SIEDY Scale 3, a New Instrument to Detect Psychological Component in Subjects with Erectile Dysfunction

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SIEDY Scale 3, a New Instrument to Detect Psychological Component in Subjects with Erectile Dysfunction jsm_2762

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Giovanni Corona, MD, PhD,*§ Valdo Ricca, MD,† Elisa Bandini, MD,* Giulia Rastrelli, MD,* Helen Casale, MD,* Emmanuele A. Jannini, MD,‡ Alessandra Sforza, MD,§ Gianni Forti, MD,¶ Edoardo Mannucci, MD,** and Mario Maggi, MD* *Andrology and Sexual Medicine Unit, Department of Clinical Physiopathology, University of Florence, Florence Italy; † Psychiatry Unit, Department of Neurological and Psychiatric Sciences, University of Florence, Florence Italy; ‡School of Sexology, Department of Experimental Medicine, University of L’Aquila, L’Aquila, Italy; §Endocrinology Unit, Medical Department, Azienda Usl, Maggiore-Bellaria Hospital, Bologna, Italy; ¶Endocrinology Unit, Department of Clinical Physiopathology, University of Florence, Florence Italy; **Diabetes Section Geriatric Unit, Department of Critical Care, University of Florence, Italy DOI: 10.1111/j.1743-6109.2012.02762.x

ABSTRACT

Introduction. We previously developed and validated a structured interview (SIEDY) dealing with the organic (Scale 1), relational (Scale 2), and psychological (Scale 3) components of erectile dysfunction (ED). Aim. To identify a pathological threshold for SIEDY Scale 3 and to analyze Scale 3 score with biological and psychological correlates in subjects with sexual dysfunction. Method. A pathological threshold of SIEDY Scale 3 score in predicting subjects with a medical history of psychopathology and using psychiatric drugs was identified through receiver operating characteristic (ROC) curve analysis in a sample of 484 patients (Sample A). Main Outcome Measure. Sensitivity and specificity, along with possible interactions with biological and psychological (Middlesex Hospital Questionnaire, MHQ-score) correlates were verified in a further sample of 1,275 patients (Sample B). Results. In sample A, 39 (8%) and 60 (12.4%) subjects reported a positive medical history for psychiatric disturbances or for the use of psychotropic medication, respectively. The association with both conditions was present in 28 (5.8%) subjects. ROC curve showed that SIEDY Scale 3 score predicts psychopathology with an accuracy of 69.5 ⫾ 5.9% (P < 0.002), when a threshold of 3 was chosen. When the same threshold was applied in Sample B, it identified a higher ranking in MHQ-A (free-floating anxiety), MHQ-S (somatized anxiety) and MHQ-D (depressive symptoms) subscales, even after adjustment for age and S-MHQ (a broader index of general psychopathology). In the same sample, we also confirmed that pathological Scale 3 score was related to a higher risk of psychopathology at medical history or to the use of psychotropic drugs as well as with risky lifestyle behaviors, including smoking and alcohol abuse, and elevated BMI. Conclusions. SIEDY represents an easy tool for the identification of patients with a relevant intra-psychic component who should be considered for psychological/psychiatric treatment. Corona G, Ricca V, Bandini E, Rastrelli G, Casale H, Jannini EA, Sforza A, Forti G, Mannucci E, and Maggi M. SIEDY Scale 3, a new instrument to detect psychological component in subjects with erectile dysfunction. J Sex Med **;**:**–**. Key Words. Erectile Dysfunction; Depression; Anxiety

Introduction

U

ntil a few decades ago sexual dysfunctions, especially in young subjects, were mostly related to psychological disturbances and, there-

© 2012 International Society for Sexual Medicine

fore, the only recognized treatment was psychotherapeutic, e.g., psychoanalysis and/or cognitivebehavioral therapy, the so-called “sex therapy” [1,2]. Nowadays, it is well recognized that this assumption is too limited. The introduction of J Sex Med **;**:**–**

