Surgery or Rehabilitation: A Randomized Clinical Trial Comparing the Treatment of Vocal Fold Polyps via Phonosurgery and Traditional Voice Therapy with "Voice Therapy Expulsion" Training.

OBJECTIVE: Phonomicrosurgery is generally considered to be the treatment of choice for removing vocal fold polyps. However, specific techniques of voice therapy may represent, in selected cases and under certain conditions, a noninvasive therapeutic option for the treatment of such laryngeal lesions. The aim of the present study is to longitudinally assess, in terms of clinical outcomes and quality of life, two groups of patients with cordal polyps, treated either with standard surgery plus standard voice therapy or with a specific training of voice therapy alone, which we have called "Voice Therapy Expulsion." STUDY DESIGN: This study is a randomized controlled trial. METHODS: A total of 150 patients with vocal fold polyps were randomly assigned to either standard surgery or "voice therapy expulsion" protocol. The trial was carried out at the Division of Phoniatrics and Audiology of the Second University of Naples and at the Division of Communication Disorders of Local Health Unit (3 Naples South) from January 2010 to December 2013. A thorough phoniatric evaluation, including laryngostroboscopy, acoustic voice analysis, global grade of dysphonia, instability, roughness, breathiness, asthenia, and strain scale, Voice Handicap Index, and Voice-Related Quality of Life, was performed by using standardized tools, at baseline, at the end of the treatment, and up to 1 year after treatment. RESULTS: We found no significant differences between the two experimental groups in terms of clinical outcomes and personal satisfaction. However, "Voice Therapy Expulsion" was associated with higher scores for quality of life at endpoint evaluation. CONCLUSIONS: Besides phonosurgery, this specific "Voice Therapy Expulsion" technique should be considered as a valid, noninvasive, and well-tolerated therapeutic option for the treatment of selected patients with vocal fold polyps.

Acceptance and safety of the intradermal influenza vaccine among the elderly in Italy: an on-field national study.

INTRODUCTION: An observational multicenter study was carried out in Italy, to evaluate the acceptability and safety of the new intradermal (ID) influenza vaccine (Intanza Sanofi Pasteur SA, Lyon, France) among subjects aged≥60 years, compared with that of other intramuscular (IM) influenza vaccines. Compliance with the use of the ID vaccine by healthcare professionals was also assessed. METHODS: A previously validated and self-administered questionnaire, Vaccinees' Perception of Injection (VAPI®), consisting of 21 questions, mainly focused on four dimensions (bother, arm movements, sleep, and acceptability), was administered to >1,600 individuals with spontaneous access to outpatient clinics, located in Northern, Central, and Southern Italy, to evaluate the acceptance of the vaccines. Occurrence of solicited and unsolicited side effects and of serious adverse events was assessed in a subset of subjects (n=500), using a clinical diary filled in by vaccinees following immunization. Compliance with the new ID vaccine by healthcare professionals was investigated using an ad-hoc questionnaire. RESULTS: A very favorable opinion concerning the acceptability of both the vaccines under survey, with the most positive answers ranging between 75.5% and 94.9%, was registered within the study population. Also the compliance by healthcare professionals (n=130) with the novel ID vaccine was favorable. No serious adverse event occurred during the 6-month follow-up period. The frequency of solicited systemic reactions was comparable between the two study groups, while solicited local reactions were significantly higher in the ID-vaccine group than in the IM-vaccine group, even if at values lower than those reported in phase 3 clinical trials (ranges=18.5-32.6% vs. 29.5-70.9%). These local events were mild and transient, thus without any clinical relevance. CONCLUSION: The novel ID influenza vaccine can be widely recommended in clinical practice, representing a useful tool to improve immunization coverage rates, and thus the control of influenza.

Choosing the nephrostomy size after percutaneous nephrolithotomy.

