Effectiveness on urinary symptoms and erectile function of Prostamev Plus® vs only extract Serenoa repens.

Prostatic inflammation is widespread in the male population. Two groups of 50 patients each with symptoms of prostatic inflammation and ecocolorDoppler indicative of prostatitis were identified. Both groups were further subdivided into two subgroups (respectively A1, A2, B1, and B2). Group A1 underwent therapy with oral levofloxacin 500 mg daily for 10 days plus co-treatment with oral Serenoa repens (320 mg) plus Bromeline plus Nettle (Prostamev Plus®) daily for two months; Group A2 with oral levofloxacin 500 mg daily for 10 days plus oral Serenoa repens extract 320 mg/day for two months; Group B1 specific antibiotic treatment for 10 days (included levofloxacin if sensitive) plus co-treatment with oral Serenoa repens (320 mg) plus Bromeline plus Nettle (Prostamev Plus®) daily for two months; Group B2 with specific antibiotic treatment for 10 days plus Serenoa repens 320 mg/day for two months. The groups treated with Prostamev Plus® in comparison to the groups treated with Serenoa repens extract (saw palmetto) achieved better improvements of both IPSS score, urinary flow and sexual life.

Prevalence, incidence estimation, risk factors and characterization of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy: results of a multicenter case-control observational study.

PURPOSE: We evaluated the prevalence and estimated the incidence and risk factors of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy. MATERIALS AND METHODS: From January to June 2006 patients from 28 Italian urological centers who were between 25 and 50 years old with symptoms of chronic prostatitis/chronic pelvic pain syndrome were consecutively enrolled in this prospective epidemiological case-control study. A total of 152 subjects of similar age, race and area of origin who were investigated for infertile couples but were otherwise healthy served as controls. All subjects provided a medical history and underwent different symptom scorings, clinical evaluation and microbiological tests. RESULTS: Of 5,540 male urological outpatients 764 with chronic prostatitis/chronic pelvic pain syndrome were enrolled, including 225 (29.4%) at the first presentation and 539 (70.6%) who underwent previous treatment. Thus, the prevalence of the syndrome was 13.8%, while the estimated incidence was 4.5%. Cigarette smoking, a high caloric diet with low fruit and vegetable consumption, constipation, meteorism, slow digestion, a sexual relationship with more than 1 partner and coitus interruptus were more likely in patients with chronic prostatitis/chronic pelvic pain syndrome than in controls (each p <0.001). The syndrome had a negative influence on sexual desire, erectile dysfunction and premature ejaculation (p <0.001). The Meares and Stamey test was positive in 13.3% of patients and in 2.9% of controls. Urethral swabs in patients with a negative Meares and Stamey test were positive for sexually transmitted pathogens in 6%. CONCLUSIONS: The prevalence and estimated incidence of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy are high. The syndrome is closely related to lifestyle, diet, smoking, gastrointestinal or anorectal disease and impaired sexual function.

Introduction to chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS).

Prostatitis is the most frequently diagnosed illness in men under 50, accounting for about 8% of all consultations with urologists. Estimates based on published studies suggest that the incidence of prostatitis in the population is somewhere between 4% and 11%. In 1995 the National Institutes of Health (NIH) classified prostatitis into 4 main categories: 1) acute bacterial; 2) chronic bacterial; 3) pelvic pain syndrome; 4) asymptomatic inflammatory. The aetiological agent most often involved is bacterial, particularly the category of Gram (-) bacteria, followed by Gram (+), chlamydiae and mycoplasmas; however many cases of prostatitis are caused by bacteria which are difficult to isolate or by aetiopathogenic mechanisms which are immunological, neurological, psychosomatic or anatomical in nature. An observational study was recently done on the Italian territory in order to estimate the incidence and risk factors of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The disease incidence estimation was 13.8%. Cigarette smoking, high caloric diet with low consumption of fruit and vegetables, constipation, meteorism, slow digestion, sexual relationship with more than one partner and coitus interruptus were more likely in CP/CPPS patients than in controls (p < 0.001). CP/CPPS had a negative influence on sexual desire, erectile dysfunction and premature ejaculation (p < 0.001). The Meares Stamey test was positive in 13.3% of patients and 2.9% of controls.

Cardiovascular parameter changes in patients with erectile dysfunction using pde-5 inhibitors: a study with sildenafil and vardenafil.

