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Erectile dysfunction in diabetes and hypertension.

By direct interrogation and specific questions, the erectile function of 1,128 male adults, aged sixteen to eighty years and over, was elicited. The erectile function was based on ability to develop an erectile angle of 90 degrees and more, and this was used for classification purposes. Three hundred seventeen consecutive, unselected male diabetics and 117 nondiabetic male hypertensives were compared with 635 consecutive adult males with neither diabetes nor hypertension. Our results indicate that erectile dysfunction, partial or complete, is more prevalent in diabetics compared with nondiabetics of the same age groups. An unexpected finding was a meager relationship between hypertension and erectile disability. Antihypertensive drugs were responsible for only 2 cases of erectile dysfunction in our male hypertensive patients. The negative impact of age was noted in all age groups and in those with or without diabetes or hypertension.

Adolescent↗

The hemodynamics of erection and the pharmacotherapies of erectile dysfunction.

The past few years have been witness to a sea of change in understanding the diagnosis and treatment of erectile dysfunction. In the wake of Viagra, effective orally administered therapies are now the expected gold standard. Currently available therapies include both peripherally (at the level of the penis) and centrally (brain, e.g., hypothalamic nuclei) acting compounds. When all modes of pharmacotherapy are considered, ranging from oral, to topical, to intraurethral, to intracavernous injection, it is clear that the vast majority of men with mild to moderate erectile dysfunction can now be effectively treated. However, all forms of pharmacotherapy have the lowest efficacy and greatest side effect profiles (including cardiovascular events) in the patients that need the therapy most, that is, those with relatively severe and longstanding erectile dysfunction. The newer generation of pharmacotherapies, which will likely include gene therapy techniques as well, will therefore have to target this latter group. Improved mechanism-based, perhaps patient-specific therapies are foreseen that will dramatically increase the number of patients seeking treatment, as well as the quality of their lives.

Adrenergic alpha-Antagonists↗

Pudendal nerve somatosensory evoked potentials in patients with voiding and/or erectile dysfunction: correlating test results with clinical findings.

PURPOSE: We evaluated the diagnostic efficacy of pudendal nerve somatosensory evoked potential testing in patients with voiding and/or erectile dysfunction. MATERIALS AND METHODS: A total of 55 consecutive patients with voiding and/or erectile dysfunction underwent pudendal nerve somatosensory evoked potential testing during a 2.5-year period. P1 latencies were analyzed in terms of neurological history and neurological physical examination. RESULTS: Abnormal P1 latencies were noted in 46.7% of patients with a positive neurological history (p = 0.0060), 52.4% with a positive neurological physical examination (p = 0.0580), and 64.7% with a positive history and physical examination (p = 0.0007). No patient with a negative neurological history had abnormal P1 latencies. CONCLUSIONS: Positive neurological history and physical examination findings in patients with voiding and/or erectile dysfunction correlate significantly with abnormal pudendal nerve somatosensory evoked potential latencies. The subgroup of patients with a positive neurological history and physical examination has the greatest diagnostic yield and is best suited for pudendal nerve somatosensory evoked potential testing.

Adult↗

[Assessment of vascular factor in erectile dysfunction occurred following surgical intervention].

Study of 33 subjects with erectile dysfunction after undergoing pelvic surgery, who were stratified in two groups: 16 where surgery appears to have no relation with the dysfunction and 17 where surgery appears to be the cause of the condition. They were compared with 151 cases with arterial dysfunction. Mean age in the group with surgery-related dysfunction (60 +/- 9.6) is higher than in the group with no relation (51.6 +/- 6.7) (p < 0.05), and in both cases similar to the group with arterial-related impotence. Both groups have vascular risk factors, superposed to those who had arteriogenic dysfunction. All flow-rate parameters in the baseline eco-doppler, degree of erectile response after intracavitary injection and flow-rate parameters after ICI can be superposed to those found in the arterial-related impotence. This suggests the existence of a likely pre-existent arterial disease which becomes unstable after surgery as a result of the vascular and nervous lesions as well as due to psychological changes. We insist on the need to gather information prior to surgery, and in the basically vascular nature of erectile dysfunctions developed in subjects who undergo pelvic surgery.

