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Francesco Montorsi

Publications and source records attributed to Francesco Montorsi.

At least 55 records · Page 3Linked to original sources
PubMed2005

BXL628, a novel vitamin D3 analog arrests prostate growth in patients with benign prostatic hyperplasia: a randomized clinical trial.

OBJECTIVE: To evaluate the effect of BXL628, a vitamin D3 analog, on prostate volume in patients with benign prostatic hyperplasia (BPH). METHODS: We conducted a phase II, double blind, randomized, placebo controlled, clinical study. Patients eligible were aged>or=50 years, had a diagnosis of BPH and a prostate volume>or=40 ml. Eligible patients were randomized and given either BXL628 150 mcg daily or placebo for 12 weeks. All randomized patients underwent at baseline and at the end of study pelvic MRI to measure prostatic volume, uroflowmetry (Qmax), American Urological Association Symptom Index (AUASI), serum PSA, testosterone, dihydrotestosterone and luteizing hormone. RESULTS: A total of 119 patients were randomized: 57 patients to BXL628 and 62 to placebo. The percentage change of prostate volume at 12 week was -2.90 in the BXL628 group vs. +4.32 in the placebo group (p-value<0.0001). The estimated difference between treatments (BXL628 minus placebo) was -7.22% (95% confidence limit -9.27 to -5.18). Considering Qmax, mean change vs. baseline was -0.30 in BXL628 vs. +1.50 in the placebo group: this finding was not statistically significant. The mean change of the AUASI total score at final visit vs. baseline was -1.77 in the BXL628 group vs. -3.45 in the placebo group (p=not significant). CONCLUSION: BXL628 was able to arrest prostate growth within 12 weeks in men aged>or=50 years with prostatic volume>or=40 ml. Its unprecedented mechanism of action may offer a new opportunity for the treatment of BPH.

Aged↗
PubMed2005

Clinical update on phosphodiesterase type-5 inhibitors for erectile dysfunction.

Erectile dysfunction (ED) affects the sexual lives of millions of men. The first-line oral pharmacotherapy for most ED patients is phosphodiesterase type-5 (PDE-5) inhibitors, of which three are available. Sildenafil is the most widely prescribed oral agent for ED and has a very satisfactory efficacy-safety profile in all patient categories. Tadalafil and vardenafil were introduced in the European Union and in the United States in 2003 and 2004, respectively. The three PDE-5 inhibitors share many pharmacological and clinical characteristics, and each has unique features. This review, which is based on the contemporary literature on PDE-5 inhibitors, describes the chemical, pharmacological, and clinical features of sildenafil, vardenafil, and tadalafil. The first section reviews the pathophysiology of penile erection and PDE-5 inhibitor pharmacology. The second section summarizes data regarding efficacy and safety of the three drugs in treating ED in the general population as well as in selected patient categories.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2005

The artery size hypothesis: a macrovascular link between erectile dysfunction and coronary artery disease.

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection satisfactory for sexual performance. Evidence is accumulating to consider ED as a vascular disorder. Common risk factors for atherosclerosis are frequently found in association with ED, and ED is frequently reported in vascular syndromes, such as coronary artery disease (CAD), hypertension, cerebrovascular disease, peripheral arterial disease, and diabetes mellitus. Finally, similar early impairment of endothelium-dependent vasodilatation and late obstructive vascular changes has been reported in both ED and other vascular syndromes. Recently, we proposed a pathophysiologic mechanism to explain the link between ED and CAD called the artery size hypothesis. Given the systemic nature of atherosclerosis, all major vascular beds should be affected to the same extent. However, symptoms rarely become evident at the same time. This difference in rate of occurrence of different symptoms is proposed to be caused by the different size of the arteries supplying different vascular beds that allow a larger vessel to better tolerate the same amount of plaque compared with a smaller one. According to this hypothesis, because penile arteries are smaller in diameter than coronary arteries, patients with ED will seldom have concomitant symptoms of CAD, whereas patients with CAD will frequently complain of ED. Available clinical evidence appears to support this hypothesis.

