Results from different patient populations using combined therapy with alprostadil and sildenafil: predictors of satisfaction

OBJECTIVE: To evaluate the outcome of combined therapy (using intraurethral alprostadil and oral sildenafil) in private and clinic patients with erectile dysfunction, and thus assess predictors of satisfaction. PATIENTS AND METHODS: In all, 360 men were treated for erectile dysfunction using single and/or combined therapy, comprising 214 private-practice and 166 clinic patients. Responses were evaluated using the International Index for Erectile Function (IIEF) questionnaire before and after treatment. Serum testosterone levels, education and socio-economic status were also assessed. Group 1a consisted of 33 private patients and Group 1b of 24 clinic patients who tried the maximum dose of intraurethral alprostadil monotherapy initially, followed by the maximum dose of sildenafil monotherapy, and remained dissatisfied. Group 2a consisted of 32 private patients and group 2b of 31 clinic patients who tried the maximum dose of sildenafil monotherapy initially, followed by the maximum dose of alprostadil monotherapy, and were also dissatisfied. These two groups of 65 private and 55 clinic patients then underwent combined therapy. RESULTS: The mean (SD) score for erectile function was 24.1 (2) for combined therapy (a 123% improvement), and 19.8 (1. 8) (83% improvement) and 15.2 (1.6) (41% improvement) for sildenafil and alprostadil monotherapies (P < 0.05 for both patient groups). The men also reported an improvement in their satisfaction with intercourse. However, at 18 months, 60 of the 65 private patients but only 40 of the 55 clinic patients continued with combined therapy; thus, the discontinuation rate was three times greater among clinic than among private patients. Furthermore, the private patients had an overall improvement in the satisfaction score of 128%, compared with 51% for the clinic patients. CONCLUSION: Although there were no significant differences in erectile function improvement within the two satisfied combined therapy groups, the differences in overall satisfaction and long-term withdrawal rates suggests that other factors beside motivation must be involved for success, e.g. education, persistence, realistic expectations, and certain psychological factors. Combined therapy should be considered for those patients who have a suboptimal response to monotherapy and refuse or are not candidates for surgical options. Generally, those patients with a higher education, greater persistence and more realistic expectations were more satisfied with combined therapy.     

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.     

Combination therapy: medicated urethral system for erection enhances sexual satisfaction in sildenafil citrate failure following nerve-sparing radical prostatectomy

The objective of our study was to assess the effectiveness of combining medicated urethral system for erection (MUSE) with sildenafil citrate in men unsatisfied with the sildenafil alone. Baseline and follow-up data from 23 patients (mean age, 62.5 +/- 5.23 years) unsatisfied with the use of the sildenafil citrate alone for the treatment of erectile dysfunction following nerve-sparing radical prostatectomy (mean use, 4 attempts/100-mg dose) was obtained. All patients started oral sildenafil citrate more than 6 months after radical prostatectomy. Combination therapy was initiated using 100 mg sildenafil citrate orally 1 hour prior to intercourse. Patients used combination therapy for a minimum of 4 attempts prior to assessment with the Sexual Health Inventory of Men (International Index for Erectile Function-5) and visual analog scale to gauge rigidity (0-100). The effect of therapy on the total International Index for Erectile Function (IIEF) score and penile rigidity score was assessed. Of the 23 patients, 4 (17%) had no improvement with the addition of medicated urethral system for erection and discontinued the drug, while 19 (83%) reported improvement with the penile rigidity and sexual satisfaction. The IIEF scores of these 19 patients showed significant improvements in each sexual domain, and the patients reported that erection was sufficient for vaginal penetration 80% of the time. Rigidity scores on a scale of 0-100 with sildenafil alone averaged 38% (23-53) for men and 46% (26-67) for their partners. With the addition of MUSE, scores increased to 76% for men and 62% for their partners. We conclude that the addition of MUSE to sildenafil improved sexual satisfaction and penile rigidity in patients unsatisfied with sildenafil alone.     