Adult↗

[Efficacy and safety of phosphodiesterase 5 inhibitors in the treatment of erectile dysfunction].

Phosphodiesterase 5 inhibitors are recommended as first-line treatment of erectile dysfunction in many guidelines, because of their convenience, higher efficacy, and less side-effects. Since its first launch in 1998, sildenafil has been currently the best investigated phosphodiesterase 5 inhibitor with respect to long-term trails and quantity. Clinical trials showed the efficacy of sildenafil compared with placebo in many of the groups of patients who have ED, including those with cardiovascular disease, diabetes mellitus, depression, radical prostatectomy and dialysis. Typically the adverse effects reported in patients from clinical trials of sildenafil have been mild to moderate, and commonly include flushing and dyspepsia and transient visual disturbances. This article summarized recent reports on efficacy and safety of phosphodiesters 5 inhibitors in the treatment of erectile dysfunction.

Erectile Dysfunction↗

Oral treatment of erectile dysfunction with apomorphine SL.

Apomorphine SL (Ixense, Uprima) is a new oral medication shown to be effective in the treatment of erectile dysfunction. This compound is a dopaminergic agonist with affinity for dopamine receptor sites - mostly D(2) - within the brain known to be involved in sexual function. Apomorphine induces selective activation in the nucleus paraventricularis leading to erectogenic signals. More than 5,000 men with erectile dysfunction participated in phase II/III clinical trials assessing the safety and efficacy of doses ranging from 2 to 6 mg. The most favorable risk/benefit ratio is seen with a dose-optimization regimen of 2-3 mg: the 3-mg dose provides efficacy comparable to that of 4 mg but with fewer side effects. Consequently, review of clinical studies focuses on data with the 2- to 3-mg dose, the registered dose for use in clinical practice. The primary efficacy endpoint in most clinical trials with apomorphine SL was the percentage of attempts resulting in erections firm enough for intercourse - one of the most rigorous endpoints used in ED trials to date. These data were collected from both patients and their partners by reviewing entries in patient diaries and partner BSFI questionnaires. Secondary endpoints included percentage of attempts resulting in intercourse and improvement in ED severity based on the International Index of Erectile Function (IIEF). The proportion of attempts resulting in erections firm enough for intercourse was 49.4% with 3 mg compared with the baseline value of 24.3%. Partner evaluations corresponded with those of the patients. Erections occurred between 18 and 19 min after taking apomorphine SL 2 or 3 mg. The most common side effect was nausea which declined with continued use. Vasovagal syncope was reported in <0.2% of men, and was preceded by clear prodromal symptoms. Thus, apomorphine SL is an effective, well-tolerated drug for erectile dysfunction.

Administration, Oral↗

Combination therapy using oral alpha-blockers and intracavernosal injection in men with erectile dysfunction.

OBJECTIVES: Intracavernosal injection with a combination of agents (ie, phentolamine plus papaverine or alprostadil) has been used in an effort to increase efficacy and reduce side effects compared with single agents. The purpose of this pilot study was to determine the potential role of oral alpha-blockers in combination with intracavernosal therapy in men with erectile dysfunction, for whom intracavernosal therapy alone failed. METHODS: Thirty-eight consecutive men with moderate to severe erectile dysfunction on the basis of history and examination and with minimal or no therapeutic response to intracavernosal alprostadil injection therapy were evaluated. All patients received daily doxazosin titrated to 4 mg over 3 weeks in combination with intracavernosal therapy as needed for 12 weeks. Efficacy was assessed at 4, 8, and 12 weeks after doxazosin titration using the 1 5-item, self-administered International Index of Erectile Function (IIEF) and a global efficacy question (GEQ: Did treatment improve your erections?). RESULTS: For the group, the mean baseline IIEF score before therapy was 29.7+/-9.8. After intracavernosal therapy (mean dose 34.7+/-7.3 microg), IIEF improved to 36.1+/-1 1.4 (17.7%). After addition of doxazosin, IIEF improved to 48.6+/-13.4, 46.4+/-10.9, and 51.5+/-14.3 at 4, 8, and 12 weeks, respectively (P < 0.01). The GEQ response improved from 25.7% at baseline to 81.4% at 12 weeks. Overall 22 (57.9%) of 38 patients with the combined regimen had a significant (more than 60% improvement in IIEF) therapeutic response. CONCLUSIONS: The addition of an oral alpha-blocker may have a beneficial effect in patients with erectile dysfunction for whom intracavernosal therapy alone fails. The synergistic effects of vascular dilation and blockade of sympathetic inhibition may explain this response. The potential role of alpha-blockade in synergy with other agents designed to treat erectile dysfunction remains to be determined.

