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The use of sildenafil in patients with erectile dysfunction in relation to diabetes mellitus--a study of 1,511 patients.

Erectile dysfunction (ED) seriously impairs the quality of life. Patients with diabetes mellitus (DM) are prone to ED due to various factors, including vasculopathy, neuropathy and sex hormone abnormalities. This is a retrospective study involving 1,511 patients taking sildenafil. Patients with DM have significantly more comorbidities like hypertension and ischaemic heart disease. They are also more likely to be on medications which may affect erectile function, including various antihypertensive drugs. 77.9% of patients with DM reported success with sildenafil, as compared to 86.5% of patients without DM. A significant number of patients with DM require a higher dose of sildenafil as compared to those without DM.

Diabetes Complications↗

The use of treatments for erectile dysfunction among survivors of prostate carcinoma.

BACKGROUND: The objectives of this survey were to describe the prevalence of using a treatment for erectile dysfunction (ED) among men after therapy for localized prostate carcinoma and to construct models explaining the variance in trying a treatment, treatment success, and adherence to treatment. METHODS: A postal survey was sent to 2636 men in The Cleveland Clinic Foundation's Prostate Cancer Registry who were treated initially with either definitive radiotherapy or prostatectomy for localized prostate carcinoma. The survey asked about demographic items, past and current sexual functioning, and the partner's sexual function. Men were asked about their current and intended use of medical treatments for ED. Standardized questionnaires included the Sexual Self-Schema Scale-Male Version, the International Index of Erectile Function, urinary and bowel symptom scales from the Los Angeles Prostate Cancer Index), and the Short-Form Health Survey. RESULTS: The return rate was 49%. Differences between men who returned the questionnaire and men who did not respond suggest that the sample was weighted toward men who were more interested in staying active sexually. ED was a problem for 85% of men, and 59% of this group used at least 1 treatment for ED. Only 38% of men found that a medical treatment was at least somewhat helpful in improving their sex lives, however, and 30% of respondents still were using at least 1 treatment at the time of the survey. Factors that were associated with the efficacy of treatments for ED and with their continued use included having a sexual partner, younger age, choosing a treatment for prostate carcinoma that was more likely to spare some sexual function, and not having had neoadjuvant or current antiandrogen therapy. Men who tried a greater number of treatments for ED were more likely to find one that worked. Men were more likely to continue using treatments for ED that produced greater improvements in sexual function. CONCLUSIONS: The success of medical treatments for men with ED among long-term survivors of prostate carcinoma is limited. Men prefer noninvasive treatments, although invasive treatments are more effective. Sexual counseling for men and their partners is recommended, because it may increase the use of medical therapies for ED. Creating more realistic expectations in both partners also may enhance treatment adherence.

Adult↗

[Evaluating the treatment satisfaction of vardenafil in men with erectile dysfunction and female partners by the Treatment Satisfaction Scale].

The Treatment Satisfaction Scale (TSS) has been developed to assess various concepts related to erectile dysfunction (ED) treatment satisfaction in patients and their partners. The self-report questionnaire consists of 4 modules: unmedicated patient, medicated patient, unmedicated partner, and medicated partner modules, measuring a range of sexuality concepts considered important by ED patients and their partners including six domains: "Confidence", "Ease with Erection", "Erectile Function Satisfaction", "Pleasure from Sexual Activity", "Satisfaction with Orgasms", and "Satisfaction with Medication". The TSS is an internationally valid, psychometrically sound instrument to assess patient and partner satisfaction with ED therapy. In a recent double-blind, multicenter, parallel arms, flexible dose clinical trial, the TSS was used to compare patient and partner's satisfaction with vardenafil and placebo therapy. The results demonstrated that vardenafil significantly improved not only erectile function, but also confidence, ease of erection, pleasure, and satisfaction with erectile function, orgasm and medication in men ED and their partners. These attributes are considered to be essential in the acceptance and continued use of PDE5 inhibitor therapy for ED.

Double-Blind Method↗

Vardenafil is effective and well-tolerated for treating erectile dysfunction in a broad population of men, irrespective of age.

