Biomedical subjects
Publications and source records attributed to Francesco Montorsi.
The introduction of new oral therapies has completely changed the diagnostic and therapeutic approach to erectile dysfunction. A panel of experts in this field has developed guidelines for the clinical evaluation and treatment based on the review of available scientific information.
INTRODUCTION AND OBJECTIVES: To systematically analyze and review the available evidence about the potential role of chronic administration of phosphodiesterase type 5 (PDE-5) inhibitors for the cure of erectile dysfunction (ED) based on clinical and basic science data. METHODS: Analysis of published full-length papers that were identified with Medline and Cancerlit from January 1993 to September 2005. Abstracts published in the journals European Urology, the Journal of Urology, the International Journal of Impotence Research, and the Journal of Sexual Medicine as official proceedings of internationally known scientific societies held in the same time period were also assessed. RESULTS: Chronic administration of PDE-5 inhibitors have reportedly been associated with increased persistent vascular and endothelial function--which represents a key factor in maintaining vascular tone and inducing vasodilation--by increasing the level of endothelial cGMP generated by activation of endothelial nitric oxide. Clinical studies have revealed a potential protective role of these compounds on endothelial function in short- and long-term assessments. Several studies based on animal models have provided direct experimental support for the role of PDE-5 inhibitors in improving the structure and function of the cavernosal tissue and have suggested potential molecular mechanisms involved. CONCLUSIONS: Although evidence increasingly supports the potential role of chronic administration of PDE-5 inhibitors for improving erectile function in patients affected by ED, long-term data are lacking. However, data available from animal models support the evidence of potential benefits induced on endothelial function by chronic exposure to PDE-5 inhibitors.
OBJECTIVES: To assess the baseline erectile function (EF) of patients with clinically localized prostate cancer (pCa), who are candidates for a bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP) to (a) objectively rate the preoperative self-reported subjective patient's EF and (b) investigate possible correlations between preoperative EF and demographic data and comorbidities. MATERIALS AND METHODS: Two-hundred-thirty-four patients, who verbally self-reported they were preoperatively fully potent and strongly motivated to maintain postoperative EF, underwent a BNSRRP. A comprehensive medical and sexual history was obtained on hospital admission the day prior to surgery. Subjectively reported potency rate was compared with the scores of the International Index of Erectile Function (IIEF). RESULTS: The EF domain of the IIEF showed a baseline normal EF in only 43% of the subjects. In contrast, 13% had a mild erectile dysfunction (ED), 8% had a mild to moderate ED, 8% complained of a moderate ED, and as many as 28% reported severe EF impairment. Interestingly, 38% of the patients with severe ED did not attempt any intercourse during the last 4 weeks prior to surgery. CONCLUSIONS: A significant proportion of patients with clinically localized pCa and self-reported total potency already had suffered from ED preoperatively. Incorrect timing of questionnaires administration, the potential influence of preoperative patient's psychological distress, and the implication of the patient's partner's psychological and sexual health may be contributing factors to the contradictory finding. The preoperative use of validated questionnaire may help to identify patients who can actually expect to regain potency following a BNSRRP.
PURPOSE: Radical prostatectomy has progressively become an elective treatment for primary localized prostate cancer as well as for incidental or subsequent prostatic cancer after previous surgery for obstructive benign disease. This increased acceptance opens concerns about oncological and functional outcomes. MATERIALS AND METHODS: Between July 1999 and August 2003, 109 patients underwent radical retropubic prostatectomy for prostate cancer as a second line approach after surgery for primary bladder outlet obstruction. Of these patients 88 had undergone previous transurethral resection of the prostate and 21 had undergone open prostatectomy. Incidental and delayed prostate cancer was detected in 71 and 38 cases, respectively. Perioperative and postoperative morbidity was evaluated in all patients, while postoperative functional outcomes were assessed by a subjective questionnaire in 43. RESULTS: As a second surgery, radical retropubic prostatectomy was generally more complex technically and it resulted in longer operative time compared to radical surgery in naïve patients. In contrast, early and delayed postoperative morbidity increased moderately. Complete urinary continence was documented in 32 (74%) and 37 patients (86%) at the 6 and 12-month follow-ups, respectively. In this patient cohort adequate erectile function was reported by 12%. CONCLUSIONS: Radical retropubic prostatectomy can be performed safely after previous prostate surgery for bladder outlet obstruction. However, a consistent surgical background in prostate surgery is needed to manage frequently unexpected difficulties. Candidates for second line prostate surgery should be informed that functional results are less predictable and satisfactory than those achieved after the same surgical approach in naïve patients.
