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PubMed2006

Prevalence of erectile dysfunction in Asian populations: a meta-analysis.

We searched for published studies on the prevalence of erectile dysfunction (ED) in Asian populations, through Medline, PubMed, PsychInfo and scanned through reference lists. Data on prevalence rates were obtained and summarized for each Asian region, and were used to calculate pooled prevalence estimates using fixed and random effects models. As significant heterogeneity existed in certain age group categories, the random effects model was preferred. Twenty general population studies were identified. Six studies were eligible to be entered into the pooling of results, and provided 8653 subjects for analysis. The prevalence of ED increased with age. Pooled random effects age-specific prevalence rates were 15.1% (12.2-18.1), 29.6% (19.7-39.6), 40.6% (23.6-57.7), 54.3% (36.0-72.6) and 70.0% (62.3-77.7) for age groups 20-29, 30-39, 40-49, 50-59 and 60-69 years, respectively. Homogeneity of results in age groups 20-29 and 60-69 years suggested equally low and high prevalences of ED across Asian regions in these age groups, respectively. The overall reported prevalence in individual studies ranged from 2 to 81.8%. Prevalence rates and related information were summarized for each Asian region and for each study.

Age Distribution↗

PubMed2004

Efficacy of apomorphine and sildenafil in men with nonarteriogenic erectile dysfunction. A comparative crossover study.

To compare the efficacy of apomorphine and sildenafil in men with nonarteriogenic erectile dysfunction (ED), 40 men were studied. Post-injection penile peak systolic velocity was greater than 25 cm s(-1). Twenty men started on apomorphine 2 mg and 20 on sildenafil 50 mg, the doses titrated up to 3 and 100 mg, respectively, if necessary. After a 1-week washout period each group switched to the other treatment mode. Efficacy was the percentage of attempts resulting in erections firm enough for intercourse, based on an event log data. The majority (85%) of the men had concomitant diseases, risk factors for ED and 95% were heavy smokers. The overall success rate of apomorphine was 62.7%, compared with 73.1% of sildenafil (Yates-corrected chi-square, P < 0.0004). The response to apomorphine 2 mg and sildenafil 50 mg was age related. Sildenafil was statistically more effective than apomorphine in impotent men with normal penile Doppler. Given the contraindication of sildenafil in men taking nitrates and the quick time of action of apomorphine, the two drugs are satisfactory first line therapeutic tools in such individuals and the choice should be based on patient's needs and preferences.

Apomorphine↗

PubMed1998

[Treatment of erectile dysfunction using intracavernous pharmacotherapy].

Intracavernous injection of vasodilators has been the greatest diagnostic and therapeutical breakthrough in erectile dysfunction (E.D.). After 15 years experience, these vasodilators have demonstrated efficacy rates over 85%. This suggests that most cases of E.D. are the result of and inability of the smooth muscle to relax. This paper presents an overview of the diagnostic and therapeutic use of intracavernous vasodilating drugs. It includes an extensive review of the literature and our personal series with regard to efficacy, indications, contraindications and side-effects of these compounds. Alprostadil i.c. injection (PGE1) is an effective (> 70%) and safe treatment, and its use has been accompanied by an increased quality of life of patients, with very few side effects. Currently, PGE1 is a first choice drug in the treatment of impotence. When no response is seen, or pain develops after PGE1 administration, a number of vasoactive compounds associations can be used instead (phentolamine + PGE1, papaverine + phentolamine, and papaverine + phentolamine + PGE1). The phentolamine + VIP association has shown encouraging results. Prior to prescribe IC treatment with vasoactive drugs it is necessary to conduct a basic diagnostic study, and advise the patient. If treatment is finally accepted, the performance of adequate training and detailed medical follow-up is crucial.

Contraindications↗

PubMed1996

[Erectile dysfunction: clinical course with intracavernous PGE1].

OBJECTIVES: The results achieved with PGE1 therapy in 66 patients with erectile dysfunction in our self-injection program are presented. METHODS: Patients with severe conditions (cancer, infectious disease, renal and hepatic failure, etc.), psychological or hormonal disorders were discarded from the study. All patients were tested with PGE1, the dose was adjusted according to individual response, the patient was instructed how to inject the vasoactive drug and included in the self-injection program. Statistical analysis of the data was performed using the chi-square and the Student 't' test. RESULTS: The mean follow-up was 9.8 months (range 1-39). Twenty-five patients (37%) withdrew from the program. Six patients (9%) received another treatment due to pain or poor response. A penile prosthesis was implanted in five patients and one patient was treated with a vacuum erection device. Although not statistically significant, local pain was associated with a shorter follow-up. Prolonged erection was also observed but did not influence the length of follow-up. CONCLUSIONS: Local pain has been associated with a shorter follow-up. A small number of non-responders warranted another therapy.