Sildenafil is the most prescribed oral agent for patients with erectile dysfunction (ED). Vardenafil is a new phosphodiesterase type 5 (Pde-5) inhibitor that was approved by the US Food and Drug Administration last year to treat patients with ED of various causes. Both of these Pde-5 inhibitors have vasodilating properties and effects on blood pressure (BP), and like nitrates, they work through the nitric oxide cyclic guanosine monophosphate pathway. The aim of this study was to investigate the influence of these Pde-5 inhibitors on BP and heart rate (HR) in normotensive men with ED by a crossover comparison. Thirty-five patients with ED were enrolled to evaluate and compare the effect of sildenafil (50 mg) and vardenafil (10 mg) on BP and HR. At the screening (baseline [B]) visit, sitting systolic blood pressure (B-SBP), diastolic blood pressure (B-DBP), and HR were measured. We performed a multiple administration for both drugs and, therefore, multiple measurements of BP and HR changes, 3 doses a week, on alternate days, late in the afternoon, and on an empty stomach. B-SBP, B-DBP, and HR were recorded before each 50-mg sildenafil dosing and after 30, 60, 120, and 240 minutes. Data were averaged over the 4 time points and compared with the baseline values obtained before each dosing. After a 3-week wash-out period, patients were crossed over to vardenafil (10 mg) with the same study design. After administration of both drugs, we observed a statistically significant decrease of BP and an increase of HR. On average, sildenafil caused a decrease of SBP ranging from 5.1 +/- 3.9 mm Hg during the first dosing to 4.7 +/- 4.2 mm Hg during the third dosing, DBP ranged from 4.4 +/- 4.9 to 4 +/- 4.1 mm Hg, and HR increased 1.8 +/- 2.0 bpm (first dose) and 1.2 +/- 0.9 bpm (third dose). With vardenafil, we recorded a greater variation for SBP and DBP. SBP decreased from 8.02 +/- 8.0 mm Hg during the first dosing to 5.4 +/- 5.5 mm Hg during the third dosing, whereas DBP decreased from 6.6 +/- 7.2 to 5.0 +/- 5.3 mm Hg, respectively. Recorded HR showed an increase of 3.1 +/- 3.2 bpm (first dose) and 2.4 +/- 2.3 bpm (third dose). After the first vardenafil administration, we recorded fainting episodes in 3 patients because of a decrease in BP greater than 20 mm Hg. Two of the patients were in therapy with doxazosin for benign prostatic hyperplasia (BPH). Cardiovascular response was not significantly different after the first dose between the 2 treatments. Vardenafil demonstrated clinically significant differences (fainting) with respect to sildenafil only during the first doses. We suggest that before starting therapies with Pde-5 inhibitors, particularly with the newer ones, that baseline cardiovascular parameters are measured and monitored, especially during the first dose, because of the presence of a "first dose effect." Moreover, it is necessary to pay particular attention to those patients in treatment with other drugs that could have a synergistic hypotensive effect as a result of vasodilation potentiation.

Effect of propionyl-L-carnitine, L-arginine and nicotinic acid on the efficacy of vardenafil in the treatment of erectile dysfunction in diabetes.

OBJECTIVE: The association of diabetes-related vascular damage and the role of metabolic factors in erectile dysfunction are well known in the literature. The compounds propionyl-L-carnitine (PLC), L-arginine (L-Arg) and nicotinic acid have numerous metabolic actions which have been reported to improve endothelial function. This study investigated the administration of the combination of these three compounds alone and in association with an inhibitor of 5-phosphodiesterase (5PDE), vardenafil, on endothelial function in diabetic patients with erectile dysfunction. METHODS: A total of 40 patients aged between 50 and 60 years with insulin-dependent diabetes (IDDM) for 3-4 years were selected from 509 patients presenting with erectile dysfunction. The patients were randomly subdivided into four groups of ten to be treated for 12 weeks. Group A was administered one sachet each day of test formulation containing PLC, L-Arg and nicotinic acid (Ezerex); group B with one 20 mg capsule of vardenafil (Levitra) twice a week; group C was treated with one sachet each day of the test formulation plus vardenafil 20 mg twice a week. Group D was administered placebo capsules twice weekly. Endothelial function was evaluated by examining flow-mediated dilation (FMD) and erectile function was estimated with the International Index of Erectile Function (IIEF5) questionnaire in all subjects. RESULTS: At the end of treatment group A showed an increment of 2 points in the IIEF5; group B showed an increment of 4 points; group C, the group which was administered all the treatments, showed an increment of 5 points, and group D, treated with placebo, showed no increment in the IIEF5. CONCLUSION: Although there was a small number of subjects in this study the data suggest that the test formulation may improve the endothelial situation in diabetes. The test formulation together with vardenafil was better than the 5PDE inhibitor alone, but further studies are needed to confirm these findings.