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.     

A double-blind,randomised- placebo,controlled, parallel group,multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea

The efficacy and safety of sildenafil was evaluated in a randomiSed, double-blind, placebo-controlled, flexible-dose study in Korean men aged 28-78 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months duration. A total of 133 patients were randomised at six centres in Korea to receive either sildenafil (50 mg initially, increased if necessary to l00 mg or decreased to 25 mg depending on efficacy and tolerance) (n=66) or matching placebo (n=67) taken on an 'as needed' basis l h prior to anticipated sexual activity for a period of 8 weeks. At the end of this time, 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 International Index of Erectile Function (IIEF) 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 56.1% of patients receiving sildenafil and 20.9% receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache and abnormalities in colour vision (31.8, 22.7 and 6.1% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western populations.     

Erectile dysfunction and the effects of sildenafil treatment in patients on haemodialysis and continuous ambulatory peritoneal dialysis.

BACKGROUND: Sexual dysfunction, including erectile dysfunction, is common in patients with uraemia. Despite successful treatment of male sexual dysfunction with sildenafil in non-uraemic population, its efficacy in dialysis patients is unknown. PATIENTS AND METHODS: In this study, 35 male HD patients (mean age 48+/-12 years) and 15 male CAPD patients (mean age 44+/-12 years) were included. In the baseline period, haemoglobin, serum urea, and albumin, Kt/V, several hormonal parameters, Beck depression scale, and penile Doppler blood flow, (peak systolic velocity after intracavernous papaverine administration) were measured. The international index of erectile function (IIEF) form was used to evaluate erectile dysfunction. Sildenafil was given to patients with erectile dysfunction at a dose of 50-100 mg/day twice a week. RESULTS: The percentage of erectile dysfunction was similar between patients on HD (71%) and those on CAPD (80%). Patients with erectile dysfunction were significantly older and had lower free-testosterone serum levels and penile blood flow than those without. In linear regression analysis for baseline IIEF score, penile blood flow was the only independent variable associated with erectile dysfunction. IIEF score increased to a similar extent after sildenafil treatment in both HD patients (from 8.10+/-5.54 to 21.70+/-9.61, P<0.001) and CAPD patients (from 9.90+/-3.87 to 21.60+/-10.18, P=0.011). Changes in IIEF scores after sildenafil treatment were associated with baseline penile blood flow as an independent variable by linear regression analysis. Adverse events observed during sildenafil treatment were dyspepsia in two patients and headache in one patient. CONCLUSION: The rate of erectile dysfunction is high in dialysis patients. Penile blood flow is the most important factor for predicting both the development of erectile dysfunction and the response to sildenafil therapy in such patients. Oral sildenafil is an effective, reliable, well-tolerated treatment for uraemic patients with erectile dysfunction.     

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.     

Sildenafil citrate (Viagra) for the treatment of erectile dysfunction in Nigerian men

Fifty-eight Nigerian outpatients with documented erectile dysfunction (ED) received open-label sildenafil citrate (Viagra) for 8 weeks. The 50-mg starting dose could be adjusted to 100 or 25 mg based on response and tolerability. The International Index of Erectile Function (IIEF) Questionnaire, a global efficacy question, and intercourse data recorded in a patient event log were used to assess efficacy. Frequency of penetration and maintained erection were both significantly enhanced (P<0.0001); 95% of patients reported improved erections and 81% of all attempts at intercourse were successful. Orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction also improved significantly (P&<0.0001). The most frequent adverse events (all-cause) were headache (17%) and myalgia (3%); only one patient discontinued treatment because of headache, which was considered unrelated to sildenafil. Oral sildenafil significantly improved erectile function and was well tolerated in this trial of Nigerian men suffering from ED. Our results are consistent with reports from other countries.     

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.     