OBJECTIVES: To assess the efficacy and safety of vardenafil in the treatment of erectile dysfunction (ED) in men of different age groups. PATIENTS AND METHODS: In a retrospective pooled subgroup analysis of randomized, double-blind, placebo-controlled studies, men from the general population with ED received either placebo or vardenafil 5, 10 or 20 mg over 12 weeks. Efficacy variables included the erectile function (EF) domain score from The International Index of Erectile Function, diary response rates to questions on vaginal penetration and maintenance of erection, and positive responses to the Global Assessment Question (GAQ) "Has the treatment you have been taking over the past 4 weeks improved your erections?'. The 1385 men were grouped by age (< 45, 45-64 and > or =65 years). RESULTS: At 12 weeks the EF domain scores approached 20 with vardenafil and 14 with placebo in men aged > or = 65 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). The corresponding scores were 22 and 14 in men aged 45-64 years and up to 24 and 16 in those aged <45 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). Vardenafil generated positive GAQ responses in approximately 71%, 76% and 85% of men aged <45, 45-64 and > or = 65 years (P < or = 0.001 vardenafil vs placebo). The corresponding placebo rates were 23%, 25% and 34%. The most common treatment-emergent adverse events were headache, rhinitis, flushing and dyspepsia, which were mild to moderate, transient and unrelated to age. CONCLUSION: Vardenafil is an effective and generally well-tolerated treatment for ED, irrespective of age.

Adult↗

Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction.

This randomised, double-blind study assessed the long-term efficacy and tolerability of vardenafil 10 and 20 mg in men with erectile dysfunction (ED). A total of 566 men who completed an initial 12-month treatment period entered a 12-month extension. In these men, both doses of vardenafil produced improvement in scores for the 'erectile function' Domain of the International Index of Erectile Function, evident from week 4 and maintained through 2 years. Sexual Encounter Profile diary responses indicated that following treatment, penetration was achieved on 92-94% of attempts and erections that lasted long enough for successful intercourse were achieved on 87-89% of attempts. In response to the General Assessment Question, 90-92% of patients reported improved erections with vardenafil. Most treatment-emergent events were mild and transient with no cardiovascular safety concerns. These results support the long-term efficacy, reliability and tolerability of vardenafil 10 and 20 mg in men with ED.

Adult↗

Is erectile dysfunction an indicator for increased risk of coronary heart disease and stroke?

BACKGROUND: Considered to be a manifestation of a generalized vascular disease, erectile dysfunction (ED) could serve as an indicator for future cardiovascular events. Aim of this study was therefore to evaluate the role of ED as a predictor for coronary heart disease (CHD) and stroke. METHODS: Men participating in a health-screening project in the area of Vienna completed the International Index of Erectile Function-5 questionnaire (IIEF5) to assess prevalence and severity of ED. Additionally, all men underwent a detailed health examination. The risk for CHD or stroke within 10 years depending on the severity of ED was estimated according to Framingham risk profile algorithms. RESULTS: In the CHD risk cohort (n = 2.495; 46.2 +/- 9.9 yrs) men with moderate/severe ED (IIEF5 5-16; n = 163) had a 65% increased relative risk for developing CHD within 10 yrs compared to those without ED (IIEF5 22-25; n = 1.784) (absolute risk: 8.0% for no ED to 13.2% for moderate/severe ED; p < 0.001). Relative risk increase ranged from 13.9% for those aged 30-39 yrs (p = 0.121), to 42.2% for 40-49 yrs (p = 0.012), 27.7% for 50-59 yrs (p = 0.048) and 27.1% for 60-69 yrs (p = 0.021). In the stroke risk population (n = 644; 61.3 +/- 5.1 yrs) men with moderate/severe ED (n = 99) were at a 43% relative risk increase for a stroke within 10 years (absolute risk: 9.3% for no ED to 13.3% for moderate/severe ED; p = 0.041). Increased risk varied between 38.6% for men aged 55-59 yrs (p = 0.013), 24.7% for 60-64 yrs (p = 0.072), 35.9% for 65-69 yrs (p = 0.046) and 43.6% for 70-74 yrs (p = 0.049). CONCLUSIONS: Moderate to severe ED, but not mild ED is associated with a considerably increased risk for CHD or stroke within 10 years. A thorough medical surveillance seems therefore advisable for men with ED including cardiological evaluation, treatment of risk factors and lifestyle modifications.

Adult↗

Coincidence of induratio penis plastica and erectile dysfunction.

There are still diverse management options in Peyronie's disease and diverse opinions about the coincidence of Peyronie's disease and erectile dysfunction (ED) as well. The connection between Peyronie's disease and ED has been proved by some articles, but on the other hand authors have refused this fact. We found ED in about 30% of our patients suffering from Peyronie's disease. We have investigated 61 patients with Peyronie's disease. A diagnostic pattern for evaluation of angulation and ED are proposed. The tunica albuginea plication technique was used in 35 patients with good results. In our investigation we cannot find any coincidence of Peyronie's disease with ED.

