Efficacy of sildenafil for Japanese patients with audio-visual sexual stimulation (AVSS) test by the RigiScan Plus

Sildenafil is most effective in men with mild-to-moderate ED, but not severe ED in Japan. In order to evaluate the efficacy of sildenafil, we conducted the present study using the AVSS test by the RigiScan Plus. The subjects were 56 patients (age: 34-82 years, mean: 60.5 years) with ED. The IIEF5 questionnaire and the AVSS test were conducted before and after administration of sildenafil. The penile rigidity could not be measured in 19 patients. Of these 19, sildenafil was effective in 7 and not effective in 12. The 7 cases in whom sildenafil was effective were all false-negatives. The sensitivity of sildenafil was 84%, and its specificity was 100%. This study suggests that the AVSS test by RigiScan Plus can objectively evaluate the efficacy of sildenafil, and shows potential for predicting that efficacy.     

Comparative study between audiovisualsexual stimulation test and nocturnal penile tumescence test using RigiScan Plus in the evaluation of erectile dysfunction

INTRODUCTION: Although the nocturnal penile tumescence (NPT) test is considered the gold standard for the differential diagnosis of psychogenic versus organic erectile dysfunction (ED), concerns have recently been raised regarding the financial and time expenditure it demands. We evaluated the diagnostic efficacy of the audiovisual sexual stimulation (AVSS) test as an alternative to the NPT test. PATIENTS AND METHODS: A total of 43 patients with ED were examined. Each patient filled in an International Index of Erectile Function (IIEF) questionnaire. The evaluation of each patient consisted of AVSS and NPT tests which were performed using the RigiScan Plus. The results obtained with the two tests were compared. The patients with normal NPT patterns were presumed to have a psychogenic etiology of their ED and those with abnormal NPT patterns to have an organic etiology. RESULTS: The overall IIEF score was 32.5 +/- (SD) 9.2, and the erectile domain score was 12.2 +/- 4.5. Twenty-three patients had normal responses to the AVSS test, while 20 had abnormal responses. Twenty-two of the former 23 patients and 9 of the latter 20 patients had normal NPT patterns. Therefore, the AVSS test discriminated psychogenic ED with 71% sensitivity and 92% specificity. The overall accuracy of the test in this study was 77%. CONCLUSIONS: The AVSS test is simple, practical, and inexpensive, and its diagnostic accuracy is comparable to that of the NPT test. We conclude that the AVSS test should be the examination of choice for the primary etiological diagnosis in ED.     

Efficacy of sildenafil in erectile dysfunction after radical prostatectomy

Radical retropubic prostatectomy (RRP) is an important cause of iatrogenic erectile dysfunction (ED). While sildenafil has been widely used since its introduction as a new treatment option for ED, its efficacy in post-RRP patients has not been extensively studied. We retrospectively compared the efficacy of sildenafil in post-RRP and non-surgical patients with ED (NSED) using a subset of questions from the International Index of Erectile Function (IIEF) and correlated results with their specific etiology of ED based on penile blood flow study (PBFS). A brief questionnaire regarding satisfaction with sildenafil was administered to 72 consecutive post-RRP patients (nerve sparing status unknown) and 32 consecutive NSED patients who had previously undergone PBFS with pharmacotesting as part of their evaluation for ED. PBFS diagnoses were arterial insufficiency (AI) for peak systolic velocity (PSV) < 25 cm/sec; venogenic (CVOD) for PSV > or = 35 cm/sec, mixed vascular for PV > 25 but < 35 cm/sec and resistive index (RI) < 0.9; a vascular normal diagnosis (neurogenic impotence) required excellent rigidity sustained for 20 min. Differences in the IIEF subscores for the different groups of patients were assessed. Success with sildenafil was defined as moderate or excellent improvement (3/4 or 4/4) with ability for penetration. No differences were found among the different subgroups of RRP patients with respect to IIEF scores or success rates with sildenafil. NSED patients had both significantly higher post-treatment IIEF scores (3.6/3.4 vs 2.5/2.2; t=4.50, P<0.0001) and success rates (63% vs 31%; t=3.11, P < 0.01) with sildenafil treatment than RRP patients. We found that sildenafil is significantly less effective in impotent RRP patients than in age-matched patients with ED (31% vs 63%). We had postulated that sildenafil would be least effective among RRP patients with excellent sustained rigidity to PGE1, as this subgroup is likely to have neurogenic impotence. We found that sildenafil response rates among subgroups of RRP patients were statistically similar regardless of PBFS diagnosis. IIEF scores for the RRP subgroups were similar but statistically lower than in men with ED and no history of RRP. While individuals with normal vascular responses to PGE1 have an increased likelihood of having neurogenic impotence, in RRP patients, we were unable to demonstrate any difference in efficacy of sildenafil, regardless of the PBFS diagnosis.     

