BACKGROUND: Proxelan® and antibiotics combined therapy was successfully previously used in the treatment of symptoms of patients with chronic prostatitis. Aim of the present study was to investigate the effects of Proxelan® monotherapy on pain symptoms of patients with chronic prostatitis (CP) or chronic pelvic pain syndrome (CPPS) in a prospective pilot study.

METHODS: Thirty consecutive patients with CP/CPPS symptoms younger than 50, without urinary obstruction, total prostate-specific antigen (PSA) <4 ng/mL, negative microbiology testing on prostate fluid and urethral swab, naïve from other treatments during the previous three months were enrolled in a pilot study. IPSS and NIH-CPSI questionnaires were administered to all the patients. Patients could choose to be investigated regarding semen quality and IL6/IL8 seminal markers for inflammatory disease prior and after the therapy course. Proxelan® suppositories were prescribed for each patient for a month with a daily dosage of 1 suppository at bed-time. The primary endpoint of the study included at least a 30% reduction of pain symptoms because similar results can be obtained in each previously investigated placebo group. Effects on semen parameters such as leukocytospermia, spermatozoa concentration and motility, cytokine levels were considered as secondary endpoints.

RESULTS: Subjective pain relief was obtained in all the patients with significant decrease of NIH-CPSI pain items (P=0.04). Urinary symptoms, investigated by IPSS questionnaire, decreased significantly (P=0.04) as well as quality of life items (P=0.04). Leukocytospermia was found in 5/15 patients available for further investigations. IL6 decreased by 11.55% one month after the treatment while sperm motility resulted increased by 17.3%.

CONCLUSIONS: Proxelan® monotherapy may represents a promising valid alternative to combined treatment with antibiotics in patients with CP/CPPS symptoms although the results obtained should be investigated in randomized controlled trials.

BACKGROUND: Prostatitis is a recurrent urinary infection in males and is often difficult to cure. The aim of the study was to examine whether anti-inflammatory effects of enhanced drainage of prostatic secretions, obtained through two months treatment with a proteolytic enzyme mucoactive (PEM) compound (Serrazyme and other constituents), influenced qualitative or quantitative expressions of bacterial growth in seminal cultures.

METHOD: 450 patients with prostatitis syndromes were randomized either to PEM therapy (intervention group) or to no treatment group. All patients were followed at the end of a 2-month PEM continuous treatment period (T2) and further two months after withdrawal (T4).

RESULTS: After treatment, 15 out of 107 (14.1%) patients with Chronic Bacterial Prostatitis (CBP) showed negative seminal cultures, while in patients with cat NIH-IIIA prostatitis seminal cultures became positive in 33.3% cases with low bacteriospermia. After two months from withdrawal, although among CBP patients the total number of isolates and colony forming units (CFU) counts showed not significant changes compared to matched-values observed at T2, microbial parameters varied significantly among inflammatory prostatitis patients.

CONCLUSION: The results of the present study showed that 2 months of treatment with PEM, decreasing bacterial adherence and inflammatory prostatitis, reveals a subgroup of apparent inflammation associated with infection that microbial biofilms likely mask in inflammatory prostatitis patients.

OBJECTIVE: To evaluate the efficacy of a phytotherapic combination of L-Methionine associated with Hibiscus sabdariffa and Boswellia serrata for treatment of acute episodes of uncomplicated urinary tract infections (UTI) in women affected by recurrent UTIs.

MATERIALS AND METHODS: In this randomized phase III clinical trial, adult females with uncomplicated UTI were enrolled into one of the following treatment groups: Group A: phytotherapic combination 1 tablet in the morning and 1 tablet in the evening for 7 days; Group B: Short term antibiotic treatment according to international guidelines recommendations. At baseline, all patients were evaluated by a urologist and quality of life (QoL) questionnaires and mid-stream urine culture. Same clinical and laboratory investigations were repeated at each follow-up visit.

RESULTS: Forty-six patients were enrolled in Group A and 47 in Group B. At the first follow-up (30 days), both groups showed a statistically significant improvement in quality of life scores as compared with baseline assessment [Group A: (QoL 94.3 VS 98.5 p < 0.001); Group B: (QoL 94.5 VS 98.7 p < 0.001)]. An improvement from baseline was also seen at the second followup evaluation after 3 months [Group A: (QoL 94.3 VS 99.1 p < 0.001); Group B: (QoL 94.5 VS 98.1 p < 0.001)]. At the second follow-up visit, a statistically significant difference in QoL was reported between the two groups (99.1 VS 98.1; p < 0.003) and a transition from UTI to asymptomatic bacteriuria (ABU) was observed 12 of 46 (26%) patients in Group A, while no patients in Group B demonstrated ABU (p = 0.007).