Combined oral therapy with sildenafil and doxazosin for the treatment of non-organic erectile dysfunction refractory to sildenafil monotherapy

The purpose of this work was to investigate the efficacy and safety of sildenafil in combination with doxazosin for the treatment of non-organic erectile dysfunction in patients who did not respond to sildenafil. We enrolled 28 patients with non-organic erectile dysfunction, for whom 3 months of sildenafil monotherapy had failed. They were divided in two random and homogeneous groups: 14 were treated with doxazosin (4 mg daily) and sildenafil (100 mg 1 h before sexual intercourse); the other 14 patients received sildenafil and placebo. The results were assessed by means of the IIEF questionnaire before the beginning of the study, after 30 days of therapy and after 60 days. Of the 14 patients treated with doxazosin and sildenafil, 11 (78.6%) showed a statistically significant increase of IIEF; in the placebo group, only one patient (7.1%) recorded a significant IIEF increase. The differences observed in the two groups were statistically very significant (P=0.0016). Blood pressure did not show significant alterations. Side effects were minimal and even present during sildenafil monotherapy. The combination therapy with sildenafil and doxazosin resulted in the safe and effective treatment of men with non-organic erectile dysfunction for whom sildenafil alone had failed.     

The utility of sildenafil citrate for infertile men with sexual dysfunction: a pilot study

OBJECTIVE: To investigate the use the sildenafil citrate, recognized as a first-line therapy for men with erectile dysfunction (ED), and which is safe and effective in men with various causes and severity of ED, including psychogenic ED, in a population of infertile men with sexual dysfunction. PATIENTS AND METHODS: Infertility is a major source of life stress and might be associated with sexual dysfunction through the erosion of self-esteem and self-confidence, and in stimulating discord in a relationship. Men presenting for evaluation of fertility who on questioning by the physician reported the recent onset of sexual dysfunction, had a history taken, a physical examination, hormonal profile, and completed the International Index of Erectile Function (IIEF), a validated inventory for assessing sexual dysfunction. Thirty men with a score of <26 on the erectile function domain of the IIEF, or who complained of new onset rapid or delayed ejaculation, were treated with sildenafil with no randomization or placebo control. The evaluation was repeated and the IIEF completed again > or =3 months after starting treatment. RESULTS: For men complaining of ED, subjective erectile rigidity, duration of erection, and the percentage of successful penetration attempts significantly improved with sildenafil. The mean (sd) IIEF domain scores for erection and satisfaction, at 18 (4) vs 27 (3), and 12 (2) vs 16 (3) (both P = 0.01), and orgasm, at 4 (1) vs 6 (3) (P = 0.001), respectively, significantly improved after treatment. In patients with ejaculatory dysfunction, the function improved in 64% after sildenafil therapy. CONCLUSIONS: We identified the nature of sexual dysfunction associated with male-factor infertility, and showed the efficacy of sildenafil therapy in men with this condition.     

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 sildenafil for treating erectile dysfunction in patients on dialysis

OBJECTIVE: To assess the efficacy of sildenafil for erectile dysfunction (ED) in patients on haemodialysis (HD) or peritoneal dialysis (PD), as men with end-stage renal disease (ESRD) often have sexual dysfunction (up to 82% among those on chronic dialysis). PATIENTS AND METHODS: Forty-one patients with ED and in ESRD participated in an open-label prospective study. Thirty patients on HD and 11 on PD were asked to complete the International Index of Erectile Function (IIEF) and Fugl-Meyer life-satisfaction scale before and after sildenafil treatment. A total score in the erectile function domain of < or = 25 was accepted as indicating ED. All patients were started on a 25-mg dose, which was increased to 50 mg if there was no response after two trials. In addition, the overall efficacy question was used to evaluate satisfaction, and patients reported any side-effects during treatment. RESULTS: The erectile function and intercourse satisfaction domains improved significantly in both groups (P < 0.01). After sildenafil treatment, two-thirds of those on HD (20/30) and nine of the 11 on PD recovered their erectile function. The pretreatment scores on the IIEF and four domains (except sexual desire) of those responding were significantly higher than in those not responding (P < 0.05). The satisfaction rate on the overall efficacy question was 80% and 82% for the HD and PD groups, respectively. At least one side-effect was seen in 17 patients (43%); one had severe hypotension in the PD group. Overall, mild headache (seven patients, 18%) and flushing (12, 30%) were reported most often. CONCLUSIONS: Sildenafil is a safe and satisfactory drug for improving erectile function in patients with ESRD. Patients were satisfied whether treated by HD or PD. Pretreatment scores on the IIEF may be useful for predicting the success of treatment.     