Adult↗

Predictive factors for erectile dysfunction in men with prostate cancer after brachytherapy: is dose to the penile bulb important?

PURPOSE: To determine predictive factors for postimplant erectile dysfunction (ED) in a cohort of patients, according to prospectively collected data; specifically, to assess the impact of penile bulb volume and D50 and D95 (dose covering 50% and 95% of the penile bulb volume, respectively) on ED. METHODS AND MATERIALS: Three hundred forty-two patients were identified who were potent before implant and who had at least 2 years' follow-up. Patient, tumor, treatment, and dosimetric data were collected on all patients. Postimplant ED was defined according to both physician-documented and patient-documented outcome data. Binary logistic regression analysis was used to create multivariable models of predictors for ED at 1, 2, and 3 years after implant. RESULTS: Physician-documented rates of ED were 57%, 48%, and 38% at 1, 2, and 3 years after implant, respectively. Patient-documented rates of ED were 70% and 66% at 1 and 2 years, respectively. Multivariable analyses revealed age and degree of pre-implant erectile function to be consistently significant predictors of ED. Use of hormones was significant at the 1-year physician-documented ED endpoint but not thereafter, in keeping with the time course of testosterone recovery. Penile bulb volume, D50, and D95 were not found to be predictive for ED at any time point, in contrast to previous studies. In addition, planning ultrasound target volume, number of needles, and institutional case sequence number were significant predictors of ED at various time points, consistent with a traumatic etiology of ED. CONCLUSIONS: We found no evidence to support penile bulb dosimetry as an independent predictive factor for ED after implant, using physician-documented or patient-documented outcomes.

Aged↗

[Comparing effect in the management of erectile dysfunction by using 2 sets of drugs of intracavernosal injection].

OBJECTIVES: To supply clinical data for drug selextion in the treatment of erectile dysfunction through intracavernosal injection. METHODS: Fifty-six ED patients were randomly classified into 2 groups and received phentolamine along with papaverine (for group 1) or phentolamine, papaverine and ligustrazin hydrochloride(for group 2). RESULTS: Patients in group 2 enjoyed a longer time of erection. More patients in group 2 succeeded in having enough erection time and hardness to complete sexual intercourse (P < 0.05). CONCLUSIONS: The extrainjection of ligustrazin hydrochloride injection can help prolong erection duration and hardness and reduce tubercles that might occur in the corpus carvernosal. Therefore it is a safe and inexpensive drug in the intracarvernous injection treatment.

Adult↗

Outcome measures for erectile dysfunction. 1: Literature review.

This article describes and evaluates critically the outcome measures available for the assessment of the conservative treatment of erectile dysfunction (ED). The literature review identified 26 outcome measures. Of these, 14 were subjective and 12 were objective. Objective measures can provide more accurate information. However, owing to the sensitive nature of the problem, questionnaires which are reliable and sensitive to change can provide valuable data. Different outcome measures were needed for each of the separate components of ED. These components were found to be rigidity, vascular flow, nerve conductivity, intracavemosal pressure, ischiocavernosus muscle power, partner satisfaction and quality of life. An evaluation of outcome measures for each component of ED is provided in the second part of this article. Quick, simple, inexpensive and efficient outcome measures can be used by nurses to evaluate the impact of conservative treatment for ED.

Erectile Dysfunction↗

Evaluation and therapeutic regulation of erectile dysfunction with visual stimulation test. An objective approach by using sildenafil citrate test.