Comparison of the International Index of Erectile Function erectile domain scores and nocturnal penile tumescence and rigidity measurements: does one predict the other?

OBJECTIVE: To describe the relationship between the International Index of Erectile Function (IIEF) erectile domain score, and nocturnal penile tumescence and rigidity values measured by RigiScan (Timm Medical Technologies, Eden Prairie, MN). PATIENTS AND METHODS: In all, 73 men were evaluated with the IIEF and 2 nights of continuous penile monitoring with the RigiScan. Twenty-six men were evaluated before and after prostatectomy, for a total of 99 pairs of data points. We dichotomized the RigiScan results as 'adequate' (no erectile dysfunction, ED), or 'inadequate' (having ED), based on the 'best erectile event' over the 2 nights of monitoring. Two separate criteria for adequate erectile function were used, one of >70% rigidity for > or = 10 min, and the other >60% rigidity for > or = 10 min. The erectile domain score of the IIEF was calculated in the standard fashion. RESULTS: Using both the 70% and the 60% rigidity criteria, there was a statistically significant association between the IIEF erectile domain scores and the RigiScan data (r = 0.27, P = 0.008 and r = 0.29, P = 0.003, respectively). However, the sensitivity of the IIEF to predict ED based on RigiScan results using the 70% rigidity criteria was 68.9%, and the specificity was 57.1%. When the IIEF was used as a continuous predictor of RigiScan results, the area under the receiver-operating characteristic (ROC) curve was 0.66. Using the 60% criteria, the sensitivity was 55.8% and the specificity was 73.2%; the area under the ROC curve was 0.72. CONCLUSIONS: IIEF erectile domain scores and nocturnal penile tumescence and rigidity measurements are weakly associated, and the clinical utility of one test to predict the other is limited. However, because of the differences in the measured outcomes (perception of erectile function vs physiological capacity), a weak association does not disqualify either test's individual utility.     

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.     

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.     

Improved spontaneous erectile function in men with mild-tomoderate arteriogenic erectile dysfunction treated with a nightly dose of sildenafil for one year： a randomized trial

Aim： To test the hypothesis that sildenafil （50 mg nightly for one year） can improve spontaneous erectile function （EF） in men with mild-to-moderate arteriogenic erectile dysfunction （ED） responsive to erectogenic treatment. Methods： In a prospective open-label trial, 112 men with ED were randomized to sildenafil 50 mg nightly or sildenafil 50 or 100 mg as needed for 12 months, followed by one-month and 6-month non-medicated periods. Non-randomized, non-medicated men with ED were also assessed. The EF domain of the International Index of Erectile Function （IIEF EF） and the peak systolic velocity （PSV） of penile cavernous arteries were used to measure the efficacy. Results： After sildenafil treatment and a subsequent non-medicated month, IIEF EF was normal in 29 of 48 （60.4%, 95% confidence interval [CI]： 45.3-74.2%） of the nightly group vs. 4 of 49 （8.2%, 95% CI： 2.3-19.6%） of the as-needed group. PSV improved by 11.2 cm/s （95% CI： 4.7-21.4; P = 0.012） in the nightly group but only by 3.4 cm/s （-5.1- 14.7; P = 0.435） in the as-needed group. IIEF EF normalized in 1 of 18 （5.6%, 95% CI： 0.1-27.3%） non-medicated men and the PSV declined slightly. Six months after treatment, the IIEF EF remained normal and PSV was stabilized in most （28/29, 97%） nightly group men who had initially normalized. Conclusion： Sildenafil nightly for one year resulted in ED regression that persisted well beyond the end of treatment, so that spontaneous EF was characterized as normal on the IIEF in most men. The results from this open-label, randomized trial warrant verification under double-blind, placebo-controlled conditions.     

