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Diagnostic testing for erectile dysfunction.

What can we expect in the next decade? In addition to the obviously anticipated clarification of normal values relating to erectile function and anatomy and refinement of examinations, tests, and procedures, there is still much to be discovered, refined, and defined. We can anticipate new medications being found to enhance penile erections. Maybe a pacemaker will be possible that will stimulate an erection. New methods will be developed to insert coils and scarring agents for veno-occlusive disorders. Drugs will be produced in the form of pills, creams, or injectables that will dilate, clean out, or prevent blockage in the arteries. Preventing erectile dysfunction should become the issue in the 1990s and the next century. Changes in life-style such as reducing stress, eating healthier, stopping smoking, exercising more, and reducing alcohol consumption will lead to better bodily functioning. Essentially, taking responsibility for our own well being will become important. Health promotion, instead of curing, will receive greater focus. Education will play an important part in realizing a goal of mature sexuality and improved general well-being.

Erectile Dysfunction↗

[Pharmacotherapy for erectile dysfunction].

In the recent few years, especially since the introduction of phosphodiesterase-5 inhibitor, sildenafil, most researchers have focused their researches on biochemistry and physiology of erectile function. New progress has been made made in basic and clinic researches on pharmacotherapy for ED. In this article, the putative molecular or cellular mechanism of actions of the available centrally and peripherally acting drugs are reviewed, providing details about the current and most explosive area of drug research and development in erectile dysfunction.

Animals↗

Vardenafil provides reliable efficacy over time in men with erectile dysfunction.

OBJECTIVES: To evaluate the reliability of vardenafil efficacy and tolerability within 12 weeks in a broad population of men with erectile dysfunction (ED). METHODS: In a retrospective analysis of two pivotal, Phase III, randomized, double-blind, placebo-controlled trials conducted in 107 centers, 1650 men aged 18 years or older with ED received vardenafil 5 mg, 10 mg, or 20 mg on demand for 12 to 26 weeks. Outcome measures included the first-time and subsequent overall success rate until week 12 for diary entries regarding vaginal penetration (Sexual Encounter Profile [SEP]-2), erection maintenance (SEP-3), satisfaction with erection hardness, and overall satisfaction with the sexual experience. Mean efficacy was calculated for each patient during 12 weeks and then averaged for all patients within each treatment group. RESULTS: At baseline, the intention-to-treat population had moderate ED (International Index of Erectile Function-Erectile Function domain score of 13). For SEP-2 (penetration), the first-attempt and subsequent success rate was 44% and 74% for placebo, 71% and 81% for vardenafil 5 mg, 76% and 86% for vardenafil 10 mg, and 76% and 91% for vardenafil 20 mg, respectively. For SEP-3 (maintenance), first-attempt and subsequent success rate was 25% and 56% for placebo, 51% and 76% for vardenafil 5 mg, 65% and 76% for vardenafil 10 mg, and 59% and 84% for vardenafil 20 mg, respectively. For overall satisfaction with the sexual experience, the first-attempt and subsequent success rate was 19% and 48% for placebo, 48% and 68% for vardenafil 5 mg, 57% and 72% for vardenafil 10 mg, and 56% and 79% for vardenafil 20 mg, respectively. The reliability of vardenafil was similar or slightly greater in sildenafil-naive subjects compared with prior sildenafil responders. The most common adverse events were mild-to-moderate headache, flushing, and rhinitis. CONCLUSIONS: Vardenafil provides reliable efficacy for key erectile function parameters important to patients when continuing oral treatment for ED.

Clinical Trials, Phase III as Topic↗

Reasons for patient drop-out from an intracavernous auto-injection programme for erectile dysfunction.

OBJECTIVE: To identify factors that contribute to patient drop-out rates from an intracavernous auto-injection programme for erectile dysfunction. PATIENTS AND METHODS: Forty-seven patients who had been successfully treated with intracavernous vasoactive agents but who subsequently failed to attend follow-up appointments were included in the study. Each patient completed a self-administered questionnaire. RESULTS: Thirty (64%) completed questionnaires were returned. The reasons for withdrawal from treatment are outlined. CONCLUSIONS: The majority of patients who discontinued intracavernous therapy did so for reasons unrelated to treatment associated problems.

