ABSTRACT: Erectile dysfunction is a common sequela following potentially curative local treatment for early-stage carcinoma of the prostate gland. Over the past decade, prostate brachytherapy has been used increasingly as definitive treatment for early-stage carcinoma of the prostate gland, with the majority of the literature on brachytherapy reporting biochemical results as favorable as those in the most positive radical prostatectomy and externalbeam radiation therapy series.[1-4] Because of a lack of definitive evidence supporting the efficacy of one local treatment approach over another, quality-of-life (QOL) parameters have assumed greater importance. Investigators are increasingly evaluating postimplant QOL with survey instruments far more detailed than previously published scales such as those of the Radiation Therapy Oncology Group (RTOG).[24] These more detailed instruments were created in an attempt to enable more uniform reporting of lifestyle effects and facilitate comparisons between different modalities.
Although QOL experts have been working to homogenize QOL parameters for comparison between treatment modalities, Merrick and colleagues have detailed specific sexual changes related to brachytherapy by means of an in-depth survey of sexual function that combines the specific erectile questions of the International Index of Erectile Function (IIEF) with a number of more detailed topics. Prostate brachytherapy does affect sexual function and, unfortunately, standard survey tools do not address these changes.
The wide range of erectile dysfunction after prostate brachytherapy may result from differences in follow-up and may be distorted by the method of data collection. Using more reliable tools and longer follow-up, two factors regarding postimplant erectile dysfunction have become apparent. The second important factor that has become clear is that erectile dysfunction increases with time after treatment. Potency preservation rates following all treatment approaches are significantly lower when patientadministered questionnaires rather than physician interview are used to collect data.
In contrast, a study in 64 patients that used a validated patient-adminĀ  istered questionnaire and a definition of potency as "the ability to engage in unassisted intercourse with or without sildenafil citrate [Viagra]" reported that 86% were potent 18 months following radical prostatectomy.[ 33] Only two patients were exclusively dependent on sildenafil.
This section presents some guidelines for the short-term and long-term use of oxygen therapy. Despite widespread adoption of the six-item erectile function (EF) domain of the International Index of Erectile Function (IIEF) as a clinical trial end point, there are currently no objective data on what constitutes a minimal clinically important difference (MCID) in the EF domain. Anchor-based MCIDs were estimated using data from 17 randomized, double-blind, placebo-controlled, parallel-group clinical trials of the phosphodiesterase type 5 inhibitor (PDE5-I) tadalafil for 3345 patients treated for 12 wk. The contextualization of treatment-related changes in terms of clinically relevant improvement is essential to understanding treatment efficacy, to interpreting results across studies, and to managing patients effectively.
The minimal clinically important difference (MCID), critical for patient management, in the erectile function domain of the International Index of Erectile Function is not known.
Self-report measures, often referred to as patient-reported outcomes (PROs) [1], are widely used in sexual medicine research [2] and [3]. The EF domain of the IIEF [4] is the primary measurement domain of the IIEF and is a commonly used primary end point in clinical trials of ED.
The primary objective of this analysis was to estimate the MCID for the EF domain of the IIEF using anchor-based methods (favored by regulatory agencies [1] and clinical investigators) in 17 randomized, double-blind, placebo-controlled, parallel-group clinical trials with virtually identical designs that assessed the efficacy of the phosphodiesterase type 5 inhibitor (PDE5-I), tadalafil for use in men with ED. An integrated post hoc analysis was performed according to a prespecified statistical analysis plan on data collected from 17 randomized, double-blind, placebo-controlled, parallel-group clinical trials with identical designs that were conducted at 148 centers in North and South America, Europe, Asia, and Australia from 1999 to 2004. Briefly, following a screening visit, patients who made at least four attempts at sexual intercourse during a 4-wk treatment-free run-in period were randomly allocated to 12 wk of treatment with placebo (n=1002) or on-demand tadalafil at fixed doses of 10mg (n=527) or 20mg (n=1816). Studies were approved by institutional review boards, and each patient gave written informed consent. Men aged >18 yr who had a minimum 3-mo history of mild to severe ED of organic, psychogenic, or mixed etiology (as determined by the investigator) with a steady female partner were eligible to participate in these studies.
The IIEF is a self-administered questionnaire that assesses five domains of male sexual function, including EF, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.