Concomitant use of sildenafil and a vacuum entrapment device for the treatment of erectile dysfunction

PURPOSE: Men not entirely satisfied with erectile function after separate use of sildenafil or a vacuum entrapment device (VED) are usually given more invasive alternatives. This prospective study was designed to evaluate the efficacy of concomitant use of sildenafil and a vacuum entrapment device in men not satisfied with erectile function while using each of these treatment modalities separately. MATERIALS AND METHODS: A total of 161 patients suffering from erectile dysfunction for at least 6 months were evaluated and treated with 100 mg sildenafil and a VED each as monotherapy. The 41 patients not satisfied with erectile function while using either modality alone were treated with concomitant use of sildenafil and a VED. The International Index of Erectile Function and global assessment question about satisfaction from treatment were used to evaluate satisfaction before and after each treatment. RESULTS: All 41 patients stated on the global assessment question that they had a greater level of satisfaction with the results of combined treatment than with each treatment alone (p <0.0001). Older (age greater than 60 years) participants reported better overall satisfaction. There was no correlation between treatment outcome and erectile dysfunction etiology or between satisfaction from treatments and the order in which they were given and the pretreatment scores for the International Index of Erectile Function domains. CONCLUSIONS: Combined use of sildenafil and a VED may be offered to patients not satisfied when either treatment is used alone.     

Synergetic effect of testosterone and phophodiesterase-5 inhibitors in hypogonadal men with erectile dysfunction: A systematic review

Testosterone deficiency seems to impair the clinical response to phophodiesterase-5 (PDE-5) inhibitors in patients with erectile dysfunction (ED). In hypogonadal men, testosterone repletion was associated with enhanced sexual function in patients who failed initial treatment with sildenafil or tadalafil. We conducted a systematic review of studies that evaluated combination therapy of testosterone and PDE-5 inhibitors in patients with ED and low, low-normal testosterone levels who failed monotherapy. The studies we examine are heterogeneous with several methodological drawbacks and that, overall, the addition of testosterone to PDE-5 inhibitors might benefit patients with ED associated with testosterone <300 ng/dL (10.4 nmol/L) who failed monotherapy. Further studies, with a randomized placebo-controlled and double blind design, are needed to describe the appropriate target patient group, testosterone cut-off and to define the optimal dose and duration of combination therapy.     

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.     

Positive effect of counseling and dose adjustment in patients with erectile dysfunction who failed treatment with sildenafil

OBJECTIVE: Many patients with erectile dysfunction (ED) stop using sildenafil due to subjective failure. This study examined whether counseling and maximal dosing (100 mg) could achieve better treatment compliance and could possibly improve treatment outcome. MATERIAL AND METHODS: Patients were recruited by newspaper advertisements and referred to 5 ED centers throughout the country. Details about their previous experiences with sildenafil were recorded and following an explicit explanation about the nature and action of the drug, were offered to enter the study. Instructions on drug use were provided during each visit in which four 100 mg Sildenafil tablets were provided. Treatment outcomes were assessed by the international index of erectile function (IIEF) questionnaire after taking 4 and 8 tablets. In 2 ED centers a short video with sexual counseling content was added in between visits. RESULTS: The study cohort was comprised of 220 patients aged 27-88 years. The majority reported having received limited or no instructions on drug use when sildenafil was first prescribed. A significant increase in IIEF erectile function domain scores (EFDS) between visits 1, 2 and 3 was observed (10.96+/-0.40, 16.73+/-0.51 and 17.82+/-0.55 mean+/-SE, respectively), with 23.6% of the study patients achieving normal erectile function at the end of the study. The parameters of age and initial severity of ED most influenced treatment success. CONCLUSIONS: Counseling and dose adjustment were directly influential in achieving an excellent response to a second trial of sildenafil in patients with ED who had previously failed treatment with the drug, and obviated their needing to seek more invasive measures.     

ERECTILE RESPONSE TO TRANSURETHRAL ALPROSTADIL, PRAZOSIN AND ALPROSTADIL-PRAZOSIN COMBINATIONS

Purpose

Transurethral alprostadil has been shown to be efficacious in many men with erectile dysfunction. We compared transurethral alprostadil and prazosin alone, and in combination to treat this disorder.

Materials and Methods

In this double-blind, placebo controlled study the erectile responses to transurethral alprostadil, prazosin and alprostadil-prazosin combinations were assessed in 234 men 26.8 to 8.15 years old with complete organic erectile dysfunction. Patients self-administered a random sequence of 7 doses in the clinic in 4 weeks. The erectile response was assessed using categorical and visual analog scales.