Alprostadil↗

PubMed2005

Enhancement of both EDHF and NO/cGMP pathways is necessary to reverse erectile dysfunction in diabetic rats.

AIMS AND METHODS: Phosphodiesterase 5 (PDE5) inhibitors are less effective in the treatment of erectile dysfunction (ED) in diabetic men than in nondiabetic patients. We have evaluated the effects of sildenafil, a PDE5 inhibitor that enhances the nitric oxide (NO)/cGMP pathway, calcium dobesilate (DOBE), which potentiates endothelium-derived hyperpolarizing factor (EDHF)-mediated responses and the combination of both on erectile responses elicited by cavernosal nerve electrical stimulation (CNES) in a rat model of ED after 8 weeks of streptozotocin-induced diabetes. RESULTS: After 8 weeks of diabetes, erectile responses to CNES were significantly decreased in diabetic animals compared with nondiabetic time controls. While intravenous administration of sildenafil (0.3 mg/kg) or DOBE (10 mg/kg), individually, enhanced erectile responses in nondiabetic rats (214.7 +/- 34.1% and 268.5 +/- 30.1% of control response at 1 Hz, respectively), each failed to significantly enhance erectile responses in diabetic rats. Only when administered in combination did DOBE and sildenafil markedly potentiate erectile responses in these animals (380.1 +/- 88.6% of control response at 1 Hz), completely restoring erectile function. CONCLUSIONS: These findings emphasize the importance of NO/cGMP and EDHF pathways for normal erectile function. They also give support to the in vitro observation that diabetes impairs NO and EDHF-dependent responses, precluding the complete recovery of erectile function with PDE5 inhibitors and explaining the relatively poor clinical response of diabetic men with ED to PDE5 inhibition. Finally, our study suggests that a pharmacological approach that combines enhancement of NO/cGMP and EDHF pathways could be necessary to treat ED in many diabetic men.

3',5'-Cyclic-GMP Phosphodiesterases↗

PubMed2003

Non-invasive vascular imaging for erectile dysfunction.

In the era of orally active agents the clinical context of the diagnosis and treatment of erectile dysfunction (ED) has radically changed. There is a general trend oriented towards choosing invasive diagnostic testing and surgical treatment solutions. Along this view, penile pharmacotesting (PPT) may represent an inexpensive and easy diagnostic procedure to be performed in the office setting. However, this procedure provides no direct vascular imaging, has a high percentage of false diagnoses and its accuracy for subsequent treatment decisions remains quite limited. Hence, home testing with orally active agents may provide better information for the patient's goals. In the diagnostic work-up of ED, the combination of PPT plus colour-duplex Doppler ultrasonography (CDDU) has gained more credit because of a higher diagnostic accuracy than PPT alone, so that it should be always performed when possible. It represents an accurate mean to predict cavernous artery inflow and venous leakage when compared to more invasive diagnostic techniques; in fact it allows the measurement of the resistive index when maximal response to vasodilator challenge has occurred. In conclusion, we recommend CDDU to all ED patients with a significant risk of cardiovascular disease, as well as in the presence of penile plaques whereas a frequent involvement of neuro-anatomical structures occurs. Other vascular testing--i.e. natural penile tumescence, cavernosometry/graphy, angiography are reserved to selected patients in whom CDDU alone has provided inconsistent information.

Erectile Dysfunction↗

PubMed2003

Current drug use as risk factor for erectile dysfunction: results from an Italian epidemiological study.

Several drugs have been associated with an increased risk of erectile dysfunction (ED). We analysed the role of pharmacological treatments on the risk of ED using data from a cross-sectional study on prevalence and risk factors for ED in the general population in Italy. A total of 2450 men aged more than 18 years were randomly identified by 143 general practioners (GP) among their registered patients and invited to a confidential interview by their GP. Patients were asked 'about their ability to achieve and maintain an erection sufficient for satisfactory sexual performance'. If they were dissatisfied, they were defined as having ED. Out of the 2450 men identified, 440 (18%) refused to participate. The present analysis therefore includes information on 2010 men. After adjustment for related pathologies, anxiolytics and antidepressants showed insignificantly higher odds ratio (ORs, respectively, 1.7 and 2.1); antipsychotic drug use significantly increased the risk of ED (OR 9.0, 95% confidence interval, CI 1.8-44.4). Diuretics (OR 3.1, 95% CI 1.4-6.9) and anticholinergic drugs (OR 12.8, 95% CI 2.7-60.1) were associated with ED risk. No association emerged between ED and H2 antagonists, anticholesterolemic or hypoglycemic drugs. In conclusion, after taking account of related pathologies, our results suggest that men treated with antipsychotic, diuretic and anticholinergic drugs are at greater risk of ED.