SILDENAFIL CITRATE AFTER RADICAL RETROPUBIC PROSTATECTOMY

PURPOSE: Erectile dysfunction continues to be a significant problem for men after radical retropubic prostatectomy despite nerve sparing techniques. Sildenafil citrate (Viagra) has proved effective for erectile dysfunction in many men. We determine the efficacy of sildenafil in men with erectile dysfunction after radical retropubic prostatectomy and examine variables that may impact the response to treatment. MATERIALS AND METHODS: A total of 84 men were prescribed sildenafil after radical retropubic prostatectomy and asked to complete a series of questionnaires, including the International Index of Erectile Function (IIEF), on erectile function before and after sildenafil administration. The importance of factors, such as patient age, time since surgery, degree of cavernous nerve sparing, preoperative prostate specific antigen, Gleason score, clinical and pathological stage, and baseline postoperative erectile function, was examined. RESULTS: Of the 84 patients 45 (53%) had improved erections and 34 (40%) had improved ability for intercourse while taking sildenafil. Mean IIEF score for the erectile function domain increased from 9 to 14 (p <0.001). Orgasmic function (p = 0.004) and intercourse satisfaction (p = 0.009) also significantly improved. The degree of nerve sparing and baseline postoperative erectile dysfunction had a significant impact on the ability of sildenafil to improve erectile function (p = 0.010 and p <0.001, respectively) and total IIEF questionnaire responses (p = 0.031 and p <0.001, respectively). Age and pathological stage also appeared to have a significant effect. CONCLUSIONS: Sildenafil improved erectile function and the ability to have intercourse in more than half of men after radical retropubic prostatectomy. Baseline postoperative erectile function, which is dependent on the degree of nerve sparing technique, significantly impacts the likelihood that patients will respond to sildenafil.     

Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone

PURPOSE: We compare the efficacy of testosterone gel (T-gel) versus placebo as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. MATERIALS AND METHODS: A randomized, placebo controlled, double-blind, parallel group, multicenter study was performed. A total of 75 hypogonadal men (18 to 80 years old, morning serum total testosterone 400 ng/dl or less) with confirmed lack of response to sildenafil monotherapy were randomized (1:1) to receive a daily dose of 1% T-gel or 5 gm placebo gel as adjunctive therapy to 100 mg sildenafil during a 12-week period. Subjects were evaluated for sexual function, primarily based on the International Index of Erectile Function (IIEF), quality of life and serum testosterone levels at baseline and weeks 4, 8 and 12. RESULTS: Testosterone treated subjects had greater improvement in erectile function compared to those who received placebo, reaching statistical significance at week 4 (4.4 vs 2.1, p = 0.029, 95.1% CI 0.3, 4.7). Similar trends were observed for improvements in orgasmic function, overall satisfaction, total IIEF score and percentage of IIEF responders. T-gel significantly (p < or =0.004) increased total and free testosterone levels throughout the study, although no significant correlations were made between testosterone levels and the IIEF at end point. CONCLUSIONS: T-gel taken with sildenafil may be beneficial in improving erectile function in hypogonadal men with erectile dysfunction who are unresponsive to sildenafil alone.     

