Long-term efficacy and safety of oral Viagra (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal

The long-term efficacy and safety of oral Viagra (sildenafil citrate), a selective phosphodiesterase 5 inhibitor, and the effect of withdrawing treatment were evaluated in men with erectile dysfunction (ED). In 233 men with ED of psychogenic or mixed organic/psychogenic aetiology, 16 weeks of open-label, flexible-dose sildenafil treatment (10-100 mg) was followed by eight weeks of double-blind, fixed-dose, randomised withdrawal to placebo or continued treatment with sildenafil. Sildenafil was taken as needed (not more than once daily) approximately 1 h prior to sexual activity. The main outcome measures were a global efficacy question, a sexual function questionnaire, an event log of erections, and adverse event recording. In the open-label phase, 200 of 216 patients (93%) reported improved erections with sildenafil; 28 patients (12%) discontinued treatment. In the double-blind phase, the significant improvements in the frequency and duration of erections were maintained in the sildenafil group but returned to pre-treatment values in patients on placebo (P values < 0.0001 versus placebo). The most frequent adverse events in the sildenafil group during the double-blind phase were flushing (7%), headache (6%), and dyspepsia (5%). Of the 192 patients enrolled in the 1-y extension, 90% completed the study; only two patients (1%) were withdrawn due to lack of efficacy. In men with ED of psychogenic or mixed aetiology, oral sildenafil is effective and well-tolerated both at the initiation of therapy and during long-term treatment. For most patients, sildenafil treatment must be continued for improvements in erectile function to be maintained.     

Efficacy and safety of fixed-dose oral sildenafil in the treatment of erectile dysfunction of various etiologies

OBJECTIVES: To determine the efficacy and safety of fixed-dose oral sildenafil in patients with erectile dysfunction (ED) of various etiologies. METHODS: In a 12-week, double-blind, randomized, placebo-controlled, fixed-dose study, 514 men (mean age 56 years) with ED were randomized to receive 25, 50, or 100 mg of sildenafil or placebo. The primary etiology of ED was determined to be organic in 32% of men, psychogenic in 25%, or mixed in 43%. Sildenafil or placebo was taken in the home setting approximately 1 hour before sexual activity, not more than once daily. Efficacy was determined by responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) of the 15-item International Index of Erectile Function (IIEF). Other measures of efficacy included the five sexual function domains of the IIEF, a global efficacy question, event log data, and a partner questionnaire. RESULTS: Sildenafil significantly increased patients' ability to achieve and maintain erections (P <0.0001), with efficacy increasing with increasing dose. Significant improvements were also observed in the IIEF domains for erectile function, orgasmic function, intercourse satisfaction, and overall sexual satisfaction (P <0.0001). The proportion of subjects who felt that treatment with sildenafil improved their erections was significantly greater (67% to 86%) than that with placebo treatment (24%, P <0.0001). The proportion of successful attempts at sexual intercourse also increased significantly with sildenafil treatment (P <0.001). Partner responses corroborated patient reports. Sildenafil was well tolerated at the three doses studied. CONCLUSIONS: Oral sildenafil is an effective, well-tolerated treatment for ED of various etiologies.     

Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction in Brazilian and Mexican men

A 12-week, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of flexible-dose sildenafil citrate (Viagra) treatment (25, 50 or 100 mg) in Brazilian and Mexican men with erectile dysfunction (ED) of broad-spectrum etiology. Efficacy was assessed on the basis of responses to the 15-item International Index of Erectile Function (IIEF) questionnaire, completed at baseline and after 12 weeks of treatment. At end point, mean scores for all IIEF domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) were significantly (P<0.0001) higher in the sildenafil group (n=109) than in the placebo group (n=105). These findings confirm the significant increases in frequency of penetration and frequency of maintained erections reported previously. Sildenafil treatment was well tolerated. The most common adverse events were headache and flushing. In conclusion, sildenafil is a well-tolerated and effective treatment for ED of broad-spectrum etiology in Latin American men.     