Results

Full penile enlargement or rigidity was achieved by 165 of the 234 men (70.5%) after at least 1 active dose of medication. The most effective alprostadil dose (500 micro g.) resulted in full penile enlargement or rigidity in 51.8% of administrations, whereas the most effective prazosin dose (2,000 micro g.) and placebo resulted in a similar response in 12.7 and 2.7%, respectively (p <0.001). The 500/2,000 micro g. alprostadil/prazosin combination, which resulted in full enlargement or rigidity in 58.9% of doses, was only slightly better than the most effective dose of alprostadil alone (500 micro g.). However, combinations of 125/500 and 250/500 micro g. alprostadil/prazosin were more effective (p <0.01) than 125 and 250 micro g. alprostadil given alone, respectively. The most common side effect of therapy was penile pain, which rarely led to study discontinuation. Hypotension most commonly developed at the higher alprostadil-prazosin combination.

Conclusions

Transurethral alprostadil and alprostadil-prazosin combinations produced erections in men with complete organic erectile dysfunction. This combination therapy may be an option in patients who do not respond to transurethral alprostadil alone.     

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.     

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.     

An open, comparative, multicentre clinical study of combined oral therapy with sildenafil and doxazosin GITS for treating Chinese patients with erectile dysfunction and lower urinary tract symptoms secondary to benign prostatic hyperplasia

This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction (ED) and lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH/LUTS). The trial was conducted in hospitals in Beijing, Shanghai, Changsha, Wuhan and Guangzhou, five major cities in China. A total of 250 patients diagnosed with ED and BPH/LUTS aged 50-75 years, and who had International Index of Erection Function-5 (IIEF-5) scores ≤21 and International Prostate Symptom Score (IPSS) ≥10 points, were enrolled and randomly divided into Group A (168 cases; doxazosin GITS 4 mg once daily plus sildenafil 25-100 mg on demand) and Group B (82 cases; sildenafil 25-100 mg on demand). Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life (QoL) questionnaire, and adverse effects were evaluated during the treatment period. There were no statistically significant differences in mean age, and IIEF-5, IPSS and QoL scores pre-treatment between the two groups. After treatment, IIEF-5, IPSS and QoL scores were significantly improved in Group A, while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment. There were no significant differences in side effects between the two groups. The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy.     

Sildenafil citrate vs intracavernous alprostadil for patients with arteriogenic erectile dysfunction: a randomised placebo controlled study

We compared the effectiveness of sildenafil citrate and alprostadil in improving arterial penile inflow (peak systolic velocity (PSV)) and penile rigidity in 55 patients with erectile dysfunction caused by atherosclerosis. A total of 35 patients with pure vasculogenic impotency were randomly assigned to alprostadil (Av group; n=11), sildenafil (Sv group; n=12), or placebo (P group; n=12), and 20 patients with nonvasculogenic impotency were randomly assigned to alprostadil (A group; n=10) or Sildenafil (S group; n=10): Av and A used alprostadil injection (capable of giving a full erection) once a week for 1 month, Sv and S took daily oral sildenafil (25 mg) for 1 month, and P took daily oral placebo for one month. The PSV was measured with Duplex sonography and penile rigidity was assessed using the IIEF-15 questionnaire, both of which were administered before and after treatment. Although both treatments improved penile rigidity, they increased PSV only in the Av and Sv groups. Our results suggest that alprostadil and oral therapy should be the starting therapy in men with vasculogenic impotency, whereas alprostadil should be avoided as the first-line approach in men with nonvasculogenic impotency.     

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.     

Treatment satisfaction in patients with erectile dysfunction switching from prostaglandin E(1) intracavernosal injection therapy to oral sildenafil citrate

Treatment satisfaction, subanalysed by demographic variables, was evaluated in patients switching from successful intracavernosal prostaglandin E(1) (PGE(1)) therapy to oral sildenafil citrate. The validated Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire was administered at the end of PGE(1) therapy and after 12 weeks of sildenafil treatment in a multicentre, open-label study. Men with erectile dysfunction (n=176) who were switched from stable PGE(1) therapy to sildenafil (25-100 mg) were equally satisfied with onset of action, duration of action, and confidence in ability to engage in sexual activity, but expressed greater overall treatment satisfaction with sildenafil (P<0.01), better ease of use (P<0.001), naturalness of erectile process (P<0.001), and intention to continue treatment (P<0.001). Partners (n=32) were overall more satisfied with sildenafil (P<0.05), and their responses correlated with patient satisfaction (r=0.68). Compared with PGE(1) injection, these data suggest that patients may be less likely to discontinue taking sildenafil treatment for their erectile dysfunction.     