Antipsychotic Agents↗

PubMed1995

[Topical treatment of erectile dysfunction. Possibilities and perspectives].

In this work the Authors speak about topical treatment in diagnosis and therapy of erectile deficit with prostaglandin, papaverine, phentolamine, V.I.P., nitroglycerine, minoxidil and others. These drugs must have some chemicophysical trait to be adsorbed by the skin. The concepts of microangiotettonic, microangiopathy, microangiokinesis are very important in erectile dysfunctions. For the future there are perspectives to use microvasculokinesic and antiperossidasic complex, alone or in association with intravenous pharmacotherapy.

Administration, Cutaneous↗

PubMed1991

Color Doppler sonography in the evaluation of erectile dysfunction: patterns of temporal response to papaverine.

Most studies of duplex Doppler sonography for the assessment of erectile dysfunction involve determination of peak systolic velocities 5 min after intracavernosal injection of papaverine. The purpose of this study was to determine the effect of the timing of Doppler measurements of flow after papaverine injection for establishing the presence of arterial and venous abnormalities. Color Doppler sonography was performed in 75 patients for evaluation of vasculogenic impotence. After intracavernosal injection of 60 mg of papaverine, measurements of peak systolic and end-diastolic velocities were obtained in each cavernosal artery at 5-min intervals for a total of 30 min. A peak systolic velocity of less than 25 cm/sec was used as the threshold for arterial insufficiency. An end-diastolic velocity of greater than 5 cm/sec was used to predict venous incompetence. Scanning was performed for direct assessment of dorsal venous flow. Thirty patients were subsequently evaluated by cavernosometry and cavernosography. In most patients (76%), maximum response to papaverine was achieved within the first 5 min. In eight patients, significant increases in systolic velocity were seen only after 5 min. In 10 patients, significant changes in end-diastolic velocity between 5 and 30 min resulted in diagnostic reclassification. Data acquisition for 30 min significantly improved the sensitivity (95%) and specificity (83%) for the prediction of venous incompetence in patients with correlative cavernosography. Transient, early dorsal vein flow was noted in normal subjects. Persistent dorsal vein flow had an 80% sensitivity and 100% specificity for venous incompetence. Our results suggest that, when using color Doppler sonography, gathering data for 30 min may improve the prediction of vasculogenic impotence.

Adult↗

PubMedDate not supplied

Evaluation of erectile dysfunction therapy in patients previously nonadherent to long-term medications: a retrospective analysis of prescription claims.

Erectile dysfunction (ED) can lead to treatment noncompliance in patients taking medications for chronic health conditions. Using the Intelligent Health Repository, NDCHealth's longitudinal, United States health care claims database, we examined the impact of treating ED on adherence to long-term therapies in previously nonadherent patients. Male patients >or=18 years of age were identified who received antidepressant (AD), antihypertensive (AH), oral hypoglycemic (OHG), or lipid-lowering (LL) agents and initiated therapy with sildenafil citrate (Viagra) between January and June 2003. Treatment adherence was determined using medication possession ratios (MPRs) for the 12 months before and after the first prescription of sildenafil. Prior to initiation of therapy for ED with sildenafil, 64% of patients with comorbid medications were not adherent (MPR <0.8). Among these patients, 728 (27%) received AD, 2112 (78%) received AH, 984 (18%) received OHG, and 1078 (40%) received LL agents, with 66% of patients receiving multiple therapeutic classes. During the 12-month period after the first sildenafil prescription, patients had a significant increase in medication adherence compared with the 12 months before the first prescription of sildenafil (P < 0.0001). The percentage of patients who became adherent (MPR >or=0.8) with medications after sildenafil treatment was from 22% to 36%. With the exception of the LL group, there was a significant relationship between >or=3 sildenafil prescriptions and change in MPR (P < 0.05). Patients aged >or=65 years had similar improvement in MPR as patients <or=65 years. Treatment of ED with sildenafil improved adherence in patients taking common long-term medications who were previously nonadherent.

