Antonio Martin Morales

Standardization of Vascular Assessment of Erectile Dysfunction

Introduction In-office evaluation of erectile dysfunction by color duplex Doppler ultrasound (CDDU) may benefit the decision-making process in regard to choosing the most appropriate therapy. Unfortunately, there is no uniform standardization in performing CDDU resulting in high variability in data expression and interpretation when comparing results among various centers, especially when conducting multicenter trials. Establishing standard operating procedures (SOPs) is a major step that will help minimize such variability.INTRODUCTION In-office evaluation of erectile dysfunction by color duplex Doppler ultrasound (CDDU) may benefit the decision-making process in regard to choosing the most appropriate therapy. Unfortunately, there is no uniform standardization in performing CDDU resulting in high variability in data expression and interpretation when comparing results among various centers, especially when conducting multicenter trials. Establishing standard operating procedures (SOPs) is a major step that will help minimize such variability. AIM This SOP describes CDDU procedure with focus on establishing uniformity and normative parameters. MAIN OUTCOME MEASURE Measure intra-arterial diameter, peak systolic velocity, end-diastolic velocity, and resistive index for each cavernosal artery. METHODS After initial discussion with the patient about his history and International Index of Erectile Function evaluation describe procedural steps to the patient. Perform the CDDU in a relaxed state, scanning the entire penis (in B-mode image) using a 7.5- to 12-MHz linear array ultrasound probe. An intracorporal injection of a single or combination of vasoactive agents (e.g., prostaglandin E1, phentolamine, and papaverine) is then administered and CDDU performed at various time points, preferably with audiovisual sexual stimulation (AVSS). RESULTS Monitor penile erection response (tumescence and rigidity) near peak blood flow. Self-stimulation or AVSS leaving the patient alone in room or redosing may be considered to decrease any anxiety and help achieve a maximum rigid erection. CONCLUSION Considering the complexity and heterogeneity of CDDU evaluation, this communication will help in standardization and establish uniformity in such data interpretation. When indicated, invasive diagnostic testing involving (i) penile angiography and (ii) cavernosography/cavernosometry to establish veno-occlusive dysfunction may be recommended to facilitate further treatment options.

Standardization of vascular assessment of erectile dysfunction: standard operating procedures for duplex ultrasound.

Introduction In-office evaluation of erectile dysfunction by color duplex Doppler ultrasound (CDDU) may benefit the decision-making process in regard to choosing the most appropriate therapy. Unfortunately, there is no uniform standardization in performing CDDU resulting in high variability in data expression and interpretation when comparing results among various centers, especially when conducting multicenter trials. Establishing standard operating procedures (SOPs) is a major step that will help minimize such variability.INTRODUCTION In-office evaluation of erectile dysfunction by color duplex Doppler ultrasound (CDDU) may benefit the decision-making process in regard to choosing the most appropriate therapy. Unfortunately, there is no uniform standardization in performing CDDU resulting in high variability in data expression and interpretation when comparing results among various centers, especially when conducting multicenter trials. Establishing standard operating procedures (SOPs) is a major step that will help minimize such variability. AIM This SOP describes CDDU procedure with focus on establishing uniformity and normative parameters. MAIN OUTCOME MEASURE Measure intra-arterial diameter, peak systolic velocity, end-diastolic velocity, and resistive index for each cavernosal artery. METHODS After initial discussion with the patient about his history and International Index of Erectile Function evaluation describe procedural steps to the patient. Perform the CDDU in a relaxed state, scanning the entire penis (in B-mode image) using a 7.5- to 12-MHz linear array ultrasound probe. An intracorporal injection of a single or combination of vasoactive agents (e.g., prostaglandin E1, phentolamine, and papaverine) is then administered and CDDU performed at various time points, preferably with audiovisual sexual stimulation (AVSS). RESULTS Monitor penile erection response (tumescence and rigidity) near peak blood flow. Self-stimulation or AVSS leaving the patient alone in room or redosing may be considered to decrease any anxiety and help achieve a maximum rigid erection. CONCLUSION Considering the complexity and heterogeneity of CDDU evaluation, this communication will help in standardization and establish uniformity in such data interpretation. When indicated, invasive diagnostic testing involving (i) penile angiography and (ii) cavernosography/cavernosometry to establish veno-occlusive dysfunction may be recommended to facilitate further treatment options.