2 type 5 phosphodiesterase inhibitors (PDE5) drastically changed scientific opinion, demonstrating that an amelioration of the organic response (penile erection) was able to improve quality of life [3,4] and marital relationship [5–9], including partner satisfaction [9–13]. Alternatively, recently published meta-analyses—assessing the effectiveness of psychological interventions for the treatment of erectile dysfunction (ED) as compared to medical treatment—still support the value of focused sex therapy alone or in combination with PDE5 [14,15]. Therefore, different therapeutic approaches are available for clinicians and should be tailored according to each individual ED profile [16]. The categorical dichotomy between psychogenic and organic ED is becoming obsolete [17–19]. ED must be considered a multi-dimensional disorder deriving from a general (or stepwise) perturbation of all the components of the erectile response, including organic (the body), relational (the couple), and intra-psychic (the mind) ones [20,21]. ED may arise from an alteration of any of these components (precipitating event), but sooner or later it will involve all the others in a redundant way, having negative effects on quality of life, interpersonal relationships, and mood [18,22–24]. This complex, multi-dimensional, interactive model of ED pathogenesis captures the ever-changing, mutual influences of biology, marital, and psychological life, and their contributions to the disturbance. Hence, for sexual medicine, instruments measuring the specific weight of these different pathogenetic components are of great clinical utility. A correct assessment of these components can be used as a guide for the identification of the most convenient therapeutic approach in individual patients. Such an approach can include, in different combinations, psychotherapy, psychopharmacology, PDE5, hormonal substitution, and specific therapy for other somatic diseases. We previously developed and validated a 13-item structured interview [21] that assesses the organic (Scale 1), relational (Scale 2), and psychological (Scale 3) components of ED. In particular, Scale 3, which corresponds to psychopathological symptoms, as assessed through other instruments ([Middlesex Hospital Questionnaire, MHQ]; [22,25]), could be of help in identifying patients who are in need of a specific treatment for psychological disturbances. The aim of the present study is the identification of a threshold for such a clinical use of the J Sex Med **;**:**–**

Corona et al. Table 1

Characteristics of the sample

Characteristics

Sample A

Age (years) 50.5 ⫾ 11.6 Education (%) None/primary school 12.9 Secondary school 34.3 Secondary higher 32.4 University 20.5 Alcohol consumption (%) None/mild 80.2 Moderate 16.8 Severe 3.0 Current smokers (%) 31.3 Morbidities (%) Hypertension 25.6 Diabetes mellitus 22.7 Cardiovascular diseases 11.0 Clinical and laboratory parameters Pulse pressure (mm Hg) 52.9 ⫾ 13.6 26.6 ⫾ 4.0 Body mass index (kg/m2) Total testosterone (nmol/L) 15.7 ⫾ 6.4 Fasting glycemia (mg/dL) 95.0 (87–108) Total cholesterol (mg/dL) 206.9 ⫾ 41.7 HDL cholesterol (mg/dL) 48.3 ⫾ 12.2 Triglycerides (mg/dL) 113 (86–160)

Sample B 49.9 ⫾ 11.8 10.9 31.6 37.4 20.1 76.3 19.1 4.7 32.3 25.5 21.7 9.9 52.4 ⫾ 12.7 26.6 ⫾ 4.2 15.8 ⫾ 6.5 95.0 (85–108) 202.0 ⫾ 39.9 48.1 ⫾ 12.8 114 (78–165)

Data are expressed as mean ⫾ standard deviation when normally distributed, median (quartiles) when not normally distributed, and as percentages when categorical. All P = NS between groups

interview. We also investigated possible interactions of SIEDY Scale 3 with other domains in ED subjects, along with its biological and psychological correlates. Materials and Methods

A non-selected series of 1,759 male patients attending our Andrology and Sexual Medicine Outpatient Clinic for sexual dysfunction for the first time was retrospectively studied. Only heterosexual patients were included in this study, to make the results more comparable. The sociodemographic and clinical characteristics of the cohort are reported in Table 1. All patients enrolled underwent the usual diagnostic protocol applied to newly referred subjects at the Andrology Outpatient clinic (see further discussion). All the data provided were collected as part of the routine clinical procedure. All patients provided an informed consent to the study. Patients were interviewed prior to the beginning of any treatment, and before any specific diagnostic procedures, using the SIEDY Structured Interview [21,26] and ANDROTEST [27] structured interview. SIEDY is a 13-item interview made up of three scales, which identify and quantify components concurring with sexual dysfunctions. Scale 1 deals with organic disorders and it is made