Efficacy and safety of oral sildenafil citrate (Viagra) in the treatment of male erectile dysfunction in Colombia,Ecuador, and Venezuela: a double-blind,multicenter, placebo-controlled study

The objective of this work was to assess the efficacy and safety of sildenafil in patients with erectile dysfunction (ED) from Colombia, Ecuador, and Venezuela. One hundred and fifty-eight outpatients with ED participated in a double-blind, flexible-dose, randomized-controlled trial. Efficacy measures included question 3 (achieving an erection) and question 4 (maintaining an erection) from the International Index of Erectile Function (IIEF), the five functional domains of the IIEF, a global efficacy question, and patient event log. Sildenafil increased patients' ability to achieve/maintain erections (P<0.01). Seventy-seven per cent of sildenafil- vs 46% of placebo-treated patients reported improved erections (P<0.001). Sixty-five percent and 35% of intercourse attempts were successful among sildenafil and placebo patients, respectively (P<0.05). Sildenafil patients showed significant improvements in three of the five IIEF functional domains (P<0.05). Adverse events were reported for 51% and 33% of sildenafil and placebo patients, respectively. It can be concluded that sildenafil is an effective, well-tolerated treatment for ED in patients from Latin America.     

A two-part pilot study of sildenafil (VIAGRA) in men with erectile dysfunction caused by spinal cord injury

STUDY DESIGN: This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildenafil 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days. OBJECTIVES: To assay the efficacy and safety of sildenafil 50 mg and placebo. SETTING: Clinic- and home-based assessments in the United Kingdom. METHODS: A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global efficacy. questionniare, diary). RESULTS: In Part I, 17/26 (65%) subjects had erections of >60% rigidity at the penile base (median duration 3.5 min) after sildenafil compared with 2/26 (8%) (median duration 0 min) alter placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildenafil and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P<0.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P<0.02). An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration (P = 0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildenafil due to adverse events. CONCLUSION: Sildenafil is an effective, well-tolerated oral treatment for ED in SCI subjects.     

Correlations between increased erection hardness and improvements in emotional well-being and satisfaction outcomes in men treated with sildenafil citrate for erectile dysfunction

To explore relationships between erection hardness and other outcomes in men with erectile dysfunction (ED). Pooled analyses were conducted on 27 randomized, double-blind, placebo-controlled trials and six open-label trials from the worldwide sildenafil database. Outcomes included erection hardness graded subjectively, hardness and sexual satisfaction questions from the International Index of Erectile Function, general and sexually-specific emotional well-being from the self-esteem and relationship questionnaire, and the erectile dysfunction inventory of treatment satisfaction. Hardness outcomes improved (with a possible dose-response relationship for the achievement of fully hard and rigid erections) and correlated positively with the other outcomes. Sildenafil 100 mg produced optimal erection hardness (fully hard and rigid erections) in a substantial proportion of men with ED. Because optimal erection hardness correlated positively with some emotional well-being and satisfaction outcomes, sildenafil 100 mg may be the most appropriate dosage for treatment of ED for most men.     

Comparison of the effect of sildenafil and apomorphine SL on nocturnal erections in healthy volunteers: a placebo-controlled study

OBJECTIVE: To compare the effects of sildenafil and sublingual (sl) apomorphine on nocturnal erections. METHODS: In a prospective, single-blinded, placebo-controlled at-home study we compared the effect of apomorphine sl and sildenafil on sleep-related erectile activity in 30 healthy potent volunteers (mean age, 26.4 years; range, 23-35 years; Erectile Function domain of the International Index of Erectile Function > or =26), not reporting any subjective sleep abnormality during 4 consecutive nights with rigidity monitoring (NPTR) with the RigiScantrade mark device. After the first night of adaptation, they were randomized to receive placebo or apomorphine sl 2mg or sildenafil 50mg taken at bedtime during the following 3 consecutive nights. RESULTS: Sildenafil increased the mean+/-SE number of erections, overall length of erectile events, and the time of erections with rigidity >60% at both tip and base, as compared to placebo. The same parameters were reduced after administration of apomorphine sl. Similar findings were observed with regards to Rigidity Activity Units and Tumescence Activity Units. CONCLUSIONS: Our results confirm that sildenafil taken at bedtime might increase nocturnal erectile activity also in young potent men as compared to placebo. Apomorphine sl taken at bedtime seems to have the opposite effect.     

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.     