PURPOSE: To evaluate the effect of nephrostomy tube size on perioperative outcomes of percutaneous nephrolithtotmy (PCNL). METHODS: Forty-five well-matched patients with normal renal function were prospectively divided in two nonrandomized groups after uneventful PCNL (to receive either a 22-Fr, group 1 (n = 24 pts), or a 12-Fr nephrostomy tube, group 2 (n = 21 pts)). In all a balloon nephrostomy catheter with detachable funnel (Rüsch Teleflex, Germany) was used. A Visual Analogue Scale (VAS) for measuring the pain was administered 8 and 24 h after the procedure. Postoperative analgesics use (Ketoralac Tromethamine 30 mg), pre- and postoperative Hb, renal function and urinary leaks were registered. RESULTS: Groups were comparable as demographics and stone characteristics. VAS pain score was significantly higher in group 1 (4.25 vs. 3.2, P < 0.001) only 8 h postoperatively. No significant difference was found in the VAS pain score 24 h p.o. Similarly, analgesics use (1.6 vs. 1.1, P = 0.05), sHb (1.42 vs. 1.21, P = 0.055) and hospital stay (3.8 vs. 3.6, P = 0.63) were not significant between the two groups of patients. CONCLUSIONS: A small bore nephrostomy catheter may reduce pain in the immediate postoperative time. It does not affect blood loss and hospital stay so it can safely be used instead of a large size nephrostomy tube, after uneventful percutaneous procedures.

Dietary factors, Mediterranean diet and erectile dysfunction.

INTRODUCTION: Although epidemiological evidence seems to support a role for lifestyle factors in the pathogenesis of erectile dysfunction (ED), limited data are available suggesting that dietary changes may improve ED. AIM: To provide an update on clinical evidence regarding the role of dietary factors in ED. METHODS: A systematic literature search was performed using MEDLINE and other database (EMBASE, SCOPUS) with MeSH terms and keywords for "erectile dysfunction", "diet", "dietary patterns", "Mediterranean diet", and "lifestyle". MAIN OUTCOME MEASURES: To examine the data relating to erectile dysfunction with dietary factors, its relationship and the impact of dietary treatment. RESULTS: Only few studies assessed the role or the effect of diet on ED. A dietary pattern which is high in fruit, vegetables, nuts, whole grains, and fish but low in red and processed meat and refined grains is more represented in subjects without ED. Mediterranean diet has been proposed as a healthy dietary pattern based on evidence that greater adherence to this diet is associated with lower all-cause and disease-specific survival. In type 2 diabetic men, those with the highest adherence to the Mediterranean diet had the lowest prevalence of ED and were more likely to be sexually active. In clinical trials, Mediterranean diet was more effective than a control diet in ameliorating ED or restoring absent ED in people with obesity or metabolic syndrome. CONCLUSION: The adoption of a Mediterranean diet may be associated with an improvement of erectile dysfunction.

Adherence to Mediterranean diet and sexual function in women with type 2 diabetes.

INTRODUCTION: There are no reported studies assessing the relation between diet and sexual function in women with diabetes. AIM: In the present study, we explored the relation between consumption of a Mediterranean-type diet and sexual function in a population of type 2 diabetic women. METHODS: Patients with type 2 diabetes were enrolled if they had a diagnosis of type 2 diabetes for at least six months but less than 10 years, age 35-70 years, body mass index (BMI) of 24 or higher, HbA1c of 6.5% or higher, treatment with diet or oral drugs. All diabetic patients were invited to complete a food-frequency questionnaire and self-report measures of sexual function. A total of 595 (90.2%) of the 659 women completed both questionnaires and were analyzed in the present study. MAIN OUTCOME MEASURES: Adherence to a Mediterranean diet was assessed by a 9-point scale that incorporated the salient characteristics of this diet (range of scores, 0-9, with higher scores indicating greater adherence). The Female Sexual Function Index (FSFI) was used for assessing the key dimensions of female sexual function. RESULTS: Diabetic women with the highest scores (6-9) had lower BMI, waist circumference, and waist-to-hip ratio, a lower prevalence of depression, obesity and metabolic syndrome, a higher level of physical activity, and better glucose and lipid profiles than the diabetic women who scored <3 points on the scale. The proportion of sexually active women showed a significant increase across tertiles of adherence to Mediterranean diet (from 54.2% to 65.1%, P = 0.01). Based on the FSFI cutoff score for female sexual dysfunction (FSD) of 23, women with the highest score of adherence had a lower prevalence of sexual dysfunction as compared with women of lower tertiles (47.6%, 53.9%, and 57.8%, higher, middle, and lower tertile, respectively, P = 0.01). These associations remained significant after adjustment for many potential confounders. CONCLUSIONS: In women with type 2 diabetes, greater adherence to Mediterranean diet is associated with a lower prevalence of FSD.