Administration, Oral↗

Penile sensory disorders in erectile dysfunction: results of a comprehensive neuro-urophysiological diagnostic evaluation in 123 patients.

A total of 123 patients with complaints of erectile dysfunction and no clinically overt neurological disease underwent a comprehensive neuro-urophysiological diagnostic evaluation. The results were compared with those obtained in 50 healthy volunteers. Data gathered consisted of somatosensory evoked potentials from the posterior tibial nerve (tibial evoked potential) and from the dorsal penile nerve (pudendal evoked potential). Also, 2 sacral reflex latencies were measured (bulbocavernosus reflex and urethro-anal reflex). A total of 58 patients (47%) had at least 1 abnormal neuro-urophysiological measurement. Neuro-urophysiological abnormalities were found more frequently in older patients. The tibial evoked potential was abnormal in 30 patients (24%), pudendal evoked potential in 21 (17%), bulbocavernosus reflex in 26 (21%) and urethro-anal reflex in 32 (26%). It was concluded that somatosensory disturbances constitute an important part of neuro-urophysiological abnormalities. Our results suggest a relationship between erectile dysfunction and subclinical, age-related (penile) sensory disorders. Our study corroborates the importance of penile sensibility for erectile (patho)physiology as suggested by others and supports the concept of sensory deficit impotence as an important cause of erectile dysfunction.

Adolescent↗

A study of treatment choices in men with erectile dysfunction and reduced androgen levels.

A large cohort of men presenting with erectile dysfunction were offered concurrent measurement of serum total testosterone. Just over one sixth (17.7%) of the initial screening values of patients suggested the possibility of hypogonadism, however, when more rigorous estimation of serum testosterone and associated parameters and the presence of clinical symptoms were applied, 3% of the population had hypergonadotropic hypogonadism. Only 10 of 44 (22.7%) eligible men agreed to a trial of testosterone therapy, however, two thirds of this eligible group also required another erectogenic agent to resolve the erectile dysfunction.

Adult↗

Intracavernous alprostadil alfadex (EDEX/VIRIDAL) is effective and safe in patients with erectile dysfunction after failing sildenafil (Viagra).

OBJECTIVES: Sildenafil (Viagra), an oral treatment for erectile dysfunction, has proved popular since its introduction in 1998. However, not all patients respond to this form of therapy. Consequently, this study investigated the efficacy of intracavernous alprostadil alfadex (EDEX/VIRIDAL) treatment in patients not responding to sildenafil. METHODS: In an open-label, multicenter study, patients with erectile dysfunction were treated with sildenafil for 4 weeks. The initial dose was 50 mg, which was increased to 100 mg if no response was achieved. Patients not responding to treatment, measured using the International Index of Erectile Function (IIEF) questionnaire, entered an alprostadil alfadex in-office titration phase, to determine the optimal dose, up to 40 microgram. A 6-week alprostadil alfadex at-home treatment phase followed. RESULTS: In 67 patients who did not respond satisfactorily to sildenafil, the alprostadil alfadex at-home therapy resulted in improvements in questions 3 and 4 of the IIEF in 60 (89.6%) and 57 (85.1%) patients, respectively. The mean improvement in IIEF score for these patients was 2.75 and 2.63 for questions 3 and 4, respectively. The most common side effect was penile pain in 25 (29. 4%) of 85 patients treated with alprostadil alfadex in-office and at home. CONCLUSIONS: Alprostadil alfadex therapy can be used effectively and safely in men who fail initial therapy with sildenafil.