For the purposes of determining the MCID of the EF domain, the change from baseline to week 12 of the EF domain score was used in calculations and models. The database of 17 studies was divided into two main groups: the development data set, in which the MCID would be derived, and the validation data set, in which the estimates of the MCID would be evaluated for external validity, convergent validity, and consistency.
Convergent validity of the MCID was examined by showing that groups identified by the MCID were consistent with responses in the active treatment and placebo groups.
The validation sample was used to replicate and confirm MCID values derived in the development sample. The MCIDs were estimated using the development sample, which was composed of 11 studies from Asia, North America, Europe, South America, and Australia.
We performed a preliminary assessment of the association between the Q7MMI and EF domain change using the ANOVA approach. The ROC-based MCID showed consistently high sensitivity and specificity in the development and validation samples. Despite widespread use of the IIEF in clinical research and practice, no published data are available concerning MCID of the EF domain.
Estimated MCIDs of the IIEF EF domain varied according to baseline ED severity, with MCIDs increasing in size with increasing baseline ED severity. We observed that regardless of the analytic method used to estimate the MCID, estimates generated from the development samples were generally replicable in the validation samples.
Another strength of this analysis is the diversity of the patient base with regard to geographic region, ED etiology and duration, and age. Data for the current analyses were based solely on 17 studies of tadalafil (10mg, 20mg) and placebo in men enrolled in ED clinical trials. Another potential limitation is our selection of the clinical anchor for our analyses (ie, IIEF Q7). This analysis considered the estimation of MCIDs using anchor-based approaches for an end point (the EF domain of the IIEF) that is commonly used in ED efficacy trials. Critical revision of the manuscript for important intellectual content: Rosen, Allen, Ni, Araujo.
See related patient information handout on erectile dysfunction, written by the author of this article.
Erectile dysfunction is defined as the persistent inability to attain or maintain penile erection sufficient for sexual intercourse. Following permanent prostate brachytherapy with or without supplemental external-beam radiation therapy, encouraging longterm biochemical outcomes-including a morbidity profile that compares favorably with competing local modalities- have been reported for patients with low-, intermediate-, and high-risk features.[1,2] The efficacy and morbidity of prostate brachytherapy are dependent on implant quality.
With the assimilation of brachytherapy into the conventional urooncology armamentarium, a rapidly expanding body of literature regarding patient selection and treatment approach has been reported.[1,2,7-15] Although not all patients are acceptable candidates for brachytherapy, a reliable set of pretreatment criteria for predicting implant-related morbidity has not been formulated. Currently, no reliable preimplant criteria can be used to predict who will develop prolonged urinary retention. Pubic arch interference-the obstruction of anterior needle placement insertion by a narrow pubic arch-has long been considered a relative contraindication to brachytherapy. In the early-to-mid 1990s, urinary incontinence developed in approximately 50% of patients with a history of a transurethral resection of the prostate gland (TURP) prior to implantation. After brachytherapy, approximately 2% of patients develop prolonged urinary retention, but the vast majority are eventually able to urinate without surgical intervention.[34] If a postimplant TURP or transurethral incision of the prostate (TUIP) is necessary, it should be delayed for as long as possible. In a small contemporary series, Wallner and colleagues reported complete dosimetric coverage of the median lobe in all patients.[36] However, 25% of patients developed prolonged postimplant urinary retention, and additional patients developed prolonged IPSS elevation. Prostatitis has been regarded as a relative contraindication to brachytherapy despite the lack of supporting documentation. Some have considered inflammatory bowel disease, ulcerative colitis, and regional enteritis (Crohn's disease) to be relative contraindications to radiation therapy. Although some patients with adverse pathologic features have subclinical distant metastatic disease at diagnosis, a high 5-year cause-specific survival has been reported in hormone-naive patients using either dose-escalated high-dose-rate brachytherapy or external-beam radiation therapy.[53,54] These findings are in sharp contrast to the assumption that most patients with adverse pathologic features have subclinical distant metastases at diagnosis.
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With larger studies and longer follow-up, it is clear that erectile dysfunction following prostate brachytherapy is more common than previously reported, with a myriad of previously unrecognized sexual symptoms. Although admirable in their intent, such efforts culminate in scores of, for example, urinary bother, functional well-being, and expanded prostate cancer index composite (EPIC) scores that are so nebulous, they are almost meaningless to patients or investigators other than QOL aficionados.[ 25-28] To make matters worse, none of the current QOL instruments adequately capture brachytherapyrelated sexual dysfunction. In order for QOL instruments to accurately reflect sexual function following brachytherapy, new validated instruments that address brachytherapy-specific symptomatology will have to be developed. However, a possible selection bias may have been present, because only 38% of the 59 patients who agreed to participate in the study returned all four questionnaires.
