no patients with EFD score <22 was definitely in agreement with Q1 or Q2; (ii) that two-thirds of men with EFD scores 22–25 agree definitely or somewhat with Q1 and Q2 and 28%
Discussion
Estimates for ED in the United States range from 20% to 50% depending on the epidemiological study cited [3–5]. ED has been demonstrated to have a negative impact on patient self-esteem, quality of life, and interpersonal relationships [6]. Many risk factors for ED have been identified including hypertension, diabetes, dyslipidemias, vascular disease, endocrine, and neurological comorbidities [3]. ED has been identified as one of the four major, noncancer disease states that adversely affect men older than 50 years [7]. The IIEF is the gold standard inventory for the assessment of sexual function in drug trials and in
Figure 3 Percentage of answers to Question 3 stratified by erectile function domain (EFD) score.
J Sex Med 2007;4:472–476
475
Erectile Function and Satisfaction responded with complete agreement for both statements; (iii) that 5% and 8% of men with EFD scores ≥26 fail to agree with Q1 and Q2, respectively; (iv) that 84% and 78% of men with EFD scores 22–25 responded in the affirmative to Q3 and Q4, respectively; (v) that 42% and 28% of men with EFD scores <22 noted improvement in erectile function and ability to have sexual intercourse since commencing the medication; and (vi) that no statistically significant difference existed between the percentage of men responding “yes” to Q3 for the 22–25 and ≥26 groups; however, the difference for Q4 was significant (P = 0.035). Thus, approximately one-quarter of men with EFD scores 22–25 consider themselves fully functional and 23% of patients with an EFD ≥26 fail to definitely agree that they can have sex whenever they want. These data highlight the complexity of satisfaction and self-perception of erectile function. Cappelleri et al. assessed the validity of severity classes on the EFD of the IIEF by determining their relationship with the self-assessment of erectile function, before and after a 12-week treatment with sildenafil, in an independent cohort of patients of 247 men with clinically diagnosed ED on a randomized, double-blind, placebocontrolled fashion. Patients assessed their degree of ED as severe, moderate, minimal/mild, or no problem at baseline and after treatment. They also responded to the six questions of the EFD, with the total score indicating the following degrees of ED: severe, EFD score 1–10; moderate, EFD score 11–16; mild to moderate, EFD score 17–21; mild, EFD score 22–25; and no ED, EFD score 26–30. The correlations were 0.65 (95% confidence interval 0.57, 0.73) at baseline, 0.86 (95% confidence interval 0.83, 0.89) after 12 weeks of treatment, and 0.73 (95% confidence interval 0.67, 0.79) at change from baseline. Patient selfassessment of erectile function and the EFD showed a good correlation after 12 weeks of treatment. However, at baseline and for change from baseline only a moderate correlation was found [9]. One possible explanation for the findings in this study is that the IIEF focuses primarily on erectile function and provides superficial assessment of domains of sexual functioning other than erection, which may be as important for certain patients, such as sexual desire, orgasmic function. Also it does not provide information on partner relationship. Another drawback of IIEF is that it was
designed to evaluate only heterosexual activity, possibly being less adequate for individuals whose primary sexual activity is homosexual. Another point is that when comparing responses to IIEF with a single item, a higher percentage of men complete the single item [10]. Limitations of our study include the nonvalidated nature of the global assessment questions, a relatively small sample size, the fact that patients had used sildenafil only a mean of 6.5 times at the time of IIEF/global assessment questions completion, and the absence of partner satisfaction information. All questionnaires were given to the patients by a female nurse and there are recent preliminary data that suggest that men may underestimate their erectile function in response to a female clinician [11]. The small number of patients prevented us from assessing age or comorbidity profiles as potential predictors of satisfaction with erection ion patients with EFD scores 22–25. Conclusions
The data indicate that a significant proportion of patients with EFD scores 21–25, considered as having ED, can have sexual relations that are satisfactory and that they are satisfied with their erection medication. Future analysis of these data is aimed at defining correlations between global assessment questions and the other questions utilized in this study, as well as assessing pretreatment EFD scores as a predictor of end-of-treatment satisfaction. Corresponding Author: John Mulhall, MD, Weill Medical College of Cornell University, Department of Urology, New York, NY 10021, USA. Tel: (212) 7465653; Fax: (212) 746-0403, E-mail: jpm2005@med. cornell.edu Conflict of Interest: Dr. John Mulhall—consultant to Pfizer, Lilly Icos, Auxilium, Johnson and Johnson. References
