Sildenafil versus intracavernous injection therapy: efficacy and preference in patients on intracavernous injection for more than 1 year

PURPOSE: To our knowledge comparative data on the effectiveness of and patient preference for intracavernous injection therapy and sildenafil are still not available. We evaluated the efficacy of sildenafil as well as patient preference in a group of impotent men on intracavernous injection for more than a year. MATERIALS AND METHODS: Patients on intracavernous injection therapy for more than a year without neurological disease and/or a contraindication to sildenafil treatment were recruited for study. In phase 1 we determined the efficacy of 50 and 100 mg. sildenafil citrate at home. In phase 2 responders to sildenafil were asked to use the preferred dose orally for a month and choose intracavernous injection or sildenafil. In phase 3 patients were asked to continue either treatment for 3 more months. Patient preferences were reported at the end of phases 2 and 3. RESULTS: Of the 180 men recruited 155 with a mean age of 56.4 +/- 12.6 years on intracavernous injection for a mean of 26 +/- 9 months accepted and were included in our series. Overall 116 men (74.8%) responded to sildenafil during study phase 1. After 1 month of treatment 71 responders (61.2%) preferred to continue with the oral drug, 31 (26.7%) returned to intracavernous injection and 14 (12.1%) used each drug alternately. Three months later 74 of the 116 responders (63.8%) preferred oral treatment and 38 (32.8%) chose intracavernous injection, while 4 (3. 4%) continued to use each treatment alternately. CONCLUSIONS: Sildenafil is highly effective in intracavernous injection responders, although a certain group prefer to continue intracavernous injection. While sildenafil should be considered first line treatment, men with erectile dysfunction should be aware of all treatment options available because nonresponders to sildenafil may respond to intracavernous injection.     

Treatment of erectile dysfunction after radical prostatectomy with sildenafil citrate (Viagra)

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 Cleveland Clinic post-prostatectomy questionnaire, 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.     

前列腺素E1与西地那非治疗ED的比较

目的 :比较口服西地那非与阴茎海绵体内注射前列腺素E1(PGE1)治疗勃起功能障碍 (ED)的疗效。　方法 :5 4例ED病人随机分为两组 ,A组口服西地那非 ,B组行海绵体内注射PGE1,均治疗 4～ 9个月 ,平均 6个月。结果 :A、B两组的有效率分别为 80 0 %和 83 3% ,两者差异无显著性 (P >0 0 5 )。A组 6例无效病人经海绵体内注射PGE1治疗 ,2例获得满意勃起 ;而B组 4例无效病人经口服西地那非治疗 ,无 1例勃起。　结论 :口服西地那非与海绵体内注射PGE1对各种病因所致的ED均有良好的治疗作用 ,对西地那非治疗无效者 ,可试用海绵体内注射PGE1,有时也能获得满意的效果     

Effect of sildenafil citrate on post-radical prostatectomy erectile dysfunction

PURPOSE: We assess the effect of sildenafil in a subgroup of patients after prostatectomy with erectile dysfunction and determine whether nerve preservation improves sildenafil response in this subgroup. MATERIALS AND METHODS: Between April 1998 and January 1999, 53 patients who had undergone radical retropubic prostatectomy and were prescribed oral sildenafil were surveyed using a confidential mail questionnaire. Of the patients 21 underwent bilateral and 15 unilateral neurovascular bundle sparing procedures, while in 17 a nonnerve sparing procedure was performed. All patients received 25 to 100 mg. sildenafil in a flexible dose escalation manner. Response, satisfaction and side effects were assessed using a modified, self-administered International Index of Erectile Function questionnaire. Response was defined as erection sufficient for intercourse. Preoperative and postoperative/pretreatment erectile functions were assessed for baseline comparison in each patient, and partner overall satisfaction with sildenafil was measured. Statistical data analysis was performed using analysis of variance and Newman-Keuls multiple comparison tests. RESULTS: Of the 21 patients who underwent a bilateral nerve sparing procedure 15 had a positive response. Of the 15 patients who had undergone a unilateral nerve sparing procedure 12 had a positive response, and only 1 of the 17 patients who had undergone a nonnerve sparing procedure responded to sildenafil. The most commonly reported adverse events of all causes were headaches (21%), flushing (8.3%), visual disturbance (6.3%) and nasal congestion (6.3%). CONCLUSIONS: Sildenafil is an equally effective treatment for erectile dysfunction after bilateral and unilateral nerve sparing procedures, and patient response to sildenafil is confirmed by the partners. However, patients who undergo nonnerve sparing procedures do not respond satisfactorily to sildenafil.     