This analysis provides, for the first time, anchor-based estimates of MCIDs in the EF domain score of the IIEF.
Among PRO measures used in assessing sexual function, none is more widely used currently than the International Index of Erectile Function (IIEF) [4].
The psychometric properties of the EF domain have been extensively reported [3], [4], [5], [6], and [7], but surprisingly, there are no studies in the literature of the minimal amount of change needed in the EF domain to be clinically meaningful to patients. Details about the general study design, efficacy and safety measures, and statistical analyses have been published in previous integrated analyses of 5 [9] and 11 [10] and [11] tadalafil trials. Patients were seen at 4-wk intervals until they completed the study or discontinued early for any reason.
Studies were conducted in accordance with the Declaration of Helsinki and guidelines for Good Clinical Practice. Patients were excluded if they failed to achieve erection following radical prostatectomy or pelvic surgery, had clinically significant penile deformities or penile implants, had clinically significant renal or hepatic insufficiency, or had a recent history of spinal cord trauma.
In the event that the patient discontinued the study prior to week 12 or the week 12 assessment is otherwise missing, the last observed postbaseline value was analyzed. A total of 1240 of the 3345 patients in the 17-study data set qualified according to these criteria. The association between minimal important changes in the anchor (independent variable) and change in EF domain score (dependent variable) was assessed preliminarily by two-sample t test of the mean EF domain scores among patients with and without minimal important changes in the anchor (later referred to as the analysis of variance [ANOVA] approach) [8], [14], and [15] and analysis of covariance (ANCOVA) models (adjusted for baseline EF domain score [16]), from which MCIDs were estimated.

The MCID would show convergent validity if the MCID cut-off discriminated between responses in the placebo versus active treatment groups. MCIDs were validated using the validation sample, composed of six studies from Asia, North America, Europe, and Africa.
The ROC-based MCID of 4 discriminates well between mean change in EF scores of the placebo group and the active groups in the development sample. Depending on the proposed use of the MCID estimate, clinicians or researchers would be advised based on these findings to consider setting an expected change for a given individual patient based on baseline severity of ED. The ANOVA-based approach is more conservative in estimating the MCID using the mean change in the EF domain for all patients who showed improvement. The large sample size and multiple clinical trials included were major strengths of the current study and allowed cross-sample replication of the main findings. MCIDs performed equally well across a broad range of geographic regions, ED etiology, and, importantly, age group.
These results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies (eg, weight loss) [20]. Anchor-based approaches to defining MCIDs should ideally use patient ratings of change administered at different periods of time or on exit from a clinical trial [1]. The anchoring of changes in the scoring of the EF domain of the IIEF in clinically meaningful terms is critical to understanding efficacy, to interpreting study results, and to managing patients. Rosen had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. The majority of cases have an organic etiology, most commonly vascular disease that decreases blood flow into the penis. The corpora cavernosa are composed of a mesh-work of interconnected cavernosal spaces lined by vascular endothelium. Normal erectile function requires a complex set of dynamic neural and vascular interactions. Most causes of erectile dysfunction were once considered to be psychogenic, but current evidence suggests that up to 80 percent of cases have an organic cause.1 Organic causes are subdivided into vasculogenic, neurogenic and hormonal etiologies. Aging is an independent risk factor, and although the incidence of erectile dysfunction increases steadily with age, it is not an inevitable consequence of aging. Information from references 7 and 8.Excessive and long-term use of a number of substances may also cause erectile dysfunction. In all instances, medical conditions having an impact on erectile function should be corrected or their progression controlled. While most alleged contraindications to brachytherapy have been propagated with little supporting data, an increasing number of evidence-based factors contributing to radiation-related morbidity have accumulated (Table 1).
Although median lobe hypertrophy should not be considered an absolute contraindication to brachytherapy, patients with this condition should be approached with caution. Consistent with these findings, tobacco consumption correlated with a trend for poorer biochemical progression-free survival following permanent prostate brachytherapy.[44] In addition, tobacco may exacerbate brachytherapyinduced morbidity. In fact, a variety of sexual symptoms other than erectile dysfunction occur following prostate brachytherapy.
MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region, ED etiology, and age group.
The IIEF was recommended by the International Consultation on Sexual Medicine in 2004 and 2010 as the gold standard self-report questionnaire for measuring erectile function (EF) in clinical trials and observational studies and has been accepted and recommended by regulatory agencies worldwide for approval of erectile dysfunction (ED) therapies. This is commonly referred to as the minimal clinically important difference (MCID), which has been defined as the smallest difference in a score in the domain of interest that patients perceive as beneficial and that would mandate, in the absence of side effects and excessive cost, a change in the patient's management [8]. All 17 studies included IIEF, Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ) as efficacy measures. Patients were also excluded from trials if they had an underlying cardiovascular disorder sufficiently severe or unstable to make sexual intercourse unadvisable (eg, unstable angina, recent myocardial infarction or stroke, recent myocardial revascularization, poorly controlled blood pressure). Values on the EF domain were set to missing if more than one of the individual items was missing; if the answer to one item was missing, then the average of the remaining items was imputed. No change at week 12 was defined as a rating of 1 or 2 at baseline, followed by a similar rating of 1 or 2 at week 12 (see Fig.
Only 93 (2.8%) of the patients in the 17-study data set had missing data for Q7 at either baseline or week 12. Of the 1240 patients in the analysis, the development and validation data sets included 863 patients (70%) and 377 patients (30%), respectively. Receiver operating characteristic (ROC) analyses [15] and [17] were also used to estimate MCIDs, whereby the Q7MMI was regressed on a dichotomized version of the EF domain score, using logistic regression. A figure displaying box plots of the change from baseline of the EF domain for each treatment group is presented, with reference lines for 0 (no change) and for the IIEF Q7-derived MCIDs using the ANOVA and ROC approaches. Box plots of the change in IIEF EF domain among patients with and without minimal improvement were reviewed for each of the subpopulations.
These samples were predicted to be similar but showed statistically significant differences in a few variables at baseline, although the samples were generally similar as middle-aged men, all with ED. After showing a statistically significant association between EF domain scores and our selected clinical anchor (ie, IIEF Q7) by means of ANOVA, we then identified optimal cut points for MCID using a traditional ROC approach. If the patient has a baseline EF score in the severe dysfunction range (6–10), for example, he would need to increase his EF score almost twice as much to achieve a noticeable improvement in satisfactory intercourse attempts compared with a man in the moderate ED range. In contrast, the ROC-based approach is used to identify an MCID that provides optimal classification of responders and nonresponders regardless of treatment condition. All patients were heterosexual and engaged in regular sexual activity with a partner as an inclusion criterion in the studies, and this profile limits generalizability. Regardless of the primary cause, erectile dysfunction can have a negative impact on self-esteem, quality of life and interpersonal relationships. An estimated 10 to 20 million American men have some degree of erectile dysfunction.1,2Increased understanding of the male erectile process and the development of several agents to improve erectile function have generated great public interest among men and their sexual partners. Penile erection can be elicited by at least two distinct mechanisms, central psychogenic and reflexogenic,3 which interact during normal sexual activity. Vasculogenic etiologies represent the largest group, with arterial or inflow disorders being the most common.
Several studies have indicated that patients and providers are reluctant to address sexual topics.
Accordingly, we have summarized evidence-based vs unsubstantiated patient selection factors that affect outcome in this setting. It is conceivable that preimplant resection of the intravesical component could reduce the incidence of brachytherapy-related morbidity. Several factors including preimplant potency, patient age, the use of supplemental external-beam irradiation, radiation dose to the prostate gland, radiation dose to the bulb of the penis, and diabetes mellitus appear to exacerbate brachytherapyrelated erectile dysfunction. A recent PubMed search indicated >1400 citations of the IIEF since its development in 1996.
Identifying a clinically meaningful change in the EF domain of the IIEF is critical to understanding efficacy, to interpreting study results, and to managing patients. Men treated with nitrates, antiandrogens, or cancer chemotherapy also were excluded from study.
The MCID was defined as the cut-off value for which the sum of sensitivity and specificity is maximized or, alternatively stated, where the most patients are correctly classified by the cut-off of the IIEF EF domain as having improved versus not having improved. Patients in the development sample had lower body mass index, consumed less alcohol, and were more likely to have psychogenic ED (Table 1). Notably, estimated MCIDs varied according to baseline ED severity, with MCIDs increasing in magnitude with increasing ED severity.