Adult↗

Prospective, randomized, crossover comparison of sublingual apomorphine (3 mg) with oral sildenafil (50 mg) for male erectile dysfunction.

PURPOSE: We established the efficacy and safety of sublingual apomorphine compared with oral sildenafil in comparable groups of patients with erectile dysfunction (ED). MATERIALS AND METHODS: This prospective, randomized, crossover study included 77 heterosexual men with ED of various etiologies and severities. A total of 62 men were randomized but only 34 were evaluable for efficacy and tolerability. The study started with a run-in period of 2 to 4 weeks. The first 4 weeks of treatment were followed by a washout period of 4 weeks, after which patients changed to the alternate treatment for an additional 4-week period. The sequence of the 2 treatments was established by a randomization list in blocks in closed packets. The primary efficacy end point was the percent of attempts resulting in erection firm enough for intercourse. Additional variables were the percent of attempts resulting in intercourse and improvement in ED, as evaluated by the erectile function domain score of the International Index of Erectile Function questionnaire. RESULTS: Sildenafil was significantly more effective than apomorphine in regard to the percent of attempts resulting in erection firm enough for intercourse (85% vs 44%, p <0.0001) and actually resulting in intercourse (81% vs 43%, p <0.0001) as well as erectile function evaluated by the erectile function domain score of the International Index of Erectile Function (p <0.001). The incidence of adverse events was not significantly different for the 2 drugs. Although the number of patients was small, this study had strong statistical power due to the striking difference in results. CONCLUSIONS: Sildenafil was significantly more effective than apomorphine for ED. No statistical difference in adverse events was noted.

Administration, Oral↗

The role of prostaglandins in the aetiology and treatment of erectile dysfunction.

Both animal and human penile tissue synthesize prostaglandins (PGs). Furthermore, intracavernous injection of certain PGs elicits erection in men with erectile dysfunction (ED). It is also well established that PGs are involved in the pathophysiology of atherosclerosis and diabetes mellitus (DM). Since atherosclerosis and DM are major risk factors for ED, it has been suggested that the disruption of PG synthesis in penile tissues and related vasculature may play a role in the pathogenesis of ED. In this review, we discuss the role of PGs in normal penile erection as well as on the pathophysiology and treatment.

Blood Vessels↗

Erectile dysfunction in systemic sclerosis.

Systemic sclerosis (SSc, scleroderma), a connective tissue disorder involving multiple organ systems, can be a causal factor in erectile dysfunction. We present a case report and a review of the literature. Awareness of this association can hasten the detection of this disorder and influence management choices.

Adult↗

Comparative study between audiovisualsexual stimulation test and nocturnal penile tumescence test using RigiScan Plus in the evaluation of erectile dysfunction.

INTRODUCTION: Although the nocturnal penile tumescence (NPT) test is considered the gold standard for the differential diagnosis of psychogenic versus organic erectile dysfunction (ED), concerns have recently been raised regarding the financial and time expenditure it demands. We evaluated the diagnostic efficacy of the audiovisual sexual stimulation (AVSS) test as an alternative to the NPT test. PATIENTS AND METHODS: A total of 43 patients with ED were examined. Each patient filled in an International Index of Erectile Function (IIEF) questionnaire. The evaluation of each patient consisted of AVSS and NPT tests which were performed using the RigiScan Plus. The results obtained with the two tests were compared. The patients with normal NPT patterns were presumed to have a psychogenic etiology of their ED and those with abnormal NPT patterns to have an organic etiology. RESULTS: The overall IIEF score was 32.5 +/- (SD) 9.2, and the erectile domain score was 12.2 +/- 4.5. Twenty-three patients had normal responses to the AVSS test, while 20 had abnormal responses. Twenty-two of the former 23 patients and 9 of the latter 20 patients had normal NPT patterns. Therefore, the AVSS test discriminated psychogenic ED with 71% sensitivity and 92% specificity. The overall accuracy of the test in this study was 77%. CONCLUSIONS: The AVSS test is simple, practical, and inexpensive, and its diagnostic accuracy is comparable to that of the NPT test. We conclude that the AVSS test should be the examination of choice for the primary etiological diagnosis in ED.

Adult↗

Are lower urinary tract symptoms associated with erectile dysfunction in aging males of Taiwan?