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.     

Clinical efficacy of sildenafil in patients on chronic dialysis

PURPOSE: We evaluate the clinical efficacy of sildenafil citrate for patients who are on chronic dialysis and who have concomitant erectile dysfunction. MATERIALS AND METHODS: A total of 35 men (mean age 60.7 years) on dialysis and with erectile dysfunction of various etiologies were administered 25 to 100 mg sildenafil for at least 6 months. The International Index of Erectile Function questionnaire (IIEF), a global assessment question and partner satisfaction question were used to evaluate sildenafil efficacy. Patients also reported any adverse events that occurred during treatment. RESULTS: Treatment was effective for 28 of the 35 (80%) patients according to the results of the IIEF and global assessment questions. Partner satisfaction correlated with the IIEF overall response (0.79) and global assessment question results (0.86). No correlation was found between sildenafil failure and patient age, the etiology of erectile dysfunction, duration of erectile dysfunction, prior treatments, testosterone and prolactin blood levels, and the duration and etiology of renal failure. Of the 35 patients sildenafil was stopped due to intolerable headaches in 3 and because of lack of efficacy in 7. CONCLUSIONS: Sildenafil is an effective and safe treatment for erectile dysfunction in most patients on chronic dialysis.     

Evaluation of a progressive treatment program for erectile dysfunction in patients with diabetes mellitus

The aim was to evaluate the effectiveness of a progressive program, starting with simple methods and, when not effective, moving to more complex methods, to treat erectile dysfunction (ED) in patients with diabetes mellitus. A total of 284 diabetic patients with ED entered into a 6-phase program starting with sildenafil citrate (Viagra). Those with contraindications, side effects, or negative response (erection insufficient for vaginal penetration) were switched to the vacuum erection device (VED), and then progressively (for failures) to intracavernous injection (ICI), sildenafil citrate+ICI, ICI+VED, and penile prosthesis. Patients were followed for 2 y. Of the 284 patients 276 patients were eligible for sildenafil citrate and 147 (53.3%) responded positively, but 25 (9.1%) patients stopped it soon due to adverse effects. Of 162 patients (129 nonresponders, eight noneligible for the sildenafil and 25 patients who dropped out due to adverse effects), treated with VED, 114 (70.4%) responded well, however, only 19 (11.7%) patients agreed to continue its use. Of the remaining 143 patients (nonresponders, noneligible for the previously mentioned treatments and patients who dropped out due to adverse effects), 103/143 (72%) responded to ICI, 27/40 (67.5%) to sildenafil+ICI, and 9/13 (69.2%) to ICI+VED. Four patients received a penile implant. At the 2 y follow-up, 81 of 284 patients who entered the study (28.5%) were still responding to sildenafil, seven (2.5%) to VED, 113 (39.8%) to ICI, 24 (8.5%) to sildenafil+ICI, two (0.7%) to ICI+VED; 15 (5.3%) had a penile implant. In all 17 (6%) patients reported spontaneous erections, 11 (3.9%) stopped the treatment due to family reasons and 14 (4.9%) failed the treatment. In conclusion, the progressive treatment program for ED seems to be very effective for diabetic patients, yielded a complete response for short-term and 91.2% rate of success at the end of 2 y follow-up.     

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.     

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.     

Different hemodynamic responses by color Doppler ultrasonography studies between sildenafil non-responders and responders

Aim： To determine if there are different penile hemodynamic patterns between sildenafil non-responders and responders by using color Doppler ultrasonography. Methods： A total of 69 erectile dysfunction （ED） patients aged 22-79 years were enrolled into the present study. Thirty-eight （55.1%） men with ED who did not respond to four attempts of treatment with 100 mg sildenafil after re-education were classified as sildenafil non-responders. A com- bination of three vasodilator drugs, 1.25 mg papaverine, 0.4 mg phentolamine and 5 ug prostaglandin E1, was given by intracavernous injection before penile Doppler ultrasonography was carried out. The erectile response to intracavernous injection and vascular parameters including peak systolic velocity （PSV）, resistance index （RI）, end diastolic velocity （EDV） and cavernosa artery diameter （CD） were measured and the results between sildenafil nonresponders and responders were compared. Results： No statistical difference in vascular parameters measured by Doppler ultrasonography studies between non-responders and responders was noted. Sildenafil non-responders had a poorer penile rigidity response to intracavernous injection than responders （P 〈 0.05）. Among patients with adequate PSV （〉 30 cm/s） and abnormal EDV （〉 5 cm/s）, individuals in the non-responder group had fewer positive responses to intracavernous vasodilator injection than in the responder group （35.3% vs. 72.2%, P 〈 0.05）. Advanced age and comorbidity with diabetes mellitus were significantly associated with sildenafil non-response （P 〈 0.05）. Conclusion： Sildenafil non-responders were characterized by a poorer penile rigidity response to intracavernous injection and had an associated impaired veno-occlusive mechanism. Advanced age and comorbidity with diabetes mellitus were two common factors associated with non-response.     