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.     

Recovery of erectile function after nerve-sparing radical prostatectomy: improvement with nightly low-dose sildenafil

OBJECTIVE

To evaluate the effect of low‐dose sildenafil for rehabilitating erectile function after nerve‐sparing radical prostatectomy (NSRP), as the delay to recovery of erectile function after NSRP remains under debate.

PATIENTS AND METHODS

Forty‐three sexually active patients had a NSRP; at 7–14 days after surgery they had a Rigiscan® (Dacomed Corporation, Minneapolis, MN, USA) measurement of nocturnal penile tumescence and rigidity (NPTR). To support the recovery of spontaneous erectile function, 23 patients with preserved nocturnal erections received sildenafil 25 mg/day at night. A control group of 18 patients were then followed but had no phosphodiesterase‐5 inhibitors. The International Index of Erectile Function (IIEF)‐5 questionnaire was completed 6, 12, 24, 36 and 52 weeks after NSRP.

RESULTS

Of the 43 patients, 41 (95%) had one to five erections during the first night after catheter removal. In the group using daily sildenafil the mean IIEF‐5 score decreased from 20.8 before NSRP to 3.6, 3.8, 5.9, 9.6 and 14.1 at 6, 12, 24, 36 and 52 weeks after NSRP, respectively. In the control group the respective scores were 21.2, decreasing to 2.4, 3.8, 5.3, 6.4 and 9.3. There was a significant difference in IIEF‐5 score and time to recovery of erectile function between the groups (P < 0.001), with potency rates of 86% vs 66%.

CONCLUSION

The measurement of NPTR after NSRP showed erectile function even the ‘first’ night after catheter removal. In cases of early penile erection, daily low‐dose sildenafil leads to a significant improvement in the recovery of erectile function.     

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

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

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.     

Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction

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

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

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

Acupuncture in the treatment of psychogenic erectile dysfunction: first results of a prospective randomized placebo-controlled study

In a prospective study, we investigated the potentially curative effect of acupuncture in patients with psychogenic erectile dysfunction (pED). A total of 22 patients with pED were randomized into two groups. They were either treated with acupuncture specific against ED (treatment group) or acupuncture specific against headache (placebo group). Nonresponders of the placebo group were crossed over to the treatment group. Prior to acupuncture, serum sexual hormone levels, IIEF score, nocturnal penile tumescence testing for three nights (Rigiscan) and the erectile response to 50 mg sildenafil were evaluated. Out of 21 patients, 20 completed the study, including 10 patients after crossover. A satisfactory response was achieved in 68.4% of the treatment group and in 9% of the placebo group (P=0.0017). Another 21.05% of the patients had improved erections, that is, sufficient rigidity under simultaneous treatment with 50 gm sildenafil. The results of our pilot study indicate that acupuncture can be an effective treatment option in more than two-thirds of patients with psychogenic erectile dysfunction.     

Efficacy of sildenafil in male dialysis patients with erectile dysfunction unresponsive to erythropoietin and/or testosterone treatments

The aim of this study was to evaluate the effects of recombinant human erythropoietin (Epo), testosterone (T) or a combination of them in the treatment of erectile dysfunction (ED) in hemodialysis patients, as well as the efficacy of sildenafil in patients unresponsive to combination treatment. A total of 23 patients with ED were divided into two groups. The international index of erectile function (IIEF) was used to evaluate ED and treatment response. Patients received Epo or T treatments for 12 weeks. Later on both groups received combination treatment for another 12 weeks. Although IIEF scores increased significantly in both groups after the combination treatment, the score changes were similar. After combination treatment, 16 patients still having IIEF score <26 were given sildenafil treatment in combination with Epo while T was discontinued. Although the IIEF scores increased significantly in all patients (17.4%), only eight of them attained an IIEF score of > or =26. The baseline IIEF scores of the patients with satisfactory response to the sildenafil treatment were higher than those with unsatisfactory response. The patients with a score of > or =22 responded better to the treatment. Although Epo and/or T therapies could partially improve ED in male dialysis patients besides correcting renal anemia and hypogonadism, sildenafil treatment could improve ED in unresponsive patients. Especially, those with higher baseline IIEF scores benefited more.     