Intrapsychic Component and Erectile Dysfunction up of questions 4, 13, and 15, concerning medical history, morning/nocturnal erection, and volume of the ejaculate, respectively. Scale 2 deals with disturbances in the patient’s relationship with his primary partner and consists of questions 7, 8, 9 and 10, concerning reported presence of primary partner’s disease, primary partner’s climax and desire, and menopausal symptoms, respectively. Scale 3 deals with psychological traits and it is made up of questions 2, 3, 6, 11, 12, and 14, concerning presence of life stressors, conflict in primary relationship and within the family, extramarital affairs, and patient’s hypoactive sexual desire, respectively. The full questions composing SIEDY Scale 3 are reported in Appendix A. ANDROTEST is a 12-item interview previously validated for the screening of hypogonadism in patients with erectile dysfunction [27]. In both structured interviews, the patient’s answer is codified on a 0–3 Likert scale by the interviewer. Intimacy during sexual intercourse was analyzed using a standard question (“Do you have enough intimacy during your sexual activity?”) rating 0 = yes, 1 = no. Frequency of sexual intercourse was assessed using a standard question (“During the last three months how many sexual attempts per month did you have?”), rating 0 ⱕ 2 times per month, 1 = equal to or higher than two times per month. Premature ejaculation was defined as ejaculation within 1 minute of vaginal intromission (as reported by the patient) according to previously described criteria [28,29]. A subset of 425 patients was also asked to complete the abridged 5-item version of the International Index of Erectile Function (IIEF-5) [30]. Hence, IIEF-5 was used to validate SIEDY Appendix A in detecting ED and severe ED. According to the NIH Consensus Conference definition of ED [31] as “the persistent inability to achieve and/or maintain an erection adequate for satisfactory sexual activity” the S of SIEDY Appendix A score regarding question 1A (Do you have full erection sufficient for penetration? rating 0 = always, 1 = often, 2 = quite often and 3 = sometimes) and question 2 (Does it occur to have a normal erection which you are not able to maintain? rating 0 = sometimes, 1 = quite often, 2 = often, and 3 = always) was used as a putative index of erectile function. Receiver operating characteristic (ROC) curve analysis showed SIEDY score predicted reduced IIEF-5 results at an accuracy of about 88% (Figure 1). Sensitivity and specificity for IIEF-5 score <21 were 90 and

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Figure 1 Receiver operating characteristic (ROC)—curve for SIEDY Appendix A score in predicting erectile dysfunction as detected by International Index of Erectile Function (IIEF-5 score <21).

79%, for SIEDY score <2, respectively. In addition, question 1D of SIEDY Appendix A (used as a dummy variable 0/1; presence or not of an absent erection for penetration in >75%; [28,29]) provided a specificity of 79%, sensitivity of 65%, and an accuracy of 81% in predicting severe ED as defined by IIEF-5 <8. In addition, the first 484 patients were studied without systematically applying a psychometric questionnaire (MHQ; Sample A). Later on, the rest of the sample (N = 1,275; Sample B) was evaluated with the use of the MHQ [25], a brief self-reported questionnaire for the screening of mental disorders in a non-psychiatric setting. MHQ provides scores for free-floating anxiety (MHQ-A), phobic anxiety (MHQ-P), obsessive– compulsive traits and symptoms (MHQ-O), somatization (MHQ-S), depressive symptoms (MHQD), and histrionic/hysterical traits (MHQ-H). The total score of MHQ (SMHQ) provides an index of mood and anxious spectrum psychopathology [22,25]. Patients were asked to report any kind of psychotropic drugs used. The two populations were comparable for demographic and clinical characteristics (Table 1).

Main Outcome Measures All patients underwent a complete physical examination, with measurement of blood pressure (mean of three measurements 5 minutes apart, in sitting position, with a standard sphygmomanometer), J Sex Med **;**:**–**

4 height, weight, and body mass index (BMI). Pulse pressure was calculated as the difference between systolic and diastolic blood pressure. Blood samples were drawn in the morning, after an overnight fast, for determination of blood glucose (by glucose oxidase method; Aeroset Abbott, Rome, Italy), total cholesterol, HDL cholesterol and triglycerides (by automated enzymatic colorimetric method; Aeroset Abbott), and total testosterone (by electrochemiluminescent method; Modular Roche, Milan, Italy).

