Sildenafil For Erectile Dysfunction Research Articles

Exploring the application of sildenafil for high-fat diet-induced erectile dysfunction based on interleukin-18-mediated NLRP3/Caspase-1 signaling pathway.

Inflammation is a key risk factor for heart disease and has also been linked to erectile dysfunction (ED). Sildenafil is a phosphodiesterase type 5 inhibitor with a strong antioxidant effect. Interleukin (IL)-18 is a proinflammatory factor. Excessive production and release of IL-18 disrupt the balance between IL-18 and IL-18 binding proteins in certain inflammatory diseases, leading to the occurrence of pathological inflammation. We evaluated the effects of sildenafil on erectile function in a rat model of high-fat diet-induced ED. Male Sprague Dawley rats (6weeks old) were divided into 5 groups: control, ED, sildenafil, IL-18, and IL-18 + sildenafil. Subsequently, intracavernous pressure and mean arterial pressure were used to assess the erectile function of these rats. The expression of endothelial nitric oxide synthase, pyroptosis factors, and the ratio of smooth muscle cells and collagen fibers were evaluated in the serum and corpora tissue. Exploring the role and mechanism of sildenafil in ED through NLRP3-mediated pyroptosis pathway. In comparison to the ED and IL-18 groups, there were statistically significant increases in the ratio of intracavernous pressure to mean arterial pressure, endothelial nitric oxide synthase expression, and the ratio of smooth muscle cells to collagen fibers following sildenafil intervention (P < .05). The sildenafil group and IL-18 + sildenafil group also showed statistically significant decreases the expression of NLRP3, caspase-1, and gasdermin D (P < .05). Sildenafil can improve erectile dysfunction by inhibiting inflammation. Strengths are that the relationship between pyroptosis and ED has been verified through in vitro and in vivo experiments. The limitation is that the conclusions drawn from animal and cells experiments need to be confirmed in clinical research. Sildenafil may reduce the effect of IL-18-induced inflammation in high-fat diet-induced ED rats through NLRP3/caspase-1 pyroptosis pathway.

Pharmacovigilance analysis of melanoma adverse events in men treated with sildenafil for erectile dysfunction

Pharmacovigilance analysis of melanoma adverse events in men treated with sildenafil for erectile dysfunction

Expression of Concern: Evaluation of the Safety and Efficacy of Sildenafil Citrate for Erectile Dysfunction in Men With Multiple Sclerosis: A Double-Blind, Placebo Controlled, Randomized Study.

No AccessJournal of UrologyExpression of Concern10 Jan 2023Expression of Concern: Evaluation of the Safety and Efficacy of Sildenafil Citrate for Erectile Dysfunction in Men With Multiple Sclerosis: A Double-Blind, Placebo Controlled, Randomized Studyis a expression-of-concern ofEvaluation of the Safety and Efficacy of Sildenafil Citrate for Erectile Dysfunction in Men With Multiple Sclerosis: A Double-Blind, Placebo Controlled, Randomized Study Mohammad Reza Safarinejad Mohammad Reza SafarinejadMohammad Reza Safarinejad *Correspondence: P.O. Box 19395-1849, Tehran, Iran telephone: 0098 21 22454499; FAX: 0098 21 22456845; E-mail Address: [email protected] More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003114AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail "Expression of Concern: Evaluation of the Safety and Efficacy of Sildenafil Citrate for Erectile Dysfunction in Men With Multiple Sclerosis: A Double-Blind, Placebo Controlled, Randomized Study." The Journal of Urology, Publish Ahead of Print, pp. – Study received Human Ethics Committee approval. From the Urology and Nephrology Research Center, Shahid Beheshti University, Tehran, Iran© 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of Urology14 Nov 2008Evaluation of the Safety and Efficacy of Sildenafil Citrate for Erectile Dysfunction in Men With Multiple Sclerosis: A Double-Blind, Placebo Controlled, Randomized Study Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mohammad Reza Safarinejad *Correspondence: P.O. Box 19395-1849, Tehran, Iran telephone: 0098 21 22454499; FAX: 0098 21 22456845; E-mail Address: [email protected] More articles by this author Expand All Study received Human Ethics Committee approval. Advertisement PDF downloadLoading ...

