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Francesco Montorsi

Publications and source records attributed to Francesco Montorsi.

At least 109 records · Page 6Linked to original sources
PubMed2004

Holmium laser enucleation versus transurethral resection of the prostate: results from a 2-center, prospective, randomized trial in patients with obstructive benign prostatic hyperplasia.

PURPOSE: To our knowledge we report the first multicenter, prospective, randomized study comparing holmium laser enucleation (HoLEP) and transurethral prostate resection (TURP) for obstructive benign prostatic hyperplasia. MATERIALS AND METHODS: From January to October 2002, 100 consecutive patients with symptomatic obstructive benign prostatic hyperplasia were randomized at 2 centers to surgical treatment with HoLEP (52 in group 1) or TURP (48 in group 2). Patients in the 2 groups were preoperatively assessed by scoring subjective symptoms questionnaires. Preoperative and perioperative parameters were also evaluated, the latter at 1, 6 and 12 months of followup. RESULTS: At baseline all patients had obstruction (Schäfer grade greater than 2). At the 1, 6 and 12-month followups no statistically significant differences were observed between the 2 groups in terms of urodynamic findings and subjective symptom scoring. In the HoLEP group mean total time in the operating room +/- SD was significantly longer than for TURP (74 +/- 19.5 vs 57 +/- 15 minutes, p < 0.05), while catheterization time (31 +/- 13 vs 57.78 +/- 17.5 minutes, p < 0.001 and hospital stay (59 +/- 19.9 vs 85.8 +/- 18.9 hours, p < 0.001) were significantly shorter in the HoLEP group. Transient stress and urge incontinence were more common in the HoLEP group, although at the 12-month followup results were comparable. The overall complication rate was comparable in the 2 groups. Erectile function was also maintained in the followup period from baseline in each group, as expected. CONCLUSIONS: HoLEP and TURP were equally effective for relieving obstruction and lower urinary tract symptoms. HoLEP was associated with shorter catheterization time and hospital stay. At 1 year of followup complications were similar in the 2 groups.

Aged↗
PubMed2004

Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification.

BACKGROUND: Vardenafil (Levitra) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. METHODS: Data from two pivotal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). RESULTS: Data from 1,385 men who received at least one dose of study medication and had pre- and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37-41% of patients had severe ED, 30-34% moderate, 22% mild-to-moderate and 6-8% mild ED. At baseline, 46-51% of patients were considered to have an organic cause for ED, 13-16% psychogenic ED, and 36-38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. CONCLUSIONS: Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2004

Does sildenafil enhance quality of nocturnal erections in healthy young men? A NPT-RigiScan study.

OBJECTIVE: To assess the effect of sildenafil on nocturnal erectile function (EF) in young healthy volunteers with normal sexual function (SF) according to the International Index of Erectile Function (IIEF) questionnaire. METHODS: Thirty-three young (mean age 21 +/- 0.3 years; range 18-25) healthy volunteers not taking any medications who had normal SF and an EF domain >26 on the IIEF questionnaire were evaluated. Erectile function was assessed using the RigiScan (Dacomed Corp., MN, USA) during three nights: night 1 = adaptation to the NPT-Rigiscan apparatus, night 2 = baseline recording of eight parameters, and night 3 = recordings after ingestion of sildenafil 100 mg. Data on the number of erections, erection duration, minimal and maximal base tumescence, minimal and maximal tip tumescence, and base and tip rigidity were analysed using anova with repeated measures. RESULTS: A statistically significant improvement in all eight parameters was observed as a result of sildenafil administration: number of erections from 3.1 +/- 0.7 to 4.0 +/- 0.7 (P < 0.05), erection time 22 +/- 3.5 to 34.2 +/- 5.9, minimal base tumescence 8.2 +/- 0.8 to 8.7 +/- 0.8, maximal base tumescence 12.1 +/- 0.7 to 14.2 +/- 0.7, base rigidity 75.6 +/- 3.1 to 81.6 +/- 3.6, tip rigidity 70.6 +/- 1.5 to 75.9 +/- 3.1, minimal tip tumescence 5.9 +/- 0.5 to 6.5 +/- 0.6, and maximal tip tumescence 8.6 +/- 0.6 to 11.7 +/- 0.7 (P < 0.0001 for each of the last seven parameters). The mean sleep duration, 7.3 hours (range 6.30-9.20 hours), was similar for both nights of recording. CONCLUSIONS: Sildenafil increases the quality and number of nocturnal erections as tested by the NPT-RigiScan in young healthy volunteers with normal EF.