A Randomized Open-Label Trial with a Crossover Comparison of Sexual Self-Confidence and Other Treatment Outcomes Following Tadalafil Once a Day Vs. Tadalafil or Sildenafil On-Demand in Men with Erectile Dysfunction

AIM To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day (OaD) vs. tadalafil 20 mg or sildenafil 100 mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). METHODS A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. MAIN OUTCOME MEASURES The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. SECONDARY OUTCOMES INCLUDED: Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. RESULTS Men naive to tadalafil OaD were enrolled (N = 378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P < 0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50 ± 0.78 following tadalafil OaD, 0.5 ± 0.72 for tadalafil PRN, and 0.39 ± 0.67 for sildenafil PRN. The difference in least-squares mean was 0.12 ± 0.04 (confidence interval [CI] = 0.04, 0.19; P = 0.001) between tadalafil OaD and sildenafil PRN and 0.01 ± 0.04 (CI = -0.06, 0.08; P = 0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P < 0.001). There were no differences in SEAR scores between treatments. CONCLUSIONS Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.

The EPIFARM Study: An Observational Study in 574 Community Pharmacies in Spain Characterizing Patient Profiles of Men Asking for Erectile Dysfunction Medication

INTRODUCTION Community pharmacists may be an important first point of contact for erectile dysfunction (ED) patients, but to date there are no reports of the characteristics of men approaching pharmacists for ED advice or treatment. AIM To characterize the profiles of men with and without phosphodiesterase-5 inhibitors (PDE5i) prescription asking for ED treatment at the pharmacy. METHODS A multicenter, observational, cross-sectional study was conducted in Spanish community pharmacies September-November 2008. Of men asking for ED advice or treatment, each investigator recruited one with and one without PDE5i prescription. Study pharmacists completed a questionnaire of patient demographic, clinical, and behavioural data including the Sexual Health Inventory for Men. MAIN OUTCOME MEASURES Demographic characteristics and responses to questionnaires. RESULTS Five hundred and seventy-four pharmacists recruited 1,147 patients; 1,113 were included for analysis. There were no statistical differences between the groups regarding weight, hypertension, diabetes mellitus, hypercholesterolemia, dyslipidemia, depression, or stress. There were no statistical differences in severity of ED (P=0.7892) or proportion of men without ED in each group (P=0.5755). ED symptoms had been present for a mean of 26 months in both groups before first consultation with a healthcare professional. The visit to the pharmacy was the first discussion about ED for 60.2% of the nonprescription group, and 50% of those who had previously discussed ED had done so with a pharmacist in the first instance. In the nonprescription group, 85.1% of men asked for a PDE5i. CONCLUSIONS Many men approached a community pharmacist for ED treatment and those with and without a PDE5i prescription had an equivalent ED severity and comorbidity profile. Community pharmacists should be trained in current concepts underlying the diagnosis and management of ED to enable them to educate men and encourage them to seek further medical care, increasing the chance of early detection of undiagnosed comorbidities such as cardiovascular disease.

Nocturnal erections, differential diagnosis of impotence, and diabetes. I Karacan, FB Scott, PJ Salis, SL Attia, JC Ware, A Altinel, and RL Williams.