Statistical Analysis Data were expressed as mean ⫾ SD when normally distributed, and as median (quartiles) for parameters with non-normal distribution, unless otherwise specified. Differences were evaluated with one-way anova or Kruskal-Wallis test, according to normal or not normal distribution. Correlations were assessed using Spearman’s or Pearson’s method when not normally or normally distributed, respectively. Unpaired two-sided Student’s t-tests were used for comparison of means of normally distributed parameters. In all other cases (i.e., not normally distributed variables), the Mann-Whitney U-test was used for comparisons between groups. Stepwise multiple linear or logistic regressions were applied for multivariate analysis, for continuous or categorical dependent variably, respectively. All statistical analysis was performed on SPSS for Windows 17.1 (SPSS Inc., Chicago, IL, USA).

Corona et al. Table 2 General Linear Model of age-adjusted risk for erectile dysfunction (SIEDY Appendix A score) of the different SIEDY scale scores and their interaction terms Parameter

Adjusted r

P

Scale Scale Scale Scale Scale Scale

0.259 0.336 0.194 -0.130 -0.052 -0.177

0.0001 0.0001 0.0001 0.016 0.293 0.0001

3 score 1 score 2 score 3 ¥ Scale 1 3 ¥ Scale 2 2 ¥ Scale 1

in different age tertiles (panel B–D). We found that Scale 3 score maintains an association with ED only in the youngest and the middle-aged subjects (Figure 2, panel B–C), whereas only Scale 1 (organic determinant) significantly contributed to ED in the oldest ones (Figure 2, panel D). A significant association of SIEDY Scale 2 (relational) with ED was verified only in the youngest subjects (Figure 2, panel B). Among subjects with ED, 138 (10.3%) reported severe erectile dysfunction. In an age-adjusted General Linear Model, where the individual contribution of the three scales of SIEDY were considered as covariates, we found that only Scale 1 was independently associated with the likelihood of severe ED (adj r = 0.166; P = 0.003).

Contribution of Scale 3 to Sexual Dysfunction Among the whole populations studied, 1,333 (75.8%) subjects reported ED, according to SIEDY Appendix A score, 468 (26.6%) premature ejaculation, and 640 (36.4%) hypoactive sexual desire.

Scale 3 and Other Sexual Dysfunctions In another age-adjusted General Linear Model, when premature ejaculation was analyzed according to a standard question, and the individual contribution of the three SIEDY scales were considered as covariates, only Scale 1 was negatively associated with premature ejaculation (Scale 1 adj r = -0.147, P < 0.0001, data not shown). The contribution of Scale 3 on hypoactive sexual desire was not evaluated since it represents one of the items of the scale. Therefore, in the subsequent analysis, only associations of Scale 3 with ED were considered.

Scale 3 and Erectile Dysfunction In an age-adjusted General Linear Model, where the individual contribution of the three scales of SIEDY were considered as covariates, we found that each scale was independently associated with the likelihood of ED (see Table 2). In the same model, scale interaction term analysis indicated that Scale 3 score decreased as a function of increasing Scale 1, while interaction with Scale 2 score was neutral. Figure 2 graphically depicts the contribution of each scale to ED (considered as Dummy variable 0/1, according to SIEDY Appendix A score ⱖ2), in the whole sample (panel A) and

Scale 3 as a Predictor of Psychopathology in ED Scale 3 Threshold Identification In sample A (first 484 patients studied without systematically applying a psychometric questionnaire), 39 (8%) and 60 (12.4%) subjects reported a positive medical history for psychiatric disturbances or for the use of psychotropic medication, respectively. The association with both conditions was present in 28 (5.8%) subjects. We assumed that this association (history of psychiatric disturbances 0/1 ¥ psychotropic medication 0/1) reflects the presence of an actual psychopathology.

Results

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Intrapsychic Component and Erectile Dysfunction I tertile (17-46 years old)

All sample

A

B

SIEDY Scale 1

SIEDY Scale 2

SIEDY Scale 3

0

1

0

2

1

2

III tertile (60-88 years old)

II tertile (47-59 years old)

C

D

SIEDY Scale 1

SIEDY Scale 2

SIEDY Scale 3 0

1

0

2

1

2

ROC—a graphical plot of the sensitivity, or true positive rate vs. false positive rate—was used as binary classifier system to identify the sensitivity and specificity of Scale 3 score in detecting psychopathology. SIEDY Scale 3 score predicts psychopathology with an accuracy of 69.5 ⫾ 5.9% (P < 0.002), showing a sensitivity of 76% and specificity of 61%, when a threshold of 3 was chosen (Figure 3).