1 Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The International Index of Erectile Function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology 1997;49:822–30. 2 Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): A state-of-the-science review. Int J Impot Res 2002;14:226–44. J Sex Med 2007;4:472–476
476 3 Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: Results of the Massachusetts Male Aging Study. J Urol 1994;151:54–61. 4 Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: Prevalence and predictors. JAMA 1999;281:537–44. 5 Laumann EO, Paik A, Rosen RC. The epidemiology of erectile dysfunction: Results from the National Health and Social Life Survey. Int J Impot Res 1999;11(suppl 1):S60–4. 6 Rosen RC, Fisher WA, Eardley I, Niederberger C, Nadel A, Sand M. The multinational Men’s Attitudes to Life Events and Sexuality (MALES) study: I. Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin 2004;20:607–17. 7 Zakaria L, Anastasiadis AG, Shabsigh R. Common conditions of the aging male: Erectile dysfunction, benign prostatic hyperplasia, cardiovascular dis-
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10
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ease and depression. Int Urol Nephrol 2001;33: 283–92. Mulhall JP. Deciphering erectile dysfunction drug trials. J Urol 2003;170:353–8. Cappelleri JC, Siegel RL, Osterloh IH, Rosen RC. Relationship between patient self-assessment of erectile function and the erectile function domain of the international index of erectile function. Urology 2000;56:477–81. Derby CA, Araujo AB, Johannes CB, Feldman HA, McKinlay JB. Measurement of erectile dysfunction in population-based studies: The use of a single question self-assessment in the Massachusetts Male Aging Study. Int J Impot Res 2000;12: 197–204. Ahn T, Paick JS, Suh JK, Kim JJ, Park NC, Park JK, Park KS, Lee SW, Hong JH. The influences of interviewer gender on the informativeness of selfadministered questionnaire for erectile dysfunction. J Sex Med 2004;1:73–4.
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The Correlation Between Erectile Function and Patient Satisfaction Patrick Teloken, MS,* Rolando Valenzuela,† Marilyn Parker, MD,† and John Mulhall, MD‡ *Fundação Faculdade Federal de Ciências Médicas de Porto Alegre, Porto Alegre, Brazil; †Department of Urology, Loyola University Medical Center, Maywood, IL, USA; ‡Weill Medical College of Cornell University, Department of Urology, New York, NY, USA DOI: 10.1111/j.1743-6109.2005.00164.x
ABSTRACT
Introduction. The International Index of Erectile Function (IIEF) has become the gold standard inventory for the assessment of sexual function in drug trials and in clinical research. Normalization of the erectile function domain (EFD) score, an end of treatment score of 26 or higher, is an end-point that is currently being used routinely in drug trials. It has been our experience that some men with scores less that 26 on a sexual pharmaceutical are content with their sexual function. We undertook this study to define what proportion of men with EFD scores <26 are satisfied with their therapeutic response. Methods. 100 consecutive patients who had presented to a sexual health clinic and who had used sildenafil citrate on at least 4 occasions completed the IIEF pertaining to their sildenafil response. They were also asked questions, pertaining to their ability to have sexual intercourse (Q1), their satisfaction with their erectogenic medication (Q2), the ability of the medication to improve erectile rigidity (Q3), and the ability of the medication to improve their ability to have sexual intercourse (Q4). Patients were subcategorized into 4 groups based on treatment IIEF scores (≥26, 22–25, 18–21, and 11–17). The IIEF scores were compared to the responses to the global assessment questions. Main Outcome Measures. The mean patient age was 58 ± 22 years. For Q1 and Q2, for each subcategory, there was a significant difference in the percentage of men answering definitely, somewhat, or not at all. In the group with EFD scores 22–25, 67% agreed at least somewhat with Q1 and 66% with Q2. In this group 84% and 78% responded in the affirmative to Q3 and Q4, respectively. No patient with an EFD score <22 definitely agreed with Q1 or Q2. Conclusions. These data indicate that a significant proportion of patients with EFD scores 21–25 can have sexual relations that are satisfactory and that they are satisfied with their erectogenic medication. Teloken P, Valenzuela R, Parker M, and Mulhall J. The correlation between erectile function and patient satisfaction. J Sex Med 2007;4:472–476. Key Words. Psychological Assessment of Sexual Dysfunction; Diagnostic Testing; Oral Vasoactive Agents
Introduction
he International Index of Erectile Function (IIEF) has become the gold standard inventory for the assessment of sexual function in drug trials and in clinical research [1,2]. This validated instrument has five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The IIEF meets psychometric criteria for test reliability and validity, has a high degree of sensitivity and specificity, and correlates well with other measures of treatment outcome [2].
