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PubMed2004

The prevalence of hypertension, hyperlipidemia, diabetes mellitus and depression in men with erectile dysfunction.

PURPOSE: We quantified the prevalence of diagnosed hypertension, hyperlipidemia, diabetes mellitus and depression in male health plan members with erectile dysfunction (ED). MATERIALS AND METHODS: We used a nationally representative managed care claims database that covered 51 health plans with 28 million lives for 1995 through 2002. Based on 272325 identified patients with ED population and age specific prevalence rates were calculated for the same period. RESULTS: The crude population prevalence rates were 41.6% for hypertension, 42.4% for hyperlipidemia, 20.2% for diabetes mellitus, 11.1% for depression, 23.9% for hypertension and hyperlipidemia, 12.8% for hypertension and diabetes mellitus, and 11.5% for hyperlipidemia and depression. The crude age specific prevalence rates varied across age groups significantly for hypertension (4.5% to 68.4%), hyperlipidemia (3.9% to 52.3%), and diabetes mellitus (2.8% to 28.7%), and significantly less for depression (5.8% to 15.0%). Region adjusted population prevalence rates were 41.2% for hypertension, 41.8% for hyperlipidemia, 19.7% for diabetes mellitus and 11.9% for depression. Only 87163 patients with ED (32%) had no comorbid diagnosis of hypertension, hyperlipidemia, diabetes mellitus or depression. CONCLUSION: Hypertension, hyperlipidemia, diabetes mellitus and depression were prevalent in patients with ED. This evidence supported the proposition that ED shares common risk factors with these 4 concurrent conditions. Therefore, as a pathophysiological event, ED could be viewed as a potential observable marker for these concurrent diseases. This finding suggests that clinicians could include ED in the assessment profile of these concurrent conditions for earlier detection and treatment.

Adolescent↗

PubMed2007

Tadalafil for treatment of erectile dysfunction in men on antidepressants.

OBJECTIVE: The objective of this post hoc analysis was to evaluate tadalafil, a treatment indicated for erectile dysfunction (ED), in men on antidepressants. METHOD: A retrospective, pooled analysis of 19 double-blind, placebo-controlled trials (N = 3864) identified 205 men with ED, mean age of 55 years (range, 27-79 years) receiving antidepressants and tadalafil 10 mg (n = 38), tadalafil 20 mg (n = 113), or placebo (n = 54). Efficacy was measured by the International Index of Erectile Function erectile function domain score, the Sexual Encounter Profile diary, and a Global Assessment Question. Tolerability was assessed via collection and analysis of treatment-emergent adverse events. RESULTS: Patients on antidepressants who were treated with tadalafil showed significantly greater baseline-to-end point improvement on the International Index of Erectile Function score compared with placebo (end point: tadalafil 10 mg, 21.7; tadalafil 20 mg, 21.8; placebo, 14.5; both P < 0.01). The mean per-patient percent successful intercourse postbaseline was also greater with tadalafil 10 mg (54%) and tadalafil 20 mg (59%) than placebo (29%, both P < 0.05). Patients taking tadalafil 10 (72%) and 20 (76%) mg both reported significant improvement in erections on the Global Assessment Question compared with placebo (33%, both P < 0.01). The incidence of treatment-emergent adverse events was low in all treatment groups with the most common being headache, dyspepsia, and back pain. CONCLUSION: Tadalafil was well tolerated and improved erectile function in patients taking antidepressant medications.

Adult↗

PubMed2004

Prevalence and risk factors of erectile dysfunction in three cities of China: a community-based study.