Validation Analysis When the same threshold (Scale 3 score ⱖ3) was applied in Sample B (N = 1,275 patients systematically evaluated with the use of the MHQ; validation sample), it identified a higher ranking in MHQ-A (free-floating anxiety), MHQ-S (somatized anxiety) and MHQ-D (depressive symptoms) subscales (Figure 4, Panel A–C). Accordingly, a pathological Scale 3 score was associated with a higher risk of pathological MHQ-A, MHQ-S, and MHQ-D score in a multivariate model, where age and S-MHQ (a broader index of general

Sensitivity

Figure 2 Age adjusted risk for erectile dysfunction as a function of each 10% SIEDY scale increment in the whole sample (Panel A) and in the different age tertiles (Panel B–D).

1-Specificity Figure 3 Receiver operating characteristic (ROC)—curve for SIEDY Scale 3 score in detecting psychopathology (medical history of psychiatric disturbances and the use of psychotropic medication) in Sample A.

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Corona et al.

A No

p<0.0001

B

YES

No

p< 0. 0 001

MHQ-D score

p<0.0001

MHQ-S score

MHQ-A score

6

C

YES

No

YES

Pathological SIEDY Scale 3

Free floating anxiety (MHQ-A)

Somatized anxiety (MHQ-S)

Depressive symptoms (MHQ-D)

D 0.6

1

1.4

Figure 4 Free-floating anxiety (Panel A; MHQ-A score), somatized anxiety (Panel B; MHQ-S score), and depressive symptoms (Panel C; MHQ-D score) in patients with or without pathological SIEDY Scale 3 score (>3). Panel D. Adjusted (age and S-MHQ-score) risk for pathological SIEDY Scale 3 score.

psychopathology) were introduced as possible confounders (Figure 4, panel D). In the validation sample, we also confirmed that pathological Scale 3 score was related to a higher risk of psychopathology at medical history or to the use of psychotropic drugs, even after the adjustment for age and S-MHQ. In addition, pathological SIEDY Scale 3 score was also associated with risky lifestyle behaviors, such as smoking and alcohol abuse, and elevated BMI. Finally, lack of intimacy during sexual intercourse, lower fre-

quency of sexual intercourse, higher guiltiness during masturbation, along with higher education, were more prevalent in subjects with a high score in Scale 3 (see Table 3). Conversely, no difference for other biochemical and hormonal parameters evaluated was observed. Discussion

In this study, we confirmed in a large patient sample that the intra-psychic domain (as measured

Table 3 Adjusted (age and S-MHQ) hazard radios for pathological SIEDY Scale 3 score (>3) for different parameters derived from the medical history in sample B Parameter

Hazard ratio

LL (95% CI)

UL (95% CI)

High education Current smokers Alcohol consumption >4 drinks/day History of psychiatric diseases Reported use of psychotropic drugs Lack of intimacy during sexual intercourse Frequency of intercourse <2 times/month Guiltiness during masturbation

2,249 1,439 1,807 1,896 1,916 1,502 1,454 2,148

1,717 1,144 1,079 1,229 1,371 1,138 1,165 1,511

2,945 1,810 3,204 2,926 2,678 1,984 1,814 3,052

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Intrapsychic Component and Erectile Dysfunction by SIEDY Scale 3 score) is significantly associated with ED, independently from the contribution of other domains (organic and marital). This study also demonstrates that SIEDY Scale 3 scoring is an easy-to-use, versatile instrument to detect, in a clinical setting of male patients with sexual dysfunction, those with psychopathological features, who should eventually undergo an in-depth psychiatric evaluation. Scale 3 was identified almost 10 years ago through factor analysis of a 13-item structured interview, SIEDY, which was specifically designed for the pathogenetic definition of erectile dysfunction [21]. Scale 3 includes six items related to attitudes toward working and family environment, and we originally postulated that it could provide insights on the psychopathological status of ED patients [21]. Elevated SIEDY Scale 3 score is more prevalent in young patients and, in this subset; Scale 3 represents the most important determinant of ED. However, in young ED individuals, the other ED domains (organic, Scale 1, and relational, Scale 2) must also be considered because they are significantly associated with the erectile problem. While Scale 3 contribution to the pathogenesis of ED also retains significance in middle-aged men, this association is lost in the oldest subgroup. Accordingly, in both middle-aged and older men, the organic factor (Scale 1) seems to be the most important determinant of ED. It could be speculated that the apparently lower impact of psychological domain in older patients is due to the fact that organic diseases leading to ED are more prevalent in this age range [19,23,32,33]. Alternatively, this result could be the effect of a selection bias, with older patients with long-lasting psychological problems affecting their sexual life less prone to seek medical advice for ED. Relational factor (Scale 2) is relevant only in the youngest patients. Interestingly, while the interaction product between intra-psychic and relational factors (Scale 3 ¥ Scale 2) was neutral, the product Scale3 ¥ Scale1 was negatively associated with ED. This is tantamount to say that, in patients with ED, the higher the intra-psychic component, the lower the organic one, as previously suggested [32]. To validate the ability of SIEDY Scale 3 to identify psychopathology, we first detected, through ROC curve analysis, a scoring threshold able to capture subjects with a positive medical history for psychiatric diseases and psychotropic medications. We then retested the putative pathological Scale 3