Adherence to Mediterranean diet and erectile dysfunction in men with type 2 diabetes.

INTRODUCTION: There are no reported studies assessing the relation between diet and erectile dysfunction (ED) in men with diabetes. AIM: In the present study, we explored the relation between consumption of a Mediterranean-type diet and ED in a population of type 2 diabetic men. METHODS: Patients with type 2 diabetes were enrolled if they had a diagnosis of type 2 diabetes for at least six months but less than 10 years, age 35-70 years, body mass index (BMI) of 24 or higher, HbA1c of 6.5% or higher, treatment with diet or oral drugs. All diabetic patients were invited to complete a food-frequency questionnaire and self-report measures of sexual function. A total of 555 (90.8%) of the 611 diabetic men completed both questionnaires and were analyzed in the present study. MAIN OUTCOME MEASURES: Adherence to a Mediterranean diet was assessed by a 9-point scale that incorporated the salient characteristics of this diet (range of scores, 0-9, with higher scores indicating greater adherence). ED was assessed with the International Index of Erectile Function-5. RESULTS: Diabetic men with the highest scores (6-9) had lower BMI, waist circumference, and waist-to-hip ratio, a lower prevalence of obesity and metabolic syndrome, a higher level of physical activity, and better glucose and lipid profiles than the diabetic men who scored <3 points on the scale. The proportion of sexually active men showed a significant increase across tertiles of adherence to Mediterranean diet (from 65.1% to 74.4%, P = 0.01). Moreover, men with the highest score of adherence were more likely to have a lower prevalence of global ED (51.9% vs. 62%, P = 0.01) and severe ED (16.5% vs. 26.4%, P = 0.01) as compared with low adherers. CONCLUSIONS: In men with type 2 diabetes, greater adherence to Mediterranean diet is associated with a lower prevalence of ED.

Hyperlipidemia and sexual function in premenopausal women.

INTRODUCTION: No reported studies exist assessing the relationship between sexual function and hyperlipidemia in women. AIM: In this study, we assessed the domains of sexual function in a representative sample of sexually active premenopausal women with hyperlipidemia, but without cardiovascular disease, as compared with an age-matched female population without hyperlipidemia. METHODS: To be enrolled in the study, women had to meet at least one of the following criteria for the diagnosis of hyperlipidemia: low-density lipoprotein (LDL) cholesterol levels >160 mg/dL; high-density lipoprotein (HDL) cholesterol levels <50 mg/dL; or triglyceride levels >150 mg/dL. Lipid parameters were assessed and verified on blood taken at least twice in the hospital during the screening phase. Four hundred forty-one premenopausal women with hyperlipidemia were compared with 115 age-matched premenopausal women without hyperlipidemia. MAIN OUTCOME MEASURES: We used the Female Sexual Function Index (FSFI) for assessing the key dimensions of female sexual function. RESULTS: The two groups were well matched for age and smoking prevalence. Compared with women of the control group, women with hyperlipidemia had reduced mean global FSFI score (22.8 +/- 6.8 vs. 29.4 +/- 4.9, P < 0.001). Individual analysis of the different domains showed that women with hyperlipidemia reported significantly lower arousal, orgasm, lubrication, and satisfaction scores than control women. Based on the total FSFI score, 51% of women with hyperlipidemia had scores of 26 or less, indicating sexual dysfunction, as compared with 21% of women without hyperlipidemia (P < 0.001). Based on a more conservative analysis including women under the lower quartile of the distribution of FSFI score, 32% of women with hyperlipidemia had scores of 23 or less, as compared with 9% of women without hyperlipidemia (P < 0.001). Multiple regression analysis identified age, body mass index, HDL-cholesterol and triglycerides as independent predictors of FSFI score. CONCLUSIONS: Women with hyperlipidemia have significantly lower FSFI-domain scores as compared with age-matched women without hyperlipidemia. HDL cholesterol and triglyceride levels were independently associated with the FSFI score.

Short-term administration of prulifloxacin in patients with nonmuscle-invasive bladder cancer: an effective option for the prevention of bacillus Calmette-Guérin-induced toxicity?