Rationale for combination therapy of intraurethral prostaglandin E(1) and sildenafil in the salvage of erectile dysfunction patients desiring noninvasive therapy

Corpus cavernosum smooth muscle relaxation and hence penile erection are regulated in part by increases in smooth muscle synthesis of the second messengers cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). The object of this study was to determine 30-month follow-up results in motivated patients desiring noninvasive medical therapy using sildenafil citrate (Viagra) in combination with intraurethral prostaglandin E(1) (PGE(1)) (Medicated Urethral System for Erection [MUSE]). Twenty-eight patients (mean +/- s.d. age, 59 +/-7.3 y; 17 who had undergone radical prostatectomy and 11 who had a diagnosis of organic erectile dysfunction) were included in this study. Detailed history taking and physical examinations were performed and vascular risk factors noted. In these patients, treatment with either 100 mg of sildenafil citrate and/or 1000 microg of MUSE had failed. None of these patients desired intracavernosal injection. Duplex Doppler ultrasonography after redosing was carried out on all patients. Dynamic infusion corpus cavernosography/cavernosometry was obtained in 17 of 28 patients, and combination therapy was initiated using 100 mg of sildenafil citrate orally 60 min before intercourse and 500 microg of MUSE intraurethrally immediately before intercourse. Independently, either 100 mg of sildenafil citrate or 1000 microg of MUSE was not efficacious in inducing an erection sufficient for vaginal penetration in any of the 28 patients. After initiating a combination therapy, at 30 months, all 28 patients were reporting erections sufficient for vaginal penetration, with 3.6 intercourse episodes per month. None of the patients crossed over to intracavernosal therapy or penile prosthesis. During therapy, eight of 28 patients reduced the dose of sildenafil citrate to 50 mg. Combination therapy with MUSE and sildenafil may be more efficacious in the salvage of patients who desire noninvasive therapy but in whom single-treatment modalities fail. Although both cAMP- and cGMP-mediated vasodilation can lead to penile erection, combining therapies that incorporate both pathways may succeed when single therapies fail.     

Use of combined intracorporal injection and a phosphodiesterase-5 inhibitor therapy for men with a suboptimal response to sildenafil and/or vardenafil monotherapy after radical retropubic prostatectomy

OBJECTIVE: To report experience with combined therapy using intracorporal injection (ICI) of alprostadil and oral phosphodiesterase 5 (PDE-5) inhibitors for the minimally invasive treatment of erectile dysfunction (ED) after radical prostatectomy (RP), as PDE-5 inhibitors are effective but a few patients may have a suboptimal response. PATIENTS AND METHODS: In a retrospective study, 34 men (aged 46-66 years) had a nerve-sparing retropubic RP and subsequent ED. Patients were titrated on sildenafil citrate or vardenafil to maximum doses. All had a suboptimal response after a maximum of eight doses of oral therapy and were then treated with ICI therapy using 15 or 20 microg alprostadil. Erectile function was assessed with the Sexual Health Inventory for Men (SHIM). RESULTS: Of the 32 patients who continued combined therapy, 22 (68%) had an improvement in erectile function after ICI therapy, as assessed by the SHIM score. On follow-up, 36% of these patients used ICI therapy only intermittently, instead of regularly, as they felt that this was adequate enough for good results. CONCLUSIONS: PDE-5 oral pharmacotherapy is the most commonly used effective therapy for ED but may not be as effective in patients who have radical surgery; the addition of testosterone patches may have side-effects or be considered a risk in patients with a history of prostate cancer. The use of ICI therapy as an adjunct or maintenance therapy to their oral medication may be another alternative in these patients.     