Arteries↗
PubMed2005

Improving the preservation of the urethral sphincter and neurovascular bundles during open radical retropubic prostatectomy.

OBJECTIVES: To describe a technique for open nerve-sparing radical retropubic prostatectomy. METHODS: The technique basically implies incising the levator and prostatic fasciae high anteriorly (1 and 11 o'clock positions) over the prostate, developing the plane between the prostatic capsule and prostatic fascia, and displacing the neurovascular network localized between the two fasciae laterally. This allows for a minimal-touch dissection of the external urethral sphincter and a very efficient dissection of the neurovascular bundles at the level of membranous urethra and prostatic apex. RESULTS: Forty-two patients underwent a bilateral nerve-sparing operation and were followed- up for 6 months. Six patients (14.3%) had positive margins: 4 patients had pT2 disease (in all, the positive margin was monofocal) and 2 patients had pT3 disease (both had multifocal positive margins). Continence (defined as being dry or having one pad remain dry for 24 hours) was achieved in 44% of patients at catheter removal, and in 60%, 72%, and 90% of patients at the 1-, 3-, and 6-month follow-up visits. Potency (defined as an erectile function domain score > or =26) was obtained in 15%, 40%, and 52% of patients at the 1-, 3-, and 6-month follow-up visits. All patients used a PDE5-inhibitor during the investigation period. CONCLUSIONS: These preliminary results suggest that the high incision of the levator and prostatic fasciae may facilitate efficient preservation of the external urethral sphincter and the neurovascular bundles innervating the corpora cavernosa and the sphincter.

Aged↗
PubMed2005

Evaluating preference trials of oral phosphodiesterase 5 inhibitors for erectile dysfunction.

More treatment options are available now for the treatment of erectile dysfunction (ED) than ever. Treatments include oral phosphodiesterase 5 (PDE5) inhibitors, intracavernosal injections, vacuum constriction devices, and penile implants. Clinicians, researchers, and patients are interested in making direct comparisons between the response of newer treatments and that of established and more developed therapies. Of the currently available treatment options for ED, the most commonly prescribed therapies are oral PDE5 inhibitors, which include sildenafil citrate (Viagra, Pfizer Inc), tadalafil (Cialis, Lilly ICOS), and vardenafil (Levitra, Bayer). However, most patient preference studies of these drugs conducted to date have serious design flaws that hinder interpretation of the data, and thus limit the utility of the results. To make an informed decision on the most appropriate treatment option available, physicians and their patients require a thorough understanding of the methodology of these studies. Clinical comparison or preference trials must establish internal and external validity if the data are to be used in a generalized patient population. We review preference studies that compared sildenafil, tadalafil, and vardenafil, and highlight study designs that can introduce bias. We propose that, like safety and efficacy trials, randomized controlled trials (RCTs) should be the gold standard for evaluating patient preference treatments for ED. We do not wish to discourage individual investigators from performing preference studies, but rather to highlight the features of current preference trials to help patients and clinicians alike become aware of potential biases from independent or industry-sponsored patient preference trials so that they can interpret the results accordingly. Key components of patient preference RCTs are reviewed: period and carryover effects, preference assessments, eligibility criteria, and data analysis. We discuss why these components of patient-preference RCTs are important for evaluating the validity and relevance of patient preference studies. The preference studies discussed in this brief review are summarized in , and the methodological problems with each study are indicated. We provide a recommendation for the design of such trials that can minimize bias and provide better data for physicians and their patients.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2005

Sexual dysfunction and cardiac risk (the Second Princeton Consensus Conference).