7 score in a second, independent sample, where the psychometric instrument MHQ was systematically applied. We found that a pathological Scale 3 score was associated with higher scores in free-floating anxiety, somatized anxiety, and depressive symptoms. No effect was found on the other MHQ subscales (phobic anxiety, obsessive, and hysterical traits). The association of Scale 3 with negative emotional states, characterized by depressive or anxious symptoms, is not surprising because men with ED often feel puzzled, disgraced, weakened, and frightened [22,34,35]. These negative emotional forces can generate psychopathological symptoms that primarily contribute to, or can be the consequence of, an unsatisfactory and dysfunctional sexual response, in particular in the youngest subjects [36,37]. The association of Scale 3 with somatization symptoms, characterized by the high attention devoted by these subjects to their body and possible bodily malfunctioning, could further exacerbate an already impaired sexual activity, therefore closing a vicious cycle [22]. The bidirectional relationship between emotional disturbances and ED can be further complicated by the potential sexual side effects of psychoactive medications used to treat mental disorders [38–42]. The use of psychoactive medications is in fact more frequent in subjects with a high Scale 3 score. In addition, Scale 3-identified psychopathology is associated with a low frequency of intercourse, and with guiltiness during autoeroticism confirming that the lack of confidence in the reliability of erections generates negative emotions that significantly lowered sexual drive [43–45]. Eating, drinking, and smoking are dysfunctional behaviors associated with high Scale 3 scores; they can derive from an ED-associated loss in sexual confidence, representing a link between unhealthy lifestyle and psychopathology [46–48]. Finally, the association between SIEDY Scale 3 and higher guiltiness during masturbation is not surprising and in line with previous findings [49]. In fact, it is well established that a sense of guilt is one of the core features of depressive symptomatology [50,51]. Several limitations of the present study should be recognized. These results are derived from patients consulting an Italian Andrology Clinic for ED, which could have different characteristics from those consulting general practitioners or not seeking medical care. Furthermore, it should be recognized that results obtained in specific clinical settings cannot be easily generalized to wider J Sex Med **;**:**–**

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populations. Conversely, phenomena observed in samples from the general population cannot always be extended to patients seeking treatment for a specific condition. The limited number of patients reporting psychopathology observed in the present study represents another limitation. Our data should be confirmed in larger studies. Finally, our data showed that the contribution of psychological domain is limited in patients with severe ED. However, considering that severe ED is more often associated with organic disturbances (i.e., vascular insufficiency), subjects with severe ED are more likely to seek treatment for ED for non-psychogenic causes. Therefore, the psychogenic disturbances among patients with severe ED can result to be diluted when compared to patients complaining of milder form of ED.

psychiatric procedures and may affect further decisions on ED patient management. Furthermore, although psychopathological symptoms can be the consequence, rather than the cause of ED, in some cases, their treatment can positively influence sexual function [18,22,55]. An easy tool for the identification of patients with a relevant intrapsychic component could be used for identifying those who should be considered for psychological/ psychiatric treatment.