Sildenafil versus the vacuum erection device: patient preference

PURPOSE: We evaluated the preference of patients with erectile dysfunction who had been effectively treated with a vacuum erection device and then switched to sildenafil. MATERIALS AND METHODS: A total of 52 patients with erectile dysfunction who achieved satisfactory erectile function according to the International Index of Erectile Function (IIEF) while using a vacuum erection device were switched to an increasing dose of sildenafil (range 25 to 100 mg.) until satisfactory erection was maintained at least twice a week for at least 1 month. The 2 treatment methods were not used concomitantly. A total of 36 patients with a mean age of 59 years (range 35 to 77) who claimed to have achieved satisfactory erections with a vacuum erection device and sildenafil reported their preference to continue sildenafil or resume the use of a vacuum erection device, reasons for the choice and any adverse side effects. RESULTS: Of the 36 participants in whom the efficacy of sildenafil was similar to that of a vacuum erection device according to the IIEF scores (mean plus or minus standard deviation 61.6 +/- 10.4 and 62.5 +/- 6, respectively), 12 (33.3%) decided to resume use of a vacuum erection device (group 1) while 24 (66.6%) preferred to continue sildenafil (group 2). There were no statistically significant differences between the groups regarding patient age or the etiology and duration of erectile dysfunction. The increase in the IIEF score while using a vacuum erection device was higher in group 1 than 2, with a mean of 66.75 versus 60.4, respectively (p = 0.002). The adverse side effects of sildenafil were the main reasons for preferring a vacuum erection device. Fewer ejaculatory difficulties, efficacy, comfort and ease of use were the main reasons for choosing sildenafil. CONCLUSIONS: Even in an era of effective oral medication, the vacuum erection device remains a preferred treatment option for a substantial number of patients with erectile dysfunction.     

Hypogonadism and erectile dysfunction: the role for testosterone therapy

The role of low testosterone levels in erectile dysfunction (ED) remains unclear. Both organic and psychogenic factors contribute to ED, with vasculogenic causes being the most common etiology. Approximately 10-20% of patients with ED are diagnosed with hormonal abnormalities. At the physiologic level, two second messenger systems are involved in mediating erections, one involving cyclic adenosine monophosphate (cAMP) and the other involving cyclic guanosine monophosphate (cGMP). PDE5 inhibitors such as sildenafil promote the cGMP pathway, while alprostadil affects the cAMP pathway. Evidence is strong that, in animal systems, testosterone has direct effects on erectile tissue. However, although testosterone clearly has an impact on libido in humans, its effect on penile function is less clear. Evaluation of ED includes medical, sexual, and psychosocial history assessments, as well as laboratory tests to check for diabetes and hormonal abnormalities. Initial interventions should involve correction of potentially reversible causes of ED, such as hypogonadism. First-line therapy for other patients is typically oral PDE5 inhibitors, such as sildenafil, tadalafil, or vardenafil. For patients who fail treatment with PDE5 inhibitors, local therapies such as intracavernous alprostadil are highly successful. Recent data also support the success of combination therapy with sildenafil and testosterone. This opens the possibility of other combinations of testosterone and other treatments of ED. The ability to exploit multiple pathways in the physiologic processes leading to erection may help improve therapy for ED.     

Multicenter study of the treatment of erectile dysfunction with transurethral alprostadil (MUSE) in Korea

A Korean multicenter study was conducted to assess the effectiveness of transurethral alprostadil with MUSE in 334 subjects with chronic erectile dysfunction (ED) who were enrolled in 21 clinical centers. Patients with psychogenic impotence comprised about 30% of subjects. Intraurethral alprostadil was titrated in a stepwise fashion in the clinics from 250 to 500 or 1000 mcg based on erectile response and tolerability. The erectile responses were evaluated using an erection assessment scale (score of 1-5). The dose that produced a maximal penile response of score 5 (full rigid erection) or 4 (full tumescence, partial rigidity) was selected for home treatment. Patients who showed partial erection (score of 3) with 1000 mcg were also included in the home-treatment group. In-clinic phase: 198 men (59.3%) had maximal penile responses of score 4 or 5. The rate of maximal responses was not related to patient age, etiology or duration of the ED. A total of 228 (68.3%) men progressed to home treatment. The overall level of comfort of the transurethral alprostadil was rated as uncomfortable or very uncomfortable in 12%. Home phase: During the two-month period of home treatment, 178 (78.1%) men had successful sexual intercourse at least once, and 78.2% of administrations (1976) resulted in successful intercourse. The main causes of drop-out were insufficient erectile response in 27 men (11.8%), adverse reactions (mostly penile or urethral pain) in 7 (3.1%) or both in 7 (3.1%). In conclusion, transurethral alprostadil could be a suitable treatment option for patients with ED regardless of age and etiology of ED. Efficacy in an Asian population (Korea) is comparable to that reported previously in Caucasians.