Adult↗

PubMed2005

Intima-media thickening of common carotid arteries is a risk factor for severe erectile dysfunction in men with vascular risk factors but no clinical evidence of atherosclerosis.

PURPOSE: The association of erectile dysfunction (ED) with vascular damage in men without clinical atherosclerosis is unknown. By B-mode ultrasound we evaluated intima-media thickness (IMT) of common carotid arteries, a measure of vascular damage, in men reporting ED with or without vascular risk factors (VRFs) but no clinical atherosclerosis. MATERIALS AND METHODS: IMT of common carotid arteries was evaluated in 270 men with ED. A total of 50 men (mean age +/- SD 39.84 +/- 12.5 years) had no VRFs, 100 (mean age 47.92 +/- 10.94 years) were overweight and/or had hyperlipidemia, and 120 (mean age 53.95 +/- 9.73 years) were affected by type 2 diabetes and/or essential arterial hypertension. RESULTS: IMT was significantly lower in men with no VRFs compared to men with VRFs (p <0.05), and correlated with the severity of ED evaluated through the Sexual Health Inventory for Men (p = 0.0008). Of men with VRFs 17.7% (39 of 220) showed an IMT score indicative of vascular damage (1.00 mm or greater), while only 1 man with no VRFs had a high IMT. Men with VRFs and a high carotid IMT score demonstrated more severe ED, were older and had a higher serum level of C-reactive protein compared to men with VRFs and an IMT of less than 1.00 mm (p <0.05). A high IMT score but not an increased measure for each VRF, including aging, significantly increased the risk of severe ED (odds ratio 2.6, confidence interval 1.1 to 5.9) even after controlling for smoking and drugs associated with ED. CONCLUSIONS: ED in men with VRFs was the only clinical correlate of unrecognized atherosclerosis of common carotid arteries.

Adult↗

PubMed2002

The cost to the United Kingdom National Health Service of managing erectile dysfunction: the impact of sildenafil and prescribing restrictions.

OBJECTIVE: To estimate the annual direct cost of managing erectile dysfunction (ED) to the UK National Health Service (NHS) and to examine the impact of the introduction of sildenafil in 1998 and Schedule 11 restrictions in 1999. DESIGN: A prevalence-based cost-of-illness approach was used. The period 1997 to 2000 was covered. The numbers of ED prescriptions, prosthesis implantations and general practitioner (GP) consultations were retrieved retrospectively from UK resource utilisation databases. The number of specialist consultations and psychosexual therapy sessions were estimated from NHS clinic data. National resource unit costs were applied. MAIN OUTCOMES AND RESULTS: Between 1997 and 2000 the number of men presenting with ED increased from 79,800 to 257,984. The cost to the NHS increased from pounds sterling 29.4 million to pounds sterling 73.8 million (2000 estimates). The cost per patient fell from pounds sterling 368 to pounds sterling 286. In 1997, most NHS costs came from psychosexual therapy (30.7%), specialist consultations (20.2%) and intracavernosal injections (26.6%). By 2000, NHS costs came primarily from specialist consultations (32.0%), sildenafil prescriptions (26.2%), psychosexual therapy (13.6%) and GP consultations (12.0%). The annual cost was most sensitive to the number of drug prescriptions and specialist consultations. CONCLUSIONS: The increased NHS cost of managing ED was due mainly to a three-fold increase in the number of men presenting to GPs, substantial numbers of whom were then referred for specialist consultations under Schedule 11 restrictions. This naturally resulted in the increased use of all resources including sildenafil. The cost effectiveness of transferring prescribing responsibility in cases of severe distress from specialists to GPs in primary care remains to be determined.

Cost of Illness↗

PubMed2003

Microarray analysis and description of SMR1 gene in rat penis in a post-radical prostatectomy model of erectile dysfunction.