A national survey of pharmacists and interns in Aotearoa New Zealand: provision and views of extended services in community pharmacies

BackgroundChanges in pharmacy models of care, services and funding have been occurring internationally, moving away from the traditional dispensing role to more extended patient-facing roles utilising pharmacists’ clinical skills. This study aimed to identify the extended services offered by community pharmacy in Aotearoa New Zealand and the barriers and facilitators to extended services provision. The study is unique in that it includes intern (pre-registration) pharmacists.MethodsAn online survey, conducted in 2018, of all pharmacists and intern (pre-registration) pharmacists working in a community pharmacy. Data were analysed using descriptive statistics and regression analyses.ResultsThe results are based on replies from 553 community pharmacists and 59 intern pharmacists (response rate: 19 and 26% respectively). Both pharmacists (83%) and interns (85%) want to work at the top of their scope of practice. Wide variation exists in the specific services individual pharmacists offer. Most pharmacists were accredited to supply the emergency contraceptive pill (95%), sildenafil for erectile dysfunction (86%) and trimethoprim for uncomplicated urinary tract infection (85%). Fewer were able to immunise (34%) or to supply selected oral contraceptives (44%). Just under a quarter could provide a Medicines Use Review (MUR) or Community Pharmacy Anticoagulation Management Service (CPAMS). Of the pharmacists not already accredited, 85% intended to gain accreditation to supply selected oral contraceptives, 40% to become vaccinators, 37% to offer CPAMS and 30% MUR. Interns expressed strong interest in becoming accredited for all extended services.Poisson regression analyses showed key factors supporting the likelihood of providing extended services were owner and management support and appropriate space and equipment. Being excited about the opportunities in community pharmacy, having employer funding and time for training and sufficient support staff were also statistically significant.ConclusionsPharmacists need time and a supportive management structure to enable them to deliver extended services. Health policy with a greater strategic emphasis on funding services and pharmacist training, and developing technician support roles, will help to minimise or eliminate some of the barriers to role expansion both in Aotearoa New Zealand and internationally.

PO-01-057 Prognostic value of penile duplex ultrasound in patients started on sildenafil for erectile dysfunction

PO-01-057 Prognostic value of penile duplex ultrasound in patients started on sildenafil for erectile dysfunction

Sildenafil/Viagra in the treatment of premature ejaculation.

The arrival of Pfizer's blue pill Sildenafil in 1998 brought a great relief both to patient and physician signalling the start of a great era of medical therapy in sexual medicine. Since then the sexual medicine experts have been prescribing sildenafil in erectile dysfunction with acceptable minor adverse events. But the use of sildenafil in premature ejaculation (PE) is still debated. 2018 being the 20th anniversary of sildenafil, we have compiled interesting facts about the role of sildenafil in PE from various original articles, systematic reviews, meta-analyses, economic brochures and sexual medicine committee guidelines. The major issues in most of these studies were the heterogeneity in the definition of PE and estimating the exact ejaculatory latency time. This perspective article highlights the positive role of sildenafil in the management of PE (even without ED) with acceptable adverse events. Now that we have a standardised definition of PE from International Society of Sexual Medicine (ISSM) and a psychogenic component in PE definition, more randomised placebo-controlled studies are required to further establish its role.

Ethnicity and age as factors in sildenafil treatment of erectile dysfunction.

Sildenafil has been evaluated in >16000 men with erectile dysfunction (ED) in double-blind, placebo-controlled trials. To assess efficacy and safety of sildenafil in ED by ethnicity (white, black Asian) and age (≤45, 46-60, ≥61years). Data were pooled from 38 double-blind, placebo-controlled, flexible-dose trials. Most had starting sildenafil doses of 50mg once daily, ~1hour before sexual activity, with adjustment to 100 or 25mg as needed. Change from baseline in International Index of Erectile Function erectile function (IIEF-EF) domain score assessed with analysis of covariance and a Global Assessment Question (GAQ; "Did the treatment improve your erections?") at endpoint assessed with logistic regression analysis. 4120 and 3714 men received sildenafil and placebo, respectively (2740 and 2671 White; 407 and 385 Black; 973 and 658 Asian). For sildenafil vs. placebo groups, overall treatment differences for IIEF-EF domain and GAQ were significant for each ethnic and age group (P<.0001); significant treatment-by-ethnicity and treatment-by-age interactions were also observed for change in IIEF-EF domain scores (P<.05), with differences significantly greater for White vs. Black (P<.0001), White vs. Asian (P=.0163), and Asian vs. Black (P=.0036) men. A significant treatment-by-ethnicity interaction was observed for GAQ (P=.0004). The OR comparison for GAQ was significantly greater (P=.0001) with sildenafil vs. placebo in White (OR=11.2) or Asian (OR=12.4) men vs. Black men (OR=5.1). Adverse-event rates were generally similar, with some age variations. Sildenafil is effective and well-tolerated regardless of ethnicity or age; however, treatment effects can vary.