Effects of sildenafil on nocturnal penile tumescence and rigidity in normal men: randomized,placebo-controlled,crossover study

We studied the effects of sildenafil on sleep-related erections in 44 adult healthy men not affected by erectile dysfunction (mean age +/- SD: 39.3 +/- 10.5 years). No subjects were administered any medication the first night, but all were randomly administered sildenafil 50 mg or placebo the second night and vice versa the third night. Sildenafil and placebo were administered 1 hour before bedtime. The following parameters of sleep-related erections, after taking sildenafil or placebo, were analyzed: total number of valid erections, total duration of rigidity more than or equal to 70% of a tightening force of 2.8 N applied by the recording device, total duration of increase in penile circumference more than or equal to 30 mm, maximum rigidity, mean of maximum rigidity, and maximum increase of tumescence. Apart from the maximum increase of tumescence, all the parameters analyzed were significantly higher after sildenafil than after placebo administration during the first 4 hours of monitoring in all subjects (n = 44) (study 1). All the parameters were significantly higher after sildenafil than after placebo administration during the whole 8 hours of monitoring in 25 of 44 subjects (study 2A) who slept at least 8 hours. Comparing both the first and the second 4 hours in the 25 of 44 subjects who slept at least 8 hours (study 2B), all the parameters were significantly higher after sildenafil than after placebo administration, apart from maximum rigidity and mean of maximum rigidity during the first 4 hours. Our data suggest that sildenafil, administered at bedtime, is efficacious in improving sleep-related erections in normal men, indirectly confirming that the nitric oxide pathway is crucial in the physiology of erections during sleep. The effect of sildenafil is prolonged up to 8-9 hours after its administration.     

Is sildenafil failure in men after radical retropubic prostatectomy (RRP) due to arterial disease? Penile duplex Doppler findings in 174 men after RRP

Sildenafil is frequently the first-line treatment for post-radical retropubic prostatectomy (RRP) erectile dysfunction (ED) with maximum treatment satisfaction rates of 43%-80%. The etiology of erectile dysfunction after RRP has been attributed to psychogenic, vascular, veno- occlusive or nerve injury causes. The purpose of this study was to gain insight into the penile duplex Doppler arterial parameters in men with ED after RRP who failed sildenafil. The purpose was to assess whether sildenafil failure after RRP is associated with underlying corporal arterial disease. A total of 174 consecutive men presenting with sildenafil refractory ED after nerve-sparing RRP underwent color duplex penile Doppler evaluation with vasoactive injection. Mean age was 59.6 y and mean time from surgery was 11.6 months. Some 81% (141/174) of the men had no pre-operative ED (PED). Significant differences in penile duplex Doppler parameters for arterial disease were seen between men with and without PED. In men without PED, 19% (27/141) manifested arterial insufficiency. However, in men with PED, 50% (16/33) demonstrated arterial disease. Nerve sparing status did not affect the presence of arterial disease. Sildenafil refractory erectile dysfunction after RRP in men without PED is not predominantly associated with penile Doppler parameters consistent with arterial insufficiency.     

Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects

OBJECTIVES: To evaluate the efficacy, safety, and tolerability of sildenafil in men with broad-spectrum erectile dysfunction (ED), with reference to age-matched healthy control subjects. METHODS: One hundred eleven patients were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, 12-week, flexible-dose study. Efficacy assessments included the International Index of Erectile Function (IIEF), a global assessment question, and patient event log data. In a separate, nontreatment study, 109 control subjects also completed the IIEF. RESULTS: Mean IIEF scores at baseline were significantly lower for patients with ED than for control subjects without a history of ED. After treatment, mean IIEF scores for patients receiving sildenafil approached values observed in control subjects and were significantly higher than mean scores for patients receiving placebo (P<0.01). Responses to the global assessment question and patient log data corroborated the IIEF results. Sildenafil was well tolerated, with no discontinuations because of adverse events. CONCLUSIONS: The results indicate that sildenafil, an effective oral therapy for the treatment of broad-spectrum ED, is associated with a near normalization of patient erectile function.     

A Placebo-Controlled,Multicenter, Randomized,Double-Blind,Flexible-Dose,Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

Background/objective: To show the efficacy, safety, and tolerability of sildenafil in men with erectile dysfunction (ED) associated with complete or incomplete spinal cord injury (SCI) and to assess its effects onquality of life (Qol) using the Life-Satisfaction Check List.

Methods: This was a placebo-controlled, multicenter, randomized, double-blind, flexible-dose, 2-way crossover study with a 2-week washout period between each phase. Patients with ED attributable to SCI(Sexual Health Inventory-Male score ≤21) received 50 to 100 mg sildenafil (n = 24) or placebo (n = 26).

