Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. A dose‐escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction Efficacy and safety of sildenafil citrate in the treatment of men with mild to moderate erectile dysfunction. Clinical efficacy of sildenafil citrate based on etiology and response to prior treatment. 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 Efficacy, safety and patient acceptance of sildenafil citrate as treatment for erectile dysfunction. Efficacy and safety of sildenafil citrate (Viagra®) for the treatment of erectile dysfunction in men in Egypt and South Africa 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 Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra®) in the treatment of erectile dysfunction in Brazilian and Mexican men Evaluation of the safety and efficacy of sildenafil citrate for erectile dysfunction in men with multiple sclerosis: a double-blind, placebo controlled, randomized study. Efficacy of sildenafil citrate for the treatment of erectile dysfunction in men taking serotonin reuptake inhibitors. The efficacy of sildenafil citrate following radiation therapy for prostate cancer: temporal considerations. Sildenafil citrate and tamsulosin combination is not superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction Efficacy and safety of sildenafil citrate in men with erectile dysfunction and stable coronary artery disease. Sildenafil citrate after radical retropubic prostatectomy. Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. Sildenafil Diabetes Study Group. Long-term efficacy and safety of oral Viagra® (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal Treatment of erectile dysfunction in men with depressive symptoms: results of a placebo-controlled trial with sildenafil citrate. Treatment of erectile dysfunction with sildenafil citrate (Viagra) in parkinsonism due to Parkinson's disease or multiple system atrophy with observations on orthostatic hypotension The efficacy and safety of oral sildenafil in Thai men with erectile dysfunction: a randomized, double-blind, placebo controlled, flexible-dose study. Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects. Sildenafil citrate (Viagra) and erectile dysfunction following external beam radiotherapy for prostate cancer: a randomized, double-blind, placebo-controlled, cross-over study. Treatment of erectile dysfunction after radical prostatectomy with sildenafil citrate (Viagra).
OBJECTIVES To assess the efficacy and safety of Viagra ( sildenafil citrate ) in male out patients with erectile dysfunction and patient and partner satisfaction with treatment using the Erectile Dysfunction Inventory of Treatment Satisfaction ( EDITS ) . METHODS A total of 247 patients with erectile dysfunction of broad-spectrum etiology were treated in a r and omized , double-blind , parallel-group , multicenter study conducted at outpatient clinics . Patients receiving oral sildenafil ( 25 , 50 , and 100 mg ) were compared with patients receiving placebo during a 12-week period . The principal efficacy measures were responses to question 3 ( ability to achieve an erection ) and question 4 ( ability to maintain an erection ) on the International Index of Erectile Function and three global efficacy questions . Patient and partner satisfaction with treatment were assessed , for the first time , using the EDITS question naire . RESULTS Efficacy scores for the International Index of Erectile Function questions and the global efficacy questions were significantly higher for patients receiving sildenafil than for those receiving placebo ( P < 0.001 ) . Both patients and partners receiving sildenafil also had significantly higher EDITS scores than those receiving placebo ( P < 0.001 ) . Adverse events were chiefly mild or moderate . Two patients receiving sildenafil and none receiving placebo discontinued treatment because of adverse events . CONCLUSIONS Sildenafil was an effective , well-tolerated treatment for erectile dysfunction in an outpatient setting . Partner evaluations corroborated patient assessment s. The results from the EDITS question naire indicated that after 12 weeks of receiving sildenafil both patients and partners reported higher levels of treatment satisfaction relative to placebo 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 BACKGROUND Erectile dysfunction is a common , multi-factorial disorder . AIMS To evaluate the efficacy , tolerability and frequency of use of sildenafil citrate in men with mild to moderate erectile dysfunction of no established organic cause . METHOD This double-blind , r and omised , placebo-controlled , flexible-dose , two-way crossover study was conducted at four centres in the UK in 44 men with mild to moderate erectile dysfunction of no clinical ly obvious organic cause . The study included two 28-day treatment periods , during which time sildenafil or placebo ( 25 - 75 mg , based on efficacy ) was taken