Adolescent↗
PubMed2004

Review of phosphodiesterases in the urogenital system: new directions for therapeutic intervention.

INTRODUCTION: With the success of Phosphodiesterase (PDE) type 5 inhibitors (i.e., sildenafil, tadalafil, vardenafil) in the treatment of erectile dysfunction (ED), PDEs are considered attractive targets for drug intervention in the urogenital tract. AIM: To review the role of PDEs, which exist as a superfamily of enzymes comprising 11 distinct families, in the urogenital system, focusing on anatomical locations, functions and dysfunctions, potential disorders that could be treated, and any promising new selective PDE inhibitors under development. METHODS: Included are (i) abstracts from 2001, 2002, and 2003; (ii) a MEDLINE search from 1996 through December 2003; and (iii) a pipeline search for therapeutics in development. Data from animal experiments are presented when there is a paucity of human data, but with the caveat that the distribution of PDE isozymes in a specific tissue can vary between species. RESULTS: PDE mRNA and protein have been localized throughout the normal human urogenital tract. Double-blind, placebo-controlled studies suggest possible new clinical roles for sildenafil, including prophylaxis to preserve penile smooth muscle and erectile function after radical prostatectomy, and treatment of ejaculatory delay secondary to serotonergic reuptake inhibitor antidepressant therapy. Open-label studies suggest a potential clinical role for: vinpocetine (a PDE1 inhibitor) in the treatment of incontinence and low-compliance bladder; and sildenafil in the treatment of premature ejaculation, prostate-related lower urinary tract symptoms, and in women who have had unsuccessful in vitro fertilization. Several new orally administered PDE5 inhibitors are in early clinical development for the treatment of ED. Potential indications for PDE inhibitors that are suggested by preclinical data include Peyronie's disease, ureteral colic, male and female birth control, and prevention of preterm labor. CONCLUSIONS: Drug selectivity and differential PDE tissue distribution allow for potential targeted intervention for numerous disorders related to the urogenital tract.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2004

Earliest time to onset of action leading to successful intercourse with vardenafil determined in an at-home setting: a randomized, double-blind, placebo-controlled trial.

INTRODUCTION: Vardenafil, a potent and selective oral PDE5 inhibitor, is efficacious and generally well-tolerated in men with erectile dysfunction (ED). Of considerable interest to patients and physicians is an understanding of the time required after dosing to attain penile erection sufficient for successful sexual intercourse. AIM: To determine the earliest time to onset of action of vardenafil 10 and 20 mg leading to successful intercourse compared to placebo in men with ED. METHODS: A prospective, randomized, double-blind, parallel-group, at-home study of 732 men with ED (mean age 55.5 years) was conducted at 64 sites in North America and Europe. Following a 4-week run-in period, patients were randomized to either vardenafil 10 (N = 237) or 20 mg (N = 248) or placebo (N = 247) to be taken on demand over 4 weeks. Using a stopwatch, patients recorded the elapsed time from dosing to attainment of an erection perceived to be adequate for penetration that led to intercourse completion. Earliest time of onset was defined as the fastest time among the first four doses for each patient. Time points from 25 to 5 minutes were tested for significance (alpha = 0.025) using a backward stepping procedure. RESULTS: Mean baseline erectile function domain score (13.4) indicated moderate ED. Within 25 minutes after dosing, 50%/53% of men on vardenafil 10/20 mg had at least one erection in the first four doses perceived to be sufficient for penetration with subsequent intercourse completion compared to 26% on placebo (P < 0.0001). A statistically superior response to vardenafil vs. placebo was observed in these responders at all times >or= 10 and >or= 11 minutes (P < 0.025) in the 10 and 20 mg groups, respectively. In a retrospective analysis using time intervals of <or= 15, <or= 20, <or= 25 and <or= 30 minutes between dosing and erection adequate for penetration, 75-77% of these intercourse attempts were successful (SEP3 positive) by patients receiving vardenafil 10/20 mg, compared to 45-47% of attempts by those who received placebo. Vardenafil 10/20 mg was generally well-tolerated with headache (7%/12% vs. 1%) and flushing (6%/9% vs. < 1%) reported more frequently than with placebo. No patient discontinued vardenafil therapy due to adverse events. CONCLUSION: In this large, at-home study, the onset of action of vardenafil with subsequent intercourse completion was recognized as early as 10 minutes after dosing.