A NEW METHOD FOR THE EVALUATION OF ERECTILE DYSFUNCTION: SILDENAFIL PLUS DOPPLER ULTRASONOGRAPHY

PURPOSE: Of the various methods of hemodynamic studies performed to evaluate erectile dysfunction penile color Doppler ultrasound is currently considered the best. However, intracavernous injection is invasive and has adverse effects, such as prolonged erection. We evaluated whether sildenafil may be used as a substitute for intracavernous agents when assessing impotence on color Doppler ultrasound. MATERIALS AND METHODS: A total of 42 patients with erectile dysfunction underwent color Doppler ultrasound before and after intracavernous injection of 60 mg. papaverine with genital and audiovisual sexual stimulation. Peak flow and end diastolic velocity were measured in the recorded waveforms obtained 0, 1, 5, 10 and 20 minutes after injection. The patients also underwent color Doppler ultrasound after a 50 mg. oral dose of sildenafil with genital and audiovisual sexual stimulation not before 3 days after the papaverine study. The same parameters were measured at 30, 45, 60, 75 and 90 minutes, and compared with the values obtained after papaverine injection. RESULTS: Mean peak flow velocity significantly increased after oral sildenafil starting at 30 minutes and achieving a maximum value at 60 minutes. There were no significant differences in the 2 methods in mean peak velocity 1, 5, 10 and 20 minutes after papaverine injection, and 30, 45, 60, 75 and 90 minutes after oral sildenafil administration. Penile color Doppler ultrasound with intracavernous papaverine injection is accepted as the gold standard but color Doppler ultrasound with sildenafil has 90% sensitivity and 100% selectivity for demonstrating arterial insufficiency. Due to prolonged erection 5 patients (11.9%) in the papaverine group required pharmacological detumescence by intracavernous injection. No adverse effects of sildenafil were observed. CONCLUSIONS: Sildenafil administration achieved increased peak flow velocity comparable to that after intracavernous papaverine injection. With no prolonged erection sildenafil emerges as a safer alternative compared to more invasive intracavernous injection.     

The efficacy, safety and tolerability of intracavernous PNU-83757 for the treatment of erectile dysfunction

PURPOSE: Despite the introduction of sildenafil citrate many men with erectile dysfunction remain dependent on intracavernous therapy. While the majority achieves satisfactory results with currently available intracavernous preparations, all preparations have undesirable side effects, including priapism, fibrosis and post-injection pain. We determined the efficacy, safety and tolerability of the erectogenic potassium channel opener PNU-83757. MATERIALS AND METHODS: We selected 66 men with erectile dysfunction of vascular etiology for intracavernous injection of PNU-83757 in a single dose, single blind, placebo controlled study. Of the 6 patients allocated into each of 11 dose groups 5 received active drug and 1 received placebo. Groups received progressive doses of PNU-83757 or placebo. Holter monitoring was performed at scheduled intervals. Heart rate, and systolic, diastolic and mean blood pressure were assessed at scheduled intervals. Blood samples were obtained for pharmacokinetic study. Patients were evaluated at regular intervals for adverse events. Investigators and patients evaluated efficacy. RESULTS: The first complete erection was observed at 10 mcg. Of the 25 patients receiving active drug in the 60 to 140 mcg. groups only 1 had no erectile response, 15 had partial erection and 9 had complete erection. No serious adverse events or cardiovascular effects were noted. CONCLUSIONS: The minimum effective dose for complete erection was 10 mcg. The erectile response reached a plateau between 60 and 140 mcg., suggesting minimal improvement in efficacy at higher doses. Patient evaluation of erectile quality corresponded well with that of investigators. PNU-83757 was efficacious and extremely well tolerated, and the only adverse events were mild. No cardiovascular side effects were observed at any dose. PNU-83757 intracavernous injections caused no post-injection pain in any patient, which may make PNU-83757 superior to alprostadil in a select group. Further study is required to evaluate the efficacy of PNU-83757 combined with other drugs and with sexual stimulation.     