INTRODUCTION: This study was conducted to evaluate the relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in aging males of Taiwan. PATIENTS AND METHODS: A free health screening for aging males (>or=45 years old) was conducted in Kaohsiung Medical University Chung-Ho Memorial Hospital in August 2004. LUTS and ED were assessed by validated symptom scales: the International Prostate Symptom Score (IPSS) and the International Index of Erectile Function-5 (IIEF-5). The subjects also completed a health and demographics questionnaire and underwent detailed physical examination, serum prostate-specific antigen level determination, and transrectal ultrasonography. RESULTS: The final study population consisted of 141 patients with a mean age of 59.8 years. The severity of LUTS and ED increased with age. After controlling for comorbidities, age (p<0.001) and IPSS score (p<0.001) were significantly associated with the IIEF-5 score. Furthermore, men with moderate to high IPSS scores were more likely to have ED as compared with those with mild symptoms after age adjustment (age-adjusted odds ratio 3.27, p=0.002). CONCLUSIONS: ED and LUTS are highly prevalent in our study population, and this prevalence increases with age. ED is significantly associated with the severity of LUTS after controlling for age and comorbidities. These results highlight the clinical importance of evaluating LUTS in patients with ED and the need to consider sexual issues in the management of patients with benign prostatic hyperplasia.

Age Factors↗

Oxidative stress and antioxidant therapy: their impact in diabetes-associated erectile dysfunction.

Oxidative stress is believed to affect the development of diabetic-associated vasculopathy, endothelial dysfunction, and neuropathy within erectile tissue. Our hypothesis is that, given adequate concentrations of the oxygen free radical scavenger vitamin E, enhanced levels of circulating nitric oxide (NO) should improve erectile function with the potential for a synergistic effect with a phosphodiesterase type 5 (PDE5) inhibitor. Twenty adult male Sprague-Dawley streptozotocin-induced (60 mg/kg intraperitoneally) diabetic rats were placed in 4 therapeutic groups (n = 5 per group) as follows: 1) peanut oil only (diabetic control), 2) 20 IU of vitamin E per day, 3) 5 mg/kg of sildenafil per day, and 4) vitamin E plus sildenafil using oral gavage for 3 weeks. In addition, 5 age-matched rats served as normal nondiabetic controls (normal). Erectile function was assessed by measuring the rise in intracavernous pressure (ICP) following cavernous nerve electrostimulation. Penile tissue was evaluated for neuronal NO synthase (nNOS), smooth muscle alpha-actin, nitrotyrosine, and endothelial cell integrity. Urine nitrite and nitrate (NOx) concentration was quantified, and electrolytes were tested by a serum biochemistry panel. A significant decrease in ICP was recorded in the diabetic animals, with improvement measured in the animals receiving PDE5 inhibitors either with or without vitamin E; the controls had a pressure of 54.8 +/- 5.3 cm H2O, the vitamin E group had a pressure of 73.5 +/- 6.6 cm H2O, the sildenafil group had a pressure of 78.4 +/- 10.77 cm H2O, and the vitamin E plus sildenafil group had a pressure of 87.9 +/- 5.5 cm H2O (P <.05), compared with the normal cohorts at 103.0 +/- 4.8 cm H2O. Histoexaminations showed improved nNOS, endothelial cell, and smooth muscle cell staining in the vitamin E plus sildenafil group compared to the control animals. Urine NOx increased significantly in all the diabetic groups but was blunted in the vitamin E and vitamin E plus sildenafil groups. A significant increase in positive staining for nitrotyrosine was observed in the vitamin E plus sildenafil group. Vitamin E enhanced the therapeutic effect of the PDE5 inhibitor in this study, supporting the potential use of oxygen free radical scavengers in salvaging erectile function in diabetic patients.

3',5'-Cyclic-GMP Phosphodiesterases↗

Challenges in the assessment of erectile dysfunction and treatment with oral therapies: review with case examples.