T
J Sex Med 2007;4:472–476
The erectile function domain (EFD) of the IIEF was evaluated using data from four clinical trials of sildenafil, totalizing 1,151 men. The optimal cutoff score was 25 with men scoring less than or equal to 25 classified as having erectile dysfunction (ED) and those scoring above 25 as not having ED (sensitivity 0.97, specificity 0.88). It was also shown to be useful in classifying ED severity into categories with substantial agreement shown between these predicted and “true” classes (weighted kappa 0.80): no ED (EFD score 26–30), mild (EFD score 18–25), moderate (EFD score 11–17), and severe (EFD score 6–10). © 2005 International Society for Sexual Medicine
473
Erectile Function and Satisfaction It is believed that a one-point improvement in each of the six questions in the EFD and a sixpoint improvement in the whole EFD are clinically meaningful. Normalization of the EFD score (i.e., an end of treatment score of 26 or higher) is an end-point that is currently being used routinely in drug trials. It has been our experience that some men with scores less that 26 on a sexual pharmaceutical are content with their sexual function. We undertook this study to define what proportion of men with EFD scores <26 are satisfied with their therapeutic response. Methods
Patient Population One hundred consecutive patients presenting with ED to a single sexual health clinic who had used sildenafil citrate on at least four occasions prospectively completed the IIEF pertaining to their sildenafil response. Demographic data were obtained from their medical record. International Index of Erectile Function The IIEF instrument is a highly validated inventory that has been used extensively in the evaluation of erectile function, particularly in response to pharmacotherapy. The questionnaire has 15 questions, questions 1–5 and 15 are organized into an EFD, which is scored 6–30. The questions ask about sexual function in frequency terms, and each is scored on a five-point Likert scale, 5 indicating “always or almost always” and 1 “never or almost never.” A score ≥26 indicates the absence of ED and a score ≤10 defines severe ED. Patients completed the IIEF during a follow-up visit after at least four attempts at intercourse using sildenafil citrate at 100 mg. Global Assessment Questions In addition to completing the IIEF, patients were also asked to complete four global assessment questions. Question 1 (Q1) posed patients with the statement “I can have sex whenever I want”; Question 2 (Q2) posed the statement “I am satisfied with my erection drug.” For these two questions patients where asked “How much do you agree with the statement” and had “definitely,” “somewhat,” and “not at all” as possible answers. Questions 3 and 4 (Q3 and Q4) asked simple “yes” or “no” response questions; Q3 asked “has the medication improved your ability to get an erection?” and Q4 “has the medication improved your ability to have sexual intercourse?” Patients were subcat-
egorized into four groups based on treatment IIEF scores (≥26, 22–25, 18–21, and 11–17) and comparisons were made in responses to Q1–4 and the IIEF subcategories.