Adult↗
PubMed2004

Summary of the recommendations on sexual dysfunctions in men.

INTRODUCTION: There are few published guidelines for the management of sexual dysfunctions in men and women, despite the prevalence and lack of attention to these problems. Disorders of sexual function in men include erectile dysfunction, orgasm/ejaculation disorders, priapism, and Peyronie's disease. AIM: To provide evidence-based and expert-opinion consensus guidelines for the clinical management of men's sexual dysfunctions. METHODS: An International Consultation in collaboration with major urological and sexual medicine societies assembled over 200 multidisciplinary experts from 60 countries into 17 consultation committees. Committee members established the scope and objectives for each chapter. Following intensive review of available data and publications, committees developed evidence-based guidelines in each area. MAIN OUTCOME MEASURE: New algorithms and guidelines for assessment and treatment of men's sexual dysfunction were developed. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of the medical literature, in addition to cultural and ethical considerations. RESULTS: Recommendations and guidelines for men's sexual dysfunction are presented. These guidelines were developed as evidence-based, patient-centered, and multidisciplinary in focus. For the clinical assessment and diagnosis of ED, a basic evaluation was recommended for all patients, with optional and specialized testing reserved for special cases. A new treatment algorithm is proposed. This algorithm provides a clinically relevant guideline for managing ED in the large majority of men. New treatment guidelines and algorithms are provided for men's orgasm and ejaculation disorders, including premature ejaculation, retrograde and delayed ejaculation. Finally, expert opinion-based guidelines for the clinical management of priapism and Peyronie's disease are provided. CONCLUSIONS: Additional research is needed to validate and extend these guidelines. Nonetheless, this summary encompasses the recommendations concerning men's sexual dysfunctions presented at the 2nd International Consultation on Sexual Medicine in Paris, France, June 28-July 1, 2003.

Algorithms↗
PubMed2004

Standards for clinical trials in male sexual dysfunction: erectile dysfunction and rapid ejaculation.

INTRODUCTION: The introduction of safe and effective therapies for sexual dysfunctions depend upon appropriate clinical protocol design, study procedures, data collection and analysis. AIM: To provide recommendations/guidelines concerning state-of-the-art knowledge for standards for clinical trials in sexual dysfunction in men, particularly in the areas of erectile dysfunction and rapid ejaculation. METHODS: An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Standards for Clinical Trials in Male Sexual Dysfunction Committee, there were six experts from four countries. MAIN OUTCOME MEASURE: Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. RESULTS: Drug development requires a multiphased approach. Phase 1 studies investigate multiple-dose safety, tolerability and pharmacokinetic issues. Phase 2 programs explore dose ranging (lowest effective, maximally tolerated and toxic doses). Phase 3 trials provide the substantial evidence including drug-drug interaction data and studies in special populations. Clinical studies require validated outcome assessment instruments conducted in defined but representative patient populations. Daily diaries or per-event questionnaires are patient-reported outcomes that assist in retrospective questionnaire interpretation. A qualified biostatistician should calculate the sample power for the trial, type of statistical model and design employed, use of covariate or subgroup analyses, and calculation of effect sizes. CONCLUSIONS: More research is needed in developing standards for use in the development of clinical trials and outcomes assessment researching either erectile dysfunction or rapid ejaculation.

Consensus↗
PubMed2004

Emerging oral drugs for erectile dysfunction.

Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men worldwide. Many drugs are now available for the treatment of ED, with oral pharmacotherapy representing the first-line option for most patients. Sildenafil citrate, an inhibitor of the enzyme phosphodiesterase type 5 (PDE5), is the most widely prescribed oral agent and has a very satisfactory efficacy-safety profile in all patient categories. Tadalafil (Cialis; Eli Lilly & Co., ICOS) and vardenafil (Levitra; Bayer Pharmaceuticals, GlaxoSmithKline) are new PDE5 inhibitors that have recently been approved worldwide. Both have been associated with significant positive efficacy-safety profiles. Apomorphine sublingual is a dopamine D1 and D2 receptor agonist, which has been approved for marketing in Europe. It is best selected for treating patients with mild-to-moderate ED, but it is seldom used in clinical practice due to its limited efficacy and side effects, particularly nausea. Patients who do not respond to oral pharmacotherapy or who are unable to use it are appropriate candidates for intracavernosal and intraurethral therapy. The efficacy of second-line treatment is high, but the attrition rate remains significant. For the purpose of this review, clinical and pharmacological analysis focuses on the recent advances in the field of oral therapy, including PDE5 inhibitors and sublingual apomorphine.