OBJECTIVE: To determine whether the new fluoroquinolone prulifloxacin might improve tolerance to Bacillus Calmette-Guérin (BCG) intravesical therapy in patients with bladder cancer. PATIENTS AND METHODS: A series of 72 patients with intermediate- or high-risk nonmuscle-invasive bladder cancer were enrolled in this prospective, randomized, open-label, controlled clinical trial performed at a single tertiary care institution. After complete transurethral resection, patients were randomized to receive induction treatment with BCG and three capsules of prulifloxacin 600 mg or no prophylactic treatment (control group). Adverse events (AEs) were self-recorded by the patients after each instillation and classified by the investigator according to a classification grid considering account duration and intensity. Cystoscopy findings at 3 and 6 months were also recorded. RESULTS: There was no significant difference in baseline symptoms between the groups. Overall, there was a significant decrease in the percentage of patients with at least one AE between instillations in prulifloxacin-treated group. The proportion of patients with moderate to severe AEs after the fourth instillation was significantly less in the prulifloxacin-treated group. There was a significant effect of prulifloxacin on the need for anti-tuberculosis treatment. More patients in the control group stopped or delayed the full induction course of BCG instillations (34% vs 19%, P=0.04). Recurrence rates were not affected by prulifloxacin treatment. CONCLUSION: Prulifloxacin reduces the incidence of moderate to severe AEs from BCG intravesical therapy in patients with nonmuscle-invasive bladder cancer, improving compliance to the induction BCG course. These preliminary findings warrant further clinical research.

Circulating CD34+ KDR+ endothelial progenitor cells correlate with erectile function and endothelial function in overweight men.

INTRODUCTION: Bone marrow-derived endothelial progenitor cells (EPCs) circulate in the peripheral blood and are involved in endothelial homeostasis and repair. AIM: The aim of this study was to assess the circulating levels of different EPC phenotypes in overweight men with or without erectile dysfunction (ED). As endothelial dysfunction is considered a necessary link with ED, endothelium-dependent vasodilation and its relation with EPCs were also investigated. METHODS: We studied 30, otherwise healthy, overweight subjects with symptomatic ED for at least 6 months, and 30 age- and weight-matched subjects without ED. Erectile function was assessed by completing the International Index of Erectile Function (IIEF-5), which consists of items 5, 15, 4, 2, and 7 from the full-scale IIEF-15. MAIN OUTCOME MEASURES: Seven subpopulations of EPCs were determined by flow cytometry on the basis of the surface expression of CD34, CD133, and KDR antigens: CD34(+), CD133(+), KDR(+), CD34(+)CD133(+), CD34(+)KDR(+), CD133(+)KDR(+), and CD34(+)CD133(+)KDR(+). Endothelium-dependent flow-mediated dilation (FMD) was evaluated in the right brachial artery with a high-resolution ultrasound machine following reactive hyperemia. RESULTS: CD34(+)KDR(+) cell count was significantly lower in men with ED as compared with men without ED (63.1 +/- 4 vs. 92.4 +/- 6 cells/10(6) events, mean +/- standard error, P < 0.01). There was a significant direct correlation between circulating CD34(+)KDR(+) cells and the IIEF score (r = 0.44; P = 0.01): men with the severe form of ED presented the lowest level of circulating EPC CD34(+)KDR(+) cells. No significant correlation was found between the circulating levels of the other EPC phenotypes and the IIEF score. There was a significant correlation between CD34(+)KDR(+) cell count and FMD (r = 0.45; P = 0.01), but not between FMD and the other phenotypes. CONCLUSIONS: Circulating levels of CD34(+)KDR(+) EPC are reduced in overweight subjects with ED and correlate with the severity of ED. Other EPC phenotypes are not related to ED, suggesting that the CD34(+)KDR(+) phenotype of EPCs may be preferred in future studies.

Effects of intensive lifestyle changes on erectile dysfunction in men.