AIM: An objective evaluation of the psychogenic cause of erectile dysfunction by performing the visual stimulation tumescence and rigidity (VSTR) test and sildenafil citrate test, together with the effectiveness of sildenafil citrate medication on impotence caused by different etiologies. MATERIAL AND METHODS: Between 1998 and 2000, a total of 36 men (12 patients with diabetic etiology, 5 patients with vasculogenic risk factor) were enrolled in this study. The mean age of patients was 53 (27-67) years. Following standard questionnaires, including a detailed anamnesis from an andrologic viewpoint, VST was performed in an ambulatory setting and beginning with a test dose of 50 mg. At the end of 2 h, the data was evaluated with computer assistance (Rigiscan device) and if a satisfactory erection had not occurred, an additional second dose of sildenafil citrate (50 mg) was given until there was a satisfactory erection. Results obtained from VST: results were classified as group I (fully rigidity, >10 min erection, >70% of rigidity, possible vaginal penetration), group II (unstable erection, 5 min erection, >70% of rigidity, possible vaginal penetration) and group III (tumescence without rigidity, <5 min erection, <70% of rigidity, impossible vaginal penetration). The results obtained during the first 1 h of the VSTR test were regarded as the patient's own erectile condition and later data was accepted as the real effect of sildenafil citrate. The Fisher exact test was used for statistical evaluation including pre- and post-sildenafil effect on erectile rigidity and duration of erection. RESULTS: The erection status of patients was sufficient in 17 (47.2%) in group I, it was insufficient but sufficient enough with an increased dose of sildenafil citrate in 10 (27.7%) in group II, and insufficient without/with full dose of sildenafil citrate in 9 (25%) in group III. Considering rigidity and total erectile period, there was a statistical significant difference between the first two groups with respect to the early and late sildenafil citrate effects on the VSTR test (p < 0.05). Again, 10 patients with known risk factors (diabetes mellitus 5 and vasculogenic 5) in the second group seemed to give a good response to repeated dosage of sildenafil citrate which has been found to be very interesting. However, the rest of the diabetic patients (n = 7) in the third group showed no erection despite the increasing and repeated doses of sildenafil citrate. CONCLUSION: Sildenafil citrate with the VSTR test has effective and reliable results which was regarded as very important to diagnose and determine objectively the amount of therapeutic doses in impotence. In accordance with the literature data, our results also confirm the reliability and the practical nature of the VSTR test, which is less time-consuming and cheaper than the nocturnal penile tumescence and rigidity (NPTR) test. In the VSTR test, necessary doses of medication needed for satisfactory erection were easily regulated in patients with certain kinds of impotence. Additionally, self-criticism advantage of the patients on erection and an unnecessary need for regular sexual partners may make this test preferable in the near future. However, we believe that a large group of patients with other definite parameters are certainly needed in order to obtain more reliable data.

Adult↗

The role of the 'lifestyle' label and negative bias in the allocation of health resources for erectile dysfunction drugs: an ethics-based appraisal.

There have been recent calls for the re-evaluation of health resource allocation for erectile dysfunction (ED) drugs. This paper discusses sociocultural prejudices associated with ED and its treatment, arising from the link with sexuality, the perception that ED is a 'lifestyle' issue and the belief that ED is part of the normal ageing process. These views diminish the perceived importance of sexual health, extending subjectively into the funding arena as a 'negative bias'. Empirical data are presented, which demonstrate that ED can have significant psychosocial consequences, and that ED drugs are valuable quality-of-life interventions. The assumption that ED is an inevitable part of ageing is also analysed and found to be questionable. Health resource allocation decisions for ED drugs must be conducted with an awareness of the ethical and clinical complexities described in this paper, and with the sensibility that negative personal value judgments (on the part of policymakers) must be guarded against.

Age Factors↗

Patient preferences in treatment of erectile dysfunction: the continuing importance of patient education.

Understanding patient preferences can be important in ensuring full benefit is derived from treatment for erectile dysfunction (ED). They seem to be important in determining whether patients continue treatment in the medium and long term. In clinical practice, discontinuation rates beyond a year are relatively high. Factors such as spontaneity, "naturalness", and onset and duration of action may all influence preference. This article discusses a number of studies looking into patient preferences for a particular class of treatment method over another, and also for individual treatments within classes. In general, patients appear to prefer oral treatments to others such as penile implant surgery, vacuum-pump therapy, apomorphine, and intracavernosal injection. In some studies, men have also shown preferences for particular oral phosphodiesterase-5 (PDE5) inhibitors over others. Providing patients with full information on the pros and cons of treatment options can help ensure patients are treated with a therapy that fits more closely with their wishes, and ensure continuation of treatment for optimal efficacy.

Carbolines↗

Intracavernosal injection therapy with and without sexological counselling in men with erectile dysfunction.

OBJECTIVE: To compare the acceptance of and satisfaction with intracavernosal injection (ICI) therapy with and without sexological counselling in men with erectile dysfunction (ED). PATIENTS AND METHODS: In a prospective randomized study, men were alternately assigned to ICI without sexological counselling (-SC) or with sexological counselling (+SC). In all, 70 patients were included, i.e. 35 in each group; 57 (28 -SC, 29 +SC) were interviewed by telephone after a mean follow-up of 11.3 months to determine their use of ICI and reasons for discontinuing. RESULTS: There were no differences between the groups in discontinuation of ICI (overall 30%), in reasons for discontinuing ICI (24% did so because of the return of spontaneous erections) or in sexual functioning. CONCLUSION: There was no positive contribution from additional sexological counselling but extensive information and support by the urologist seems to be sufficient, resulting in a high acceptance rate of ICI. The discontinuation rate (30%) is one of the lowest reported.