Results: Compared with placebo, sildenafil produced higher levels of successful sexual stimulation,intercourse success, satisfaction with sexual life and sexual relationship, erectile function, overall sexual satisfaction, and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score, with no clinically relevant effects onvital signs. Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI, producing significant improvements, compared with placebo, in a number of measures only in patients with incomplete SCI. All patients who expressed a preference selected sildenafil over placebo, although the drug had no effect on patient Qol. Sildenafil was well tolerated, with a profile comparable to that of placebo.

Conclusions: Compared with placebo, treatment with oral sildenafil safelyand effectively improved erectile function in patients with ED attributable to SCI, especially in those with incomplete injury, and was theagent of choice in those who expressed a preference.     

A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction

OBJECTIVE: To assess the efficacy and safety of sildenafil citrate (Viagra, Pfizer Inc., USA) in a double-blind, placebo-controlled, dose-escalation study over a period of 26 weeks in men with erectile dysfunction of a broad spectrum of aetiology. PATIENTS AND METHODS: In all, 315 patients from five countries were randomized to receive treatment with placebo (156 men) or sildenafil (159 men). Significant concomitant medical conditions were hypertension (20%), a history of pelvic surgery (19%), diabetes mellitus (15%), and ischaemic heart disease (10%). Patients randomized to treatment received a starting dose of 25 mg of sildenafil or matching placebo, which could be increased to 50 mg and then to 100 mg of sildenafil, based on efficacy and tolerability. Assessments of efficacy comprised the 15-item International Index of Erectile Function (IIEF), including question three (ability to achieve an erection) and question four (ability to maintain an erection), a partner questionnaire, an overall efficacy question, and event-log data. RESULTS: After 12 weeks of treatment, 26%, 32% and 42% of patients were taking 25, 50 and 100 mg of sildenafil, respectively. A similar distribution of doses was reported after 26 weeks of treatment. Treatment with sildenafil significantly improved the patients' abilities to achieve and maintain an erection compared with treatment with placebo (P < 0.001). Scores for four of the five sexual function domains of the IIEF (erectile function, orgasmic function, intercourse satisfaction and overall satisfaction) also improved significantly (P < 0.001). There was a significant improvement in the mean score for the erectile function domain, regardless of the aetiology of erectile dysfunction (P < 0.001). After 12 weeks and 26 weeks of treatment, 82% and 79% of patients receiving sildenafil reported improved erections, compared with 24% and 23% of patients receiving placebo, respectively (P < 0.001). Treatment-related adverse events were mild to moderate and occurred in 27% of patients receiving sildenafil, compared with 8% of patients receiving placebo. CONCLUSION: Sildenafil is an effective and well-tolerated treatment for men with erectile dysfunction of a broad spectrum of aetiology.     

Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction

The aim of this study was to evaluate the efficacy and safety of oral sildenafil to treat erectile dysfunction (ED) in chronic renal failure in patients on hemodialysis (HD). A double-blind, randomized, placebo-controlled study of oral sildenafil (50 mg) administered as required in HD patients with ED was designed. Patients on HD for at least 6 mo and who had a stable relationship with a female sexual partner were included. Patients older than 70 yr with penile anatomic abnormalities, cirrhosis, diabetes, angina, severe anemia, and those who were on nitrate treatment or with a recent history of stroke or myocardial infarction were not included. The International Index of Erectile Dysfunction (IIEF) was employed to evaluate ED and treatment response. Forty-one patients were evaluated (21 received placebo, and 20 sildenafil). Baseline clinical and demographic parameters were similar in both groups. Sildenafil was associated with improvement in the score of all questions and domains of the IIEF, except those related to sexual desire. Using the erectile function domain to evaluate primary efficacy, improvement was observed in 85% of the sildenafil patients compared with 9.5% of placebo patients. Sildenafil use resulted in normal EF scores in 35% of sildenafil patients. Sildenafil was well tolerated. Headaches and flushing occurred in both groups. Dyspepsia was reported by two patients in the sildenafil group. In conclusion, oral sildenafil seems to be an effective and safe treatment for ED in selected patients with chronic renal failure on hemodialysis.     