as required . RESULTS Compared with placebo , sildenafil was associated with increases in frequency of use , erections adequate for sexual intercourse and level of sexual satisfaction ( P:<0.0001 ) . More patients receiving sildenafil stated they would use the treatment again compared with those receiving placebo ( P:<0.0001 ) . There were no discontinuations due to sildenafil treatment . CONCLUSIONS Sildenafil is effective and well tolerated in men with mild to moderate erectile dysfunction of no clinical ly identifiable organic cause PURPOSE We assess the clinical efficacy of sildenafil citrate and predictors of satisfactory outcome . MATERIAL S AND METHODS All patients treated with sildenafil citrate within the first 6 weeks of its release were evaluated with a self-administered question naire before and at completion of therapy to assess etiology of erectile dysfunction , level of sexual function , libido , response to previous therapies , response to therapy with sildenafil citrate and quality of life . Sexual function was measured before and during therapy using an abbreviated version of the International Index of Erectile Function , with a successful outcome defined as a level of satisfaction of 4 or 5 on a 5-point scale . RESULTS Followup was obtained in 267 of the 308 patients who entered the study . Mean age plus or minus st and ard deviation was 61+/-9.6 years and duration of erectile dysfunction was 4.1+/-3 years .  Overall satisfaction with sildenafil citrate for the entire patient population was 65 % and response to prior therapies did not affect satisfaction . There was a significant positive correlation between baseline sexual function and response to sildenafil citrate but even patients with severe erectile dysfunction had a 41 % satisfaction rate . Etiology of erectile dysfunction had a significant impact on satisfaction rate , with neurogenic causes of erectile dysfunction ( diabetes , prostate surgery and so forth ) having significantly lower rates than psychogenic or vasculogenic erectile dysfunction . CONCLUSIONS Sildenafil citrate is a highly effective oral agent for the treatment of erectile dysfunction in clinical practice . The best predictors for response to sildenafil citrate therapy are baseline sexual function and etiology of erectile dysfunction . However , we could not identify any patient characteristic that would predict absolute failure for sildenafil citrate therapy . Therefore , all patients with erectile dysfunction who do not have specific contraindications should be considered for sildenafil citrate therapy 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 out patients with ED participated in a double-blind , flexible-dose , r and omized-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 PURPOSE We assessed the efficacy and safety of sildenafil citrate as treatment for erectile dysfunction . MATERIAL S AND METHODS A total of 433 completely evaluated men with chronic erectile dysfunction were treated with sildenafil citrate . Response was assessed prospect ively by baseline and followup physician interviews , and by a patient self-administered 15-item question naire on the domains of patient treatment response and satisfaction , partner treatment satisfaction , comparative previous treatment satisfaction , adverse effects , and patient and partner quality of life . RESULTS Of the 304 men ( 70.2 % ) who completed the question naire 278 received sildenafil , including 186 who previously had undergone treatment for erectile dysfunction , principally involving intracavernous injection therapy . A response was elicited by a median dose of 100 mg . in 188 patients ( 67.6 % ) who achieved erection suitable for sexual intercourse . Those with psychogenic erectile dysfunction responded significantly better than those with organic dysfunction ( p < 0.001 ) . Erection suitable for intercourse was attained by 30.8 % of patients with erectile dysfunction after radical prostatectomy and 80 % with cavernous veno-occlusive dysfunction . Of previous intracavernous injection responders 29.9 % were refractory to sildenafil , while 33 . 3 % of previous intracavernous injection nonresponders responded to sildenafil . The sildenafil response was considered inferior to the intracavernous injection response by 43.6 % of the men who previously responded to intracavernous injection , of whom 51.5 % continued to receive intracavernous injection as the only treatment ( 19.5 % ) or as an alternative to sildenafil ( 32 % ) . Adverse effects in 53.6 % of cases were assessed as mild in 56.4 % , moderate in 38.3 % and severe in 5.3 % . Multiple adverse effects were reported by 62.4 % of patients , while 17 ( 6.1 % ) discontinued sildenafil as a direct result of intolerable adverse effects . The most common adverse effects were facial flushing in 33.5 % of cases , headaches in 23.4 % , nasal congestion in 12.6 % , dyspepsia in 10.1 % and dizziness in 