Statistical Analysis Comparisons were made using analysis of variance (ANOVA; SPSS, Chicago, IL, USA). Results
Patient Population The mean patient age was 58 ± 22 years. The mean duration of ED was 2.2 ± 4.2 years. The mean number of vascular risk factors was 2.5 ± 2.1. There were 10 patients in the 11–17 group (10%), 32 in 18–21 (32%), 36 in 22–25 (36%), and 22 in ≥26 groups (22%). The mean EFD scores at baseline and on sildenafil were 16.5 ± 7 and 21.8 ± 8.1. The mean number of sildenafil doses used at the time of completion of the questionnaires was 6.5 ± 5.4 (4–13). Global Assessment Question Outcomes For Q1 and Q2, for each subcategory, there was a significant difference in the percentage of men answering “definitely,” “somewhat,” or “not at all” (Figures 1 and 2). No patient with an EFD score <22 definitely agreed with Q1 or Q2. In the 11– 17 group 10% of patients answered “somewhat” to both Q1 and Q2. In the 18–21 group, 13% and 18% answered “somewhat” to Q1 and Q2, respectively. In the 22–25 group, 28% of patients answered “definitely” to both Q1 and Q2, while 39% and 38% answered “somewhat” to these questions. In the ≥26 EFD score group 77% and 76% answered “definitely” to Q1 and Q2, respectively, while 18% and 16% answered only “somewhat” to these questions.
Figure 1 Percentage of answers to Question 1 stratified by erectile function domain (EFD) score.
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Figure 2 Percentage of answers to Question 2 stratified by erectile function domain (EFD) score.
Figure 4 Percentage of answers to Question 4 stratified by erectile function domain (EFD) score.
In the 11–17 group 22% and 6% answered “yes” to Q3 and Q4, respectively. In the 18–21 group 42% and 28% answered “yes” to Q3 and Q4. In the 22–25 group 84% and 78% answered “yes” to Q3 and Q4, while 92% and 84% answered “yes” to Q3 and Q4 in the ≥26 group (Figures 3 and 4). No statistically significant difference existed between Q3 responses for 22–25 and ≥26 groups. The difference for Q4 was significant between the two groups (P = 0.035).
clinical research, and few clinical trials have been performed since the approval of sildenafil citrate, in which the IIEF has not been used as a primary efficacy end-point. One of the frequently cited endpoints in contemporary trials is termed “normalization of the EFD score.” A score of 26 or greater on the EFD is deemed to represent “no ED.” However, some have suggested that such an endpoint may be overly rigorous as some men with scores less than this are satisfied with their sexual function. Indeed, it has been our clinical impression that erectogenic pharmacotherapy responders with scores above 20 but less than 26 have a significant likelihood of proclaiming satisfaction with their drug, whether it is oral, intraurethral, or intracavernosal. To the best of our knowledge there has been no study to date to define satisfaction levels of men at various EFD score levels. While the global assessment questions that were used in this study have not been formally validated, Q3 and Q4 are routinely used in ED drug trials; indeed, Q3, “has the medication improved your ability to get an erection?” is a major end-point in many of these trials [8]. These questions were chosen in an attempt to define the likelihood of patients continuing treatment. Given the fact that men are largely interested in using an erectogenic drug that permits them to have a reproducibly rigid and durable erection, in other words, they need to have restoration of sexual confidence, posing them with the statement “I can have sex whenever I want (with my erection drug)” (Q1) and “I am satisfied with my erection drug” (Q2) and asking for their level of agreement with these are reasonable measures of this. The most notable findings from our data are: (i) that no patients with EFD score <22 was definitely in agreement with Q1 or Q2; (ii) that two-thirds of men with EFD scores 22–25 agree definitely or somewhat with Q1 and Q2 and 28%
Discussion
Estimates for ED in the United States range from 20% to 50% depending on the epidemiological study cited [3–5]. ED has been demonstrated to have a negative impact on patient self-esteem, quality of life, and interpersonal relationships [6]. Many risk factors for ED have been identified including hypertension, diabetes, dyslipidemias, vascular disease, endocrine, and neurological comorbidities [3]. ED has been identified as one of the four major, noncancer disease states that adversely affect men older than 50 years [7]. The IIEF is the gold standard inventory for the assessment of sexual function in drug trials and in
Figure 3 Percentage of answers to Question 3 stratified by erectile function domain (EFD) score.