Sildenafil citrate (Viagra) in the treatment of men with erectile dysfunction in southern Latin America: a double-blind,randomized, placebo-controlled,parallel-group,multicenter, flexible-dose escalation study

Our objectives were: (1) to determine the efficacy, safety, and tolerability of sildenafil citrate (Viagra) administered to men with broad-spectrum erectile dysfunction (ED) in southern Latin America; and (2) to correlate Rigiscan measurements assessing ED etiology with the investigator's assessment. A total of 141 men with broad-spectrum ED (mean age 57) were enrolled in a randomized, 12-week, double-blind, placebo-controlled, flexible-dose escalation study of sildenafil. After the 12-week treatment period, the mean score for the primary efficacy variables had risen significantly: for the sildenafil group, 66.2% from baseline for question 3 of the International Index of Erectile Function and 77.6% for question 4, vs 15.1% and 21.2% for the placebo group, respectively (P<0.0001). Rigiscan data confirmed investigator assessments of etiology. Headache and flushing, usually mild and transient, were the most common adverse events. Sildenafil was an effective, well-tolerated treatment for men in southern Latin America with broad-spectrum ED.     

Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial

PURPOSE: We evaluated sildenafil for erectile dysfunction and lower urinary tract symptoms in men with the 2 conditions. MATERIALS AND METHODS: This was a 12-week, double-blind, placebo controlled study of sildenafil in men 45 years or older who scored 25 or less on the erectile function domain of the International Index of Erectile Function and 12 or greater on the International Prostate Symptom Score. Men with confirmed or suspected prostate malignancy, or prostate specific antigen 10 ng/ml or more were excluded. End points were changes in International Index of Erectile Function domain scores, International Prostate Symptom Score (irritative, obstructive and quality of life), the Benign Prostatic Hyperplasia Impact Index, the Self-Esteem And Relationship questionnaire and Erectile Dysfunction Inventory of Treatment Satisfaction Index Score. RESULTS: The 189 men receiving sildenafil had significant improvements in erectile function domain score vs the 180 on placebo (9.17 vs 1.86, p<0.0001) and on all other International Index of Erectile Function domains. In men on sildenafil vs placebo significant improvements were observed in International Prostate Symptom Score (-6.32 vs -1.93, p<0.0001), Benign Prostatic Hyperplasia Impact Index (-2.0 vs -0.9, p<0.0001), mean International Prostate Symptom Score quality of life score (-0.97 vs -0.29, p<0.0001) and total Self-Esteem And Relationship questionnaire scores (24.6 vs 4.3, p<0.0001). There was no difference in urinary flow between the groups (p=0.08). Significantly more sildenafil vs placebo treated patients were satisfied with treatment (71.2 vs 41.7, p<0.0001). Sildenafil was well tolerated. CONCLUSIONS: Improved erectile dysfunction and lower urinary tract symptoms with sildenafil in men with the 2 conditions were associated with improved quality of life and treatment satisfaction. Daily dosing with sildenafil may improve lower urinary tract symptoms. However, the lack of effect on urinary flow rates may mean that a new basic pathophysiology paradigm is needed to explain the etiology of lower urinary tract symptoms.     

Role of sildenafil citrate in treatment of erectile dysfunction after radical retropubic prostatectomy

BACKGROUND: Sildenafil citrate was introduced as a treatment for erectile dysfunction in April 1998 in the United States and has been available since March 1999 in Japan. In this article, we assess the efficacy of sildenafil in the treatment of erectile dysfunction in Japanese men after radical retropubic prostatectomy for localized prostate cancer. METHODS: Of 106 men who underwent radical retropubic prostatectomy between January 1994 and March 2000, 43 were prescribed sildenafil at their request after radical retropubic prostatectomy. Medication was initiated at 25 mg, and if this was ineffective, the dose was increased to 50 mg. Of the patients, 18 underwent bilateral and 21 unilateral nerve sparing (NS) procedures, while in 4 patients, a non-NS procedure was performed. These patients were interviewed using a questionnaire about their response to sildenafil and using the 5-item International Index of Erectile Function (IIEF-5) questionnaire. RESULTS: Thirty-three of the 43 patients were eligible for evaluation of the efficacy of sildenafil and 27 completed the IIEF-5 questionnaires. Sildenafil at 50 mg had a better effect on sexual function than 25 mg in most Japanese patients. Of the 16 patients who underwent bilateral NS procedures, 10 (62.5%) had improved ability for intercourse and 3 (18.8%) had improved erections. Of the 13 patients who underwent unilateral NS procedures, 7 (53.8%) had improved ability for intercourse and 4 (30.8%) had improved erections. None of the 4 patients who underwent non-NS procedures had a positive response. Of 24 patients with positive response to sildenafil, 3 (12.5%) did not have to take sildenafil after receiving it because they did not require it for intercourse. Mean IIEF-5 score increased from 4.3 to 11.4 (P < 0.0001). Patient age, time since surgery, PSA and pathological stage did not have statistically significant effects on outcome. The most commonly cited adverse effect was headache (21%). CONCLUSION: Sildenafil is equally effective for erectile dysfunction in Japanese patients who have undergone bilateral and unilateral NS procedures, and aids recovery of natural erectile function after radical retropubic prostatectomy. However, non-NS procedure patients had no response to sildenafil. This study suggested that sildenafil is well tolerated and should be initially used for treatment of Japanese men with erectile dysfunction after radical retropubic prostatectomy.     