OBJECTIVES: To compare urodynamic findings after holmium laser enucleation of the prostate (HoLEP) and transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia-related bladder outlet obstruction. METHODS: From January to October 2002, 100 consecutive patients with benign prostatic hyperplasia with obstructive lower urinary tract symptoms were randomized to surgical treatment with either HoLEP (group 1, n = 52) or TURP (group 2, n = 48). All patients were preoperatively assessed using the International Prostate Symptom Score and quality-of-life question, total serum prostate-specific antigen measurement, transrectal ultrasonography, and complete urodynamic study. The operative time, catheterization time, and overall hospital stay were also recorded for both groups. All patients were assessed at 1, 6, and 12 months postoperatively using a complete urodynamic evaluation. RESULTS: All patients were obstructed preoperatively (Schäfer grade greater than 2). Both groups were comparable in terms of age, total serum prostate-specific antigen level, International Prostate Symptom Score, and urodynamic results. At 1, 6, and 12 months of follow-up, no statistically significant differences were recorded in terms of detrussor pressure at maximal urinary flow rate, Schäfer grade (linear passive urethral resistance relation), maximal urinary flow rate, International Prostate Symptom Score, and quality-of-life score. In the HoLEP group, the catheterization time and hospital stay were significantly shorter. Transitory lower urinary tract symptoms after 3 months of follow-up and dysuria were more frequent in the HoLEP group than in the TURP group, although at 12 months of follow-up, the results were comparable. CONCLUSIONS: Both HoLEP and TURP were equally effective in relieving bladder outlet obstruction. Although associated with greater early self-resolving irritative symptoms, HoLEP can guarantee a shorter catheterization time and hospital stay with longer operative times, proposing itself as an attractive alternative to standard TURP.
OBJECTIVES: To compare the cost of open transvesical prostatectomy (OP) with that of holmium laser enucleation (HoLEP) in the treatment of bladder outlet obstruction (BOO) attributed to benign prostatic hyperplasia. METHODS: From February to May 2004, 63 consecutive patients with symptomatic benign prostatic hyperplasia in a large prostate (70 to 220 g) and documented BOO were randomized to surgical treatment with OP (29 in group 1) or HoLEP (34 in group 2). All costs associated with the procedures during the hospital stay were recorded prospectively, and a cost-effectiveness analysis of the critical perioperative (ie, intraoperative and postoperative to hospital discharge) data was performed. RESULTS: The cost analysis showed a mean perioperative cost of 2868.9 euros (3556.3 dollars) for group 1 and 2356.5 euros (2919.4 dollars) for group 2. A direct comparison analysis showed that the most significant cost factors were the operative time (average 16.1% and 25.1% to the cost of OP and HoLEP, respectively), operating room surgical setup/disposables, including laser fiber and resectoscope loop in group 2 (average 13.3% and 29.3% to the cost of OP and HoLEP, respectively), and length of postoperative hospital stay (average 53.3% and 32.0% to the cost of OP and HoLEP, respectively). Overall, the hospitalization cost of HoLEP was 9.6% less than that for OP. CONCLUSIONS: Our data have demonstrated that HoLEP is associated with a significant hospital net cost savings compared with OP in patients undergoing surgery for symptomatic benign prostatic hyperplasia in large glands.