Safety and efficacy of sildenafil in postmenopausal women with sexual dysfunction

OBJECTIVES: Sildenafil has been demonstrated to be safe and effective in the treatment of men with erectile dysfunction. The role of sildenafil in treating women with sexual dysfunction has heretofore not been reported. The purpose of this preliminary study was to ascertain the response of postmenopausal women with self-described sexual dysfunction treated with sildenafil for 3 months. METHODS: Thirty-three consecutive postmenopausal women with sexual dysfunction based on history were entered in this open-label, nonrandomized study. All patients received 50 mg of sildenafil. Efficacy was assessed at weeks 4, 8, and 12 using a newly developed 9-item, self-administered Index of Female Sexual Function (IFSF) and a global efficacy question ([GEQ] Did treatment improve your sexual function?). The IFSF quantifies the domains of desire, quality of sexual intercourse, overall satisfaction with sexual function, orgasm, lubrication, and clitoral sensation. RESULTS: Of the group, 30 women (91 %) completed the study and were available for follow-up at 3 months. Mean baseline IFSF score before therapy was 24.8+/-9.8. Mean usage of sildenafil was 3.1+/-1.4 times per week for the duration of the study. The IFSF score improved to 29.5+/-7.6, 30.3+/-8.5, and 31.4+/-10.4 at 4, 8, and 12 weeks, respectively (P = 0.25). Mean scores for questions 2 (lubrication), 8 (orgasm), and 9 (clitoral sensation) improved by 23.2%, 7.4%, and 31.3%, respectively, at 12 weeks. Seven women (21%) noted improvement on the GEQ. Overall, only 6 (18.1%) of 33 patients had a significant (more than 60% improvement in IFSF score) therapeutic response. Clitoral discomfort and "hypersensitivity" occurred in 7 women (21%), 3 of whom withdrew from the study. Other side effects, which did not result in withdrawal from the study, included headache (n = 5), dizziness (n = 4) and dyspepsia (n = 3). CONCLUSIONS: The data suggest that sildenafil is well tolerated in postmenopausal women with sexual dysfunction. Overall sexual function did not improve significantly, although there were changes in vaginal lubrication and clitoral sensitivity. The role of sildenafil in treating sexual dysfunction in various cohorts of women remains to be determined.     

Combined use of androgen and sildenafil for hypogonadal patients unresponsive to sildenafil alone

To investigate the therapeutic effect of androgen on hypogonadal patients unresponsive to sildenafil alone. In total, 32 hypogonadal patients with erectile dysfunction (ED), initially had an inadequate response to sildenafil (100 mg). Oral testosterone undecanoate (Restandol, 80 mg, bid or tid) alone was supplied for 2 months, and if patients could not achieve a satisfactory erection, combined use of testosterone and sildenafil was continued thereafter. Total testosterone (TT), free testosterone (FT), and the parameters of the International Index of Erectile Function (IIEF), International Prostate Symptom Score (IPSS), and uroflow rate (UFR) were assessed. Eleven patients (34.3%) achieved satisfactory erectile function after testosterone replacement only. Another 12 (37.5%) patients experienced satisfactory intercourse after combined therapy. Serum TT and FT levels significantly increased after the use of testosterone alone (415+/-163 vs 220+/-101 ng/dl, P<0.01; 10.4+/-4.6 vs 5.1+/-1.9 ng/dl; P<0.01, respectively) and the combined use of testosterone and sildenafil (498+/-178 vs 220+/-101 ng/dl, P<0.01; 11.7+/-4.6 vs 5.1+/-1.9 ng/dl, P<0.001, respectively); as did the IIEF score (14.8+/-6.8 vs 12.6+/-7.5, P<0.01, 17.5+/-5.2 vs 12.6+/-7.5, P<0.001, respectively). However, no statistical differences were demonstrated for IPSS or UFR. In conclusions, one-third of hypogonadal patients with ED who failed to respond to sildenafil, responded to testosterone alone, another third responded to sildenafil again after normalization of testosterone. So, in hypogonadal patients with ED, androgen supplementation is first-line therapy. If patients are unresponsive to androgen alone or sildenafil alone, combined use may improve erectile function and enhance the therapeutic effect of PDE-5 inhibitors.     

Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian men

AIM: Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on-demand tadalafil for the treatment of ED in South-East Asian men. METHODS: This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo (n = 122), tadalafil 10 mg (n = 120), or tadalafil 20 mg (n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). RESULTS: Men from China, Singapore, and the Philippines participated in this trial (n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes (P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group (P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group (P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. CONCLUSIONS: Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED.     

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.     

Analysis of the efficacy and safety of sildenafil citrate in the geriatric population

OBJECTIVE: To define the efficacy and tolerability of sildenafil in elderly men, as epidemiological data show an increasing life-expectancy of the population, and age is not only correlated with increasing morbidity but also an increase in the prevalence of erectile dysfunction (ED), for which sildenafil, available for >8 years, is effective and safe across a wide variety of medical comorbidities, severity and causes of ED. PATIENTS AND METHODS: A database was generated from all sildenafil users in one sexual medicine practice, and data were extracted for men aged >60 years. The database included data on patient demographics, comorbidities, International Index of Erectile Function (IIEF) scores and adverse events (AEs). The patients were subdivided into those aged 60-69 (group 1), 70-79 (group 2), and > or = 80 years (group 3). Analysis of variance was used to assess differences among the three groups for several variables of demographics and erectile response. RESULTS: In all, 167 patients were analysed; there were no significant differences in the duration of ED (5 +/- 3 years) or presence of comorbidities among the three groups. With a mean of two risk factors, the overall incidence of comorbidities was hypertension in 37%, dyslipidaemia in 28%, diabetes in 26%, coronary artery disease in 18% and lower urinary tract symptoms in 46%. The efficacy data showed that overall, 54% of men responded to sildenafil, with a mean increase in IIEF EF domain score of 5.7. Within the three groups there was a significant age-related decrease in response rate and IIEF EF domain score with age. However, there was no difference in AE incidence among the three groups, with an overall profile of 18% headache, 8% flushing, 8% dyspepsia, 5% nasal congestion and 2% visual changes. No overt cardiovascular events were reported. CONCLUSIONS: From these data, sildenafil is an effective agent in elderly men, but had a lower efficacy rate with increasing age, especially in men aged >80 years. The incidence of side-effects was similar to that in the general population taking sildenafil, with no difference in AEs among the different age groups.     

The efficacy of sildenafil in different etiologies of erectile dysfunction

PURPOSE: The aim of this study was to evaluate the efficacy of sildenafil and success of treatment in particular etiological causes in erectile dysfunction lasting more than 3 months. MATERIAL AND METHODS: A total of 141 patients between 27 and 78 years old without any cardiac compromise, despite controversial, which precludes sildenafil (Viagra) treatment, were included in this study. All patients had only International Index of Erectile Capacity Form (IIEF) for pre-treatment evaluation and 50 mg sildenafil was started. Patients were assessed monthly for 6 months thereafter. Erectile capacity changes were questioned by IIEF on each follow-up and 100 mg sildenafil was given in patients without a response and monthly follow-up was scheduled. All patients had SMA-12, hormonal analyses and penile colour Doppler ultrasonography during the treatment course. The difference between IIEF score of each patient was displayed by Paired-t test and p-values less than 0.05 was applied as significant. RESULTS: The average beginning IIEF score of 141 patients was 11.80 +/- 0.47 [6-22], and increased to 20.70 +/- 0.62 [6-30] after a month of 50 mg sildenafil treatment. The mean increase was 75.4% and found to be significant (p = 0.000, p < 0.05). The average IIEF scores were recorded as 22.57 +/- 0.69 after 3, and 22.12 +/- 0.24 after 6 months. There was no difference between these values and 2nd month controls (P3 month = 0.5675, P6 month = 0.6138, p > 0.05). A positive response was recorded in 102 patients (72.3%) and 39 (27.7%) patients were unresponsive. Doubled doses of sildenafil (100 mg) was effective in additional 17 patients. After overall treatment, 119 (84.4%) patients had benefit from sildenafil. Penile Doppler ultrasonography displayed arterial insufficiency in 79 (56.03%), veno-occlusive dysfunction in 14 (9.93%), mixt vascular pathology in 14 (9.93%) patients. Normal ultrasonographic findings in 32 patients (22.7%) were classified as psychogenic dysfunction. Among the organic causes, sildenafil was found to be most effective in arterial insufficiency group. CONCLUSION: Sildenafil is a successful management modality in erectile dysfunction with minimal pre-treatment evaluation. As far as etiological causes concerned, sildenafil was found to be most effective in arterial insufficiency group and psychogenic group. The efficacy of sildenafil treatment has not been changed with the treatment time, since IIEF scores were stable during follow-up controls.     