NNOS polymorphisms are associated with responsiveness to sildenafil in clinical and postoperative erectile dysfunction.

Sildenafil potentiates the nitric oxide (NO) signaling pathway. Since neuronal NOS is very important in the penis, we assessed whether NOS1 polymorphisms are associated with altered responsiveness to sildenafil in erectile dysfunction (ED). Patients (n = 137) were divided as clinical ED or postoperative ED. They were subdivided as good responders or poor responders to sildenafil, and genotypes for rs41279104 and rs2682826 NOS1 polymorphisms were determined. We found that the rs41279104 CT genotype was associated with good responders in postoperative ED patients, while rs2682826 CT genotype was associated with good responders in postoperative ED, and the TT genotype associated with good responders in both groups. Finally, the CT haplotype was associated with good responders in postoperative ED. NOS1 polymorphisms are associated with responsiveness to sildenafil in ED. Original submitted 20 November 2013; Revision submitted 31 January 2014.

Long-term testosterone supplementation is useful for ED with testosterone deficiency

Long-term testosterone supplementation is useful for ED with testosterone deficiency

A Systematic Review Assessing the Economic Impact of Sildenafil Citrate (Viagra®) in the Treatment of Erectile Dysfunction

Sildenafil was the first oral phosphodiesterase type 5 (PDE5) inhibitor introduced as primary therapy for erectile dysfunction (ED). In the 7 years following its market launch, sildenafil was prescribed by more than 750,000 physicians to more than 23 million men worldwide. To date, few studies have evaluated the economic impact of sildenafil in treating ED. To evaluate the cost-effectiveness and impact of sildenafil on health care costs for patients with ED in multiple countries. Economic outcomes including cost, cost-effectiveness, cost of illness, cost consequence, resource use, productivity, work loss, and willingness to pay (WTP) were investigated. Using keywords related to economic outcomes and sildenafil, we systematically searched literature published between July 2001 and July 2011 using MEDLINE and EMBASE. Included articles pertained to costs, WTP, and economic evaluations. In the last 10 years, 12 studies assessed economic outcomes associated with sildenafil for ED. Most studies were conducted in the United States and the United Kingdom, with one study identified in Canada and one from Mexico. Six studies evaluated cost of illness, cost consequence, or cost of care, and four studies evaluated WTP or drug pricing by country in the United States and the United Kingdom. In the United States and the United Kingdom, costs to health care systems have increased with demand for treatment. Cost analyses suggested that sildenafil would lower direct costs compared with other PDE5 inhibitors. U.S. and U.K. studies found that patients exhibited WTP for sildenafil. The two cost-effectiveness models we identified examined ED sub-groups, those with spinal cord injury and those with diabetes or hypertension. These models indicated favorable cost-effectiveness profiles for sildenafil compared with other active-treatment options in both Mexico and Canada. The relative value of sildenafil vs. surgically implanted prosthetic devices and other PDE5 inhibitors, is underscored by patients' WTP, and cost-effectiveness in ED patients with comorbidities.

Multi-domain Longitudinal Modeling: An Application to the International Index of Erectile Function

Individual domains of multi-domain, patient-reported outcome instruments are typically analyzed independently, without considering inherent interdependency. The authors assessed correlations across time (longitudinal) and across domains of a multi-domain instrument, simultaneously, in a single, unified, and cohesive integrated model. International Index of Erectile Function (IIEF) data from a trial of sildenafil in erectile dysfunction were used. For the multi-domain longitudinal modeling, covariance of response was constructed using (1) the Kronecker product of an unstructured covariance matrix to model across domains, with an unstructured covariance matrix to model across time, and (2) a completely general, unstructured covariance matrix. Treatment effects for all IIEF domain scores calculated using individual or multi-domain modeling were similar, reflecting the robust application of the integrated model to these data. In conclusion, modeling correlations simultaneously across domains and across time more rigorously address the natural interrelationship between domains and can provide a more accurate representation of treatment effects.