OBJECTIVES: To investigate the clinical and pathologic characteristics of patients with bone metastases identified at the time of newly diagnosed prostate carcinoma at biopsy. METHODS: From November 2002 to May 2004, 1587 consecutive patients had a pathologic diagnosis of prostate cancer and underwent conventional technetium-99m methylene diphosphonate scintigraphy of the entire body. The clinical and pathologic features of those patients with positive bone scan findings (group 1) were compared with those of a subcohort of 372 patients with negative bone scan findings performed at the same nuclear medicine department (group 2). RESULTS: A retrospective complete data collection was available for 1242 of 1587 patients. Bone metastases were found in 31 patients (2.5%). As expected, patients with skeletal metastases had a significantly greater mean serum total prostate-specific antigen level, and a Gleason sum of 8 or 9 was significantly more frequent in the pathologic findings of these subjects. Group 1 patients had a significantly greater prevalence of previous nonprostate primary neoplasms (chi-square 12.74, df = 1, P = 0.0004) and reported a greater prevalence of current use of H2 blockers for the treatment and prevention of gastroesophageal reflux disorders (chi-square 37.52, df = 1, P < 0.0001) than did group 2 patients. CONCLUSIONS: Our data have confirmed that bone metastases are more frequent in patients with high prostate-specific antigen levels and poorly differentiated tumors at biopsy regardless of the patient's age. A history of previous nonprostate primary neoplasms and the use of H2 blockers seemed to be more prevalent in those patients with bone metastases at diagnosis.
We aimed to determine whether erectile function (EF) and assessments of erection hardness correlate positively with measures of psychosocial outcomes (ie, emotional well-being, sexual satisfaction, and satisfaction with erectile dysfunction [ED] treatment) in men treated with sildenafil citrate (Viagra; Pfizer Inc, New York, NY). Data were collected from 33 worldwide phase 2, 3, and 4 sildenafil clinical trials, which included almost 10,000 men with ED. Most of these trials were randomized, double-blind, and placebo-controlled (n = 27) and were undertaken to assess doses of 50 mg adjustable to 25 mg or 100 mg, depending on efficacy and tolerability (n = 32). Doses were taken approximately 1 hour before anticipated sexual activity but not more often than once daily. EF was assessed with use of the EF domain of the International Index of Erectile Function (IIEF) and with assessments of erection hardness (Erection Hardness Grading Scale [EHGS] and IIEF Q2 [the frequency of erections hard enough for penetration]). Change (baseline to end point) in emotional well-being in men treated for ED was assessed with the Self-Esteem and Relationship (SEAR) questionnaire, which consisted of the Confidence domain (ie, the Self-Esteem subscale and Overall Relationship subscale) and the Sexual Relationship domain. End point treatment satisfaction (overall, speed of onset, and duration of action) was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). The IIEF was used to assess change and end point sexual satisfaction by means of the Intercourse Satisfaction domain, Q7 (frequency of satisfactory sexual intercourse), and the Overall Satisfaction domain (ie, Q13, satisfaction with sex life, and Q14, satisfaction with sexual relationship). In men treated with sildenafil for ED, scores for measures of EF (IIEF EF domain, IIEF Q2) and the percentage of erections graded completely hard and fully rigid (EHGS grade 4) correlated positively with scores for measures of psychosocial outcomes (SEAR emotional well-being, IIEF sexual satisfaction, and EDITS ED treatment satisfaction), indicating that when EF improved and erection hardness increased, these measures of psychosocial function also improved.