Accordingly, using the ROC approach, 73% of patients were correctly classified as having improved, whereas the ANOVA approach resulted in only 47% of the patients being correctly classified as having improved.
Additional studies are also needed in special medical or surgical populations, such as men with ED secondary to radical prostatectomy, spinal cord injury, pelvic trauma, or Peyronie's disease. Of the items available in the integrated data set, Q7 of the IIEF represented the clinical intent and spirit of MCID analyses by allowing us to select an item that could quantify the minimally important difference and that was directly relevant to the NIH definition of ED (ie, inability to perform satisfactory intercourse) [12]. Based on these results, responder rates can be calculated more accurately and used as study end points in terms of normalization of function, as traditionally defined (ie, EF score >25) [4], or as the percent of subjects who achieve MCID, correcting for baseline severity of ED. An assessment of patient-reported outcomes for men with erectile dysfunction: Pfizer's perspective. A comparison of the International Index of Erectile Function and erectile dysfunction studies. The initial step in evaluation is a detailed medical and social history, including a review of medication use.
These advances are expanding the treatment options available to primary care physicians in the management of erectile dysfunction.
3 Blood flow is provided primarily by the cavernosal branches of the internal pudendal artery. Psychogenic erections are initiated centrally in response to auditory, visual, olfactory or imaginary stimuli. Consideration should be given to discontinuation of any medication suspected of contributing to the erectile problem or, if required, switching to an alternative medication less likely to interfere with erectile function.

The majority of patients with brachytherapy- induced erectile dysfunction respond favorably to sildenafil citrate (Viagra). Recently, an abbreviated version of the IIEF [5] has been adopted as a screening tool for clinicians. Importantly, there was no difference in baseline scores of the IIEF EF domain between the development and validation samples and no difference in the change from baseline to week 12 EF outcome measure. The mean improvement in each of the subgroup comparisons was generally consistent with both methods. Regardless of the analytic method used to estimate the MCID, estimates generated from the development samples were generally replicable and were confirmed in the validation samples. Published reports in the literature have similarly shown greater relative improvements in patients with lower initial values in EF domain scores [9], [18], and [19].
In keeping with regulatory guidelines that suggest a responder criterion be developed, we chose to emphasize the ROC-based approach as offering evidence-based cut points for classifying ED patients in clinical trials as responders or nonresponders [1]. There were insufficient numbers of patients with these conditions in our integrated analyses for adequate replication. Research instruments for the diagnosis and treatment of patients with erectile dysfunction. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. Minimum detectable and minimal clinically important changes for pain in patients with nonspecific neck pain. The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Each branch divides into numerous terminal branches that open directly into the cavernous spaces. Reflexogenic erections result from stimulation of sensory receptors on the penis which, through spinal interactions, cause somatic and parasympathetic efferent actions.3On arousal, parasympathetic activity triggers a series of events starting with the release of nitric oxide and ending with increased levels of the intracellular mediator cyclic guanosine monophosphate (cGMP).
Regardless of the primary etiology, a psychologic component frequently coexists.5The severity of erectile dysfunction is often described as mild, moderate or complete, although these terms have not been precisely defined.
Despite reports questioning the potency-sparing advantage associated with brachytherapy, recent elucidations of brachytherapyrelated erectile dysfunction may result in refinement of treatment techniques, an increased likelihood of potency preservation, and ultimately, improved quality of life. Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies.
Multiple validation studies and systematic reviews of the IIEF have been published supporting its use in both clinical and research settings [3], [6], and [7].
Additionally, across geographic regions, ED etiology, and age groups, we found consistent support for the ROC-based MCID in the EF domain.
In contrast, no differences in MCID were observed across age groups, etiology, or geographic regions. Increases in cGMP cause penile vascular and trabecular smooth muscle relaxation.3,4 Blood flow into the corpora cavernosa increases dramatically. First, provide information about conditions that are commonly associated with sexual dysfunction, then follow with a question about the individual's concerns. Patients with a week 12 score >3 were excluded because these patients would have experienced more than a minimal improvement in intercourse satisfaction. The SEP measure has a similar binary rating of intercourse success and is rated on every intercourse event rather than for the overall treatment period. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Laboratory tests are useful to screen for common etiologic factors and, when indicated, to identify hypogonadal syndromes. The rapid filling of the cavernosal spaces compresses venules resulting in decreased venous outflow, a process often referred to as the corporeal veno-occlusive mechanism. The male sexual response cycle consists of four major phases: (1) desire, (2) arousal (erectile ability), (3) orgasm and (4) relaxation. Before the initiation of testosterone therapy, the patient should be evaluated for the possibility of an occult prostate malignancy, which may be stimulated by supplemental testosterone. For these and other reasons, we selected IIEF Q7, which we noted has been used previously as an anchor item in the development and validation of severity cut points on the EF domain of the IIEF [3] and [13].