维持性血液透析患者勃起功能障碍的初步研究

目的 明确维持性血液透析（MHD）男性患者勃起障碍的发病率，及评价西地那非的疗效与副作用。方法 以国际勃起功能指数（IIEF）对22例HD男患者进行评分。勃起障碍者给予西地那非，每次从25mg/d开始，最高为100mg/d，治疗12周，对比治疗前后IIEF分值变化。结果 MHD勃起障碍发病率为72.73%。西地那非总有效率为87.5%。常见的副作用为头痛，面色潮红等。结论 西地那非对于正在接近血液透析治疗的肾衰患者安全性和有效性等同于其它人群。     

Effect of sildenafil on nocturnal erections of potent men

We try to evaluate the effect of sildenafil on nocturnal penile erections of potent men. We recruited 22 potent men (eight medical students and 14 urology residents) 23-29 years old into the study. A disorder-free medical and sexual history and normal erectile functions were the only inclusion criteria. All subjects completed three sessions of consecutive nights using the RigiScan Plus device. After a first night of adaptation, night 2 recordings were their baseline values whereas they received sildenafil 100 mg on night 3. We observed statistically significant improvement with regard to those NPT parameters at the nights with sildenafil: number of erectile episodes; duration of tip rigidity >60%, RAU tip, RAU base and TAU tip (P<0.005). Although the duration of erectile episodes (min) and TAU base were greater during the sildenafil night, these did not reach statistical significance. In conclusion, our study showed that sildenafil can improve nocturnal erectile quality not only in patients with erectile dysfunction as previously published but also in potent males.     

Association between International Index of Erectile Function and axial penile rigidity in patients with erectile dysfunction

We investigated the association between the International Index of Erectile Function (IIEF) and axial penile rigidity parameters in patients with erectile dysfunction (ED). A total of 516 male patients (491 patients with ED and 25 patients without ED) were assessed using IIEF. Patients were assessed for axial penile rigidity (APR) using a digital inflection rigidometer. Mean age+/-s.d. was 52.4+/-9.9 y. ED was mild in 11.4% of the patients, moderate in 40.1%, and severe in 48.5%. Regarding APR, the following was found: (1) no significant difference between patients who had a mild degree of ED and patients who had no ED (P>0.05); (2) a significant difference between patients with different degrees of ED (P<0.05 for each); (3) a significant association between overall presence of ED and low APR (P<0.05). IIEF score is associated with APR and can differentiate between patients with and without ED.     

Erectile dysfunction in a primary care setting: results of an observational, no-control-group, prospective study with sildenafil under routine conditions of use

In order to assess the effectiveness of sildenafil under routine conditions of use in primary care settings and to evaluate its impact on patient's life satisfaction and partner's satisfaction with treatment for erectile dysfunction (ED), an open, multicentre, observational, prospective study was designed in which 2816 patients were treated with sildenafil for at least 10 weeks. Effectiveness was assessed using the International Index of Erectile Dysfunction (IIEF), life satisfaction was measured with 'Life-satisfaction Check List' (LISAT 8), and EDITS was optionally used to assess the partner's satisfaction with ED therapy. Sildenafil was effective in 86.6% of patients. All dimensions of IIEF significantly increased with sildenafil, particularly erectile domain which overall sample mean score improved was 13.2 points (P < 0.001). The greatest increases in satisfaction with all aspects of life were seen in sex life and relationship with partner dimensions. The patients' partners, answered by a minority of partners, were highly satisfied with the treatment and its rapid action, therefore they were in favour of continuing with same. The adverse events occurring were similar to those seen in clinical research on sildenafil in the premarketing phase. No control group was included in this study.     

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.