PURPOSE: We focused on the post-radical prostatectomy model to advance the understanding of neurogenic erectile dysfunction. We attempted to identify previously undescribed molecular changes via gene discovery methods using GeneChip (Affymetrix, Santa Clara, California) microarray technology. MATERIALS AND METHODS: Five male adult 120-day-old Sprague-Dawley rats underwent bilateral cavernous nerve neurectomy. Five age matched controls were prepared simultaneously. The penises were harvested on postoperative day 2 and snap frozen in liquid nitrogen. RNA was prepared and pooled into cut and uncut groups. Synthesis of cRNA was performed according to the GeneChip technical manual. Microarray analysis was performed on a U34A Rat Array (Affymetrix). This array has approximately 8,800 gene probe sets, approximately 6,600 known genes and approximately 2,200 estimated sequence transcripts. RESULTS: Dramatic results were found during GeneChip microarray expression analysis. A total of 126 candidate genes were noted to be altered based on the magnitude of expression change using rigorous statistical criteria, including 47 that were down-regulated and 79 that were up-regulated. Among the many significant changes seen 1 dominant class of genes was the submandibular rat genes. Submandibular rat 1 (SMR1) was down-regulated 82.5 fold. Other genes in this family were down-regulated 226 and 90 times. This result was confirmed by reverse transcriptase-polymerase chain reaction and Western blot analyses. These assays verified decreases in SMR1 at multiple time points after surgery. CONCLUSIONS: Impressive and previously unrecognized genetic changes are being intensely investigated as they are being unmasked by GeneChip technology. We have identified and begun the investigation of 1 interesting family of genes, namely submandibular gland proteins. The role of SMR as a clinically relevant change in penile and/or urethral function following cavernous nerve injury is speculative.

Animals↗

PubMed2006

Effect of nonsteroidal anti-inflammatory drug use on the incidence of erectile dysfunction.

PURPOSE: We estimated the effect of nonsteroidal anti-inflammatory drug use on the incidence of erectile dysfunction. MATERIALS AND METHODS: The target population consisted of men 50, 60 or 70 years old residing in the study area in Finland in 1994. Questionnaires were mailed to 3,143 men in 1994 and to 2,864 men 5 years later. The followup sample consisted of 1,683 men who responded to baseline and followup questionnaires. We estimated the effect of NSAIDs on the incidence of ED in men free from moderate or complete ED at baseline (in 1,126). ED was assessed by 2 questions on subject ability to achieve or maintain an erection sufficient for intercourse. Confounding was assessed by stratification and by adjustment in multivariate Poisson regression model. RESULTS: The incidence of ED was 93 cases per 1,000 person-years in men who used and 35 in those who did not use NSAIDs. Among men with arthritis, the most common indication for NSAID use, ED incidence was 97 cases per 1,000 in those using and 52 in men who did not use NSAIDs. Compared with men who did not use NSAIDs and were free from arthritis, the relative risk of ED after controlling for the effects of age, smoking, and other medical conditions and medications was higher in men who used NSAIDs but were free of arthritis (IDR 2.0, 95% CI 1.2-3.5) and in those who used NSAIDs and had arthritis (IDR 1.9, 95% CI 1.2-3.1). The relative risk was only somewhat higher in men who had arthritis but did not use NSAIDs (IDR 1.3, 95% CI 0.9-1.8). CONCLUSIONS: The use of nonsteroidal anti-inflammatory drugs increases the risk of ED and the effect is independent of indication.

Aged↗

PubMed2005

Treatment for erectile dysfunction based on patient-reported outcomes: to every man the PDE5 inhibitor that he finds superior.

Erectile dysfunction (ED) is a common medical condition linked both to aging and to many medical conditions such as diabetes mellitus and cardiovascular disease. Although a common condition, treatment for ED has in the past been conducted by a few specialists, mostly urologists and sex therapists. The revolutionary introduction of oral therapy, and the massive amount of research into sexual dysfunction that followed, has led to paradigm shift in the treatment of ED. This is no longer something done by a few for a few; it involves all disciplines of medicine and more patients are being treated by a greater number of physicians. Several medications administered by different routes are available for treating ED but oral pharmacotherapy represents the first-line option. Phosphodiesterase (PDE) type 5 inhibitors are the most widely prescribed oral agents and they have a satisfactory efficacy-safety profile in patients of all categories. An alternative for men who do not respond to PDE5 inhibitors is intracavernosal injection therapy with alprostadil, a prostaglandin analogue. Other alternatives include sublingual apomorphine and intraurethral alprostadil. Both agents have a less satisfactory efficacy profile than PDE5 inhibitors and a low compliance rate. The aim of ED treatment is to restore an erection satisfactory for the sexual needs of the patient. Thus, the patient-reported outcome is the gold standard in efficacy evaluation. There are now three PDE inhibitors available, all with satisfactory efficacy-safety profiles, but with different pharmacokinetic properties. The availability of three different agents has initiated studies aiming to evaluate them regarding patient preference. However, the results are rather conflicting with some studies suggesting that tadalafil has the best patient preference, while others fail to demonstrate a clinically significant difference between the three agents. However, there is a tendency for younger men to choose tadalafil because it gives them a broader window of opportunity, while older men tend to prefer vardenafil or sildenafil. These data could be used when making a decision on which PDE5 inhibitor to prescribe, although another option is to let the patient try all three available agents and make his own choice.