AIM: To determine the age-adjusted prevalence of erectile dysfunction (ED) in 3 big cities of China and to explore its potential sociodemographic, medical and lifestyle correlates. METHODS: A cross-sectional, population-based survey was conducted in three cities of China. Structured questionnaires were administered to 2 226 men, aged 20 - 86 years, by trained interviewers. RESULTS: The age-adjusted prevalence of ED was 28.34 % (mild 15.99 %, moderate 7.14 %, severe 5.21 %). In the men above 40, the prevalence was 40.2 %. Age was positively correlated with ED (P<0.01). Education was negatively correlated with ED (P<0.01). Spouse companionship, living condition were positively correlated with ED (P<0.01). Histories of cardiovascular disease, diabetes, and hyperlipidemia were positively correlated with ED (P<0.01). Cigarette smoking was not correlated with ED (P>0.05), while the cigarette consumption and duration were positively correlated with ED (P<0.01). Alcohol drinking is negatively correlated with ED (P<0.01). The duration of drinking was positively correlated with ED (P<0.01). Weekly alcohol consumption was not correlated with ED (P>0.05). CONCLUSION: The prevalence of ED increased with age. Cardiovascular disease, diabetes and hyperlipidemia were positively correlated with the increased prevalence. Sociodemographic and lifestyle factors, such as education, spouse companionship, living condition, cigarette and alcohol consumption or duration also have association with the prevalence of ED.

Adult↗

PubMed2003

Sildenafil citrate does not reduce exercise tolerance in men with erectile dysfunction and chronic stable angina.

AIMS: The aim of this study was to evaluate whether sildenafil, used for treatment of erectile dysfunction (ED), affects the exercise tolerance and ischaemic threshold in men with exercise-induced angina not taking nitrates. METHODS: This was a double-blind placebo-controlled study in men with ED and chronic stable angina, assessing the effect of sildenafil on time to limiting angina during incremental treadmill exercise. Patients remained on their antianginal therapy and received a 100-mg dose of sildenafil or placebo 1h prior to treadmill exercise. Other measurements included times to onset of angina, 1-mm ST-segment depression, and total exercise time. RESULTS: Adjusted treatment differences for the time to limiting angina, time to onset of angina, total exercise time, and time to 1-mm ST-segment depression were (mean+/-SE) 20+/-10s (95% CI, 1-39; P=0.040), 32+/-11s (95% CI, 11-53; P=0.004), 20+/-10s (95% CI, 0-39; P=0.049), and 12+/-17s (95% CI, -21 to 45, P=0.48), respectively, in favour of sildenafil. There were no serious treatment-related adverse events. CONCLUSIONS: Sildenafil was well tolerated and did not adversely affect any exercise parameter in men with coronary artery disease and ED. Favourable trends in total exercise duration and times to onset of angina and limiting angina were recorded with sildenafil use.

Adolescent↗

PubMedDate not supplied

Electrocavernosogram in erectile dysfunction: a diagnostic tool.

Corpora cavernosa (CC) evoke electric waves that appear to be of diagnostic significance in evaluation of erectile dysfunction (ED). We investigated the hypothesis that electrocavernosography (ECG) exhibits different patterns in the various types of ED: neurogenic, vasculogenic, and psychogenic. Electrocavernosography was performed in the flaccid phase in 16 neurogenic, 28 vasculogenic (15 arteriogenic, 13 venogenic), and 24 psychogenic patients with ED, and in 15 healthy volunteers (controls). Two needle electrodes were introduced into the CC and the EMG activity was recorded in each of the 2 CCs of the same subject. Two 20 minute recording sessions were performed for each subject. The controls recorded slow waves (SWs) with regular rhythm and identical frequency, amplitude and conduction velocity from the 2 electrodes of the same subject. Random action potentials (APs) were superimposed on or followed the SWs. The ECG in the neurogenic ED recorded no waves in 14/16 patients and occasional irregular waves in 2. The SWs of the arteriogenic ED had irregular rhythm and variable and low parameters compared to those of the controls. The ECG of the patients with venogenic ED was similar to that of the controls, while the ECG of the psychogenic ED exhibited SWs with irregular rhythm and higher parameters than the controls. The study has revealed various ECG patterns in ED: "silent" in neurogenic. "bradyarrhythmic" in arteriogenic, "normal" in venogenic, and "overactive" in psychogenic ED. We suggest that electrocavernosography has the potential to function as an investigative tool in diagnosing the type of ED provided further studies are performed to verify the described findings.