Sildenafil citrate for erectile dysfunction in patients with multiple sclerosis

Erectile dysfunction (ED) is a common sexual disease in male patients with multiple sclerosis (MS). Sildenafil citrate is considered as an effective drug in the treatment of male ED in the general population, but it has not been systematically reviewed in patients with MS. To assess the efficacy and safety of sildenafil citrate for ED in patients with MS. We searched the Cochrane (November 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4 of 4, 2011), MEDLINE (PubMed) (January 1966 to November 2011), EMBASE (January 1974 to November 2011) and the China Biological Medicine Database (CBM) (1979 to November 2011). We searched trials registers and conference proceedings and contacted pharmaceutical company and authors of included studies for additional data. There were no language restrictions. Randomised controlled trials comparing sildenafil citrate with placebo or no treatment for ED in patients with MS. Two review authors independently selected articles for inclusion, extracted data and assessed trial quality. Disagreements were resolved by discussion between review authors. Authors of included studies were contacted for additional information. Results were presented as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CI). Two randomised controlled trials involving a total of 420 patients were identified. Both trials investigated the short-term efficacy and safety of sildenafil citrate for ED in patients with MS. Patients taking sildenafil citrate were more likely to improve their ability to achieve and maintain an erection measured by International Index of Erectile Function and achieve vaginal penetration ( (RR 1.28, 95%CI 0.92 to 1.78) and complete intercourse measured by Sexual Encounter Profile diary (RR RR 1.38, 95%CI 1.00 to 1.90). and receive A global well respond measured by Global Assessment Question (RR 2.72, 95%CI 1.40 to 5.28) was reported. One trial showed sildenafil citrate is effective in quality of life improvement, while the other trial did not find any significant difference between both groups. Both included trials were judged as high risk of attrition bias. Adverse events were also reported: the most common were headache, flushing, rhinitis, visual disturbances and dyspepsia. Two patients suffered serious adverse events: one with coronary artery disease requiring triple bypass surgery and one with a cerebrovascular accident. There is limited evidence to support sildenafil citrate as an effective treatment for ED in patients with MS. Future well designed randomised, double blinded, placebo-controlled trials with long-term duration are needed.

Poster 437 Nontraumatic Spinal Cord Injury Secondary to Anterior Spinal Infarction in a Patient Taking Sildenafil for Erectile Dysfunction: A Case Report

Poster 437 Nontraumatic Spinal Cord Injury Secondary to Anterior Spinal Infarction in a Patient Taking Sildenafil for Erectile Dysfunction: A Case Report

Sildenafil for Erectile Dysfunction in the Middle East: Observational Analysis of Patients with Diabetes and/or Hypertension Treated in the Clinical Practice Setting

The effectiveness and tolerability of 12 weeks of open-label treatment with sildenafil citrate for erectile dysfunction (ED) associated with a diagnosis of diabetes mellitus and/or hypertension were assessed in clinical practice in three Middle Eastern countries. The dose was initially 50 mg and was adjusted by the physician as needed (permissible dose range 25 - 100 mg). Total mean ± SD score on the five-item version of the International Index of Erectile Function (severe ED, score 0 - 7; no ED, score 22 - 25) was 13.6 ± 5.7 at baseline (4556 patients) and increased significantly to 21.7 ± 4.1 at week 12. Global effectiveness was rated as good or very good by 91.4% of patients, 93.9% rating their sexual activity as spontaneous and 91.4% as natural. Discontinuation of sildenafil due to adverse events was infrequent (0.5%). Tolerability was rated as good or very good by 95.7% of patients. It is concluded that sildenafil was a well-tolerated and highly effective treatment of ED in outpatients with diabetes and/or hypertension from the three Middle Eastern countries studied.

Efficacies of papaverine and sildenafil in the treatment of erectile dysfunction in early-stage paraplegic men

The aim of the study was to determine which vasoactive agent was more efficacious for erectile dysfunction (ED), intracavernosal papaverine or oral sildenafil, in paraplegic men within the first year after injury by using a penile color Doppler ultrasound as a quantitative imaging method and to determine the association between responses to these two vasoactive agents and factors such as neurological lesion level and lesion severity. A total of 31 male in-patients with spinal cord injury, aged over 18 years, and with neurological lesions below the T6 level within the first year after injury with ED were included. Visual and auditory sexual stimulus (VASS) on day 1 (group 1), VASS with 25 mg intracavernosal papaverine (group 2) and after a wash-out period of papaverine on day 2, and VASS with 50 mg oral sildenafil on day 5 (group 3) were administered to each patient. Measurements of the peak systolic velocity and end diastolic velocity, which were used as vascular parameters during each procedure type, were taken using penile color Doppler ultrasound. Considering the severity of the lesion and the levels of the neurological lesion, there was a statistically significant difference between the PSV values of the group 1 and the other two groups (P<0.05). There was no statistically significant difference between the peak systolic velocity and end diastolic velocity values of groups 2 and 3 (P>0.05) in terms of both the severity and the levels of the lesion. Efficacies of intracavernosal papaverine hydrochloride or oral sildenafil citrate for ED were similar at all neurological lesion levels and lesion severity in paraplegic men within the first year after spinal cord injury.