Adult↗

Validation of the German version of the International Index of Erectile Function (IIEF) in patients with erectile dysfunction, Peyronie's disease and controls.

The objective of this study was to validate the German translation of the International Index of Erectile Function (IIEF). The IIEF was administered to 59 patients with erectile dysfunction (ED), to 38 patients with Peyronie's disease and to 33 controls. All patients were investigated by standardized German versions of international questionnaires of anxiety, depression, social desirability, quality of partnership, physical complaints and life-satisfaction. The five subscales of the English version, however, could not be replicated. Internal consistency for the complete questionnaire of 15 items was high (Cronbach's alpha=0.95). Based on the total scale and two subscales, we were able to discriminate sexual function between the ED group and the comparison groups. There was no significant correlation between the IIEF scores and anxiety, depression, somatic complaints and life-satisfaction. The German version of the IIEF has found good comprehension, and acceptance by the majority of patients. Its use is somewhat limited by its focus on sexual activity in partnership. In contrast to the English version, it mainly addresses a single factor of sexual function.

Adult↗

Sildenafil citrate significantly improves nocturnal penile erections in sildenafil non-responding patients with psychogenic erectile dysfunction.

Effects of sildenafil citrate on nocturnal penile tumescence and rigidity (NPTR) were evaluated among sildenafil non-responding patients with psychogenic erectile dysfunction. All patients (n=30), equally divided into groups I and II, completed four consecutive nights using the RigiScan Plus device. Sildenafil citrate (50 mg) was given in the third night in group I and in the fourth in group II, whereas a placebo was given in the remaining nights. Additional patients (n=12) receiving only a placebo served as a control group. Results of NPTR recordings revealed neither significant differences between the control and non-sildenafil nights of both test groups, nor between the corresponding values of both groups (P>0.05). On the other hand, when sildenafil citrate nights of groups I and II taken together were compared with placebo nights, a significant increase of total events duration (P<0.001), average rigidity of the tip (P<0.05) and base (P<0.01), and rigidity activity unit (RAU) and tumescence activity unit (TAU) of tip and base (P<0.001) was observed. These results suggest that performance anxiety may be responsible for failure of response during awakening.

Adult↗

On-demand IC351 (Cialis) enhances erectile function in patients with erectile dysfunction.

IC351 (Cialis) is a selective inhibitor of PDE5. The efficacy and safety of on-demand dosing of IC351 in men with erectile dysfunction was assessed in a multicenter, double-blind, placebo-controlled study. One hundred seventy-nine men (mean age: 56 y) were randomized to receive placebo or IC351 at doses of 2, 5, 10 or 25 mg, taken on demand over a 3-week period. The primary endpoints were change from baseline in responses to Questions 3 (Q3) and 4 (Q4) of the International Index of Erectile Function (IIEF). IC351 significantly improved IIEF Q3 scores at all doses vs placebo (P < or =0.003). IC351 also significantly improved IIEF Q4 scores in all but the 2 mg group (P < or =0.0003). No significant changes in laboratory values, ECGs, or blood pressure were observed. The most common adverse events were headache and dyspepsia. The conclusion of this study was that on-demand IC351 at doses up to 25 mg was well tolerated and significantly improved erectile function.

Adult↗

Management of erectile dysfunction: barriers faced by general practitioners.

AIM: To explore the barriers faced by general practitioners (GPs) in the management of patients with erectile dysfunction (ED). METHODS: This was a qualitative analysis of focus group discussions and in-depth interviews involving 28 Malaysian GPs. RESULTS: GPs' perception of ED being not a serious condition was a major determinant of their prescribing practice. Doctor's age (younger), gender (female), short consultation time and lack of experience were cited as barriers. The GPs' prescribing habits were heavily influenced by the feedback from the first few patients under treatment, the uncertainty of etiology of ED without proper assessment and the profit margin with bulk purchase. Other barriers include Patients' coexisting medical conditions, older age, lower socio-economic status, unrealistic expectations and inappropriate use of the anti-impotence drugs. Cardiovascular side effects and cost were two most important drug barriers. CONCLUSION: The factors influencing the management of ED among the general practitioners were multiple and complex. An adequate understanding of how these factors (doctors, patients and drugs) interact can assist in the formulation and implementation of strategies that encourage GPs to identify and manage ED patients.

Adult↗