Administration, Oral↗

[Treatment with sildenafil and satisfaction with life in depressive patients with erectile dysfunction].

INTRODUCTION: To evaluate the effectiveness of Sildenafil in the treatment of erectile dysfunction (ED) in patients with depression; and the satisfaction with differents aspects of life. METHODS: A multicenter, observational, prospective and non-comparative study conducted in primary care units. Effectiveness was measured by the questionnarie International Index of Erectile Function (IIEF), satisfaction with life by the Life Satisfaction Check-List (LSCL), and partner's satisfaction by Satisfaction with treatment of erectile dysfunction (EDITS). The study enrolled 330 patients with ED and Depression, treated with 50 mg (adjusted to 25/100 mg according to response) of Sildenafil for at least 10 weeks. RESULTS: The erections improved for the 84.2%. At the initial visit a 58.2% had a severe dysfunction, and at the post-treatment visit for the 41.2% of the sample, the dysfunction was light. The most important increase in the LSCL was sexual activity and partner relationship. CONCLUSIONS: Significant increases were observed in the LSCL was sexual activity and partner relationship.

Depression↗

Oral drug therapy for erectile dysfunction.

Oral drugs are a well-established, first-line therapy for erectile dysfunction. As a result of the success of sildenafil, a plethora of new drugs for erectile dysfunction are on the horizon. Apomorphine and IC351 are in late phase III development. Vardenafil (Bayer, New Haven, CT), a PDE5 inhibitor, and the combination of yohimbine and L-arginine (NitroMed, Boston, MA) are in early phase III development. Early clinical and preclinical studies are investigating new phosphodiesterase inhibitors, cyclic AMP activators, alpha-adrenergic antagonists, dopamine agonists, melanocyte-stimulating hormone, potassium channel modulators, endothelin antagonists, and new nitric oxide donors. The future is bright for this infant field of sexual pharmacotherapy.

3',5'-Cyclic-GMP Phosphodiesterases↗

[Efficacy and safety of oral vardenafil in the treatment of erectile dysfunction].

OBJECTIVE: To evaluate the efficacy and safety of vardenafil on men with erectile dysfunction (ED) of various etiologies. METHODS: A total of 88 men with mild to severe erectile dysfunction were enrolled in the randomized, double-blind, placebo-controlled, fixed-dose trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil. RESULTS: This study indicated that vardenafil dosages of 5, 10 and 20 mg were significantly superior to placebo for the treatment of ED, on the basis of the primary study endpoints of the EF domain score of the IIEF, diary-recorded success rates for penetration and maintenance of erection during the intercourse and the GAQ. Vardenafil was well tolerated. The incidence of adverse events was higher for vardenafil than for placebo. CONCLUSION: Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for ED patients with mixed etiologies.

Administration, Oral↗

Randomized, double-blind, placebo-controlled trial of sildenafil (Viagra) for erectile dysfunction after rectal excision for cancer and inflammatory bowel disease.