Recent studies have highlighted the relation between erectile dysfunction (ED) and cardiovascular disease. In particular, the role of endothelial dysfunction and nitric oxide in ED and atherosclerotic disease has been elucidated. Given the large number of men receiving medical treatment for ED, concerns regarding the risk for sexual activity triggering acute cardiovascular events and potential risks of adverse or unanticipated drug interactions need to be addressed. A risk stratification algorithm was developed by the First Princeton Consensus Panel to evaluate the degree of cardiovascular risk associated with sexual activity for men with varying degrees of cardiovascular disease. Patients were assigned to 3 categories: low, intermediate (including those requiring further evaluation), and high risk. This consensus study from the Second Princeton Consensus Conference corroborates and clarifies the algorithm and emphasizes the importance of risk factor evaluation and management for all patients with ED. The panel reviewed recent safety and drug interaction data for 3 phosphodiesterase (PDE)-5 inhibitors (sildenafil, tadalafil, vardenafil), with emphasis on the safety of these agents in men with ED and concomitant cardiovascular disease. Increasing evidence supports the role of lifestyle intervention in ED, specifically weight loss and increased physical activity, particularly in patients with ED and concomitant cardiovascular disease. Special management recommendations for patients taking PDE-5 inhibitors who present at the emergency department and other emergency medical situations are described. Finally, further research on the role of PDE-5 inhibition in treating patients with other medical or cardiovascular disorders is recommended.

Age Distribution↗
PubMed2005

Dynamics of male sexual arousal: distinct components of brain activation revealed by fMRI.

The peripheral mechanisms of male sexual arousal are well known. Recently, neuroimaging techniques, such as PET or fMRI, allowed the investigation of the subjacent cerebral mechanisms. In ten healthy subjects, we have simultaneously recorded fMRI images of brain activation elicited by viewing erotic scenes, and the time course of penile tumescence by means of a custom-built MRI-compatible pneumatic cuff. We have compared activation elicited by video clips with a long duration, that led to sexual arousal and penile erection, and activation elicited by briefly presented still images, that did induce sexual arousal without erection. This comparison and the use of the time course of penile tumescence in video clips allowed to perform a time resolved data analysis and to correlate different patterns of brain activation with different phases of sexual response. The activation maps highlighted a complex neural circuit involved in sexual arousal. Of this circuit, only a few areas (anterior cingulate, insula, amygdala, hypothalamus, and secondary somatosensory cortices) were specifically correlated with penile erection. Finally, these areas showed distinct dynamic relationships with the time course of sexual response. These differences might correspond to different roles in the development and appraisal of the sexual response. These findings shed light on the psychophysiology of male sexuality and open new perspectives for the diagnosis, therapy, and possible rehabilitation of sexual dysfunction.

Adult↗
PubMed2005

Dorsal onlay graft urethroplasty using penile skin or buccal mucosa for repair of bulbar urethral stricture: results of a prospective single center study.

OBJECTIVE: To compare the outcomes of dorsal onlay graft urethroplasty using penile skin (PS) or buccal mucosa (BM) free grafts in the repair of adult bulbourethral strictures. METHODS: From January 1998 to March 2003, 30 patients with bulbar urethral strictures underwent urethral reconstruction with PS (17) or with BM free graft (13). Follow-up was done at 6, 12 and 18 months postoperatively, and every year subsequently. Success was defined as normalization of IPSS and a stable Q(max) value >20 ml/s. Any further instrumentation for stricture recurrence was considered a failure. RESULTS: Mean follow-up was 51 months (20-74). The overall success rate was 80% (85% in the BM and 76% in the PS group). Improvement of uroflowmetry, IPSS and QoL did not show a significant difference between the two groups. A significant improvement of the orgasmic function domain of the IIEF was found in patients treated with a PS graft. Post-operative complications were lip hypoesthesia (30%), retraction of the ventral skin of the penis (7%), post-voiding dribbling (8% with BM graft, and 7%, with PS graft). Six patients, 2 with BM (15%) and 4 with PS graft patch (24%) required further treatment due to stricture recurrence. CONCLUSION: Results of PS or BM graft are comparable at 18 month follow-up, although orgasmic function is significantly improved in patients receiving a PS graft. Nevertheless, with extended follow-up, the use of PS seems to be associated with a higher failure rate.

Adult↗
PubMed2005

Vardenafil for the treatment of erectile dysfunction: a critical review of the literature based on personal clinical experience.