K et al. published this landmark paper [1] in 1976 with the aim of proposing the monitoring of nocturnal penile erections as “the” tool that might remove the bias in the diagnosis of erectile dysfunction. In the Introduction authors stated that the diagnosis and treatment of impotence remained, at that time, “essentially an art, if not a myth,” because of a belief that impotence was only result of psychological disturbances. They wrote that nocturnal erections had been known for almost 30 years and in the last 10 years their group had concluded that the normality of nocturnal penile tumescence (NPT) was a reliable and objective indicator of the psychological or organic basis of erectile dysfunction (ED); an abnormal NPT indicated an organogenic ED, whereas a normal NPT lead to the diagnosis of psychogenic ED. The objective of the paper was to describe their first 100 patients and to present NPT data on patients with psychogenic and organogenic ED. Most of the patients had been referred for prosthesis implantation with Dr. Brantley Scott. NPT recording was part of an extensive “medical, neurological, endocrinological, psychiatric, and psychological evaluation” that the patient underwent before the surgery itself. For NPT recording patients usually spent three nights in the Sleep Disorder Center, where three electroencephalography channels, two eye movement channels, two penile circumference channels, and two perineal muscle activity channels were monitored continuously throughout each night. Penile circumference was monitored with mercury-filled strain gauges placed at the tip and at the base of the penis. On one evaluation night a patient was awakened during a typical erection the degree of the erectile response. The examiner tested at that moment the buckling tendency of the penis and photographed the erect penis. Based on the data on penile circumference change and rigidity, the patient’s NPT was classified as normal, borderline normal, abnormally diminished, or absent. From the sample of 100 patients, authors selected 11 patients with ED and diabetes who had exhibited absent or abnormal NPT and 11 patients with ED, age-matched with the first group, without known medical diseases and whose nocturnal erections were normal. They also selected for comparison 11 age-matched normal individuals who had undergone three consecutive nights of NPT monitoring. The diabetic patients had significantly less nocturnal erections and spent less time with full erections than other patients and normal control subjects. The maximum penile circumference change exhibited by diabetic patients was approximately one-fifth that of individuals of the other two groups. In the discussion, authors claimed that their study provided the first objective data on the organic impairment of erection of diabetic patients. They concluded that “NPT recording

Classic Citations: Nocturnal Erections, Differential Diagnosis of Impotence, and Diabetes I Karacan, FB Scott, PJ Salis, SL Attia, JC Ware, A Altinel, and RL Williams

K et al. published this landmark paper [1] in 1976 with the aim of proposing the monitoring of nocturnal penile erections as “the” tool that might remove the bias in the diagnosis of erectile dysfunction. In the Introduction authors stated that the diagnosis and treatment of impotence remained, at that time, “essentially an art, if not a myth,” because of a belief that impotence was only result of psychological disturbances. They wrote that nocturnal erections had been known for almost 30 years and in the last 10 years their group had concluded that the normality of nocturnal penile tumescence (NPT) was a reliable and objective indicator of the psychological or organic basis of erectile dysfunction (ED); an abnormal NPT indicated an organogenic ED, whereas a normal NPT lead to the diagnosis of psychogenic ED. The objective of the paper was to describe their first 100 patients and to present NPT data on patients with psychogenic and organogenic ED. Most of the patients had been referred for prosthesis implantation with Dr. Brantley Scott. NPT recording was part of an extensive “medical, neurological, endocrinological, psychiatric, and psychological evaluation” that the patient underwent before the surgery itself. For NPT recording patients usually spent three nights in the Sleep Disorder Center, where three electroencephalography channels, two eye movement channels, two penile circumference channels, and two perineal muscle activity channels were monitored continuously throughout each night. Penile circumference was monitored with mercury-filled strain gauges placed at the tip and at the base of the penis. On one evaluation night a patient was awakened during a typical erection the degree of the erectile response. The examiner tested at that moment the buckling tendency of the penis and photographed the erect penis. Based on the data on penile circumference change and rigidity, the patient’s NPT was classified as normal, borderline normal, abnormally diminished, or absent. From the sample of 100 patients, authors selected 11 patients with ED and diabetes who had exhibited absent or abnormal NPT and 11 patients with ED, age-matched with the first group, without known medical diseases and whose nocturnal erections were normal. They also selected for comparison 11 age-matched normal individuals who had undergone three consecutive nights of NPT monitoring. The diabetic patients had significantly less nocturnal erections and spent less time with full erections than other patients and normal control subjects. The maximum penile circumference change exhibited by diabetic patients was approximately one-fifth that of individuals of the other two groups. In the discussion, authors claimed that their study provided the first objective data on the organic impairment of erection of diabetic patients. They concluded that “NPT recording