Nocturnal penile tumescence activity unchanged after long-term intracavernous injection therapy

PURPOSE: Anecdotal evidence suggests that some men have restored erectile function after long-term intracavernous injection therapy for erectile dysfunction. We objectively assessed this phenomenon using nocturnal penile tumescence testing. MATERIALS AND METHODS: In our retrospective study 19 men with a mean age of 53.5 years who had organic erectile dysfunction underwent nocturnal penile tumescence testing before and after prostaglandin E1 based intracavernous injection at least 6 months in duration. The nocturnal penile tumescence parameters measured included the number of erectile episodes, base and tip tumescence, and percent of time with rigidity greater than 70% at the penile base and tip. A 5-item questionnaire was given to all patients after the intracavernous injection period to assess subjective changes in erectile quality. RESULTS: Mean time on intracavernous injection was 2.42 years and mean injection frequency was 3.74 times monthly. Prostaglandin E1 only, and combined prostaglandin E1, phentolamine and papaverine were used in 7 and 9 cases, respectively. Nine patients believed that unaided erection improved after intracavernous injection and 6 achieved intercourse without injection who were unable to do so before injection. No statistically significant changes were noted in any of the 5 objectively measured nocturnal penile tumescence parameters. CONCLUSIONS: Long-term prostaglandin E1 based intracavernous injection may provide subjective improvement in erectile function in some men. However, as measured by nocturnal penile tumescence testing, no objective improvement in spontaneous erectile function occurs.     

The impact of sildenafil citrate on sexual satisfaction profiles in men with a penile prosthesis in situ

OBJECTIVE: To assess the efficacy of sildenafil in increasing penile glans tumescence and improving patient satisfaction in men with a penile prosthesis, as this remains a major treatment for erectile dysfunction but a common complaint is the lack of glans engorgement. PATIENTS AND METHODS: To determine whether sildenafil combined with a penile prosthesis improves satisfaction, patients used an implant alone for at least 1 month, after which they completed the International Index of Erectile Function (IIEF) questionnaire. The same patients were then given sildenafil citrate and completed the IIEF questionnaire after using the sildenafil/implant combination. RESULTS: Patients who responded to sildenafil with glans engorgement reported significantly greater satisfaction scores than with an implant alone. CONCLUSION: We currently offer sildenafil citrate after implantation to all men who have a penile prosthesis placed.     

Intracavernous injections for erectile dysfunction in patients with cardiovascular diseases and failure or contraindications for sildenafil citrate

The aim of this study was to evaluate the effectiveness of a progressive program for the treatment of erectile dysfunction in patients with cardiovascular disease in whom sildenafil citrate (Viagra) was not an option. The study population included 106 patients selected from 267 with cardiovascular disease. The intracavernous injection program consisted of three protocols of increasingly complex combinations of vasoactive drugs, papaverine, phentolamine, prostaglandin E1 and atropine sulfate. Patients who failed the first protocol were switched to the second, and those who failed the second were switched to the third. A positive response was defined as an erection sufficient for vaginal penetration. A positive response was achieved on protocol I in 61 of the 106 patients (57.5%); protocol II in 32 of the remaining 45 patients (71.1%); and protocol III in seven of the remaining 13 patients (53.8%); the total success rate was 94.3%. These 100 patients were included in the 1-year follow-up, and 90 reported successful coitus at the end of that period: 79 patients (87.8%) with intracavernous injection and 11 (12.2%) without injection. The remaining 10 patients (10%) dropped out of the program, seven (7.0%) for health or marital reasons and three (3.0%) because of treatment failure. We conclude that a progressive program of intracavernous injections of vasoactive drugs may be a good alternative for the treatment of erectile dysfunction in patients with cardiovascular disease.     