Impact of erectile dysfunction on confidence, self-esteem and relationship satisfaction after 9 months of sildenafil citrate treatment

PURPOSE: The first double-blind, placebo controlled trial in the United States of the Self-Esteem And Relationship questionnaire revealed that treatment with sildenafil citrate improves erectile function and measures of quality of life in men with erectile dysfunction. We investigated long-term improvement, and correlations between improved erectile function and confidence, self-esteem and sexual relationship satisfaction in men with erectile dysfunction. MATERIALS AND METHODS: This was a 36-week open label extension of the double-blind, placebo controlled trial. The blind was not broken. Patients were 18 years or older with clinically diagnosed erectile dysfunction. Erectile function was assessed using the International Index of Erectile Function. Self-esteem, confidence and relationship satisfaction were assessed using the Self-Esteem And Relationship questionnaire. Correlations were determined using Pearson's product moment coefficients. RESULTS: A total of 204 participants were enrolled in the open label extension, including 108 on placebo and 96 on sildenafil. In men who received placebo in the double-blind, placebo controlled phase mean erectile function scores and self-esteem, confidence and relationship satisfaction scores were increased significantly at week 36 of the open label extension (p < 0.0001). Men who received sildenafil in the double-blind, placebo controlled phase maintained high scores in the open label extension. Correlations between improved erectile function, and self-esteem, confidence and relationship satisfaction were strong and positive (p < 0.0001). CONCLUSIONS: Open label extension sildenafil after double-blind, placebo controlled placebo significantly improved erectile function, self-esteem, confidence and relationship satisfaction. Following an initial 12 weeks of double-blind, placebo controlled sildenafil therapy for erectile dysfunction improvements were sustained an additional 9 months. Positive correlations between erectile function, and self-esteem, confidence and relationship satisfaction suggest that improved erectile quality can improve long-term psychosocial quality of life.     

Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial

OBJECTIVE: To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil. PATIENTS AND METHODS: A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged > or = 18 years with moderate-to-severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4-week treatment-free run-in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ). RESULTS: There was significantly better EF with vardenafil than with placebo throughout the study. The least-square mean EF domain scores increased from 9.3 at baseline to 17.6 at the 'last' observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least-square mean per-patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score > or = 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase-5 inhibitor profile. CONCLUSION: Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).     

ASSESS-3: a randomised, double-blind, flexible-dose clinical trial of the efficacy and safety of oral sildenafil in the treatment of men with erectile dysfunction in Taiwan

The efficacy and safety of sildenafil were evaluated in a randomised, double-blind, placebo-controlled, flexible-dose study in Taiwanese men aged 26 to 80 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months' duration. A total of 236 patients were randomised at six medical centres in Taiwan to receive either sildenafil (50 mg initially increased if necessary to 100 mg or decreased to 25 mg depending on efficacy and toleration) (n=119) or matching placebo (n=117) taken on an 'as needed' basis 1 h prior to anticipated sexual activity for a period of 12 weeks. At the end of 12 weeks, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the IIEF (International Index of Erectile Function) scale, (2) the percentage of successful intercourse attempts; and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P<0.0001). Treatment-related adverse events occurred in 43.7% of patients receiving sildenafil and 18.8% receiving placebo. The most common adverse events with sildenafil were flushing, dizziness and headache (25.2, 6.7 and 5.9% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in the population of Taiwanese men appears similar to that reported in other studies in western populations.