Action Potentials↗

PubMed2005

The costs of caring for erectile dysfunction in a managed care setting: evidence from a large national claims database.

PURPOSE: We examined the direct costs of erectile dysfunction (ED) empirically. MATERIALS AND METHODS: A naturalistic cohort study was done in 285,436 patients with ED and 51 health plans that covered 28 million lives nationwide from 1999 through 2001. Based on claims that had an ED related diagnosis code, procedure code or medication code we categorized the cost structure of ED care and calculated the annual costs of ED care per patient with ED, per user and per member monthly for individual and for all categories of ED care. RESULTS: A patient with ED in a health plan spent about an average of 83.91 dollars in 1999, 95.41 dollars in 2000 and 119.26 dollars in 2001 for ED care. In 2001, 37.08% of ED care costs per patient with ED were spent on phosphodiesterase type 5 (PDE-5) inhibitor therapy, 14.36% were spent on physician office visits, 10.19% were spent on diagnosis procedures, 8.45% were spent on testosterone hormone therapy, 3.85% were spent on penile prosthesis implantation, 4.41% were spent on intracavernous injection, 2.68% were spent on alprostadil pellet insertion and 0.81% was spent on vacuum erection devices. Of the 7 commonly used ED treatments PDE-5 inhibitor therapy has the lowest annual cost per user. CONCLUSIONS: In 2001 ED imposed a 122,669 dollars annual burden to a health plan with 100,000 members, that is or 0.108 dollars per member monthly. Each patient with ED spent 119.26 dollars annually for all ED related services or treatments. Of the 7 commonly used treatments PDE-5 inhibitor therapy had the lowest annual cost per user.

Adolescent↗

PubMed2000

Three-year outcome of a progressive treatment program for erectile dysfunction with intracavernous injections of vasoactive drugs.

OBJECTIVES: To perform a comparative evaluation and follow-up of patients with erectile dysfunction (ED) who were treated with intracavernous injection of vasoactive drugs, starting with simple drugs and advancing to complex combinations. METHODS: The study included 625 patients, 26 to 85 years old, with ED. Four intracavernous injection protocols were used: protocol 1, papaverine plus phentolamine; protocol 2, prostaglandin E(1); protocol 3, papaverine, phentolamine, and prostaglandin E(1); and protocol 4, atropine sulfate, papaverine, phentolamine, and prostaglandin E(1). A positive response was defined as an erection sufficient for penetration. Patients for whom the basic protocol failed were successively switched to the more advanced protocols until a positive response was achieved. RESULTS: A positive response was achieved by 415 (66.4%) of the 625 patients given protocol 1; 75 (36%) of the remaining 210 patients given protocol 2; 98 (72.6%) of the 135 patients given protocol 3; and 22 (59.5%) of 37 patients given protocol 4. All four protocols failed in only 15 patients (2. 4%). At the 3-year follow-up visit (n = 610), 349 had achieved coitus, 65 (10.6%) without an injection and 202 (33.1%) with an injection. Eighty-two patients sometimes performed coitus without an injection. Sixty-three patients (10.3%) abandoned the program because of marital or health problems; 198 asked to be switched to Viagra during the follow-up period, and 120 returned to the program. CONCLUSIONS: Overall, our progressive treatment yielded a high positive response rate (97.6%), with 57.2% achieving successful coitus on follow-up. The main advantage of the program is that it spares patients who are responsive earlier from using more complex, painful, and costly drugs.

Adult↗

PubMed2006

Left ventricular diastolic function and endothelial function in patients with erectile dysfunction.