10.8 % . Baseline patient and partner quality of life scores significantly improved after sildenafil treatment ( p < 0.001 ) , while significantly improved quality of life was noticed by 51.5 % and 43.1 % , respectively . CONCLUSIONS Sildenafil citrate is effective oral first line treatment for erectile dysfunction . Although more than 50 % of men reported adverse effects , most were considered mild and rarely result ed in treatment cessation . There was a trend in those on intracavernous injection who responded to sildenafil to continue intracavernous injection as the only therapy or as an alternative to sildenafil . Also , we noted that some cases refractory to sildenafil responded to intracavernous injection . These findings imply that intracavernous injection remains an effective erectile dysfunction treatment option 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 r and omized , 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 r and omized 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 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 r and omized , 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 assessment s 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 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 ) question naire , 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 PURPOSE We evaluated the safety and efficacy of sildenafil citrate for treating erectile dysfunction in patients with multiple sclerosis . MATERIAL S AND METHODS A total of 203 patients with multiple sclerosis ( age range 18 to 50 years old ) with erectile dysfunction were r and omly assigned to receive 50 to 100 mg sildenafil ( 102 patients in group 1 ) or a similar regimen of placebo ( 101 patients in group 2 ) 45 minutes to 2 hours before sexual stimulation . Patients were asked to use at least 24 doses/attempts at home . Primary outcome measures consisted of responses to questions 3 and 4 from the International Index of Erectile Function question naires well as responses to Sexual Encounter Profile diary questions 2 and 3 . We also assessed the number of attempts at sexual intercourse , the number of attempts that were successful and adverse drug effects . RESULTS Improved erections ( positive response to the Global Assessment Question naire ) were reported by 32.8 % of patients receiving sildenafil and 17.6 % of those receiving placebo ( p = 0.04 ) . For Sexual Encounter Profile question 2 ( successful penetration ) the increase from baseline in mean per patient percentage of yes responses was 29.4 % after sildenafil vs 18.8 % after placebo ( p = 0.04 ) . The proportion of successful sexual attempts ranged from 12 % to 26 % for sildenafil and from 9 % to 21 % for placebo , respectively ( p = 0.044 ) . Of patients taking sildenafil and placebo 24 ( 23.5 % ) and 9 ( 8.9 % ) experienced 81 and 31 adverse events , respectively ( p = 0.01 ) . CONCLUSIONS Compared with placebo , sildenafil has little effect on multiple sclerosis emergent erectile dysfunction and , therefore , can not be recommended for the routine treatment of erectile dysfunction in patients with multiple sclerosis . This finding implies that there must be other mechanisms that are not affected by sildenafil or are resistant to the effects of sildenafil OBJECTIVE This study was an evaluation of whether sildenafil citrate is effective for the treatment of  erectile dysfunction in men taking concomitant serotonin-reuptake-inhibiting antidepressants . METHOD A retrospective sub analysis of combined data from 10 phase II/III double-blind , placebo-controlled , fixed- and flexible-dose trials ( 12 - 26 weeks ) identified a group of men with erectile dysfunction receiving 5 to 200 mg/day of sildenafil ( N=65 ) or placebo ( N=33 ) and concomitant serotonin-reuptake-inhibiting antidepressants .  Efficacy was measured by responses to questions from the International Index of Erectile Function on ability to achieve erection , ability to maintain erection , ejaculation frequency , orgasm frequency , and sexual desire . RESULTS Patients with erectile dysfunction receiving sildenafil and concomitant serotonergic antidepressants had significantly greater improvements in ability to achieve and maintain an erection , frequency of ejaculation , and orgasm frequency than did patients receiving placebo , without increased sexual desire . CONCLUSIONS Sildenafil significantly improved  erectile dysfunction  in patients taking concomitant serotonergic antidepressants PURPOSE Erectile dysfunction is a recognized complication of radiation therapy for prostate cancer . Sildenafil citrate is a well-known management strategy for erectile dysfunction that has been found to be efficacious across a wide spectrum of comorbidities , including post-radiation erectile dysfunction . We defined the efficacy of sildenafil citrate in patients with erectile dysfunction following radiation therapy for prostate cancer and assessed the impact of the interval after radiation on the success of this therapy . MATERIAL S AND METHODS Baseline and followup data on 110 patients presenting with erectile dysfunction secondary to radiation for prostate cancer was obtained . A total of 68 patients underwent 3-dimensional conformal external beam irradiation ( CRT ) , while 42 underwent brachytherapy ( BT ) without and rogen deprivation .  