INTRODUCTION: Limited data are available supporting the notion that treatment of lifestyle risk factors may improve erectile dysfunction (ED). AIM: In the present study, we analyzed the effect of a program of changing in lifestyle designed to improve erectile function in subjects with ED or at increasing risk for ED. METHODS: Men were identified in our database of subjects participating in randomized controlled trials evaluating the effect of lifestyle changes. A total of 209 subjects were randomly assigned to one of the two treatment groups. The 104 men randomly assigned to the intervention program received detailed advice about how to reduce body weight, improve quality of diet, and increase physical activity. The 105 subjects in the control group were given general information about healthy food choices and general guidance on increasing their level of physical activity. MAIN OUTCOME MEASURES: Changes in erectile function score (International Index of Erectile Function-5 [IIEF-5]; items 5, 15, 4, 2, and 7 from the full-scale IIEF-15) and dependence of the restoration of erectile function on the changes in lifestyle that were achieved. RESULTS: Erectile function score improved in the intervention group. At baseline, 35 subjects in the intervention group and 38 subjects in the control group had normal erectile function (34% and 36%, respectively). After 2 years, these figures were 58 subjects in the intervention group and 40 subjects in the control group, respectively (56% and 38%, P = 0.015). There was a strong correlation between the success score and restoration of erectile function. CONCLUSIONS: It is possible to achieve an improvement of erectile function in men at risk by means of nonpharmacological intervention aiming at weight loss and increasing physical activity.

Phenotypic assessment of endothelial microparticles in diabetic and nondiabetic men with erectile dysfunction.

INTRODUCTION: Endothelial microparticles (EMPs) may play a role as biomarkers of vascular injury. EMPs are higher in men with diabetes diabetic men with erectile dysfunction (ED) than in nondiabetic potent men. AIM: The aim of this study was to quantize different phenotypic circulating EMP levels among diabetic and nondiabetic patients with ED, and to determine whether EMPs are released as a result of activation or apoptosis. METHODS: We studied 30 type 2 diabetic and 24 nondiabetic subjects with symptomatic ED from at least 6 months, and 20 nondiabetic men without ED matched for age and weight with diabetic and nondiabetic subjects. Erectile function was assessed by completing the International Index of Erectile Function (IEEF)-5, which consists of Items 5, 15, 4, 2, and 7 from the full-scale IIEF-15. A score of 21 or less indicates the presence of ED. MAIN OUTCOME MEASURES: EMP levels in plasma were quantified by flow cytometry. Markers for apoptosis (platelet/endothelial cell adhesion molecule 1/CD31 antigen) and activation (E-selectin/CD62E antigen) were compared. Endothelium-dependent flow-mediated dilation (FMD) was evaluated in the right brachial artery with a high-resolution ultrasound machine following reactive hyperemia. RESULTS: Diabetic patients were found to have the highest levels of EMP31+; diabetic and nondiabetic men with ED were found to have significantly higher levels of EMP62+ than nondiabetic men without ED. The EMP62/EMP31 ratio, an index of endothelial activation (high ratio) or apoptosis (low ratio), was lowest in diabetic men with ED (0.20). In the whole group of 54 men with ED (diabetic and nondiabetic), there was an inverse correlation between FMD and the number of circulating EMPs (P < 0.05). CONCLUSIONS: The presence of diabetes in subjects with ED is associated with a different pattern of endothelial cell injury. The phenotypic assessment of EMPs in diabetic patients with ED is consistent with increased apoptotic activity.

Modified supine versus prone position in percutaneous nephrolithotomy for renal stones treatable with a single percutaneous access: a prospective randomized trial.

OBJECTIVES: To compare operative time, safety, and effectiveness of percutaneous nephrolithotomy in the supine versus prone position in a prospective randomized trial. MATERIAL AND METHODS: From October 2005 to June 2007, 75 patients (33 men, 42 women; mean age, 39.3 yr) were prospectively enrolled and randomly divided into group A (39 patients, supine position) and group B (36 patients, prone position). Inclusion criteria were diagnosis of single or multiple renal stones (pelvic-caliceal) treatable with a single percutaneous access, stone diameter >2.5cm, body mass index (BMI) <30kg/m(2), and no contraindications to perform the operation in the prone position. Exclusion criteria were stones in more than one calyx, complete staghorn stones, and coexisting renal anomalies. RESULTS: The two groups were comparable in age, BMI, male-to-female ratio, and stone size. No significant difference was ascertained between the two groups in terms of stone-free rate (group A, 88.7% vs. group B, 91.6%, p=0.12), mean blood loss (group A, Delta hemoglobin -2.3g/dl vs. group B, -2.2g/dl, p=0.23), and mean hospital stay (group A, 4.3 d vs. group B, 4.1 d, p=0.18). The only significant difference reported was mean operative time (group A, 43min vs. group B, 68min, p<0.001). No blood transfusions were needed and no organ injuries were reported. CONCLUSIONS: In this carefully selected patient population with uncomplicated renal stones, the supine position was similar to the prone position for percutaneous stone removal.