High dose sildenafil citrate as a salvage therapy for severe erectile dysfunction

The objectives of this study were to evaluate the efficacy and tolerability of high dose sildenafil as a salvage therapy for patients refractory to the maximum recommended dose of sildenafil. Fifty four fully evaluated patients with chronic erectile failure (ED) who had previously failed to respond to a home trial of sildenafil (100 mg) with erections suitable for sexual intercourse were studied. Each man was treated at home with sildenafil at escalating doses of up to 200 mg until either maximal response or intolerable adverse effects occurred. Erectile function was quantified using the erectile function domain of the International Index of Erectile Function (IIEF) before treatment, with sildenafil 100 mg and with maximal dose of sildenafil and a global efficacy question after 4 weeks of treatment.The mean age of the study group was 59.6+/-11.2 y. 13/54 (24%) had arteriogenic ED, 16/54 (30%) had mixed vasculogenic ED, 9/54 (17%) had cavernosal veno-occlusive dysfunction, 11/54 (20%) had post radical retropubic prostatectomy ED and 5/54 (9%) had psychogenic ED. 13/54 (24.1%) responded to sildenafil at a median maximal dose of 200 mg, 4/13 required 150 mg and 9/13 required 200 mg. 41/54 (76%) failed to respond to sildenafil. Mean IIEF question 3 and 4 scores were 1.5 and 1.4 at baseline, 2.2 and 1.9 with sildenafil 100 mg, 2.8 and 2.5 with sildenafil 150 mg and 3.0 and 2.9 with sildenafil 200 mg, respectively. After 4 weeks, treatment was regarded as having improved their erections by 37%, 46.3% and 68% of patients with sildenafil 100 mg, 150 mg and 200 mg, respectively. 34/54 (63%) reported adverse effects with maximal dose sildenafil comprising headache (19), facial flushing (32), dyspepsia (14), nasal congestion (11), dizziness (5) and visual disturbances (5). 4/13 (31%) responders refused to continue treatment due to adverse effects.In conclusion, sildenafil at doses of up to 200 mg is an effective salvage therapy for 24.1% of previous sildenafil non-responders but is limited by a significantly higher incidence of adverse effects and a 31% treatment discontinuation rate.     

Erectile dysfunction in men with obstructive sleep apnea syndrome: a randomized study of the efficacy of sildenafil and continuous positive airway pressure

The aim of this study was to compare the efficacy of sildenafil and continuous positive airway pressure (CPAP) in men with erectile dysfunction (ED) and obstructive sleep apnea syndrome (OSAS). In all, 30 men were randomly treated for 12 weeks either with sildenafil 100 mg before intercourse (15 men) or CPAP during night time sleep (15 men). Under sildenafil, 97/180 (53.9%) of attempted intercourses were successful compared to 33/138 (23.9%) under CPAP. The mean IIEF (erectile function domain score) was 12.9 and 9.3 after sildenafil and CPAP treatment, respectively (P=0.007), compared to 7.9 and 7 at baseline. In all, 53.3% of patients were satisfied with sildenafil and 20% with CPAP for ED treatment (P=0.058). Although sildenafil was superior to CPAP, comorbidities and OSAS per se possibly resulted in a lower effectiveness of sildenafil compared to that in the general population of ED men. While about half of the patients were not satisfied even with the more effective treatment, we conclude that a combination of the two therapeutic tools or a different therapeutic mode should be studied further.