REPORTSStandardization of Vascular Assessment of Erectile Dysfunction

Introduction In-office evaluation of erectile dysfunction by color duplex Doppler ultrasound (CDDU) may benefit the decision-making process in regard to choosing the most appropriate therapy. Unfortunately, there is no uniform standardization in performing CDDU resulting in high variability in data expression and interpretation when comparing results among various centers, especially when conducting multicenter trials. Establishing standard operating procedures (SOPs) is a major step that will help minimize such variability.INTRODUCTION In-office evaluation of erectile dysfunction by color duplex Doppler ultrasound (CDDU) may benefit the decision-making process in regard to choosing the most appropriate therapy. Unfortunately, there is no uniform standardization in performing CDDU resulting in high variability in data expression and interpretation when comparing results among various centers, especially when conducting multicenter trials. Establishing standard operating procedures (SOPs) is a major step that will help minimize such variability. AIM This SOP describes CDDU procedure with focus on establishing uniformity and normative parameters. MAIN OUTCOME MEASURE Measure intra-arterial diameter, peak systolic velocity, end-diastolic velocity, and resistive index for each cavernosal artery. METHODS After initial discussion with the patient about his history and International Index of Erectile Function evaluation describe procedural steps to the patient. Perform the CDDU in a relaxed state, scanning the entire penis (in B-mode image) using a 7.5- to 12-MHz linear array ultrasound probe. An intracorporal injection of a single or combination of vasoactive agents (e.g., prostaglandin E1, phentolamine, and papaverine) is then administered and CDDU performed at various time points, preferably with audiovisual sexual stimulation (AVSS). RESULTS Monitor penile erection response (tumescence and rigidity) near peak blood flow. Self-stimulation or AVSS leaving the patient alone in room or redosing may be considered to decrease any anxiety and help achieve a maximum rigid erection. CONCLUSION Considering the complexity and heterogeneity of CDDU evaluation, this communication will help in standardization and establish uniformity in such data interpretation. When indicated, invasive diagnostic testing involving (i) penile angiography and (ii) cavernosography/cavernosometry to establish veno-occlusive dysfunction may be recommended to facilitate further treatment options.

JSM HIGHLIGHTSClassic Citations: Nocturnal Erections, Differential Diagnosis of Impotence, and Diabetes I Karacan, FB Scott, PJ Salis, SL Attia, JC Ware, A Altinel, and RL Williams

K et al. published this landmark paper [1] in 1976 with the aim of proposing the monitoring of nocturnal penile erections as “the” tool that might remove the bias in the diagnosis of erectile dysfunction. In the Introduction authors stated that the diagnosis and treatment of impotence remained, at that time, “essentially an art, if not a myth,” because of a belief that impotence was only result of psychological disturbances. They wrote that nocturnal erections had been known for almost 30 years and in the last 10 years their group had concluded that the normality of nocturnal penile tumescence (NPT) was a reliable and objective indicator of the psychological or organic basis of erectile dysfunction (ED); an abnormal NPT indicated an organogenic ED, whereas a normal NPT lead to the diagnosis of psychogenic ED. The objective of the paper was to describe their first 100 patients and to present NPT data on patients with psychogenic and organogenic ED. Most of the patients had been referred for prosthesis implantation with Dr. Brantley Scott. NPT recording was part of an extensive “medical, neurological, endocrinological, psychiatric, and psychological evaluation” that the patient underwent before the surgery itself. For NPT recording patients usually spent three nights in the Sleep Disorder Center, where three electroencephalography channels, two eye movement channels, two penile circumference channels, and two perineal muscle activity channels were monitored continuously throughout each night. Penile circumference was monitored with mercury-filled strain gauges placed at the tip and at the base of the penis. On one evaluation night a patient was awakened during a typical erection the degree of the erectile response. The examiner tested at that moment the buckling tendency of the penis and photographed the erect penis. Based on the data on penile circumference change and rigidity, the patient’s NPT was classified as normal, borderline normal, abnormally diminished, or absent. From the sample of 100 patients, authors selected 11 patients with ED and diabetes who had exhibited absent or abnormal NPT and 11 patients with ED, age-matched with the first group, without known medical diseases and whose nocturnal erections were normal. They also selected for comparison 11 age-matched normal individuals who had undergone three consecutive nights of NPT monitoring. The diabetic patients had significantly less nocturnal erections and spent less time with full erections than other patients and normal control subjects. The maximum penile circumference change exhibited by diabetic patients was approximately one-fifth that of individuals of the other two groups. In the discussion, authors claimed that their study provided the first objective data on the organic impairment of erection of diabetic patients. They concluded that “NPT recording