Combining Intracavernous Injection and External Vacuum as Treatment for Erectile Dysfunction

We studied the effect of combining intracavernous injection and an external vacuum in 10 men with erectile dysfunction who previously failed attempts at treatment with either method as single therapy. We measured the length, circumference and buckling pressure of the penis at baseline, after applying negative pressure (250 mm. Hg for 2 minutes), 15 minutes after intracavernous injection of 60 mg. papaverine or 30 microgram prostaglandin E1 and after combining both modalities. No patient achieved adequate rigidity (defined as a penile buckle pressure greater than 450 gm.) with single therapy. The mean buckle pressure using vacuum alone was 125.0 plus/minus 53.6 gm. After intracavernous injection the mean buckle pressure was 117.0 plus/minus 38.3 gm. In contrast, all 10 subjects responded to combination therapy with a mean buckle pressure of 565.0 plus/minus 56.8 gm. (p less than 0.0001). After 10 months of followup 3 subjects were still using the combination and were satisfied with the erectile response, 1 found that he no longer needed the addition of external vacuum after using combination therapy for 3 months, 1 used the combination for 9 months and then stopped because of an intervening acute illness, 1 lost the partner due to death, 2 found combination therapy to be too cumbersome and 2 were lost to followup. We conclude that external vacuum devices can augment a partial response to intracavernous injection and the combination may be an alternative treatment before intrapenile prosthesis implantation.     

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.     

Effect of incision and saphenous vein grafting for Peyronie's disease on penile length and sexual satisfaction

PURPOSE: We determined the effect of incision and saphenous vein grafting on penile length, erectile function and overall sexual satisfaction in men with Peyronie's disease. MATERIALS AND METHODS: A total of 24 consecutive men underwent plaque incision and saphenous vein grafting with postoperative daily use of a vacuum erection device. Erect penile length, pain, curvature and erectile function were assessed before and after surgery, and overall sexual satisfaction was scored from 1 to 5 by a validated instrument. RESULTS: Of the 22 patients in whom adequate followup data were available mean penile length was increased 2.1 cm. as a result of surgery (p <0.001). Median score of overall satisfaction with sex life was 4 or moderately satisfied. Of the 86% of men who achieved sexual intercourse after surgery 54% used no erectile aids and 32% required sildenafil or intracavernous injection. Complete erectile dysfunction was present in 14% of cases. Patients who reported erectile difficulty preoperatively were significantly more likely to have erectile dysfunction postoperatively that required erectile aids. Arterial insufficiency on duplex Doppler ultrasound was associated with a higher likelihood of complete erectile dysfunction. Complications in 33% of patients included complete erectile dysfunction in 3 and significant persistent penile curvature in 1. CONCLUSIONS: Incision and venous grafting of plaque leads to statistically and clinically significant increases in penile length in men with Peyronie's disease. Preoperative erectile dysfunction and cavernous arterial insufficiency were associated with a higher risk of postoperative erectile dysfunction. Nevertheless, patients reported a high degree of satisfaction with their overall sex life.     

The use of prostaglandin E1 for diagnosis and treatment of erectile dysfunction

Summary Since 1982, many substances have been used for intracavernous injection to produce erections. Because the first-generation drugs (phenoxybenzamine, papaverine) were associated with severe side effects, including priapism and fibrosis of the penis, it was important that a safe and effective substance for intracavernous injection be found. In our series of 550 men with erectile dysfunction who received a test dose of 20 g prostaglandin E₁, 385 (70%) developed an erection lasting more than 30 min. Side effects were minimal: only one patient required treatment for priapism, and no fibrosis was found. A total of 275 patients entered an autoinjection protocol. All of these men were capable of engaging in intercourse and experienced no major side effects. In conclusion, prostaglandin E₁ is effective, safe and preferable to all other drugs currently used for intracavernous injection.     

根治性前列腺切除术后勃起功能障碍的PDE5抑制剂治疗现状

前列腺癌根治性前列腺切除术(RRP)术后勃起功能障碍(ED)的发生率10%~100%,保留神经的根治性前列腺切除术(NS-RRP)术后ED也超过三分之一。5型磷酸二酯酶(PDE5)抑制剂可用于各种原因ED的治疗。西地那非、伐地那非和他达拉非临床应用显示对RRP术后勃起功能的治疗有相似的作用,保留双侧神经的患者,服用西地那非的有72%的成功勃起率(阴道插入);服用伐地那非20 mg和10 mg的反应率是71.1%和59.7%;服用他达拉非的所有患者,平均成功的插入率是54%,平均成功性交率是41%,术后有某种程度勃起的患者,平均成功的插入率和成功性交率是69%和52%。但未有三者对RRP术后ED治疗的直接比较。