Administration, Oral↗
PubMed2003

Brain activation patterns during video sexual stimulation following the administration of apomorphine: results of a placebo-controlled study.

OBJECTIVES: To evaluate the in vivo effect of apomorphine sublingual versus placebo on cortical and subcortical brain activation during video sexual stimulation. METHODS: Ten patients with psychogenic erectile dysfunction and six potent controls underwent functional magnetic resonance of the brain during video sexual stimulation after the administration of either apomorphine sublingual 4mg or placebo following a randomized, double blind design. Functional magnetic resonance sessions were performed with a 7-day interval. RESULTS: In potent controls, viewing erotic versus neutral films induced bilateral activations in a network of occipito-parietal and temporal inferior regions, in dorsolateral and premotor frontal cortex, in anterior temporal limbic areas and the thalamus, which were comparable to the patient activations during erotic stimulation in the placebo condition. However, a striking difference was found in patients, who demonstrated a significant and extended activation in the cingulate gyrus, frontal mesial and frontal basal cortex, bilaterally, in comparison with potent controls. These activated neural systems were modulated by apomorphine administration which produced a picture that was similar to the one seen in potent controls. In patients with spychogenic erectile dysfunction apomorphine sublingual caused an increase in the extension of the activated networks, plus additional activation foci in subcortical and deep structures, namely in the nucleus accumbens, hypothalamus and mesencephalon: this activation was greater than that seen with placebo. Interestingly, a down-regulation in the frontal basal and temporal limbic cortex was present as shown by a decrease of functional magnetic resonance imaging signal reflecting a deactivation of these regions. CONCLUSIONS: Apomorphine significantly enhances the activation of cortical and subcortical brain function during video sexual stimulation. Patients with psychogenic erectile dysfunction may have an underlying functional abnormality of the brain acting as a previously unrecognised aetiological factor.

Administration, Sublingual↗
PubMed2003

Erectile dysfunction prevalence, time of onset and association with risk factors in 300 consecutive patients with acute chest pain and angiographically documented coronary artery disease.

OBJECTIVES: The aim of this study was to assess erectile dysfunction prevalence, time of onset and association with risk factors in patients with acute chest pain and angiographically documented coronary artery disease. METHODS: 300 consecutive patients with acute chest pain and angiographically documented coronary artery disease were assessed using a semi-structured interview investigating their medical and sexual histories, the International Index of Erectile Function and other instruments. RESULTS: Patient mean age was 62.5+/-8 years (range 33-86 years). Mean duration of symptoms or signs of myocardial ischaemia prior to enrollment in the study was 49 months (range 1-200). Coronary angiography showed 1-, 2- and 3-vessel disease in 98 (32.6%), 88 (29.3%) and 114 (38%) patients, respectively. The prevalence of ED among all patients was 49% (147/300). Erectile dysfunction was scored as mild, mild to moderate, moderate and severe in 21 (14%), 31 (21%), 20 (14%), and 75 (51%) of patients, respectively. There was no significant difference between patients with ED (n=147) or without ED (n=153) as far as clinical and angiographic characteristics were concerned. In the 147 patients with co-existing ED and CAD, ED symptoms were reported as having become clinically evident prior to CAD symptoms by 99/147 (67%) patients. The mean time interval between the onset of ED and CAD was 38.8 months (range 1-168). There was no significant difference in terms of risk factor distribution and clinical and angiographic characteristics between patients with the onset of ED before vs. after CAD diagnosis. Interestingly, all patients with type I diabetes and ED actually developed sexual dysfunction before CAD onset (p<0.001). CONCLUSIONS: Our study suggests that a significant proportion of patients with angiographically documented coronary artery disease have erectile dysfunction and that this latter condition may become evident prior to angina symptoms in almost 70% of cases. Future studies including a control group of patients with coronary artery disease and normal erectile function are required in order to verify whether erectile dysfunction may be considered a real predictor of ischemic heart disease.

Adult↗
PubMed2003

Multiple vesico-urethral biopsies following radical prostatectomy: the predictive roles of TRUS, DRE, PSA and the pathological stage.