The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire. Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change.
Appropriate evaluation of erectile dysfunction leads to accurate advice, management and referral of patients with erectile dysfunction.
This information may help assess the patient's sexual problems as well as identify high-risk behaviors and other concerns affecting the patient's overall health.Once a concern with the patient's sexual function is identified, the next step is to differentiate erectile dysfunction from other sexual problems, such as loss of libido or ejaculatory problems. The physician should use appropriate vocabulary, avoiding slang or excessively technical terminology. Patients with suspected vasculogenic or neurogenic causes can be considered for a trial of therapy in the primary care setting.
Having the patient define the terms in his own words will help the physician and patient communicate more effectively.13 The International Index of Erectile Function (IIEF)14 is a valuable tool for defining the area of sexual dysfunction (Figure 4). Patients with a suspected psychogenic etiology should be considered for sexual counseling or psychiatric referral as well.Patients requesting a more comprehensive evaluation or those not responding to initial therapy should be referred for further evaluation and treatment.
The IIEF is designed to be a self-administered measure of erectile dysfunction, but it also assesses a patient's function in other phases of sexual function. As such, it should be viewed as an adjunct to, rather than a detailed sexual history.Reprinted with permission from Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile dysfunction (IIEF): a multidimensional scale for assessment of erectile dysfunction. Because erectile dysfunction is frequently caused by medication, a review of the patient's drug therapy is essential and should include prescription and over-the-counter medications.
Life stressors such as change in social status, divorce, death of spouse, loss of job, or family problems may have an effect on erectile function. Difficulty in erectile function affects the patient and his partner, so it is important to assess whether the erectile problem is troubling one partner more than the other, and if so, who and why.
Finally, the physician should determine the patient's and the partner's level of understanding of sexual anatomy and function, as well as what expectations each has with regard to treatment outcome. Men with erectile dysfunction and their partners often lack a full understanding of sexual processes or have unrealistic expectations regarding sexual performance and satisfaction.5PHYSICAL EXAMINATIONThe physical examination should assess the patient's overall health. Particular attention should be given to the cardiovascular, neurologic and genitourinary systems, as these systems are directly involved with erectile function.
The cardiovascular examination should include assessment of vital signs (especially blood pressure and pulse) and signs of hypertensive or ischemic heart disease. Abdominal or femoral artery bruits and asymmetric or absent lower extremity pulses are indicative of vascular disease.
Skin and hair pattern evidence of vascular insufficiency should be noted.The patient's demeanor, dress, speech and overall appearance should be noted for signs suggestive of anxiety or depressive disorders. The superficial anal reflex, indicative of normal somatic function of sacral cord levels S2–4, is assessed by touching the perianal skin and noting contraction of the external anal sphincter muscles.
It is performed by placing a finger in the rectum and noting contraction of the anal sphincter and bulbocavernosus muscle when the glans penis is squeezed.
External anal sphincter tone can be assessed during this maneuver as well.The genital evaluation should assess for local abnormalities, such as hypospadias or phimosis, and evidence of hypogonadism.
The penis should be palpated to determine the presence of local abnormalities such as fibrous plaques of the fascial covering (Peyronie's disease). The prostate gland should be assessed for size, consistency and symmetry.ADDITIONAL STUDIESIf not previously done, some basic studies should be considered to identify unrecognized systemic conditions that may predispose to erectile dysfunction.
The specific testosterone assay to be obtained is debated.15,17 Testosterone is predominately protein-bound and is influenced by a variety of clinical conditions.
An age-adjusted, first-morning, free testosterone level is probably the most accurate measure.17 If the initial testosterone level is low, follow-up studies should include luteinizing hormone and follicle-stimulating hormone levels to differentiate testicular from hypothalamic-pituitary dysfunction.
These tests are not usually performed in the family physician's office and are not necessary before the initiation of therapy for most patients. Many of these tests are subject to significant variation in interpretations and are most appropriate for use in refractory cases.

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