The aim of this study was to assess left ventricular diastolic function and forearm endothelial function in patients with erectile dysfunction (ED) without overt cardiovascular disease. Forearm endothelial function and diastolic Doppler parameters, including tissue Doppler imaging, were studied in 32 men with ED and 27 age-matched, healthy, male control subjects. Left ventricular diastolic function in patients with ED and the relation between endothelium-dependent vasodilation and the Doppler parameters of left ventricular diastolic function, including tissue Doppler imaging, were assessed. Endothelium-dependent vasodilation (4.1+/-3.3% vs 9.7+/-4.2%, p<0.001) as well as the mitral inflow E velocity (0.66+/-0.17 vs 0.80+/-0.16 m/s, p=0.01), the E/A ratio (the ratio of mitral inflow E velocity to mitral inflow A velocity; 0.91+/-0.3% vs 1.22+/-0.26%, p<0.001), and the E/Em ratio (the ratio of mitral A-wave velocity to early diastolic velocity in the annulus derived by tissue Doppler imaging; 7.4+/-2.7% vs 6.6+/-1.6%, p=0.03) were smaller in the ED group than in the control group. Deceleration time (228.6+/-61.6 vs 192.9+/-44.6 ms, p=0.03) and isovolumetric relaxation time (112.8+/-18 vs 94+/-15.9 ms, p<0.001) were also prolonged in the ED group compared with the control group. The mitral E-wave velocity (r=0.40, p=0.022), the E/A ratio (r=0.40, p=0.027), and the E/Em ratio (r=-0.52, p= 0.003) were related to endothelium-dependent vasodilation by nivariate analysis. Only the E/Em ratio was correlated with endothelium-dependent vasodilation by multivariate analysis. In conclusion, this study indicates that endothelial function and left ventricular diastolic function are impaired in patients with ED without overt cardiovascular disease.

Blood Flow Velocity↗

PubMed2000

Safety and efficacy of alprostadil sterile powder (S. Po., CAVERJECT) in diabetic patients with erectile dysfunction.

OBJECTIVES: To evaluate the long-term efficacy and safety of intracavernosal alprostadil (CAVERJECT((R))) in diabetic patients with erectile dysfunction (ED). PATIENTS AND METHODS: This study included 31 diabetic men (aged 44-75 years) with ED of >/=4 months duration. All patients were initially instructed in the self-injection technique at the investigator's clinic. The optimal dose was determined for each patient and set at one of the following: 5, 10, 20, 30, 40, 50, or 60 microg. After the optimal dose was determined and the patient was well trained, the self-injection home phase was followed for 6 months. The efficacy and adverse events were documented. RESULTS: An optimal dose was determined for 29 men (93.5%) and in 16 men (55%) it was >/=20 microg. During the home phase, 76.5% of injections assessed by the patients resulted in satisfactory sexual activity and 72.5% of injections assessed by partners resulted in satisfactory intercourse. A total of 16 patients dropped out during the titration phase (n = 2) and the home phase (n = 14). The most common reasons included lack of efficacy (n = 3, all in the home phase), intolerable penile pain (1 in the titration phase, 2 in the home phase) and dissatisfaction with the higher dosage (n = 2). Penile pain occurred in 19 (61%) of 31 patients. Most were tolerable, and the incidence decreased with time. Prolonged erection occurred in 2 men (6.5%), and no priapism was noted. Penile fibrosis occurred in 1 patient (3. 2%). None of the systemic medical events were related to the study mediction. However, 1 patient suffered from right putaminal hemorrhage in the last month, and this was considered to be caused by underlying hypertension and not drug-related. CONCLUSION: Despite the high incidence of penile pain, most of the occurrences were tolerable. Despite a higher withdrawal rate in this study, intracavernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is established by titration and patients are trained in the self-injection technique with period supervision.

Adult↗

PubMed2001

Plasma levels of angiotensin II during different penile conditions in the cavernous and systemic blood of healthy men and patients with erectile dysfunction.