All patients were considered to have erectile dysfunction after radiotherapy , as assessed by the International Index of Erectile Function ( IIEF ) , and they were prescribed sildenafil citrate . Mean time + /- SD between the completion of radiation therapy and the initiation of sildenafil was 8 + /- 4 months . The response to sildenafil was assessed using the IIEF question naire . Within and between group comparisons were done for 3 time points , that is less than 12 , 13 to 24 and 25 to 36 months following the completion of radiation therapy . RESULTS The respective response rates in men who underwent BT/CRT at the 3 time points of less than 12 , 13 to 24 and 25 to 36 months was 76%/68 % , 54%/46 % and 44%/38 % , respectively . Mean IIEF erectile function domain scores for these 3 time points after BT/CRT was 26/23 , 22/19 and 17/15 , respectively . The percent of patients who achieved normalization of the IIEF erectile function domain at the 3 time points in the BT/CRT groups was 60%/50 % , 48%/42 % and 26%/19 % , respectively . CONCLUSIONS Sildenafil citrate improves erectile function in men in whom erectile dysfunction develops following radiation therapy for prostate cancer . There is a clear time dependence for the response to this therapy with a stepwise decrease in all end points examined serially in a 3-year period Purpose To evaluate the efficacy of sildenafil citrate only , 25 mg . Four times/week , tamsulosin only , 0.4 mg once daily , and the combination of both on lower urinary tract symptoms ( LUTS ) suggestive of benign prostate hyperplasia ( BPH ) and erectile dysfunction . Methods A total of 60 men with BPH-related LUTS were r and omized to receive sildenafil citrate only ( n = 20 ) , tamsulosin only ( n = 20 ) , and the combination of both ( n = 20 ) for 8 weeks . Changes from baseline in International Prostate Symptom Score ( IPSS ) , maximum urinary flow rate ( Qmax ) , post voiding residual urine volume ( PRV ) , Sexual Health Inventory for Male ( SHIM ) score , 3rd and 4th questions of International Index of Erectile Function ( IIEF ) were assessed at the end of the treatment . Results The mean age was 58 years .  IPSS , Qmax , PRV , SHIM scores , and 3rd and 4th questions in IIEF significantly improved in each group . Improvement of IPSS was more remarkable in combination ( 40.1 % ) and tamsulosin only ( 36.2 % ) groups in comparison with sildenafil citrate only group ( 28.2 % ; p < 0.001 ) . Improvement of Qmax and PRV were greater in tamsulosin only and combination than sildenafil citrate only group . SHIM scores significantly improved in sildenafil citrate only ( 65 % ) and combination ( 67.4 % ) than tamsulosin only ( 12.4 % ; p < 0.001 ) . Increases in the 3rd and 4th questions of IIEF were greater in sildenafil only and combination than tamsulosin only ( p < 0.001 ) . Conclusions Treatment with the combination of tamsulosin only and sildenafil citrate only was not superior to tamsulosin only to enhance voiding symptoms . Also , sexual function improvement was similar for both the combination and sildenafil citrate only treatments This was a double-blind , placebo-controlled , flexible-dose study of the efficacy and safety of sildenafil in men with erectile dysfunction ( ED ) and clinical ly stable coronary artery disease ( CAD ) . Patients were r and omized to receive sildenafil or placebo for 12 weeks . Primary outcomes were questions 3 and 4 of the International Index of Erectile Function ( IIEF ) . Secondary outcomes included the other IIEF questions and functional domains , the Life Satisfaction Checklist , the Erectile Dysfunction Inventory of Treatment Satisfaction , 2 global efficacy assessment questions , and intercourse success rate . By week 12 , sildenafil-treated patients ( n = 70 ) showed significant improvements on questions 3 and 4 compared with placebo-treated patients ( n = 72 ; p < 0.01 ) . Larger percentages of sildenafil-treated patients reported improved erections ( 64 % ) and improved intercourse ( 65 % ) compared with placebo-treated patients ( 21 % and 19 % , respectively ) . Sildenafil-treated patients were highly satisfied with treatment and their sexual life compared with placebo-treated patients . Forty-seven percent of sildenafil- and 32 % of placebo-treated patients experienced adverse events , including transient headache , hypertension , flushing , and dyspepsia . There were no serious drug-related cardiovascular effects . Thus , sildenafil is an effective and well-tolerated treatment for ED in men with