Conclusions

Statement of Authorship

Sexual health and ED are the results of a complex interplay among biophysical, psychological, and relational factors. According to Sexual Tipping Point Model, the etiology of ED is a combination of psychosocial and organic factors that can both excite and inhibit sexual response [52]. Positive mental and psychological factors increase the likelihood of a response, while negative mental and physical factors inhibit the sexual response [52]. The same factors should be considered for the evaluation of treatment outcomes and relapse prevention. Accordingly, Metz & McCarthy [53], in their Good-Enough Sex model, indicates that psychological, biological, and relational expectations are essential for sexual satisfaction. In the clinical setting, the weight of each of these domains should be carefully evaluated. SIEDY Scale 3 is a rapid case history tool able to detect the psychopathological symptoms in patients suffering from ED, allowing the identification of those subjects who should undergo an in-depth psychiatric evaluation. High Scale 3 score may in fact alert physicians to the presence of a psychopathology in ED subjects. Systematic testing of patients with ED through psychiatric questionnaires is recommended to detect even slight or moderate psychopathological distresses, which are specifically associated with and exacerbate sexual disturbances [54]. However, they are, in clinical practice, not routinely applied. Using Scale 3, which explores relevant items of a patient’s medical history related to stress at work or within the family environment, might assist clinicians in suspecting such psychological disturbances that may deserve further diagnostic

Category 1

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Corresponding Author: Prof. Mario Maggi, MD, Sexual Medicine and Andrology Unit, Department of Clinical Physiopathology, Viale Pieraccini 6, 50139 Florence, Italy. Tel: +39 55 4271415; Fax: +39 55 4271413; E-mail: [email protected]fi.it Conflict of Interest: None.

(a) Conception and Design Giovanni Corona; Mario Maggi (b) Acquisition of Data Giovanni Corona; Giulia Rastrelli; Helen Casale; Alessandra Sforza (c) Analysis and Interpretation of Data Giovanni Corona; Mario Maggi

Category 2 (a) Drafting the Article Giovanni Corona; Giulia Rastrelli; Mario Maggi (b) Revising It for Intellectual Content Giovanni Corona; Valdo Ricca; Elisa Bandini; Helen Casale; Emmanuele A. Jannini; Gianni Forti; Edoardo Mannucci; Mario Maggi

Category 3 (a) Final Approval of the Completed Article Giovanni Corona; Mario Maggi

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Appendix A.

SIEDY Questions Composing Scale 3

2. Are you satisfied with your job/occupation? 0 Fully gratifying job/occupation; 1 The patient is fairly satisfied; 2 The patient would have preferred to have a different job/ occupation; 3 Completely unsatisfied.

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Notice: even those who do not have a job, such as retired persons, can have occupations. 0 Very satisfied 1 Fairly satisfied 2 Not very satisfied 3 Unsatisfied 3. Do you ever think of your job out of the working hours? We refer to the last month. Sometimes: the patient has got occasional thoughts about his job which do not interfere with his normal life; quite often: frequent thoughts that interfere with normal life; often: very frequent thoughts rendering the patient incapable to concentrate on his normal life. For those who do not have a job, score is 0. 0 never 1 sometimes 2 quite often 3 often 6. Do you have a difficult relationship with your partner? Do you quarrel often? Do you avoid each other? A relationship in which there is little conflict and a good dialogue is considered normal; occasional quarrels (1) when there is a good dialogue and quarrels occur seldom, without disturbing family relationships; frequent quarrels (2) if there are some attempts to dialogue, but the quarrels disturb family relationship; always means a total absence of dialogue including total avoidance of each other. 0 No, I have normal relationships 1 No, occasional quarrels 2 Yes, frequent quarrels 3 Always 11. Are there any conflicts at home (with children, or other persons living with you?) A relationship in which there is little conflict and a good dialogue is considered normal; occasional quarrels (1) when there is a good dialogue and quarrels occur seldom, without disturbing family relationships; frequent quarrels (2) if there are some attempts to dialogue, but the quarrels disturb family relationship; always means a total absence of dialogue including total avoidance of each other. 0 No, I have normal relationships 1 No, occasional quarrels 2 Yes, frequent quarrels 3 Always 12. Do you have other sexual relationships (with people other than your usual partner)? 0 No 1 Occasionally 2 Another stable relationship 3 Another stable relationship and occasional intercourse with different partners 14. Did you have more or less desire to make love in the last three months? Was your desire increased or reduced when compared to the past? 0 when the patient’s desire is unmodified or increased; 1 if desire is moderately reduced, in less than 50% of potential occasions; 2 if desire is reduced in more than 50% of potential occasions; 3 if the patient has had no desire to make love. The question investigates only the patient’s, and not the partner’s, desire. The last three months should be considered. 0 Unmodified or increased desire 1 Desire present but moderately reduced 2 Desire remarkably reduced 3 Desire never present