OBJECTIVES: To detect changes in plasma levels of angiotensin II (Ang II) under different functional conditions of the penile erectile tissue in the cavernous and systemic blood of patients with erectile dysfunction (ED) and compare them with the course of Ang II in healthy male subjects. It has been shown that the mammalian corpus cavernosum produces and secretes physiologically relevant amounts of the vasoconstrictive peptide Ang II and that intracavernosal injection of Ang II terminates penile erection in the dog. Thus, we speculated whether a dysregulation in the secretion or degradation of Ang II might contribute to the manifestation of ED. METHODS: Thirty-four healthy adult men and 48 patients with ED of either organogenic or psychogenic etiology were exposed to visual and tactile erotic stimuli to elicit penile tumescence and, in the group of healthy subjects, rigidity. Whole blood was simultaneously aspirated from the corpus cavernosum and the cubital vein during the different functional conditions of the penis. Ang II plasma levels were measured using a radioimmunoassay. RESULTS: In healthy men, the Ang II levels in the cavernous plasma increased from 22.1 +/- 7.1 pg/mL in the phase of penile rigidity to 27.9 +/- 10 pg/mL in the detumescence phase. In the peripheral plasma, the Ang II levels were 17.2 +/- 6.2 to 19.5 +/- 6.5 pg/mL over the respective penile stages. The courses of Ang II registered in the patients were similar to those detected in the healthy men. In the patients and healthy men, systemic Ang II levels were found to be lower than the concentrations detected in the cavernous blood. In the group of organogenic patients, the Ang II levels during penile flaccidity in the systemic and cavernous blood were higher than those registered in the blood samples taken from the healthy men. CONCLUSIONS: Our results suggest that cavernous smooth muscle tone is, in part, balanced by Ang II-induced contraction and that Ang II might be involved in the initiation of penile detumescence in men. That Ang II plasma levels are generally elevated in the systemic and cavernous blood of patients with an organogenic etiology of ED may hint at the significance of Ang II in the pathophysiology of ED. Since the tissue and plasma levels of Ang II are regulated by the activity of angiotensin-converting enzyme, there might be a rationale for the use of angiotensin-converting enzyme inhibitors in the treatment of vasculogenic ED.

Adult↗

PubMed2006

Prevalence of erectile dysfunction among middle-aged men in a metropolitan area in Germany.

The comparison of results of previous studies on the prevalence of erectile dysfunction is hampered due to differences in study design and research instruments including definitions used. The aim of the study was to determine the prevalence of erectile dysfunction/erectile disorder (ED) using different definitions. An epidemiological cross-sectional study was conducted between May and November 2002 in Berlin, Germany. A total of 6000 men between 40 and 79 years of age were randomly selected by the Berlin Office of Vital Statistics and were sent a questionnaire by mail. The prevalence of ED was determined using five different methods. A total of 1915 questionnaires were eligible for analysis. The five different definitions yielded age-adjusted ED prevalence rates between 18 and 48%. Age was strongly correlated with all five definitions (P<0.001). These results indicate the need for standardized criteria when conducting future studies on ED and may aid in designing public health and clinical management strategies.

Adult↗

PubMed2003

Efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in Egypt and South Africa.

The efficacy of sildenafil citrate (Viagra), an oral agent for the treatment of erectile dysfunction (ED), has been demonstrated in global studies. This 12-week randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study assessed the efficacy and safety of sildenafil to treat ED in men in Egypt and South Africa. Men with ED of varied etiology were randomized to receive sildenafil 50 mg (n=128) or placebo (n=126); doses could be adjusted to 100 or 25 mg. Questions from the International Index of Erectile Function (IIEF) assessing the ability to achieve (Q3) and maintain (Q4) erections demonstrated a significant improvement with sildenafil compared with placebo (P<0.0001). Improved erections were reported by 74% of patients receiving sildenafil and 27% of those receiving placebo (P<0.0001). Headache, dyspepsia, and flushing were the most common adverse events in sildenafil-treated patients. These results are consistent with clinical trials in other countries. We conclude that sildenafil is an efficacious and well-tolerated treatment for men with ED in Egypt and South Africa.