CAD . Sildenafil was not associated with additional safety risks in this patient population 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 . MATERIAL S AND METHODS A total of 84 men were prescribed sildenafil after radical retropubic prostatectomy  and asked to complete a series of question naires , 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 question naire 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 CONTEXT  Erectile dysfunction  is common in men with diabetes . OBJECTIVE To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes . DESIGN A multicenter , r and omized , double-blind , placebo-controlled , flexible dose-escalation study conducted May through November 1996 . SETTING Patients ' homes and 19 clinical practice centers in the United States . PATIENTS A total of 268 men ( mean age , 57 years ) with erectile dysfunction ( mean duration , 5.6 years ) and diabetes ( mean duration , 12 years ) . INTERVENTIONS Patients were r and omized to receive sildenafil ( n = 136 ) or placebo ( n = 132 ) as needed , but not more than once daily , for 12 weeks . Patients took the study drug or placebo 1 hour before anticipated sexual activity . The starting dose of sildenafil citrate was 50 mg , with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability , to be taken as needed . MAIN OUTCOME MEASURES Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events . RESULTS Two hundred fifty-two patients ( 94 % ) completed the study ( 131/136 in the sildenafil group , 121/132 in the placebo group ) . By intention-to-treat analysis , at 12 weeks , 74 ( 56 % ) of 131 patients in the sildenafil group reported improved erections compared with 13 ( 10 % ) of 127 patients in the placebo group ( P<.001 ) . The proportion of men with at least 1 successful attempt at sexual intercourse was 61 % ( 71/ 117 ) for the sildenafil group vs 22 % ( 25/114 ) for the placebo group ( P<.001 ) . Adverse events related to treatment were reported for 22 ( 16 % ) of 136 patients taking sildenafil and 1 ( 1 % ) of 132 patients receiving placebo . The most common adverse events were headache ( 11 % sildenafil , 2 % placebo ) , dyspepsia ( 9 % sildenafil , 0 % placebo ) , and respiratory tract disorder ( 6 % sildenafil , 2 % placebo ) , predominantly sinus congestion or drainage . The incidence of cardiovascular adverse events was comparable for both groups ( 3 % sildenafil , 5 % placebo ) . CONCLUSION Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes 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 , r and omised 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 question naire , 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 OBJECTIVE Depressed men commonly have erectile dysfunction , and men with erectile dysfunction are frequently depressed . Since the etiologic and modulatory relationships between depression and erectile dysfunction have been poorly characterized , a 12-week , r and omized , double-blind , placebo-controlled trial was conducted at 20 urologic clinics to evaluate the effects of sildenafil treatment in men with erectile dysfunction and mild-to-moderate comorbid depressive illness . METHOD Men ( N=152 , mean age=56 years ) with erectile dysfunction for > or = 6 months ( mean=5.7 years ) , a DSM-IV diagnosis of depressive disorder not otherwise specified , and a Hamilton Depression Rating Scale score > or = 12 ( mean at baseline=16.9 ) were r and omly assigned to flexible-dose treatment with sildenafil citrate or matching placebo . Interviewer-rated and self-report instruments were used to assess changes in sexual function , depressive symptoms , and quality of life . Conservative criteria were used to classify erectile dysfunction treatment response and nonresponse . RESULTS Sildenafil was strongly associated with erectile dysfunction treatment response .  Fifty-eight men met the conservative criteria for response ( 48 given sildenafil , 10 given placebo ) , and 78 men did not respond ( 18 given sildenafil , 60 given placebo ) . Mean decreases of 10.6 and 2.3 in Hamilton depression scale scores were seen in treatment responders and nonresponders , respectively ; 76 % of treatment responders showed a > or = 50 % decline in Hamilton depression scale score versus 14 % of nonresponders . Quality of life was similarly improved in treatment responders . CONCLUSIONS Sildenafil is efficacious for erectile dysfunction in men with mild-to-moderate depressive illness . Improvement of erectile dysfunction is associated with marked improvement in depressive symptoms and quality of life OBJECTIVES To assess the efficacy and safety of sildenafil citrate ( Viagra ) in men with erectile dysfunction and parkinsonism due either to Parkinson 's disease or multiple system atrophy . METHODS Twenty four patients with erectile disease were recruited , 12 with Parkinson 's disease and 12 with multiple system atrophy , into a r and omised , double blind , placebo controlled , crossover study of sildenafil citrate . The starting dose was 50 mg active or placebo medication with the opportunity for dose adjustment depending on efficacy and tolerability . The international index of erectile function question naire ( IIEF ) was used to assess treatment efficacy and a quality of life question naire to assess the effect of treatment on sex life and whole life . Criteria for entry included a definite neurological diagnosis and a st and ing systolic blood pressure of 90–180 mm Hg and diastolic blood pressure of 50–110 mm Hg , on treatment if necessary .  