PURPOSE: We compared the impact of HoLEP and TURP on sexual function. MATERIALS AND METHODS: Between January 2002 and January 2003, 120 patients with a mean age +/- SD of 65.2 +/- 7.1 years who had benign prostatic hyperplasia were enrolled in this 2-center, prospective, randomized study. A total of 60 patients with a mean age of 65.25 +/- 6.9 years underwent HoLEP (group 1) and 60 with a mean age of 64.18 +/- 7.2 years underwent TURP (group 2). Patients were assessed before surgery, and at 12 and 24-month followup visits. Subjective symptoms were scored by the International Prostate Symptom Score, the International Prostate Symptom Score quality of life question, IIEF, 10 nonvalidated general assessment questions, physical examination, serum prostate specific antigen and transrectal ultrasonography. RESULTS: A total of 32 patients (53.3%) in group 1 and 31 (51.6%) in group 2 reported various degrees of erectile dysfunction before surgery according to the IIEF-EF score. Differences between preoperative and postoperative orgasmic domain scores in each group were significant (p <0.001). A slight but not significant increase in the mean IIEF-EF domain score was reported in each group at postoperative assessments without any difference between the 2 surgical approaches. According to general assessment question analysis the prevalence of subjectively reported postoperative retrograde ejaculation was significantly higher than at baseline assessment in the 2 groups with no differences between the 2 surgical procedures. CONCLUSIONS: TURP and HoLEP significantly lowered the IIEF orgasmic function domain with no differences between techniques. This was caused by retrograde ejaculation. Marginal, nonsignificant erectile function improvement was reported after surgery in the 2 groups.
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AIM: To assess the impact of spinal anesthesia (SpA) combined with three different forms of conscious sedation on intraoperative and postoperative outcome in patients undergoing radical retropubic prostatectomy (RRP) for organ confined prostate cancer (pCa). METHODS: A total of 121 consecutive patients with pCa undergoing RRP were randomized into four groups. They were randomized as follows: group 1 (general anesthesia: 34 patients), group 2 (lumbar 2 to lumbar 3 interspace SpA with diazepam as sedative agent: 28), group 3 (SpA with propofol: 30), and group 4 (SpA with midazolam: 29). Intraoperative and perioperative parameters were collected. RESULTS: The present study showed that muscle relaxation throughout RRP was not different in the four groups; bleeding was significantly (P = 0.04) lower with SpA, regardless of the form of sedation. Group 3 patients reported the best postoperative oxygen saturation percentage by pulse oximetry and sedation score (P = 0.02; d.f. = 3 and P < 0.0001; d.f. = 3, respectively), the shortest waiting time in the postoperative holding area (P < 0.001; d.f. = 3), the lowest pain on postoperative day 1 (P = 0.0004; d.f. = 3), and the highest frequency of first flatus passage (P = 0.0001; d.f. = 3). A higher number of group 4 patients were able to carry out unassisted ambulation (P < 0.0001; d.f. = 3). CONCLUSIONS: Conscious sedation coupled with SpA is a safe, reliable and effective procedure for patients undergoing RRP. The use of propofol as sedative agent offers several advantages both over other types of conscious sedation and general anesthesia.
OBJECTIVES: To evaluate the morphological changes induced by a 3-month course of neoadjuvant bicalutamide 150 mg/day before radical prostatectomy (RP) on prostatic adenocarcinoma and high-grade prostatic intraepithelial neoplasia (HGPIN). PATIENTS AND METHODS: In all, 90 patients with cT1-T2 prostate cancer and HGPIN on prostatic biopsy were randomized to receive bicalutamide (150 mg/day for 3 months) before RP, or to have immediate surgery. Surgical specimens were assessed for the histopathological features of cancer, HGPIN and benign epithelium in a blinded manner. The volumes of prostate cancer and HGPIN were evaluated using a stereological (i.e. grid) method. RESULTS: Compared with the bicalutamide-treated group, the ratio of stroma to epithelium, evaluated by visual microscopic assessment in the normal epithelium of the three prostate zones, was significantly lower in the control group, at 2.27 (sd 1.13), than in the treated group, at 1.87 (sd 0.72) (P = 0.048). The mean (sd) tumour volume was significantly lower in the bicalutamide-treated than in the control group, at 0.914 (0.13) vs 1.47 (0.24) mL (P = 0.044). Similarly, the mean (sd) volume of HGPIN was significantly lower in the bicalutamide-treated than in the control group, at 0.34 (0.06) vs 0.62 (0.07) mL (P = 0.003). At RP, specimen Gleason scores in the bicalutamide-treated group were similar to those in the control group, and were no different from the biopsy Gleason scores. CONCLUSIONS: Involution and epithelial shrinkage of prostate cancer and HGPIN were evident after neoadjuvant treatment with bicalutamide 150 mg. There was no evidence of the emergence of higher-grade cancer after treatment.