What happens to the abstracts presented at the Societè Internationale d'Urologie meeting?

OBJECTIVES: To estimate the acceptance rate on peer-reviewed journals, describe the time-course of subsequent full publication, and identify those with characteristics associated with publication from the abstracts presented at the Societè Internationale d'Urologie (SIU) meeting. METHODS: All abstracts accepted for presentation at the annual 2002 and 2004 SIU meetings were identified from the published supplements in the BJU International. The subsequent publication rate for the corresponding studies by scanning Medline was evaluated. RESULTS: Overall, 1877 abstracts were presented, 415 of which (22.1%) were followed by publication in peer-reviewed journals. The mean time to publication was 13 months (range, 1 to 45 months). A total of 60.6% of the published articles were in print within 1 year of presentation "In most of the cases the reports were published in The Journal of Urology (76 reports) and in Urology (49 reports). Abstracts on kidney cancer, urinary diversion, incontinence, and urolithiasis had the highest publication rates (43.4%, 36.6%, 33.3%, and 29.2%, respectively). Studies from North America and from Oceania had the highest publication rate (26.8% and 26.6%, respectively). CONCLUSIONS: One fifth of the abstracts presented at the SIU meetings are ultimately published in indexed journals. Delegates attending these meetings should be aware of this issue when taking into account findings from meeting reports for their clinical practice. Factors influencing their publication are the abstract geographical area of origin, the study subject, and the research type. The Journal of Urology and Urology represented target journals for the publication more than other ones.

Quantitative sensory and autonomic testing in nondiabetic women with sexual dysfunction.

INTRODUCTION: Female sexual dysfunction (FSD) is a significant public health problem. There are no reported studies assessing the relation between sexual function and neuropathy in women, except for diabetes mellitus. AIM: The aim of this study was to explore the correlations between peripheral and autonomic neuropathy, and Female Sexual Function Index (FSFI) among nondiabetic women with or without FSD. METHODS: During a 6-month period, women were screened among outpatients seeking routine weight loss help. Cases were women, either pre- or postmenopausal, with abnormal values of FSFI score; controls were women from the same population with normal values of FSFI score, matched with cases for age and menopausal status. The total score range was 2-36; a score of 23 or lower indicated sexual dysfunction. The tool was administered during the follicular (days 5-8) phase of the menstrual cycle. MAIN OUTCOME MEASURES: The assessment of peripheral neuropathy was based on the quantitative sensory examination using the vibratory, thermal, and pain sensory thresholds. The assessment of autonomic neuropathy was based on cardiovascular reflex tests (deep breathing and squatting). RESULTS: The results of the quantitative sensory testing examination showed pathological changes in about 20% of women with FSD; the tests were abnormal in about 5% of women in the group without FSD. The percentage of women with abnormalities of autonomic cardiovascular tests was higher in the group with FSD compared with the group without FSD. CONCLUSIONS: Our results suggest an involvement of both somatic and autonomic nerve fibers in nondiabetic women with FSD.

A new transportable shock-wave lithotripsy machine for managing urinary stones: a single-centre experience with a dual-focus lithotripter.