Blood pressure was taken at r and omisation ( visit 2 ) and crossover ( visit 5 ) lying , sitting , and st and ing , before and 1 hour after taking the study medication in hospital . RESULTS Sidenafil citrate was efficacious in men with parkinsonism with a significant improvement , as demonstrated in question naire responses , in ability to achieve and maintain an erection and improvement in quality of sex life . In Parkinson 's disease there was minimal change in blood pressure between active and placebo medication . In multiple system atrophy , six patients were studied before recruitment was stopped because three men showed a severe drop in blood pressure 1 hour after taking the active medication . Two were already known to have orthostatic hypotension and were receiving treatment with ephedrine and midodrine but the third had asymptomatic hypotension . However , the blood pressures in all three had been within the inclusion criterion for the study protocol . Despite a significant postural fall in blood pressure after sildenafil , all patients with multiple system atrophy reported a good erectile response and were reluctant to discontinue the medication . CONCLUSIONS Sidenafil citrate ( 50 mg ) is efficacious in the treatment of erectile dysfunction in parkinsonism due to Parkinson 's disease or multiple system atrophy ; however , it may unmask or exacerbate hypotension in multiple system atrophy . As Parkinson 's disease may be diagnostically difficult to distinguish from multiple system atrophy , especially in the early stages , we recommend measurement of lying and st and ing blood pressure before prescribing sildenafil to men with parkinsonism . Furthermore , such patients should be made aware of seeking medical advice if they develop symptoms on treatment suggestive of orthostatic hypotension OBJECTIVE To evaluate the efficacy and safety of sildenafil citrate ( Viagra ) in a r and omized , double-blind , placebo-controlled , flexible-dose study in Thai men with erectile dysfunction of broad-spectrum etiology and more than 6 months ' duration . MATERIAL AND METHOD 125 patients aged 26 to 77 years were r and omized at 4 centers in Thail and to receive either sildenafil citrate ( 50 mg initially , increased if necessary up to 100 mg or decreased to 25 mg depending on efficacy and /or tolerability ) ( n = 63 ) or a matching placebo ( n = 62 ) taken on an ' as needed ' basis approximately 1 hour prior to anticipated sexual activity for a period of 12 weeks . Efficacy was assessed by the patients ' responses to the 15- question International Index of Erectile Function ( IIEF ) , to questions on the event log of sexual activity , and to the global efficacy assessment question concerning improvement in erections . RESULTS At the conclusion of the study , both the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse and the secondary efficacy variables , which included the 5 separate domains of sexual functioning of the IIEF , the percentage of successful attempts at sexual intercourse , and the global efficacy assessment question concerning improvement in erections , were all significantly improved statistically by sildenafil in comparison with placebo except in the sexual desire domain which showed no difference . The percentage of successful attempts at sexual intercourse in the sildenafil group was 66.16 per cent while in the placebo group it was 33.05 per cent . The percentage of global efficacy assessment was improved in the sildenafil group by 82.5 per cent compared to 36.1 per cent in the placebo group . Adverse events considered treatment-related occurred in 19 patients ( 30.2 % ) receiving sildenafil and 7 ( 11.3 % ) receiving placebo . The most common adverse events with sildenafil were vasodilatation ( flushing ) , headache , and dizziness , which occurred in 14.3 per cent , 6.3 per cent , and 6.3 per cent of patients respectively . All events were mild in nature . CONCLUSIONS Sildenafil is a safe and effective treatment for erectile dysfunction of broad-spectrum etiology in Thai men . Its efficacy appears similar to that reported in other studies in Western population 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 r and omized , double-blind , placebo-controlled , parallel-group , 12-week , flexible-dose study . Efficacy assessment s 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 PURPOSE To determine the efficacy of sildenafil citrate ( Viagra ) in patients with erectile dysfunction after three-dimensional conformal external beam radiotherapy ( 3D-CRT ) for prostate cancer . METHODS AND MATERIAL S 406 patients with complaints of erectile dysfunction and who completed radiation at least 6 months before the study were approached by mail .  