Clinical Trials as Topic↗

PubMed1999

Insights into the management of erectile dysfunction: Part I.

It is estimated that as many as 30 million men in the United States suffer from erectile dysfunction (ED). Because ED is so widespread, especially among the older population, it is imperative that this disorder be recognized as an important and manageable health problem.

Erectile Dysfunction↗

PubMed2001

[Erectile dysfunction: prevalence and effect on the quality of life; Boxmeer study].

OBJECTIVE: To assess the prevalence of erectile dysfunction (ED), and its influence on both the quality of life, and health care seeking behaviour. METHOD: An age-stratified random sample was drawn from men aged 40-79 years in Boxmeer, the Netherlands (n = 1771), together with their partners. A questionnaire was mailed to the study population to collect data on ED, and the quality of life, both general and disorder related. The prevalence of ED was measured with the direct question 'Do you have problems getting an erection?'. The influence of ED on sexual function was measured with the Dutch version of the Sexual Function Inventory questionnaire. RESULTS: Seventy percent of all men (n = 1233) and 73% of their partners (n = 1071) responded to the questionnaire. The prevalence of ED increased with age class. To the question regarding problems to get an erection, 13% (95% confidence interval: 11-15%) of all men answered affirmatively (40-49 years: 6%; 50-59: 9%; 60-69: 22%; 70-79: 38%). All men aged 40-49 years of age with ED and 16% of men aged 70-79 with ED considered their ED as bothersome. Amongst 40 to 49 year old men with ED, 64% considered their ED as a big or rather a big problem. Amongst older men this percentage was much smaller: 50-59 years: 38%; 60-69: 37%, and 70-79: 27%. Thirty-four percent of all men with ED and 16% of their spouses were dissatisfied with their sex life. Twenty-five percent of men with ED consulted a doctor, with a mean delay of 13 months. ED bore a strong correlation with the general quality of life and comorbidity. CONCLUSION: ED was a common disorder within the population. Its prevalence was higher among older age groups, but they regarded ED as less of a problem than the younger age groups. Only a quarter of all men with ED consulted a physician.

Adult↗

PubMed2005

Vardenafil improves satisfaction rates, depressive symptomatology, and self-confidence in a broad population of men with erectile dysfunction.

INTRODUCTION: Vardenafil is a potent and selective phosphodiesterase 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction (ED). Fixed-dose and flexible-dose studies have previously established the efficacy and tolerability of vardenafil. AIM: To assess, besides the usual measures of efficacy, the quality of erection, satisfaction with the sexual experience, symptoms of depression, and overall confidence. METHODS: This 12-week double-blind, placebo-controlled flexible-dose study assessed patients from the general ED population. Patients underwent a 4-week treatment-free period before randomization to vardenafil or matching placebo. Initial dosage was vardenafil 10 mg for 4 weeks. At 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose switching was also optional for the last 4 weeks. This paper describes per-patient success in satisfaction with hardness of erection, satisfaction with overall sexual experience, effect on overall self-confidence, and an assessment of symptoms of depression using the Center for Epidemiologic Studies Depression Scale. RESULTS: Mean per-patient satisfaction rates with erection hardness increased after vardenafil treatment to 43%, 59%, and 63% at weeks 4, 8, and 12, respectively, compared to placebo with 10%, 21%, and 23% (all P < 0.005 vs. placebo). Vardenafil also improved mean per-patient overall satisfaction 50-65% over the 4-12 week study period compared with 17-28% for placebo (P < 0.005). Symptoms of depression were statistically significantly reduced compared to placebo (P = 0.02); the effect was observed particularly in patients who were depressed at baseline (P = 0.01). Significantly more patients in the vardenafil treatment group reported improved self-confidence than those who received placebo (P < 0.005). CONCLUSIONS: A flexible-dose regimen of vardenafil improved satisfaction rates, symptoms of depression, and self-confidence, providing patients with an effective ED therapy that contributes to overall improvements in sexual function and confidence.

Analysis of Variance↗