Emotional Changes in Men Treated With Sildenafil Citrate for Erectile Dysfunction: A Double‐Blind, Placebo‐Controlled Clinical Trial

Erectile dysfunction (ED) has been associated with several comorbidities and can cause significant loss of quality of life and self-esteem. In men with ED, to use the validated Self-Esteem and Relationship (SEAR) questionnaire to evaluate changes in self-esteem associated with sildenafil treatment of ED and to assess changes dependent on concomitant comorbid conditions. This was a 14-week, international, randomized, parallel-group, double-blind, flexible-dose (25, 50, or 100 mg), placebo-controlled study of sildenafil in men aged >or=18 years with a clinical diagnosis of ED (score <or= 21 on the Sexual Health Inventory for Men). The primary outcome was the change in the SEAR Self-Esteem subscale score from baseline to the end of treatment. Secondary outcomes were the change in SEAR component scores stratified by ED comorbidity, the change in the International Index of Erectile Function (IIEF) domain scores and in the intercourse success rate, and the response to the global efficacy assessment and to the global satisfaction assessment. A total of 841 patients were included in the intent-to-treat efficacy analysis (559 sildenafil, 282 placebo). Patients randomized to sildenafil had significantly greater change scores from baseline to the end of treatment on all components of the SEAR and all domains of the IIEF (P < 0.0001) compared with placebo. This finding was also consistent for all SEAR components when stratified by each ED comorbidity. In the sildenafil group, the improvement in the mean Self-Esteem subscale score correlated with improvements in the mean Erectile Function domain score (r = 0.6338, P < 0.0001). The physiologic and emotional benefits of sildenafil in the treatment of ED were confirmed, overall and in men with comorbid hypertension, hyperlipidemia, benign prostatic hypertrophy, and/or depression. Using both the IIEF and the SEAR questionnaires provides a more complete assessment of ED.

Evaluation of the Safety and Efficacy of Sildenafil Citrate for Erectile Dysfunction in Men With Multiple Sclerosis: A Double-Blind, Placebo Controlled, Randomized Study

We evaluated the safety and efficacy of sildenafil citrate for treating erectile dysfunction in patients with multiple sclerosis. A total of 203 patients with multiple sclerosis (age range 18 to 50 years old) with erectile dysfunction were randomly assigned to receive 50 to 100 mg sildenafil (102 patients in group 1) or a similar regimen of placebo (101 patients in group 2) 45 minutes to 2 hours before sexual stimulation. Patients were asked to use at least 24 doses/attempts at home. Primary outcome measures consisted of responses to questions 3 and 4 from the International Index of Erectile Function questionnaires well as responses to Sexual Encounter Profile diary questions 2 and 3. We also assessed the number of attempts at sexual intercourse, the number of attempts that were successful and adverse drug effects. Improved erections (positive response to the Global Assessment Questionnaire) were reported by 32.8% of patients receiving sildenafil and 17.6% of those receiving placebo (p = 0.04). For Sexual Encounter Profile question 2 (successful penetration) the increase from baseline in mean per patient percentage of yes responses was 29.4% after sildenafil vs 18.8% after placebo (p = 0.04). The proportion of successful sexual attempts ranged from 12% to 26% for sildenafil and from 9% to 21% for placebo, respectively (p = 0.044). Of patients taking sildenafil and placebo 24 (23.5%) and 9 (8.9%) experienced 81 and 31 adverse events, respectively (p = 0.01). Compared with placebo, sildenafil has little effect on multiple sclerosis emergent erectile dysfunction and, therefore, cannot be recommended for the routine treatment of erectile dysfunction in patients with multiple sclerosis. This finding implies that there must be other mechanisms that are not affected by sildenafil or are resistant to the effects of sildenafil.