CONCLUSIONS: Here, we demonstrated that this phytotherapic combination is able, in comparison to antibiotic treatment, to improve patients quality of life, reducing symptoms in acute setting and preventing the recurrences. Interestingly, a significantly higher proportion of patients in the phytotherapy group had ABU after three months. Our findings are of great interest in an antibiotic stewardship perspective.

OBJECTIVE: Adjuvants or alternatives to antibiotics in urinary tract infections (UTIs) during pregnancy seem advisable because of possible fetal stress. The present study assessed the effectiveness of a food supplement containing L-methionine and Hibiscus sabdariffa L. and Boswellia serrata Roxb. extracts as a treatment for symptomatic UTIs in pregnancy.

DESIGN: Pregnant patients with symptomatic cystitis were screened for UTIs in three different clinical centers. Those unwilling to take antibiotics were offered two alternative treatments: (A) a 1-week treatment with the food supplement or (B) a week in which they were advised to increase their fluid consumption to more than 1.5 L daily. After 1 week, group B patients who still had positive urine cultures (UCs) or had no UC performed took the food supplement for an additional week. UCs were performed on all patients at the first visit (w0) and on most of them at 7 days (w1). Patients who were still positive at w1 or had no UC performed at w1 had UC performed 14 days (w2) thereafter.

RESULTS: Of 264 pregnant women enrolled, 216 joined group A, while 48 joined group B. At w1, 70.0% of group A patients and 43.2% of those in group B had negative UCs (p = 0.003). The reduction of bacterial load was 42.2% ± 8.0% and 4.5% ± 9.2%, respectively (p < 0.0001). At w1, symptoms disappeared in 135 patients (62.5%) in group A and 22 patients (45.8%) in group B (p = 0.03). At w2, 30 of 32 group B patients who switched to taking the supplement for the second week had negative UCs, including 20 who had been positive at w1. At w2, all group A patients had negative UCs. No side effects were reported.

CONCLUSIONS: The food supplement provided effective treatment and might be an adjuvant or alternative to antibiotic therapy of symptomatic UTI in pregnancy.

AIM: Inflammatory diseases of the prostate are one of the most difficult problems to manage in the fertile male aged between 20 and 50. Antibiotics are the gold standard for the treatment of both bacterial (category II-NIH) and non bacterial prostatitis (category III-NIH). However, antibiotics need to be associated with other therapies focused on reducing symptoms and providing a better quality of life. In the present study we sought to test the effectiveness of antibiotics and the medical device Proxelan suppositories taken together.

METHODS: Starting in January 2011, we conducted a randomized controlled trial involving 60 subjects with bacterial and non bacterial chronic prostatitis, who were divided into two groups. Subjects allocated in group A received only antibiotics for 28 days; subjects in group B received antibiotics + Proxelan, for 28 days as well. Before randomization all subjects underwent Meares-Stamey test, IPSS and NIH-CPSI questionnairs. All of those were repeated 60 and 120 days after randomization. Microbiological and clinical efficacy were compared using specific statistical analyses.

RESULTS: Data were obtained from 29 subjects allocated in group A and 31 in group B. Minor side effects were observed which did not cause study interruption in any case. Of the total population, 68,3% resulted positive to the Meares-Stamey test at study start. Proxelan was not better than antibiotics alone under a microbiological point of view (OR)=0.9; (IR) 0.3-2.8; P=0.46. According to the answers provided at the NIH-CPSI questionnaire, subjects in the group B obtained a better score compared to group A, either after 2 months (OR:2.8; 95%IC 1.2-4.1; P=0.017) and after 4 months (OR:1.67; 95%IC 0.9-2.9; P=0.04). With regards to the IPSS questionnaire, 2 months after treatment start, subjects in the group A had a probability of having urinary symptoms 2 times higher compared to subjects in group B (OR:1.9; 95%IC 1.0-3.5; P=0.028). Although Proxelan seems to improve IPSS also after 4 months, the difference does not reach the level of statistical significance.

CONCLUSION: Compared to antibiotics alone, the combination of antibiotics and Proxelan improve both symptoms associated to chronic prostatitis and urinary symptoms, however microbiological results are not different. Future studies may be required to confirm our results and to explain the mechanism of action of Proxelan.