PURPOSE: Controlled trials have demonstrated the efficacy of sildenafil for "mixed etiology" erectile dysfunction, but this may not be the case if there is underlying pelvic parasympathetic nerve damage. We aimed to determine the efficacy of sildenafil after rectal excision for rectal cancer and inflammatory bowel disease. METHODS: Patients with erectile dysfunction after rectal excision were randomly assigned in a double-blind manner to sildenafil or placebo groups. After unblinding, placebo patients crossed over to open sildenafil. Primary end points were improvement in erectile function on a global efficacy question and erectile function questionnaire scores. Secondary end points were frequency and severity of side effects. RESULTS: Thirty-two patients were randomly assigned, and two dropped out before randomization. Fourteen received sildenafil, and 18 received placebo. Eleven (79 percent) of 14 responded to sildenafil, on global efficacy assessment, compared with 3 (17 percent) of 18 taking placebo (mean difference, 61.9 percent; 95 percent confidence interval, 34.4 to 89.4 percent; P = 0.0009). Sildenafil improved both erectile function domain scores (mean difference, 13.3; 95 percent confidence interval, 7.9 to 18.7; P = 0.0001) and total International Index of Erectile Function scores (mean difference, 30.6; 95 percent confidence interval, 18.7 to 42.6; P < 0.0001) from pretreatment baseline scores. Placebo did not produce improvement in either erectile function (mean difference, 1.7; 95 percent confidence interval, -0.8 to 4.2; P = 0.16) or total International Index of Erectile Function scores (mean difference, 5; 95 percent confidence interval, -1.1 to 11.1; P = 0.1). Ten (100 percent) of 10 crossover patients not responding to placebo did respond to sildenafil (difference, 100 percent; P < 0.0001). Sildenafil improved both erectile function domain scores (mean difference, 16.8; 95 percent confidence interval, 9.7 to 24; P = 0.002) and total International Index of Erectile Function scores (mean difference, 29.5; 95 percent confidence interval, 15.8 to 43.2; P = 0.003) from precrossover baseline scores. Seven (50 percent) of 14 patients on sildenafil compared with 4 (22 percent) of 18 on placebo experienced side effects (difference, 28 percent; 95 percent confidence interval, -4.4 to 60.4 percent; P = 0.14), 91 percent of which were mild and well tolerated. CONCLUSION: Sildenafil completely reverses or satisfactorily improves postproctectomy erectile dysfunction in 79 percent of patients. Side effects are usually mild and well tolerated. The damage incurred by the pelvic nerves after proctectomy, less profound than after prostatectomy, is likely to result in a partial parasympathetic nerve lesion.

Adult↗

The corpus cavernous electromyography in the erectile dysfunction diagnosis.

The single potential analysis of cavernous electric activity (CC-EMG), registration bands were studied in 144 patients with erectile dysfunction followed from November 1992 to March 1993. We attempted to correlate abnormal electromyographic records with reduction of the cavernous bodies and albuginea expansibility, as measured by cavernosometry/rigidometry. In this selected group of patients, with venous leak of different flow, the main associated causes of the erectile dysfunction were cavernous neuromyopathy (91), diabetes mellitus (20), disturbances of the arterial influx (7), endocrinological factors (4), Peyronie's disease (3). Some patients (15) presented with a penile bend. A history of alcohol and tobacco use was obtained: 38 patients smoked 15 to 60 cigarettes/day and 43 patients drank moderate to heavy. The coexistence of other pathologies, has been investigated, showed many other associated diseases. The study attempts to determine if some electromyographic standards in patients with erectile dysfunction, could, by themselves, be a formal indication to penile implant, for a PGE1 self-injection program or for use of a vacuum device. Our results suggest that at least in some cases CC-EMG studies may be clinically relevant and allow choice of optimal therapy.

Action Potentials↗

A risk-benefit assessment of sildenafil in the treatment of erectile dysfunction.