INTRODUCTION: The aim of this study is to verify the predictive role of transrectal ultrasound (TRUS) of prostatic fossa, digital rectal examination (DRE), prostate specific antigen (PSA) and pathological stage after radical prostectomy in the detection of a prostate tumor recurrence at the level of the vesico-urethral anastomosis by means of multiple TRUS biopsies (6-8 cores). MATERIAL AND METHODS: From October 1997, following a radical prostatectomy, 119 consecutive patients (median age: 67.9 years) with a PSA>or=0.2 ng/ml (median PSA: 0.9 ng/ml) underwent DRE and TRUS examinations with a 5.0-7.5 MHz variable frequency end-fire probe (Hitachi Medical System) and an EUB-525 machine. All patients received six TRUS-guided biopsies of the vesico-urethral anastomosis, and 1-2 additional biopsies directed to hypo-echoic or suspicious areas, if detected by TRUS. RESULTS: Biopsies revealed recurrent carcinoma in 50% of patients (60/119). TRUS proved more sensitive than DRE (75% vs. 50%; p=0.01) and, conversely, DRE proved more specific than a TRUS (85% vs. 66%; p=0.03). Cancer was detected in 45% of the 34 patients with a PSA or=2.0 ng/ml (24 patients), TRUS was able to detect every biopsy-proven local recurrence lesion (sensitivity: 100%). Conversely, all patients with a PSA>or=2.0 ng/ml and a negative TRUS had a negative biopsy (negative predictive value: 100%). In a multi-variable logistical analysis, the most predictive parameters determining a positive biopsy rate among those values studied (PSA, DRE, TRUS, positive surgical margins, pathological stage and time to PSA elevation) were TRUS and DRE findings (p=0.003, with an odds ratio of 4.6 and p=0.02, with an odds ratio of 4.1, respectively). CONCLUSION: TRUS and TRUS biopsies utilizing 6-8 cores are efficient tools in the detection of local recurrence after a radical prostatectomy, even with a PSA or=2.0 ng/ml and a negative TRUS, a biopsy of the vesico-urethral anastomosis could be avoided since the negative predictive value is 100%. Cancer recurrence detection seems to be predicted by TRUS and DRE findings, but not by PSA levels, pathological stage, status of the surgical margins or time to PSA elevation.

Aged↗
PubMed2003

Laparoscopic nerve- and seminal-sparing cystectomy with orthotopic ileal neobladder: the first three cases.

INTRODUCTION AND OBJECTIVES: Seminal and prostate sparing cystectomy represents an alternative in young patients where preservation of urinary continence and sexual potency are fundamental. We present our preliminary experience with this procedure performed laparoscopically. METHODS: Three men-53, 58 and 49 years old-suffering from recurrent superficial transitional cell carcinoma of the bladder, resistant to intravesical therapy, underwent laparoscopic nerve, prostate and seminal vesical sparing cystectomy. One week before surgery, TURP was performed to create an adequate prostate capsule. After pneumoperitoneum induction and the positioning of five/six trocars, the ureters were clipped and transected, the vas deferens and seminal vescicles were identified and prepared for the conservative procedure. Cystectomy was performed with vascular pedicles transection by EndoGia. The reconstruction of the bladder was obtained through a 7 cm longitudinal periumbilical incision using 60 cm of ileus and an orthotopic neobladder realized outside the abdomen. The ileocapsular anastomosis was performed laparoscopically after the re-induction of pneumoperitoneum. RESULTS: No major complications were recorded. The surgical time was respectively 480, 450 and 410 min. Blood loss was 150, 220 and 300 ml respectively. Drains were removed after 4 days (two patients) and 6 days (one patient) and the patients were discharged after 8 days (two patients) and 9 days. The patients were fully continent after catheter removal with normal uroflowmetry. At the three month follow-up they had a normal sexual function, equivalent to the preoperative assessment. The patients reported adequate erections for intercourse. CONCLUSIONS: Laparoscopic prostate and seminal cystectomy with orthotopic ileal neobladder is a safe, feasible, reproducible surgical technique. In patients who desire to preserve sexual functioning and obtain complete continence it represents a valid alternative to classic radical cystectomy.

Carcinoma, Transitional Cell↗
PubMed2003

Peyronie's disease: a review.