J Sex Med 2007;4:472–476
475
Erectile Function and Satisfaction responded with complete agreement for both statements; (iii) that 5% and 8% of men with EFD scores ≥26 fail to agree with Q1 and Q2, respectively; (iv) that 84% and 78% of men with EFD scores 22–25 responded in the affirmative to Q3 and Q4, respectively; (v) that 42% and 28% of men with EFD scores <22 noted improvement in erectile function and ability to have sexual intercourse since commencing the medication; and (vi) that no statistically significant difference existed between the percentage of men responding “yes” to Q3 for the 22–25 and ≥26 groups; however, the difference for Q4 was significant (P = 0.035). Thus, approximately one-quarter of men with EFD scores 22–25 consider themselves fully functional and 23% of patients with an EFD ≥26 fail to definitely agree that they can have sex whenever they want. These data highlight the complexity of satisfaction and self-perception of erectile function. Cappelleri et al. assessed the validity of severity classes on the EFD of the IIEF by determining their relationship with the self-assessment of erectile function, before and after a 12-week treatment with sildenafil, in an independent cohort of patients of 247 men with clinically diagnosed ED on a randomized, double-blind, placebocontrolled fashion. Patients assessed their degree of ED as severe, moderate, minimal/mild, or no problem at baseline and after treatment. They also responded to the six questions of the EFD, with the total score indicating the following degrees of ED: severe, EFD score 1–10; moderate, EFD score 11–16; mild to moderate, EFD score 17–21; mild, EFD score 22–25; and no ED, EFD score 26–30. The correlations were 0.65 (95% confidence interval 0.57, 0.73) at baseline, 0.86 (95% confidence interval 0.83, 0.89) after 12 weeks of treatment, and 0.73 (95% confidence interval 0.67, 0.79) at change from baseline. Patient selfassessment of erectile function and the EFD showed a good correlation after 12 weeks of treatment. However, at baseline and for change from baseline only a moderate correlation was found [9]. One possible explanation for the findings in this study is that the IIEF focuses primarily on erectile function and provides superficial assessment of domains of sexual functioning other than erection, which may be as important for certain patients, such as sexual desire, orgasmic function. Also it does not provide information on partner relationship. Another drawback of IIEF is that it was
designed to evaluate only heterosexual activity, possibly being less adequate for individuals whose primary sexual activity is homosexual. Another point is that when comparing responses to IIEF with a single item, a higher percentage of men complete the single item [10]. Limitations of our study include the nonvalidated nature of the global assessment questions, a relatively small sample size, the fact that patients had used sildenafil only a mean of 6.5 times at the time of IIEF/global assessment questions completion, and the absence of partner satisfaction information. All questionnaires were given to the patients by a female nurse and there are recent preliminary data that suggest that men may underestimate their erectile function in response to a female clinician [11]. The small number of patients prevented us from assessing age or comorbidity profiles as potential predictors of satisfaction with erection ion patients with EFD scores 22–25. Conclusions
The data indicate that a significant proportion of patients with EFD scores 21–25, considered as having ED, can have sexual relations that are satisfactory and that they are satisfied with their erection medication. Future analysis of these data is aimed at defining correlations between global assessment questions and the other questions utilized in this study, as well as assessing pretreatment EFD scores as a predictor of end-of-treatment satisfaction. Corresponding Author: John Mulhall, MD, Weill Medical College of Cornell University, Department of Urology, New York, NY 10021, USA. Tel: (212) 7465653; Fax: (212) 746-0403, E-mail: jpm2005@med. cornell.edu Conflict of Interest: Dr. John Mulhall—consultant to Pfizer, Lilly Icos, Auxilium, Johnson and Johnson. References
1 Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The International Index of Erectile Function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology 1997;49:822–30. 2 Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): A state-of-the-science review. Int J Impot Res 2002;14:226–44. J Sex Med 2007;4:472–476
476 3 Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: Results of the Massachusetts Male Aging Study. J Urol 1994;151:54–61. 4 Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: Prevalence and predictors. JAMA 1999;281:537–44. 5 Laumann EO, Paik A, Rosen RC. The epidemiology of erectile dysfunction: Results from the National Health and Social Life Survey. Int J Impot Res 1999;11(suppl 1):S60–4. 6 Rosen RC, Fisher WA, Eardley I, Niederberger C, Nadel A, Sand M. The multinational Men’s Attitudes to Life Events and Sexuality (MALES) study: I. Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin 2004;20:607–17. 7 Zakaria L, Anastasiadis AG, Shabsigh R. Common conditions of the aging male: Erectile dysfunction, benign prostatic hyperplasia, cardiovascular dis-
J Sex Med 2007;4:472–476
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