OBJECTIVE: To critically review the literature on vardenafil in the treatment of erectile dysfunction while integrating the clinical findings with the personal experience of the authors. METHODS: Analysis of published full-length papers that were identified through Medline search from January 2000 through May 2004. Abstracts published in peer-reviewed journals from the same period were also considered. RESULTS: Efficacy, tolerability and safety, as reported in the peer-reviewed literature compares well with the authors' personal experience. Authors' personal observations include discussions on potency, selectivity, selection of initial dose, counselling for patients characteristically considered difficult-to-treat (diabetes, prostatectomy, depression), including the determination of the maximal efficacious dose and the possible role of daily dosing, optimisation of the use of vardenafil according to its pharmacokinetic and pharmacodynamic profiles (onset and reliability), and management of ED patients with or at risk for cardiovascular disease. CONCLUSIONS: Extensive experience with vardenafil as reported in peer reviewed literature confirms the important role of vardenafil in the management of patients with ED. The development of each physician's own experience with vardenafil is key to optimise overall satisfaction of this therapy by the patient and his partner.

Clinical Competence↗
PubMed2005

Comparison of the effect of sildenafil and apomorphine SL on nocturnal erections in healthy volunteers: a placebo-controlled study.

OBJECTIVE: To compare the effects of sildenafil and sublingual (sl) apomorphine on nocturnal erections. METHODS: In a prospective, single-blinded, placebo-controlled at-home study we compared the effect of apomorphine sl and sildenafil on sleep-related erectile activity in 30 healthy potent volunteers (mean age, 26.4 years; range, 23-35 years; Erectile Function domain of the International Index of Erectile Function > or =26), not reporting any subjective sleep abnormality during 4 consecutive nights with rigidity monitoring (NPTR) with the RigiScantrade mark device. After the first night of adaptation, they were randomized to receive placebo or apomorphine sl 2mg or sildenafil 50mg taken at bedtime during the following 3 consecutive nights. RESULTS: Sildenafil increased the mean+/-SE number of erections, overall length of erectile events, and the time of erections with rigidity >60% at both tip and base, as compared to placebo. The same parameters were reduced after administration of apomorphine sl. Similar findings were observed with regards to Rigidity Activity Units and Tumescence Activity Units. CONCLUSIONS: Our results confirm that sildenafil taken at bedtime might increase nocturnal erectile activity also in young potent men as compared to placebo. Apomorphine sl taken at bedtime seems to have the opposite effect.

Adult↗
PubMed2005

Pfannenstiel versus vertical laparotomy in patients undergoing radical retropubic prostatectomy with spinal anesthesia: results of a prospective, randomized trial.

OBJECTIVE: To evaluate the impact of a standard vertical laparotomy versus a Pfannenstiel transverse laparotomy on intra-, peri-operative, and 6-month follow-up outcome in patients undergoing radical retropubic prostatectomy with pelvic lymphadenectomy with spinal anesthesia. METHODS: Between January 2003 and June 2003, 69 age-matched consecutive patients with clinically localized prostate cancer underwent radical retropubic prostatectomy with pelvic lymphadenectomy with spinal anesthesia and were randomized into Group 1 (vertical laparotomy: 35 patients) and Group 2 (Pfannenstiel laparotomy: 34 patients). An extensive analysis of the critical intra-, peri-operative, and 6-month follow-up clinical parameters was performed. RESULTS: Both the hemodynamics and the biochemical balance were not significantly different between the two groups. Overall blood loss (p = 0.78), autologous (p = 0.88) and homologous (p = 0.36) blood transfusions were similar regardless of the type of laparotomy. Surgical time was not significantly (p = 0.27) different between the two groups. Similarly, the two forms of laparotomy did not differ regarding the length of the surgical incision (p = 0.21), as measured at the end of the procedure. Post-operative oxygen saturation percentage by pulse oximetry, as well as post-op sedation score, were not significantly different (p = 0.06 and p = 0.97, respectively). Waiting time in the post-operative holding area (p = 0.15), and pain score in the post-operative holding area (p = 0.9) as well as on post-operative day 1 (p = 0.1) were not significantly different between the two groups. The rate of first flatus passage and of unassisted ambulation were similar regardless of the type of laparotomy during post-operative day day 1. The two types of incision made it possible to remove a similar (p = 0.34) number of pelvic lymph nodes and were associated to a similar rate of positive surgical margins among pT2 patients. At the 6-month follow-up the occurrence of a pelvic lymphocele and of deep venous thrombosis was similar in the two groups (p = 0.6 and p = 0.16, respectively). Complete urinary continence and spontaneous erectile function recovery was reported in a similar number of patients regardless of the type of surgical incision (p = 0.59 and p = 0.40, respectively). CONCLUSIONS: These results suggest that a Pfannenstiel transverse suprapubic laparotomy does not result in a significantly different outcome from a standard vertical laparotomy in patients undergoing a radical retropubic prostatectomy with pelvic lymphadenectomy with L2-L3 spinal anesthesia for clinically localized prostate cancer.