PURPOSE OF REVIEW: This review is aimed to summarize the most recent findings about this topic, by reviewing the literature published in 2002 and 2003 regarding the epidemiology, pathophysiology, diagnosis and treatment of Peyronie's disease. RECENT FINDINGS: Although many aspects in pathophysiology, diagnosis, medical and surgical treatment of Peyronie's disease still remain under debate, recent interesting advances have been made regarding the different aspects of this condition. Topical and systemic medical therapies have been associated with varying degrees of results, depending on modalities and timing of the treatment itself. A wide range of surgical modalities have been recently developed, although the ideal surgical procedure especially in case of severe and complex curvature does not seem to be reached yet. Furthermore this condition is often associated with psychological distress that could be responsible for performance anxiety, leading to improvement of abnormalities in erectile functioning eventually associated with Peyronie's disease. SUMMARY: Peyronie's disease consists of an acquired penile deformity caused by the formation of fibrous plaques within the tunica albuginea, leading to bio-mechanical and vascular abnormalities. In the last decade numerous advances have been made regarding pathophysiology, diagnosis and treatment of this condition, allowing for improved patient clinical prognosis. Nevertheless, although improvements in medical and surgical therapies have substantially increased the successful patients' outcome rate, Peyronie's disease is still not completely understood and its treatment remains often frustrating for the practicing urologist. Clinical presentations of this disease include penile deformities or shortening during erection, painful erection, palpable plaque or induration throughout the length of the penile shaft and erectile dysfunction.

Humans↗
PubMed2003

Sildenafil in erectile dysfunction: a critical review.

Sildenafil citrate (Viagra) is a potent orally active cGMP-specific phosphodiesterase type 5 (PDE5) inhibitor that is effective as a peripheral conditioner in the treatment of male erectile dysfunction (ED) of organic, psychogenic or mixed aetiology. Sildenafil is the first effective oral agent in the management of ED that has had a revolutionary impact on management of ED. The present review has been subdivided into five major sections. Based on the most recent peer-reviewed publications, the first section is aimed at critically evaluating PDE5 selectivity as well as the pharmacokinetics and pharmacodynamics of the drug, mainly to assess the best doses for each group of patients (i.e. adult and elderly men). Effectiveness in a broad spectrum ED population is the subject of the second section of the review, principally reporting post-marketing company-independent results. Safety and tolerability are the key concerns of the third section, with a broad consideration of the most commonly reported adverse events. Special attention has been paid to the cardiovascular safety of the drug, chiefly outlining the positive and potentially protective cardiac effects of sildenafil. Moreover, the impact of sildenafil in special patient populations is considered, namely in men complaining of diabetes mellitus, depression, neurological disorders, renal failure and those who have undergone a radical prostatectomy. Sildenafil and the ageing male has been especially underlined. Finally, the review covers a few new potential applications of sildenafil in ED patients with regard to high-dose treatment and combination therapy. The review ends with several considerations regarding the direct and/or indirect impact of sildenafil over quality of life and quality of partnership.

Adult↗
PubMed2003

Sildenafil citrate for treatment of erectile dysfunction in men with type 1 diabetes: results of a randomized controlled trial.

OBJECTIVE: In the 5-10% of diabetic men with type 1 diabetes, erectile dysfunction (ED) may be a particularly common and unwanted complication. This is the first study focusing exclusively on the effects of sildenafil in men with type 1 diabetes and ED. RESEARCH DESIGN AND METHODS: A total of 188 patients were entered into a double-blind, placebo-controlled, parallel-group, flexible-dose study and were randomized to receive sildenafil (25-100 mg; n = 95) or placebo (n = 93) for 12 weeks. Efficacy was evaluated using questions three (Q3; achieving an erection) and four (Q4; maintaining an erection) from the International Index of Erectile Function (IIEF), a global efficacy question (GEQ; "Did treatment improve your erections?"), and a patient event log of sexual activity. RESULTS: Improvements in mean scores from baseline to end-of-treatment for IIEF Q3 (35.7 vs. 19.9%) and Q4 (68.4 vs. 26.5%) were significant in patients receiving sildenafil compared with those receiving placebo (P = 0.0001). Moreover, the percent of improved erections (GEQ, 66.6 vs. 28.6%) and successful intercourse attempts (63 vs. 33%) was significantly increased with sildenafil compared with placebo. Improvements in sexual function were seen irrespective of the degree of ED severity. Adverse events were generally mild to moderate in severity, with headache (20 vs. 8%), flushing (18 vs. 3%), and dyspepsia (8 vs. 1%) reported more often in the sildenafil than in placebo-treated patients. CONCLUSIONS: Treatment with sildenafil for ED was effective, resulting in an increased percentage of successful attempts at intercourse, and was well tolerated among men with type 1 diabetes.

Adult↗