Adult↗

PubMedDate not supplied

Andropause: endocrinology, erectile dysfunction, and prostate pathophysiology.

This review summarizes major biological aspects of andrology of andropause, deficiency in androgens/growth hormones, and molecular parameters; erectile dysfunction (ED), the use of malleable, mechanical, inflatable devices as well as the application of Viagra (Sildenafil), alprotadil (Caverject), Yohimbine, and other drugs not yet approved by FDA, such as Papaverine, phentolamine (Vasomax), and apormorphine (Uprima); osteopenia/osteoporosis: testosterone/osteoporesis; supplementation during andropause: administration of andiogens, possible risk factors of androgens, calcium supplement and muscle mass; prostate pathophysiology: consequences of prostatectomy, prostate cancer, benign prostatic hyperplasia (BPH), hormone-dependent cancers; bladder and urethral dysfunction: neurological parameter, urodynamics technology; models on aging in male animals: comparative physiology of prostate of laboratory animals/farm animals; future research: functional anatomy of male reproductive organs, pharmacokinetics of osteoporosis, endocrinology/neuroendocrinology/chromosome anomalies supplementation during andropause, experimental animal models and future multicenter multidisciplinary research.

Androgens↗

PubMed1999

Erectile dysfunction in spina bifida is treatable.

We undertook a prospective, blinded, randomised, placebo-controlled, dose escalation, crossover study that showed that erectile dysfunction in spina bifida is medically treatable, specifically with sildenafil citrate.

Adult↗

PubMed2004

Clinical application of prognostic factors for patients with organic causes of erectile dysfunction on 100 mg of sildenafil citrate.

OBJECTIVES: There are still no clinical predictive factors to determine the response rate of erectile dysfunction (ED) patients to sildenefil citrate. The aim of the present study is to evaluate and stratify the risk factors and attempted to determine the prognostic factors in clinical practice to predict the response rate. This is important in improving cost effectiveness and avoiding side-effects. MATERIAL AND METHODS: This is an open label prospective study including patients attending the andrology clinic in Tan Tock Seng Hospital, Singapore, over 2 years. The patients were evaluated and investigated for possible underlying causes and ED severity was assessed by five-items of the International Index of Erectile Function questionnaire (IIEF-5), together with the duration, degree and rigidity of erection. Psychogenic causes were excluded with a minimal follow up of 6 months. All patients were placed on 100 mg of sildenafil citrate and were reassessed at the end of 6 months. Logistic regression with univariate and multivariate was used as the method of statistical analysis. RESULTS: A total of 232 patients were in the cohort. The overall response rate was 43%, with the best response rate in veno-occlusive cases and the worst responses from neurogenic causes. Age, smoking, diabetes mellitus, hypertension, hyperlipidemia, pretreatment IIEF-5 score, interval to achieve erection and duration of erection were significant in univariate analysis, but only age, smoking and IIEF-5 score were significant in multivariate analysis. With a combination of these factors, a table was formed to determine the possible response rate in clinical practice. This will assist physicians in selecting patients with potentially favorable responses and avoid side-effects and an unnecessary wastage of time and cost. CONCLUSION: Possible factors could be determined and used clinically to predict the response rate to sildenafil citrate.

Age Factors↗

PubMed1999

Erectile dysfunction and sildenafil citrate and cardiologists.

Since the release of sildenafil citrate (Viagra), increasing numbers of patients are seeking treatment for erectile dysfunction (ED). Many of the risk factors for ED are the same as those for cardiac disease. Sildenafil citrate is a highly effective oral agent for ED. It is absolutely contraindicated in patients receiving organic nitrates. The issue of cardiac deaths associated with sildenafil citrate and ways of potentially minimizing these cases are discussed.