OBJECTIVE: To assess the efficacy and safety of a transportable extracorporeal shock wave lithotripsy (ESWL) machine, the Modulith SLX-F2(TM) (Storz Medical Italia, Rome, Italy), in the management of solitary urinary calculi. PATIENTS AND METHODS: The study included 233 patients (mean age 51 years; 172 male, 61 female) with symptomatic solitary renal (group A, 170, mean diameter 15.5 mm) or ureteric stones (group B, 63, mean diameter 9.5 mm) treated in a tertiary care institution. Exclusion criteria for the analysis were: pelvi-ureteric junction obstruction, multiple stones, stone diameter >2 cm, stones in a lower calyx with unfavourable anatomy, active infection, or impacted ureteric stones. Selected patients had ureteric stenting before treatment, and all patients were treated with no anaesthesia. Hospitalization, complications and subsequent auxiliary procedures were evaluated. Patients were assessed after a single ESWL session and after 3 months by a plain abdominal film and renal ultrasonography. Stone-free status was defined as no evidence of calculi, and clinical success as the presence of stone fragments of <4 mm. An efficiency quotient (EQ) was calculated for the ESWL treatment. Pain was assessed using a visual analogue scale. RESULTS: The mean number of shocks used was 3779 and the mean (range) treatment time was 35 (5-55) min. The overall clinical success rate after one ESWL session was 83.7% and 82.5% for renal and ureteric stones, respectively, and the overall 3-month stone-free rate was 77% and 74.6%, respectively; the overall EQ was 0.64. When risk factors for persistent calculi were analysed simultaneously in a logistic regression model, only stones of >1 cm were statistically significant (P < 0.05). Most patients reported that pain during ESWL was mild to moderate and easily tolerated. Only minor complications occurred, with an overall complication rate of 3.8%. CONCLUSIONS: This transportable lithotripter is a safe and effective device for managing solitary stones throughout the urinary tract. Its main advantage is represented by the dual-focus system. Moreover, it shares with other contemporary machines several important features such as outpatient setting, no need for anaesthesia, easy patient positioning, and the capability of ancillary procedures.

Thalidomide in combination with oral daily cyclophosphamide in patients with pretreated hormone refractory prostate cancer: a phase I clinical trial.

AIM: This is a phase I study investigating the toxicity and the potential efficacy of thalidomide and oral cyclophosphamide in patients with hormone refractory prostate cancer (HRPC), previously treated with docetaxel-based regimens. METHODS: Two dose levels of thalidomide (100 and 200 mg every day) were studied. Patients were accrued to each dose level in cohorts of 3 starting from dose 1 level (100 mg). Thalidomide was started on day 1 at the assigned dose and continued for four consecutive weeks; oral cyclophosphamide (50 mg for day) was given for four consecutive weeks (1 cycle) starting on the same day initiating thalidomide. Toxicity was evaluated every two weeks; changes in prostate-specific antigen (PSA) levels were evaluated every cycle. Treatment was planned for four cycles. RESULTS: Sixteen men were treated. Ten patients in cohort 1, and 6 in cohort 2 were enrolled respectively. Grade 1-2 constipation, peripheral neuropathy and fatigue were the most common side effects, noted in 6 (37.5%), 5 (31.25%) and 3 (19%) patients, respectively. Three patients stopped the treatment at level 2, during the first cycle, for toxicity. Those three patients were evaluable only for toxicity. The MTD was 100 mg thalidomide. Thirteen patients completed two cycles. Two patients (15%) had a >50% decrease in PSA, while in one patient (8%) the PSA decrease was less of 50%. Overall PSA decrease was of 23%. CONCLUSIONS: The oral combination of thalidomide and cyclophosphamide is well tolerated and appears to be associated with biochemical response in this population. Future phase II trials, in pre-treated and untreated patients, are needed to evaluate clinical efficacy of this regimen in HRPC.

Sexual dysfunction and the Mediterranean diet.

OBJECTIVES: To discuss present knowledge about the relation between sexual dysfunction, metabolic factors and the Mediterranean-style diet. DESIGN: Review of the literature and personal perspectives. SETTING AND RESULTS: Sexual problems appear to be widespread in society, influenced by both health-related and psychosocial factors, and are associated with impaired quality of life. Epidemiological studies suggest that modifiable health behaviours, including physical activity and leanness, are associated with a reduced risk for erectile dysfunction (ED) among men. Data from other surveys also indicate a higher prevalence of impotence in obese men. Obesity and the metabolic syndrome may be a risk factor for ED. The high prevalence of ED in patients with cardiovascular risk factors suggests that abnormalities of the vasodilator system of penile arteries play an important role in the pathophysiology of ED. We have shown that one-third of obese men with ED can regain their sexual activity after 2 years of adopting health behaviours, including a Mediterranean-style diet associated with regular exercise. CONCLUSIONS: Western societies actually spend a huge part of their health care costs on chronic disease treatment and interventions for risk factors. The adoption of healthy lifestyles can reduce the prevalence of obesity and the metabolic syndrome, and hopefully the burden of sexual dysfunction.

Effect of a mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial.