PURPOSE: To review the clinical dimensions, etiology, assessment, and treatment of erectile dysfunction (ED) and to increase awareness of oral therapies for this condition. DATA SOURCES: Scientific literature, consensus guidelines, and manufacturers' product information and guidelines. CONCLUSIONS: A prevalent condition, particularly in middle-aged and elderly men, ED is vastly underreported and undertreated. Oral therapies, including phosphodiesterase type 5 inhibitors, are effective and well tolerated in many patients and represent potential first-line treatments for ED. IMPLICATIONS FOR PRACTICE: ED has been associated with both life-threatening illnesses and reduced quality of life. Improving recognition and treatment of this condition and counseling patients about ED represent important clinical opportunities. A broad and expanding array of ED treatments enable therapy to be individualized to the needs of patients and their partners.

Aged↗

Intracavernous injection of prostaglandin E1 plus procaine in the treatment of erectile dysfunction.

Despite the availability of prostaglandin E1 for more than 7 years as a diagnostic and therapeutic tool in patients with erectile dysfunction, the problem of penile discomfort after prostaglandin E1 application has remained unsolved. In a randomized, double-blind, crossover study we investigated the effect of 2 different prostaglandin E1-procaine concentrations on 24 patients suffering from pain following intracorporeal injection of prostaglandin E1 alone. Intracavernous injection of 20 micrograms. prostaglandin E1 with 10 mg. procaine (study 1) failed to improve local painful sensations. The combination of 20 micrograms. prostaglandin E1 with 20 mg. procaine (study 2) decreased the incidence of local pain significantly (p < 0.01). These preliminary results show that the combination of prostaglandin E1 plus procaine represents a beneficial alternative in patients with penile pain due to the single substance.

Adult↗

Risk factors in predicting a poor response to sildenafil citrate in elderly men with erectile dysfunction.

OBJECTIVE: To assess the clinical efficacy of sildenafil and the potential predictors of poor response to sildenafil in elderly patients with erectile dysfunction (ED). PATIENTS AND METHODS: The study included 162 patients (aged > or = 60 years) treated with sildenafil for at least 8 weeks; all patients were evaluated with a history, physical examination, measurement of total testosterone and a pharmacological erection test. Sexual function before and 8 weeks after treatment was assessed using the self-administered International Index of Erectile Function (IIEF). Treatment was considered successful when the patient attained a higher grade on the erectile function (EF) domain score, and an affirmative response to the overall assessment question. Factors influencing treatment outcome were evaluated by univariate and multivariate statistical analysis. RESULTS: The overall efficacy with sildenafil was 47% (76/162). On univariate analysis, uncontrolled diabetes, current smoking, hypogonadism (<3 microg/L testosterone) and low pretreatment EF domain score (<17) were selected as predictors of a poor response. On multivariate logistic regression, a low pretreatment EF domain score was the strongest independent prognostic factor for a poor response (odds ratio 2.25, 95% confidence interval, 1.45-7.33), and this was followed by hypogonadism (1.89, 1.12-3.16) and current smoking (1.34, 1.04-3.52). CONCLUSION: In a real clinical setting, sildenafil was effective for about half of the elderly men. The baseline EF domain score, hypogonadism and current smoking were significantly associated with failure of sildenafil. These results suggest that modifying reversible risk factors, e.g. stopping smoking and replacing testosterone, would be beneficial in augmenting the efficacy of sildenafil in elderly men.

Aged↗

Erectile dysfunction in men with diabetes mellitus.

During a fourteen-month period, 497 men were evaluated for a primary complaint of erectile dysfunction. The initial evaluation consisted of a history taken in a conventional manner and supplemented by a patient-completed sexual function questionnaire, a physical examination, and serum testosterone, serum prolactin, and nocturnal penile tumescence studies. When appropriate, additional evaluations, including penile vascular studies, two-hour oral glucose tolerance tests, and psychiatric consultation were obtained. Abnormal glucose metabolism was present in 161 men (32%). Five men (1%) had insulin-dependent diabetes mellitus (IDDM), 80 men (16%) had noninsulin-dependent diabetes mellitus (NIDDM), 55 men (11.1%) had newly diagnosed noninsulin-dependent diabetes mellitus, and 21 men (4.2%) had impaired glucose tolerance tests. One hundred forty-seven of these men (91.3%) had organic pattern impotence, and 14 (8.7%) had psychogenic pattern impotence.

Adult↗

[Erectile dysfunction. An important manifestation of autonomic diabetic neuropathy].