Sildenafil is an oral treatment for erectile dysfunction (ED). It acts as an inhibitor of 3',5'-cyclic guanosine monophosphate-phosphodiesterase type 5. An effective treatment for ED is required to produce an erectile response sufficient for satisfactory sexual performance. This has been documented for sildenafil in men with ED of differing aetiologies and baseline severity in various types of clinical trials. Sildenafil treatment is characterised by a good tolerability profile and low treatment digcontinuation rate caused by treatment-related adverse effects. Most of the adverse effects associated with sildenafil are extensions of the pharmacological action of the drug. There is no significant difference in the adverse effect profile (headache, flushing, dyspepsia, nasal congestion and abnormal vision) of this agent as assessed by clinical data obtained either in the pre- and postlaunch periods. Because of its acceptable risk-benefit ratio, sildenafil can be prescribed to a very large group of patients with ED. The reports of serious cardiovascular events associated with the use of sildenafil (including anecdotal reports of deaths) have been very thoroughly analysed. A number of studies have not shown any difference in the risk of serious cardiovascular events in sildenafil- and placebo-treated patients. However, when making a risk-benefit evaluation, certain subgroups of patients need to be considered separately. In particular, sildenafil is contraindicated in patients receiving nitrate therapy. In some other subgroups of patients, the risks and benefits of treatment need to be assessed on an individual basis and it is hoped that additional data will clarify any possible risks associated with sildenafil administration such patients. It is helpful to compare the risk-benefit profile of sildenafil with the characteristics of other oral drugs for ED. According to the preliminary data, apomorphine and phentolamine are possible future options for the treatment of ED; however, there needs to be further clinical evaluation of these agents. Initial data have shown that sildenafil can be successfully combined with intracavernosal injection in patients nonresponders to either therapy. In conclusion, favourable characteristics make sildenafil suitable for the first-line therapy for a substantial proportion of patients with ED.

3',5'-Cyclic-GMP Phosphodiesterases↗

The impact of prostate biopsy on patient well-being: a prospective study of pain, anxiety and erectile dysfunction.

PURPOSE: We prospectively studied the impact of transrectal ultrasound guided prostate biopsy on patient well-being. MATERIALS AND METHODS: We enrolled 211 consecutive men who underwent a total of 218 biopsy events in a questionnaire based survey focusing on pain, anxiety and erectile dysfunction risk factors. Surveys were administered before, and immediately, 1 week and 1 month after biopsy. Quantitative information on the intensity of symptoms and signs was obtained using a uniform grading system. RESULTS: Intraoperative pain considered severe in 20% of the biopsy events was associated with pain in the first 24 hours postoperatively, leading to analgesic use in 10%. Inflammatory infiltrate in the biopsy core and younger patient age correlated with persistent pain on days 2 and 7 after biopsy, respectively. Preoperative anxiety was reported in 64% of biopsy events and predictive of intraoperative pain. Anxiety peaked before result disclosure. Erectile dysfunction attributed to anxiety in anticipation of biopsy was reported in 7% of cases. At days 7 and 30, 15% of previously potent patients reported erectile dysfunction. CONCLUSIONS: The impact of prostate biopsy on patient well-being begins while waiting for the scheduled procedure. Shortening the anticipation period before results are disclosed and administering pre-biopsy anxiety decreasing measures may benefit patients. Analgesic therapy is recommended in younger patients, those reporting moderate to severe intraoperative pain and those with known prostatic inflammatory infiltrate. The risk of acute erectile dysfunction should be discussed cautiously with patients who are potent before biopsy.

Adult↗

[Effectiveness and safety of the treatment with sildenafil (Viagra) in patients with erectile dysfunction and arterial hypertension].

OBJECTIVES: To evaluate the efficacy and safety of sildenafil in the treatment of erectile dysfunction in hypertensive patients taking antihypertensive drugs, and to investigate factors associated to treatment failure. METHODS: Observational prospective study comparing two groups of patients suffering from erectile dysfunction with or without hypertension. Patients were evaluated by anamnesis, physical examination, blood tests, and the International Index of Erectile Function (IIEF). Blood pressure was measured before and after treatment with an automatic digital oscillometric device. RESULTS: Erections improved in 88.2% and 91.7% of the patients with an without hypertension respectively. On the initial visit 55.2% of all patients had severe dysfunction, which was reduced after sildenafil treatment to 4.7%. Diastolic arterial blood pressure, evaluated in random measures, was slightly reduced after starting treatment with Viagra. No significant adverse events were registered. CONCLUSIONS: Oral treatment with sildenafil in patients with erectile dysfunction and hypertension is effective, well-tolerated and does not produce pharmacologic interactions with antihypertensive drugs.

Adult↗