CONTEXT: The metabolic syndrome has been identified as a target for dietary therapies to reduce risk of cardiovascular disease; however, the role of diet in the etiology of the metabolic syndrome is poorly understood. OBJECTIVE: To assess the effect of a Mediterranean-style diet on endothelial function and vascular inflammatory markers in patients with the metabolic syndrome. DESIGN, SETTING, AND PATIENTS: Randomized, single-blind trial conducted from June 2001 to January 2004 at a university hospital in Italy among 180 patients (99 men and 81 women) with the metabolic syndrome, as defined by the Adult Treatment Panel III. INTERVENTIONS: Patients in the intervention group (n = 90) were instructed to follow a Mediterranean-style diet and received detailed advice about how to increase daily consumption of whole grains, fruits, vegetables, nuts, and olive oil; patients in the control group (n = 90) followed a prudent diet (carbohydrates, 50%-60%; proteins, 15%-20%; total fat, <30%). MAIN OUTCOME MEASURES: Nutrient intake; endothelial function score as a measure of blood pressure and platelet aggregation response to l-arginine; lipid and glucose parameters; insulin sensitivity; and circulating levels of high-sensitivity C-reactive protein (hs-CRP) and interleukins 6 (IL-6), 7 (IL-7), and 18 (IL-18). RESULTS: After 2 years, patients following the Mediterranean-style diet consumed more foods rich in monounsaturated fat, polyunsaturated fat, and fiber and had a lower ratio of omega-6 to omega-3 fatty acids. Total fruit, vegetable, and nuts intake (274 g/d), whole grain intake (103 g/d), and olive oil consumption (8 g/d) were also significantly higher in the intervention group (P<.001). The level of physical activity increased in both groups by approximately 60%, without difference between groups (P =.22). Mean (SD) body weight decreased more in patients in the intervention group (-4.0 [1.1] kg) than in those in the control group (-1.2 [0.6] kg) (P<.001). Compared with patients consuming the control diet, patients consuming the intervention diet had significantly reduced serum concentrations of hs-CRP (P =.01), IL-6 (P =.04), IL-7 (P = 0.4), and IL-18 (P = 0.3), as well as decreased insulin resistance (P<.001). Endothelial function score improved in the intervention group (mean [SD] change, +1.9 [0.6]; P<.001) but remained stable in the control group (+0.2 [0.2]; P =.33). At 2 years of follow-up, 40 patients in the intervention group still had features of the metabolic syndrome, compared with 78 patients in the control group (P<.001). CONCLUSION: A Mediterranean-style diet might be effective in reducing the prevalence of the metabolic syndrome and its associated cardiovascular risk.

Effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial.

CONTEXT: Healthy lifestyle factors are associated with maintenance of erectile function in men. OBJECTIVE: To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men. DESIGN, SETTING, AND PATIENTS: Randomized, single-blind trial of 110 obese men (body mass index > or =30) aged 35 to 55 years, without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF). The study was conducted from October 2000 to October 2003 at a university hospital in Italy. INTERVENTIONS: The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise. MAIN OUTCOMES MEASURES: Erectile function score, levels of cholesterol and triglycerides, circulating levels of interleukin 6, interleukin 8, and C-reactive protein, and endothelial function as assessed by vascular responses to l-arginine. RESULTS: After 2 years, body mass index decreased more in the intervention group (from a mean [SD] of 36.9 [2.5] to 31.2 [2.1]) than in the control group (from 36.4 [2.3] to 35.7 [2.5]) (P<.001), as did serum concentrations of interleukin 6 (P =.03), and C-reactive protein (P =.02). The mean (SD) level of physical activity increased more in the intervention group (from 48 [10] to 195 [36] min/wk; P<.001) than in the control group (from 51 [9] to 84 [28] min/wk; P<.001). The mean (SD) IIEF score improved in the intervention group (from 13.9 [4.0] to 17 [5]; P<.001), but remained stable in the control group (from 13.5 [4.0] to 13.6 [4.1]; P =.89). Seventeen men in the intervention group and 3 in the control group (P =.001) reported an IIEF score of 22 or higher. In multivariate analyses, changes in body mass index (P =.02), physical activity (P =.02), and C-reactive protein (P =.03) were independently associated with changes in IIEF score. CONCLUSION: Lifestyle changes are associated with improvement in sexual function in about one third of obese men with erectile dysfunction at baseline.