In Germany, some 4-6 million men, including 1.2 million diabetics, suffer from erectile dysfunction (ED). Various other diseases including heart disease, hypertension, arteriosclerosis, hyperlipidemia, endocrine disorders, chronic renal insufficiency, prior radical prostatectomy, neurological diseases, trauma and the abuse of alcohol, tobacco, and side effects of medications, are frequently associated with ED. Medical history, clinical examination, routine blood chemistry and sexual hormone levels may help clarify the etiology of ED. Normally, relaxation of the smooth muscles of the corpus cavernosum--mediated by cGMP and cAMP--together with dilatation of penile arteries and occlusion of venous outflow, results in an erection. The oral type V phosphodiesterase inhibitor, Sildenafil, or prostaglandin E1 injection elevates the cGMP and cAMP levels, respectively. Other therapeutic options include mechanical aids, surgery, hormone replacement or sublingual apomorphine. Since 1998, Sildenafil, an effective, simple and safe oral treatment, has been available.

Aged↗

Role of radionuclide phallogram in therapeutic decision-making for erectile dysfunction.

OBJECTIVE: The purpose of this study is to evaluate the role of radionuclide phallograms in therapeutic decision-making for erectile dysfunction. METHOD: Forty-eight impotent men being considered for pharmacologically-induced penile erection therapy (PIPE) had radionuclide phallograms (RP) as part of their evaluation. RP were performed using 99mTc-labeled autologous red blood cells and provided a measurement of penile blood volume (PBV) change following the intracorporeal injection of 0.25 to 0.3 mL of a papaverine/phentolamine mixture. RESULTS: Thirty-eight patients showed a good response with a mean PBV increase 2.6 times baseline (range 1.2 to 8.9). Ten patients had significantly lower PBV changes (P = 0.001) than the first group, with a mean PBV increase of 1.6 times baseline (range 1.1 to 2.4). These ten patients were dissatisfied with pharmacologically induced penile erection (PIPE) therapy after an unsuccessful treatment trial. CONCLUSION: We conclude that the RP can help to discriminate between patients who will benefit from PIPE therapy and those who will not.

Adult↗

Patient-reported erectile dysfunction: a cross-validation study.

Previous work highlighting a significant correspondence between patient-reported sex history information and physiological indices of erectile functioning was cross-validated. The matched sample comprised of 46 older male veterans presenting with erectile dysfunction, with many experiencing chronic physical illnesses. All subjects underwent a comprehensive medical and psychological evaluation, followed by 2 consecutive nights of in-hospital Rigiscan diagnostic monitoring, to evaluate penile rigidity, tumescence, and duration of erectile episodes. Stringent criteria were employed to control for confounding of Rigiscan results, with elimination from the study for affective, thought, or sleep disorders. Results from the multiple regression analyses showed that patient reports of AM erections and erectile quality accounted for significant proportions of the variance in the Rigiscan criterion measures, with 3 of the 4 R2 values falling within the Herzberg criterion for cross-validation. Results confirm the diagnostic significance of patient self-report for the population of older, chronically ill men who present with impaired erectile functioning.

Adult↗

Erectile dysfunction in diabetic men: the neurological factor revisited.

In the literature the importance of the neurological factor in the etiology of erectile dysfunction in patients with diabetes mellitus is subject to debate. We report on the findings of neurophysiological investigations in 27 impotent and 30 potent diabetic patients, as well as 102 impotent nondiabetic patients. Additionally, hormonal and vascular evaluations were done. The neurophysiological evaluations consisted of assessment of somatic as well as autonomic sensory nerves, by measuring the latencies of somatosensory evoked potentials of the posterior tibial and pudendal nerves, and of the bulbocavernosus and urethro-anal reflexes. The results show a higher incidence of more severe peripheral and autonomic sensory neuropathy in impotent diabetic men. Also, a preponderance of abnormal intracavernous pharmacological tests, suggesting vasculogenic impotence, was found in impotent diabetic patients. No important endocrinological differences were found among the 3 groups under investigation. Significant differences occurred for plasma glucose and glycosylated hemoglobin. We conclude that diabetic urogenital sensory neuropathy has a crucial role in the etiology of diabetic impotence. Angiopathy seems to be of secondary importance. The results show that poor diabetes regulation is associated with diabetic impotence.

Adult↗