OBJECTIVE: To explore the rate of significant upgrading from biopsy to radical prostatectomy (RP) specimens in a contemporary cohort, and to develop a prognostic model capable of predicting the probability of significant upgrading, as previous reports indicate that up to 43% of men with low-grade prostate cancer at biopsy will be diagnosed with high-grade cancer at RP. PATIENTS AND METHODS: The study cohort comprised 4789 men (median age 63 years, range 39-82) treated with RP, with available clinical stage, prostate-specific antigen levels, biopsy and RP Gleason sum values. These variables were used as predictors in multivariate logistic regression models (LRMs) addressing the rate of significant Gleason sum upgrading, defined as a Gleason sum increase either from < or = 6 to > or = 7 or from 7 to > or = 8 between the biopsy and RP specimens. Regression coefficients were used to develop and validate (200 bootstrap re-samples) a nomogram predicting significant biopsy Gleason sum upgrading. RESULTS: Significant biopsy Gleason sum upgrading was recorded in 1349 (28.2%) patients. In multivariate LRMs, all predictors were highly significant (all P < 0.001). The bootstrap-corrected accuracy of the nomogram predicting the probability of significant Gleason sum upgrading between biopsy and RP specimens was 75.7%. CONCLUSION: Our nomogram might prove highly useful when the possibility of a more aggressive Gleason variant could change the treatment options.
INTRODUCTION: Historically chocolate has been reported to exert several effects on human sexuality, mainly acting as an effective aphrodisiac, increasing sexual desire, and improving sexual pleasure. AIM: The aim of our study was to assess whether there is an association between daily chocolate intake and sexual function in a convenience sample of Northern Italian women. METHODS: A convenience sample of 163 women (mean +/- SD age: 35.3 +/- 9.2 years; body mass index [BMI]: 22.5 +/- 3.5 kg/m2), recruited through advertising, completed an anonymous semistructured interview on recreational habits and questionnaires to assess sexual function (Female Sexual Function Index [FSFI]), sexual distress (Female Sexual Distress Scale), and depression (Beck Depression Inventory and Center for Epidemiological Survey Depression Scale). RESULTS: Complete data were available for 153/163 (93.8%) women. Participants who reported daily chocolate intake (Group 1: 120 women) were significantly younger than those (Group 2: 33 women) who did not report to eat chocolate (33.9 +/- 0.8 years vs. 40.4 +/- 1.6 years, respectively) (P = 0.0003), despite a similar BMI. Participants in Group 1 had significantly higher total (P = 0.002) and desire domain (P = 0.01) FSFI scores than participants in Group 2. No differences between the two groups were observed concerning sexual arousal and satisfaction, sexual distress and depression. Our data also confirm that aging has a high statistically significant impact on women's sexual function. CONCLUSIONS: It is alluring to hypothesize that chocolate can have either a psychological or a biological positive impact on women's sexuality. In our sample women reporting chocolate consumption have higher FSFI scores than women who do not eat chocolate. However, when data are adjusted for age FSFI scores are similar, regardless of chocolate consumption.