Effect of Sildenafil Citrate on the Male Sexual Experience Assessed with the Sexual Experience Questionnaire: A Multicenter, Double‐Blind, Placebo‐Controlled Trial with Open‐Label Extension

The Sexual Experience Questionnaire (SEX-Q) enables quick and easy assessment of functional, emotional, and satisfaction-related aspects of the sexual experience in men with erectile dysfunction (ED). To assess correlations between improvement on the SEX-Q and outcomes on other validated questionnaires. METHODS. Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function [IIEF]) who had used less than or equal to six doses of any phosphodiesterase 5 inhibitor (none within 6 months) were randomized to 10 weeks of double-blind, placebo-controlled (DBPC) flexible-dose sildenafil citrate (50 or 100 mg, as needed), followed by 6 weeks of open-label (OL) sildenafil. SEX-Q, IIEF, Quality of Erection Questionnaire (QEQ), Self-Esteem and Relationship (SEAR) Questionnaire, Erection Hardness Score (EHS), successful intercourse attempts (SIAs), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and global efficacy questions (GEQs). Compared with the placebo group (N = 105), the sildenafil group (N = 104) at DBPC end of treatment (EOT) had significantly more improvement (P < 0.05) on all SEX-Q, IIEF (except the Sexual Desire domain), QEQ, and SEAR outcomes, more frequent SIAs and EHS 3 (hard enough for penetration but not completely hard) or EHS 4 (completely hard) erections (odds ratio [OR], 2.52 and 3.46, respectively), EHS 4 erections four times as often (OR, 6.41), more men satisfied with treatment (EDITS; OR, 2.6), approximately twice as many men with improved erections (GEQ1; OR, 5.8) and ability to have sexual intercourse (GEQ2; OR, 5.4), and GEQ3 scores that indicated better sex (P < 0.0001). SEX-Q score improvements correlated positively with all other outcomes. At OL EOT, most outcomes were >60% (and approximately half were > or =80%) of the maximum positive result. SEX-Q change scores correlate with several other functional, emotional, and satisfaction-related outcomes in men treated with sildenafil for ED, allowing a simple and focused evaluation of the sexual experience.

Analysis of single items on the Self‐Esteem And Relationship questionnaire in men treated with sildenafil citrate for erectile dysfunction: results of two double‐blind, placebo‐controlled trials

To evaluate the effect of sildenafil citrate on each item of the 14-item Self-Esteem And Relationship (SEAR) questionnaire, which is used to measure self-esteem, confidence, satisfaction with sexual relationship, and overall relationship satisfaction in men with erectile dysfunction (ED). Data were combined from two 12-week, double-blind, placebo-controlled, flexible-dose sildenafil trials having identical protocols, one conducted in the USA and the other in Mexico, Brazil, Australia and Japan. All men had ED and were aged >or=18 years. Response categories of each SEAR item used a 4-week reference period and were based on a five-point scale (1, almost never/never; 2, a few times; 3, sometimes; 4, most times; 5, almost always/always). The difference (sildenafil vs placebo) in the change from baseline to week 12 was evaluated with a Wilcoxon rank sum test using ridit analysis, and an analysis of covariance model that included treatment group, centre, study and baseline item score. Compared with the 274 patients receiving placebo, the 279 receiving sildenafil reported significantly greater mean and median improvements (P < 0.001) in each of the 14 SEAR items. The probability of increased psychosocial benefit from baseline to week 12 was higher with sildenafil for each SEAR item, and ranged from 0.60 ('My partner was unhappy with the quality of our sexual relations'[item reverse-scored]) to 0.72 ('I was satisfied with my sexual performance'). Across all items, the mean (sd) probability was 0.67 (0.04) that a randomly selected patient in the sildenafil group would have a more favourable change relative to a randomly selected patient in the placebo group. Sildenafil produced substantial and meaningful improvements at the item-specific level. This analysis complements previously published work on self-esteem, confidence and relationship satisfaction.

Clinically meaningful improvement on the Self-Esteem And Relationship questionnaire in men with erectile dysfunction

To estimate the minimal clinically meaningful improvement (MCMI) on the Self-Esteem And Relationship (SEAR) questionnaire. Using combined data from the 2 pivotal SEAR trials of men treated with sildenafil for erectile dysfunction (ED), MCMIs were estimated as the lower limit of the 2-sided 95% confidence intervals of SEAR mean change scores (from baseline to end of study) for 2 anchor groups: (1) men who improved 1 ED severity category on the Erectile Function domain of the International Index of Erectile Function, and (2) men who improved 5-60% (inclusive) on these erectile function scores. Both anchors gave comparable results. A 10-point MCMI was proposed because the estimates of 95% lower bounds centered on around 10 points for most SEAR components (Sexual Relationship, Confidence, Self-Esteem, Overall Score). An exception was the Overall Relationship whose 95% lower bounds were too low to recommend them as an MCMI. Two anchor-based approaches suggest that a change of about 10 points represents an MCMI on most components of the SEAR questionnaire.