Aged↗
PubMed2005

Predictors of prostate cancer after initial diagnosis of atypical small acinar proliferation at 10 to 12 core biopsies.

OBJECTIVES: To evaluate the factors that predict prostate cancer detection by means of 10 to 12 core repeat biopsies in patients with atypical small acinar proliferation (ASAP) results on initial biopsy. METHODS: From 1998 to 2004, 110 of 127 patients (87%) with a diagnosis of ASAP were rebiopsied with the same technique plus additional biopsies on the ASAP site (12.6 +/- 1.1 cores [mean +/- standard deviation]). Each histologic slide was reviewed blindly by a single experienced pathologist, who also differentiated highly suspicious (ASAPH) and not highly suspicious (ASAPB) lesions for cancer. RESULTS: On initial biopsy, a concomitant high-grade prostatic intraepithelial neoplasia (HGPIN) was present in 26 patients (23%) with ASAP. The overall cancer detection rate was significantly higher in patients who had ASAP associated with HGPIN (58%), compared with patients who had isolated ASAP (35%; P = 0.04). The cancer detection rate was not significantly higher in patients with ASAPH than in those with ASAPB (49% versus 33%, respectively; P = 0.11). In the group of patients who had isolated ASAP, the rate of cancer detection was significantly higher in patients who had a prostatic volume less than 50 mL (56%) than in patients with a prostatic volume of 50 mL or more (27%; P = 0.03). CONCLUSIONS: The cancer detection rate was significantly higher in patients with an ASAP associated with HGPIN on initial biopsy than in patients with isolated ASAP. In ASAP patients, the detection rate was lower for patients with a larger prostate than in those with a smaller prostate.

Adenocarcinoma↗
PubMed2005

Assessment, diagnosis, and investigation of erectile dysfunction.

Diagnosis of erectile dysfunction (ED) now largely rests on the medical, sexual, and psychosocial history of the patient, ideally involving the man's partner. The medical history is crucial because ED is associated with so many common disorders and their treatment. A range of validated questionnaires may be used in taking the history. They can provide an objective and systematic record. The history helps identify whether the ED is largely physical or psychogenic. In particular, gradual onset suggests a physical cause, and sudden onset suggests a psychogenic cause. Physical examinations are not usually necessary. Taking blood pressure and physical examination of the genitals for signs of Peyronie's disease and hypogonadism may be helpful. Laboratory tests that identify diabetes (glycosylated haemoglobin), hyperlipidaemia (lipids), and hypogonadism (testosterone) may identify causes of ED. A range of specialized investigations, such as ultrasound and nocturnal penile tumescence and rigidity assessment, is also available, but is not used routinely in most patients with ED.

Erectile Dysfunction↗
PubMed2005

Drug Insight: oral phosphodiesterase type 5 inhibitors for erectile dysfunction.

Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men. At present, first-line oral pharmacotherapy for most patients with ED is a phosphodiesterase type 5 (PDE-5) inhibitor, of which three are currently available worldwide. Sildenafil (Viagra, Pfizer) has a very satisfactory efficacy-safety profile in all patient categories. The first PDE-5 inhibitor to reach the market, it is now the most widely prescribed oral agent for ED. Tadalafil (Cialis, Lilly ICOS) and vardenafil (Levitra, Bayer/GlaxoSmithKline) were introduced to the European Union and the US in 2003 and 2004, respectively. These three PDE-5 inhibitors share many characteristics, but each has unique features. This review describes the chemical, pharmacologic and clinical features of sildenafil, vardenafil and tadalafil as oral first-line treatments for ED. First, we describe the physiology of penile erection and PDE-5 inhibitor pharmacology, including chemistry, PDE selectivity, pharmacokinetics, and possible drug interactions. We then summarize data on the efficacy and safety profiles of the three PDE-5 inhibitors for the treatment of ED in the general population, in patients with diabetes mellitus and in men that have undergone bilateral nerve-sparing retropubic radical prostatectomy.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2005

Update of the minimally invasive therapies for benign prostatic hyperplasia.

PURPOSE OF REVIEW: The elevated impact benign prostatic hyperplasia has on patient quality of life has determined continuous research into the development of minimally invasive therapies aimed at restoring or preserving a good quality of life. The purpose of this review is to highlight recent developments in the field of minimally invasive treatment of benign prostatic hyperplasia, and to determine their possible impact on everyday clinical practice. RECENT FINDINGS: Recent publications have described some interesting new therapies and provided data concerning long-term follow up and cost-effectiveness that have been lacking up until now. The review mainly focuses on transurethral microwave thermotherapy, interstitial laser coagulation, transurethral laser ablation, laser prostatectomies (resection and enucleation), transurethral ethanol injection therapy, transurethral electrovaporization, and high-power (80-W) potassium titanyl phosphate laser vaporization. SUMMARY: Recent developments, new approaches and long-term reports of previously described minimally invasive therapies for the treatment of benign prostatic hyperplasia are presented. Cost-effectiveness studies were also carried out to complete the comparison with standard everyday procedures. Currently, transurethral microwave thermotherapy seems to offer the soundest basis for management of the condition, providing the longest term follow up and the largest numbers of studies completed to date. Among surgical alternatives, holmium laser enucleation has gained ground as an encouraging new approach, being similar to standard transurethral resection of the prostate, but reducing perioperative morbidity with the same long-term results. More randomized comparisons correctly conducted need to be undertaken before an accurate general picture is available for the urologist.

Humans↗
PubMed2005

Passerini-glazel feminizing genitoplasty: a long-term followup study.

PURPOSE: We report our experience with early 1-stage Passerini-Glazel feminizing genitoplasty with special emphasis on long-term results of vaginoplasty. MATERIALS AND METHODS: A total of 66 patients with ambiguous genitalia underwent 1-stage Passerini-Glazel feminizing genitoplasty. Long-term followup included an outpatient visit at 1 year postoperatively and a genital assessment with the patient under general anesthesia performed before menarche courses in those operated on at age 6 months to 8 years, and at 2 years postoperatively for those operated on at 9 years or older. RESULTS: All patients underwent the first long-term followup evaluation and no major complications were observed. The second long-term followup evaluation was performed in 46 patients (70%). In all cases the vaginal introitus was located in the physiological position and was large and elastic. Vaginal caliber at the suture line between the tubularized flap and vaginal mucosa was the same size as the vaginal introitus and distal native vagina in 20 of 46 patients (43%), slightly smaller in 10 (22%) and stenotic in 16 (35%). Stenosis at the suture line was corrected with simple Y-V introitoplasty performed at the same followup visit. CONCLUSIONS: Early 1-stage Passerini-Glazel feminizing genitoplasty is a safe and effective procedure that allows total surgical correction of ambiguous genitalia in infancy and good cosmetic results. Incidence of vaginal stenosis at the suture line is high but it can be repaired with simple introitoplasty performed before menarche occurs. Good functional results are presumed.

Adolescent↗