OBJECTIVE: Erectile dysfunction and depression are highly associated. Previous studies have shown benefits of phosphodiesterase-5 inhibitor treatment for erectile dysfunction associated with antidepressant therapy or subsyndromal depression. The present study assessed the safety and efficacy of vardenafil in men with erectile dysfunction and untreated mild depression. METHOD: In this 12-week, multicenter, randomized, flexible-dose, parallel-group, double-blind study, 280 men with erectile dysfunction for at least 6 months and untreated mild major depression received placebo or vardenafil, 10 mg/day, for 4 weeks, with the option to titrate to 5 mg/day or 20 mg/day after each of two consecutive 4-week intervals. Endpoints included International Index of Erectile Function erectile function domain and 17-item Hamilton Depression Rating Scale (HAM-D) scores. RESULTS: Vardenafil produced statistically significant and clinically meaningful improvement in all erectile function parameters. The International Index of Erectile Function erectile function domain score was 22.9 with vardenafil compared to 14.9 with placebo. The HAM-D score was lower in the vardenafil group (7.9) than in the placebo group (10.1). Treatment with vardenafil was the most important predictor for return to normal erectile function. Improvement in International Index of Erectile Function erectile function domain score was the most important predictor of remission in depressive symptoms. CONCLUSIONS: Vardenafil was well tolerated and highly efficacious in men with erectile dysfunction and untreated mild major depression. Significant improvements in erectile function and depression were observed in patients treated with vardenafil versus placebo. Erectile dysfunction treatment should be considered a component of therapy for men with depression and erectile dysfunction.
Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men worldwide. First-line oral therapy for ED includes the use of phosphodiesterase type 5 inhibitors (sildenafil, tadalafil and vardenafil) and sublingual apomorphine. Apomorphine is a dopamine D(1) and D(2) receptor agonist that has been approved for marketing in Europe. Different apomorphine formulations have been tested, such as sublingual, subcutaneous and intranasal. However, the sublingual formulation has shown the best results in terms of efficacy, safety and tolerability, especially the 2mg and 3mg doses. Although clinical studies of the efficacy and tolerability of apomorphine sublingual (SL) have included older patients, who are more likely to have ED, no study has specifically assessed the efficacy and tolerability of different doses of apomorphine SL in aging men. Therefore, a MEDLINE search was conducted from January 1987 to November 2005 to identify studies of the efficacy, safety (in particular cardiovascular safety) and tolerability of different apomorphine formulations and doses as treatments for ED in the subcohort of aging men. On the basis of the most recent peer-reviewed publications, the first part of this article critically evaluates data regarding the epidemiology of ED in the aging population. The second part of the article focuses on the mechanism of action and pharmacokinetics of apomorphine both in the general and the elderly population. Finally, a critical analysis of the efficacy and safety of different apomorphine formulations and doses for the treatment of ED is reported. Apomorphine represents a first-line oral treatment for ED. Available formulations include only sublingual administration. Few studies have assessed the efficacy and safety of apomorphine in the elderly population. However, in clinical practice, older patients with multiple vascular risk factors and systematic vascular damage show poor overall response to apomorphine SL for the treatment of ED.
OBJECTIVE: Aims of this study were 1) to assess sexual function and endocrine profile among fertile type 1 diabetic women during the follicular and luteal phases of the menstrual cycle, 2) to compare these results with those obtained among healthy fertile women who served as control subjects, and 3) to explore the correlations between sexual function and endocrine milieu among patients and control subjects during the follicular and luteal phases of the menstrual cycle. RESEARCH DESIGN AND METHODS: Fifty fertile women with type 1 diabetes and 47 healthy control subjects completed a semistructured medical interview and filled in self-administered validated instruments to evaluate sexual function, depression, and sexual distress. Venous blood samples were drawn to measure glycated hemoglobin and an endocrine profile during either the follicular or the luteal phase of the menstrual cycle. RESULTS: Type 1 diabetic women had decreased sexual function and increased sexual distress compared with control subjects during the luteal, but not the follicular, phase of the menstrual cycle. During the follicular phase, patients had lower estrogenic basal tone, lower "weak" androgen (namely Delta4-androstenedione and dehydroepiandrosterone sulfate) production, and lower free-triiodothyronine and free-thyroxine levels compared with control subjects. During the luteal phase, total testosterone levels were higher in patients than control subjects, while 17beta-estradiol and progesterone levels were lower in patients than control subjects. CONCLUSIONS: Among type 1 diabetic women, sexual function and sexual distress vary according to the phase of the menstrual cycle. This finding may have implications on the clinical assessment of sexual function in type 1 diabetic women.
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.