Cardiovascular Diseases↗

PubMed2004

Time/duration effectiveness of sildenafil versus tadalafil in the treatment of erectile dysfunction in male spinal cord-injured patients.

STUDY DESIGN: A randomized, blinded, crossover clinical trial comparing sildenafil versus tadalafil for erectile dysfunction (ED) in male spinal cord-injured (SCI) patients. OBJECTIVES: To compare the safety, time/duration effectiveness, and the impact on the quality of life (QoL) of tadalafil 10 mg versus sildenafil 50 mg. SETTING: Neurourology Section, Careggi Hospital, Florence, Italy. METHODS: During a screening (visit 1), a diary card was distributed, in which the subjects assessed, after each attempt at intercourse the quality of their erection, responding (Yes/No) to both Sexual Encounter Profile Questions 2 (SEP2) and 3 (SEP3). The subjects made at least four attempts at intercourse. At visit 2, 15 patients (group 1) were assigned sildenafil and 15 (group 2) started with tadalafil. Responses to baseline International Index of Erectile Function 5 items (IIEF-5), Questions 13-14 (IIEF 15 items) and SEP diary were recorded. Patients attempted intercourse on four separate occasions: within 4 h of taking the first tablet, within 12 h for the second tablet, 24 h for the third, and the fourth from 24 to 36 h. At visit 3, the investigators evaluated the effectiveness with the same measures used at baseline. After a wash-out period, at visit 4, Group 1 was given tadalafil, and Group 2 was given sildenafil. Patients were required to observe the same criteria in taking the four tablets as in visit 2. After 4 weeks (visit 5), we evaluated the patients as we did in visit 3. RESULTS: Overall, 28 patients completed the study. No subjects discontinued the drugs due to drawbacks. Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 h postdosing compared to sildenafil (P<0.01) and improved overall sex life satisfaction as well as sexual relations with partner. CONCLUSION: Based on these data, tadalafil may have the potential to become an important treatment option for ED in SCI patients. SPONSORSHIP: This study was not sponsored.

Carbolines↗

PubMed1995

[Efficacy and tolerance of intracavernous injection of moxisylyte in patients with erectile dysfunction: double-blind placebo-controlled study].

OBJECTIVE: To evaluate the efficacy of intracavernous moxisylyle versus placebo in patients with erectile dysfunction of various origins. To assess the local tolerance and systemic safety of moxisylyte by self-administered injection. METHODS: Multicentre study, comprising two treatment phases: The first, double-blind phase, was conducted in two parallel groups of randomized patients, over a 1-month period (1 injection per week) in the investigator's office; the second phase was conducted under open conditions in the patient's home, over a period of 3 to 11 months. Self-administered injections (1 to 2 per week) were performed using a prefilled syringe containing 10 mg of moxisylyte. RESULTS: Out of 307 patients evaluated during the first phase, the qualitative and quantitative superiority of erectile response induced by moxisylyte compared to placebo was confirmed (p < 0.0001). The stability of the response to moxisylyte was also confirmed on 4 injections, and the frequency of responses compatible with sexual intercourse ranged from 48% to 52% from one injection to another. This efficacy was also maintained during the open phase, as 92% of the 4,487 self-administered injections generated positive erectile responses. The quality of these responses was considered sufficient to allow sexual intercourse after 62% of injections. The local tolerance was considered to be excellent for more than 95% of injections, without any major adverse effects, and a very low risk of prolonged erection and fibrotic reaction. The systemic safety was also considered to be excellent for more than 98% of erections. CONCLUSION: This study confirms the possibility of obtaining an erectile response by intracavernous injection of 10 mg of moxisylyte with a very low incidence of local and systemic adverse effects. It also tends to confirm the superior efficacy of moxisylyte by self-administered injections at home than by injection in the doctor's office.

Adult↗