3D-CRT had been delivered ( mean dose 68 Gy ) . Sixty patients were included and entered a double-blind , placebo-controlled , cross-over study lasting 12 weeks . They received during 2 weeks 50 mg of sildenafil or placebo ; at Week 2 the dose was increased to 100 mg in case of unsatisfactory erectile response . At Week 6 , patients crossed over to the alternative treatment . Data were collected using the International Index of Erectile Function ( IIEF ) question naire , and side effects were recorded . RESULTS Mean age was 68 years . All patients completed the study . For most questions of the IIEF question naire there was a significant increase in mean scores from baseline with sildenafil , but not with placebo . Ninety percent of the patients needed a dose adjustment to 100 mg sildenafil .  Side effects were mild or moderate . CONCLUSION Sildenafil is well tolerated and effective in improving erectile function of patients with ED after 3D-CRT for prostate cancer OBJECTIVES To determine whether the response to the new oral medication , sildenafil citrate ( Viagra ) , was influenced by the presence or absence of the neurovascular bundles , as recent reports on its success did not specify the efficacy of the drug in patients with erectile dysfunction after radical prostatectomy . METHODS Baseline and follow-up data from 28 healthy patients presenting with erectile dysfunction after radical prostatectomy were obtained . Patients receiving any neoadjuvant/adjuvant hormones or adjuvant radiation therapy were excluded . Patients reported what their erectile status was before surgery , before sildenafil therapy , and after using a minimum of four doses of sildenafil . Both the patients and their spouses were interviewed using the Clevel and Clinic post-prostatectomy question naire , which includes questions about response to therapy , duration of intercourse , spousal satisfaction , side effects , and related topics . The patients were compared on the basis of the type of surgical procedure they had undergone-nerve sparing or non-nerve sparing . A positive response to sildenafil was defined as erection sufficient for vaginal penetration . RESULTS Of the 15 patients who had bilateral nerve-sparing procedures , 12 ( 80 % ) had a positive response to sildenafil , with a mean duration of 6.92 minutes of vaginal intercourse . These 12 patients also reported a spousal satisfaction rate of 80 % . All 12 of the responders had a positive response within the first three doses , and 10 of the 12 responded with the first or second dose . None of the 3 patients who had undergone a unilateral nerve-sparing procedure responded , nor did any of the 10 patients who had undergone a non-nerve-sparing procedure . The two most common side effects of the drug were transient headaches ( 39 % ) and abnormal color vision ( 11 % ) . No patients discontinued the medication because of side effects . CONCLUSIONS Successful treatment of erectile dysfunction in a patient after prostatectomy with sildenafil citrate may depend on the presence of bilateral neurovascular bundles . No patient who had undergone a non-nerve-sparing procedure responded . Whether patients who undergo unilateral nerve-sparing procedures will respond to sildenafil is still unclear because of the small number of patients in our study . These findings should encourage urologists to continue to perform and perfect the nerve-sparing approach . The ability to restore potency with an oral medication after radical prostatectomy will impact our discussion with the patient on the surgical morbidity of radical prostatectomy
In data pooled from 6 parallel-group , fixed-dose trials , efficacy appeared slightly greater at higher doses .
Treatment response appeared to vary between patient subgroups , although relative to placebo , sildenafil significantly improved erectile function in all evaluated subgroups .
In trials with parallel-group design and flexible dosing , men r and omized to receive sildenafil were less likely than those receiving placebo to drop out for any reason and no more likely to drop out due to an adverse event or laboratory abnormality .
Sildenafil was not significantly associated with serious cardiovascular events or death .
CONCLUSIONS Sildenafil improves erectile function and is generally well tolerated .
Treatment response seems to vary between patient subgroups , although sildenafil has greater efficacy than placebo in all evaluated subgroups
OBJECTIVE To determine the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction .