Daidzein plus isolase associated with zinc improves clinical symptoms and quality of life in patients with LUTS due to benign prostatic hyperplasia: Results from a phase I-II study.

OBJECTIVE: In the last years there is a growing interest in nutraceutical substances that seems able to improve clinical symptoms in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). In this paper, we evaluated both efficacy and safety of a combination of daidzein with isolase and zinc in patients with LUTS due to BPH. MATERIALS AND METHODS: In a phase I-II study clinical trial we enrolled patients with clinical and instrumental diagnosis of LUTS associated to BPH that received a six-month treatment with a combination of daidzein with isolase and zinc (1 tablet/day). Clinical, laboratory and instrumental analyses were carried out at the time of admission (T0) and 6 months after the ending of the treatment (T1). The Italian version of International Prostatic Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) and Quality of Well-Being (QoL) questionnaires were used. The development of adverse drug reactions (ADRs) and drug interactions (DDIs) were recorded using the Naranjo scale and drug interaction probability scale. Student's t test and Anova test were used for statistical analysis, and the threshold of statistical significance was set at P < 0.05. RESULTS: We enrolled 71 patients, 62 (87.3%) completed the follow-up and we documented a significant differences between T0 and T1 in terms of IPSS [21.5 ± 1.2 vs 16.2 ± 1.5; (-4.8); p < 0.001], Cmax [9.7 ± 3.7 vs 15.3 ± 2.5; (+5.6); p < 0.001] and QoL [0.56 ± 0.15 vs 0.84 ± 0.19; (+0.28); p < 0.001]. In contrast, no significant difference were recorded in terms of IIEF-5 [p = 0.50] and PSA [p = 0.67]. Finally, we did not record any significant ADRs or DDIs during the study. CONCLUSIONS: In this study, we documented that a combination of daidzein with isolase and zinc, reduces the clinical symptoms of LUTS and improves the quality of life in patients with BPH, without the development of ADRs or DDIs.

Proficiency score as a predictor of early trifecta achievement during the learning curve of robot-assisted radical prostatectomy for high-risk prostate cancer: Results of a multicentric series.

Background: Recently, an innovative tool called "proficiency score" was introduced to assess the learning curve for robot-assisted radical prostatectomy (RARP). However, the initial study only focused on patients with low-risk prostate cancer for whom pelvic lymph node dissection (PLND) was not required. To address this issue, we aimed to validate proficiency scores of a contemporary multicenter cohort of patients with high-risk prostate cancer treated with RARP plus extended PLND by trainee surgeons. Material and methods: Between 2010 and 2020, 4 Italian institutional prostate-cancer datasets were merged and queried for "RARP" and "high-risk prostate cancer." High-risk prostate cancer was defined according to the most recent European Association of Urology guidelines as follows: prostate-specific antigen >20 ng/mL, International Society of Urological Pathology ≥4, and/or clinical stage (cT) ≥ 2c on preoperative imaging. The selected cohort (n = 144) included clinical cases performed by trainee surgeons (n = 4) after completing their RARP learning curve (50 procedures for low-risk prostate cancer). The outcome of interest, the proficiency score, was defined as the coexistence of all the following criteria: a comparable operation time to the interquartile range of the mentor surgeon at each center, absence of any significant perioperative complications Clavien-Dindo Grade 3-5, no perioperative blood transfusions, and negative surgical margins. A logistic binary regression model was built to identify the predictors of 1-year trifecta achievement in the trainee cohort. For all statistical analyses, a 2-sided p < 0.05 was considered significant. Results: A proficiency score was achieved in 42.3% patients. At univariable level, proficiency score was associated with 1-year trifecta achievement (odds ratio, 8.77; 95% confidence interval, 2.42-31.7; p = 0.001). After multivariable adjustments for age, nerve-sparing, and surgical technique, the proficiency score independently predicted 1-year trifecta achievement (odds ratio, 9.58; 95% confidence interval, 1.83-50.1; p = 0.007). Conclusions: Our findings support the use of proficiency scores in patients and require extended PLND in addition to RARP.

Predictors of trainees' proficiency during the learning curve of robot-assisted radical prostatectomy at high- -volume institutions: results from a multicentric series.

Introduction: The aim of this series was to evaluate predictors of Proficiency score (PS) achievement on a multicentric series of robot-assisted radical prostatectomies (RARP) performed by trainee surgeons with two different surgical techniques at four tertiary-care centers. Material and methods: Four institutional datasets were merged and queried for RARPs performed by surgeons during their learning curve (LC) between 2010 and 2020 using two different approaches (Group A, Retzius-sparing RARP, n = 164; Group B, standard anterograde RARP, n = 79). Logistic regression analysis was performed to identify predictors of PS achievement for the overall trainee cohort. For all analyses, a two-sided p <0.05 was considered significant. Results: Group B showed significantly increased median operative time, positive surgical margins (PSM) status, increased number of nerve-sparing procedures, shorter LC time (each p <0.04). PS, continence status, potency, biochemical recurrence and 1-year trifecta rates were comparable between groups (each p >0.3). On multivariable analysis, time from LC starting ≥12 months (OR = 2.79; 95%IC [1.15-6.76]; p = 0.02) and a nerve-sparing intent (OR = 3.18; 95%IC [1.15-8.77]; p = 0.02) were independent predictors of PS score achievement (Table 3). Conclusions: Higher PS rates for RARP trainees may be expected after 12 months from LC beginning. Short-term training courses are unlikely to confer proper surgical training, while long-term structured training programs seem to be beneficial on perioperative outcomes.

External Validation of a Novel Comprehensive Trifecta System in Predicting Oncologic and Functional Outcomes of Partial Nephrectomy: Results of a Multicentric Series.

BACKGROUND: To validate a novel trifecta for evaluating outcomes of partial nephrectomy (PN) on a multicentric dataset. METHODS: Between 2007 and 2020, three renal cancer databases were queried for patients with solitary renal masses who underwent PN (n = 649). Trifecta was estimated for overall cohort and contributing centers. Overall survival (OS), cancer-specific survival (CSS) and end-stage renal disease (ESRD) probabilities were assessed by Kaplan-Meier. Cox regression was used to identify predictors of OS, CSS, ESRD. For all analyses, a p < 0.05 was considered significant. RESULTS: At a median follow-up of 22.7 months (IQR 12.5-76.5) overall trifecta was 76.7% [Centre A; (n = 230; 68.6%), B (n = 68; 77.3%), C (n = 200; 88.4%); p = 0.001). On Kaplan-Meier, patients achieving trifecta exhibited higher OS (p = 0.024), higher CSS (p = 0.015) and lower ESRD rates (p = 0.024). On multivariable analysis, age (HR 1.04; 95% CI 1.01-1.08) and trifecta (HR 0.34; 95% CI 0.15-0.76) were independent predictors of OS while pT stage (HR 1.95; 95% CI 0.45-8.43) and trifecta (HR 0.33; 95% CI 0.16-0.67) were predictors of CSS (each p < 0.01). Preoperative CKD stage ≥ 3a (HR 13.1; 95% CI 4.07-42.6) and trifecta (HR 0.41; 95% CI 0.19-0.87) were independent predictors of ESRD (each p < 0.05). CONCLUSIONS: On external validation, trifecta was an independent predictor of all PN endpoints, regardless of hilar control and ischemia duration.

Visceral adiposity is associated with worse urinary and sexual function recovery after radical prostatectomy: Results from a longitudinal cohort study.

OBJECTIVE: A prospective longitudinal cohort study on the impact of anthropometric measures on the sexual function and continence recovery in patients treated with laparoscopic radical prostatectomy (LRP) is presented. MATERIAL AND METHODS: Anthropometric measures, International Index of Erectile Function (IIEF-5) and International Prostatic Symptoms Score questionnaires, were collected before surgery and at the end of follow-up period. All patients were assigned into the following groups: A) non-obese; B) non-obese with central adiposity; C) obese without central adiposity; D) obese with central adiposity. Urinary and sexual functions were the outcome measures. RESULTS: At the end of follow-up, in 29 patients with visceral adiposity (VA) the median IIEF-5 was 14 (IQR 7-18) while in 49 non-VA patients (62.8%) was 22 (IQR 17-24) (p < 0.001). Twenty-three patients (79.3%) with VA reported complete continence, while 6 (20.7%) used ≥ 2 pads per day. Forty-eight patients (97.9%) without VA reported complete continence. VA was confirmed as a strong independent predictor for worse continence (HR 3.67; 2.75-4.51 CI95% p = 0.003) and sexual function recovery (HR: 4.51; 3.09-5.63 CI95% p < 0.001). CONCLUSION: We truly believe obese with visceral adiposity patients with prostate cancer should receive detailed preoperative counseling before surgery, including higher risk of suboptimal functional outcomes.

Teleurology in the Time of Covid-19 Pandemic: Here to Stay?

OBJECTIVE: To assess the implementation and outcomes of telemedicine in a Department of Urology in Northern Italy during the outbreak of the Covid-19 pandemic. METHODS: All the outpatient clinical activities during the 4 weeks following the national lockdown (March 9-April 3, 2020) in the Department of Urology of the Trento Province, Italy, were reviewed and categorized. Expert staff members examined the electronic records, selecting whether the clinic appointments should be canceled or confirmed (via telephone consultation or face-to-face visit). The rate, indication, and modality of visits were investigated. RESULTS: Overall, 415 of 928 (45%) scheduled patients canceled their clinic appointment themselves or were canceled by staff members without rescheduling. The remaining 523 (55%) cases were screened undergoing telephone consultation in 295 (56%) and face-to-face visit in 228 (44%). The rate of face-to-face visit decreased from 63% to 9% during week 1 and 4, respectively. Seventy-four percent of face-to-face visits regarded suspected recurrent or new onset malignancy or potentially dangerous clinical conditions (severe urinary symptoms or complicated urinary stones or infection). The median age of patients in the face-to-face and telephone groups was 59 (range 20-69) and 65 years old (range 37-88), respectively. CONCLUSION: A pandemic is a dynamic scenario, requiring reorganization and flexibility of the healthcare delivery. Forty-five percent visits were canceled without rescheduling. Although a minimum portion of face-to-face visit (<10% 1 month after the lockdown) was preserved mostly for suspected malignancy or potentially life-threatening conditions, telemedicine proved a pragmatic approach allowing efficient screening of cases and adequate protection for patients and clinicians.

Sutureless laparoscopic partial nephrectomy using fibrin gel reduces ischemia time while preserving renal function.

OBJECTIVES: We evaluated the efficacy of sutureless laparoscopic partial nephrectomy (LPN), using a fibrin gel in order to minimize renal ischemia time and preserve kidney function. MATERIALS AND METHODS: Nineteen patients (mean age 58.3 ± 7.1) undergoing sutureless LPN using a fbrin gel were compared with a control group consisting of 21 patients (mean age 57.9 ± 7.5) subjected to LPN with standard suturing. Intraand post-operative data for the two groups were compared. The following parameters were recorded: patient demographics, Charlson Comorbidity Index, tumor characteristics according to the RENAL score, warm ischemia and operative times, estimated blood loss, mean hospital stay, post-operative complications referring to the Clavien-Dindo classification, renal function parameters pathologic and follow-up data. The main outcome measure was renal ischemia time and maintenance of kidney function. RESULTS: Median warm ischemia time was 13 minutes (range 11-19) in the group treated with fibrin gel and 19 (range 17- 29) in the control group, with a statistically significant difference (p < 0.001). The two groups were homogeneous in terms of the Charlson Comorbidity Index (4.6 vs 4.8) and RENAL score (9.6 vs 9.4). Median operative time differed significantly in the two groups, 183 minutes (range 145-218) in the group treated with fibrin gel and 201 (range 197-231) in the control group (p < 0.001). A negative surgical margin was reported in 18 patients (94.7%) in the group treated with fibrin gel and in 21 patients (100%) in the control group. No difference in renal function was found between the two groups. CONCLUSIONS: Sutureless LPN with fibrin gel can reduce warm ischemia and total operative time while preserving kidney function.

The Clinical Efficacy of Pollen Extract and Vitamins on Chronic Prostatitis/Chronic Pelvic Pain Syndrome Is Linked to a Decrease in the Pro-Inflammatory Cytokine Interleukin-8.

PURPOSE: We aim to evaluate the efficacy of pollen extract in association with vitamins in patients affected by chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and to evaluate the level of the pro-inflammatory mediators interleukin (IL)-6, IL-8, and IL-10. MATERIALS AND METHODS: Patients diagnosed with CP/CPPS between January and December 2015 were enrolled in this study. Participants were randomly assigned to receive oral capsules of pollen extract and vitamins (group A) or bromelain (group B) for 3 months. At the enrolment time and 3 months after enrolment, all patients completed questionnaires (the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI] and the Short Form-36 and underwent urological examinations and microbiological evaluation. Levels of IL-6, IL-8, and IL-10 were evaluated in seminal plasma. RESULTS: Sixty-five male patients (mean age of 32.7±4.7 years) were analysed (group A, n=32; group B, n=33). At the follow-up examination, 24 of the 32 patients in group A showed a significant reduction in the NIH-CPSI total score compared with 8 of the 33 patients in the bromelain group (p<0.001). Moreover, the mean level of IL-8 was significantly lower in the pollen extract and vitamins group when compared with the bromelain group (298 pg/mL vs. 736 pg/mL, respectively; p<0.001). In group A we found a statistically significant reduction in the levels of IL-8 between enrolment and the follow-up visit (878 pg/mL vs. 298 pg/mL, respectively; p<0.001). CONCLUSIONS: Treatment with pollen extract and vitamins improved the quality of life in CP/CPPS patients by reducing the levels of pro-inflammatory IL-8.

Retropubic, Laparoscopic, and Robot-Assisted Radical Prostatectomy: A Comparative Analysis of the Surgical Outcomes in a Single Regional Center.

BACKGROUND: To compare the surgical outcomes of radical prostatectomy (RP) performed via 3 different approaches: retropubic (RRP), laparoscopic-assisted (LRP), and robot-assisted (RARP), in a single non-academic regional center by a single surgeon. MATERIALS AND METHODS: The data of patients undergoing RP from 2005 to 2014 were reviewed. The standard approach changed through the years: RRP (n = 380, years 2005 to 2008), LRP (n = 240, years 2009 to 2011), and RARP (n = 262, years 2012 to 2014). Our analysis included the last consecutive 100 RP for each surgical technique by a single surgeon. A logistic regression model adjusted for pre-and postoperative variables was done to evaluate whether transfusion, conversion, and post-operative complication rates were influenced by the approach. RESULTS: RARP was associated with significantly lower blood loss (400 vs. 600 and 600 ml, respectively), transfusion (6 vs. 21 and 21%, respectively), and shorter hospital stay (6 vs. 7 and 8 days, respectively), compared to LRP and RRP, and a lower conversion rate (1 vs. 12%) compared to LRP. Multivariate analysis adjusted for confounders confirmed that the risk of transfusion and conversion was significantly lower in the RARP group compared to the LRP and RRP groups. The RARP group was also associated with a significantly lower risk of complications compared to the RRP group and with a trend in favor of the RARP group compared to the LRP group. The 1-year continence rate was significantly higher in the RARP group compared to the RRP and LRP groups (80 vs. 72 and 68%, respectively). CONCLUSION: The surgical approach affected the operative outcomes in a regional setting. The advantages of RARP over RRP (complications, transfusion, conversion, hospital stay, 1-year continence) were over LRP as well, with the only exception being complications.

Adherence to European Association of Urology Guidelines on Prophylactic Antibiotics: An Important Step in Antimicrobial Stewardship.

BACKGROUND: The evolution of resistant pathogens is a worldwide health crisis and adherence to European Association of Urology (EAU) guidelines on antibiotic prophylaxis may be an important way to improve antibiotic stewardship and reduce patient harm and costs. OBJECTIVE: To evaluate the prevalence of antibiotic-resistant bacterial strains and health care costs during a period of adherence to EAU guidelines in a tertiary referral urologic institution. DESIGN, SETTING, AND PARTICIPANTS: A protocol for adherence to EAU guidelines for antibiotic prophylaxis for all urologic procedures was introduced in January 2011. Data for 3529 urologic procedures performed between January 2011 and December 2013 after protocol introduction were compared with data for 2619 procedures performed between January 2008 and December 2010 before protocol implementation. The prevalence of bacterial resistance and health care costs were compared between the two periods. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The outcome measures were the proportion of resistant uropathogens and costs related to antibiotic consumption and symptomatic postoperative infection. We used χ2 and Fisher's exact tests to test the significance of differences. RESULTS AND LIMITATIONS: The proportion of patients with symptomatic postoperative infection did not differ (180/3529 [5.1%] vs. 117/2619 [4.5%]; p=0.27). A total of 342 isolates from all patients with symptomatic postoperative infections were analysed. The rate of resistance of Escherichia coli to piperacillin/tazobactam (9.1% vs. 5.4%; p=0.03), gentamicin (18.3% vs. 11.2%; p=0.02), and ciprofloxacin (32.3% vs. 19.1%; p=0.03) decreased significantly after protocol introduction. The defined daily dose (DDD) use of ciprofloxacin fell from 4.2 to 0.2 DDD per 100 patient-days after implementation (p<0.001). Antibiotic drug costs (€76,980 vs. €36,700) and costs related to postoperative infections (€45,870 vs. €29,560) decreased following introduction of the protocol (p<0.001). CONCLUSIONS: Adherence to EAU guidelines on antibiotic prophylaxis reduced antibiotic usage without increasing post-operative infection rate and lowered the prevalence of resistant uropathogens. PATIENT SUMMARY: We analysed the impact of adherence to European Association of Urology guidelines on antibiotic prophylaxis for all surgical urologic procedures on the prevalence of infections and resistant bacterial strains and on costs. We found that adherence to the guidelines reduced the rate of bacterial resistance, in particular against piperacillin/tazobactam, gentamicin, and ciprofloxacin, and reduced costs without increasing the risk of postoperative infection after urologic procedures. We recommend adherence to the guidelines as an important part of antibiotic stewardship programmes.

Single-session supine bilateral percutaneous nephrolithotomy.

OBJECTIVE: To evaluate the effectiveness and safety of supine bilateral percutaneous nephrolithotomy (BPCNL) performed in the same session in patients affected with bilateral renal calculi. METHODS: We retrospectively identified patients with bilateral renal stones with diameters >2 cm for each side, who had been treated with supine BPCNL in the same session, from November 2006 to April 2014. We reviewed demographic and stone characteristics, intraoperative and perioperative outcomes, and complications related to the procedure adopted. The stone size was calculated by measuring the maximum stone diameter by computed tomography scan. Stone-free rate was defined as clinically insignificant when residual fragments of ≤2 mm were detected by computed tomography scan. RESULTS: Twenty-five patients were included in the study; the mean age was 51.9 ± 11.4 years; the mean maximum stone diameter per renal unit was 3.1 ± 0.8 cm. Statistical significant differences in creatinine serum levels were detected at day 1 postoperatively compared with the baseline (P <.0001) values that became insignificant at 1 week and 1 month postoperatively (P >.05). The primary stone-free rate was 80%; ancillary procedures were performed in 3 of 25 patients (12%). Grade I complications occurred in 3 patients (12%), grade II in 4 patients (16%), and grade IIIA in 1 patient (4%). CONCLUSION: Supine BPCNL performed in the same session is a safe and effective procedure in patients affected with bilateral renal calculi. On the other hand, it is still a very challenging operation, and consequently, it should be performed only by experienced surgeons in a tertiary center.

Pollen extract in association with vitamins provides early pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome.

The therapeutic efficacy for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is currently unsatisfactory. The aim of the present study was to assess the safety and efficacy of pollen extract in association with vitamins (DEPROX 500®) in males with CP/CPPS. All patients with a diagnosis of CP/CPPS attending the same urologic centre between March and October 2012 were enrolled in this randomised controlled phase III study. Participants were randomised to receive oral capsules of DEPROX 500® (two capsules every 24 h) or ibuprofen (600 mg, one tablet three times a day) for four weeks. The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), International Prostate Symptom Score and Quality of Well-Being (QoL) questionnaires were used. In the intention-to-treat analysis, 87 males (25 class IIIa and 62 class IIIb) with a mean age of 33.6±5.9 years were randomly allocated to the DEPROX 500® (n=41) or ibuprofen (n=46) treatment groups. At the follow-up examination (following one month of treatment), in the DEPROX 500® group, 31/41 patients (75.6%) reported an improvement in quality of life, defined as a reduction of the NIH-CPSI total score by ≥25%, compared with 19/46 (41.3%) in the control group (P=0.002). The greater improvement in the DEPROX 500® group compared with the ibuprofen group was statistically significant (treatment difference in the NIH-CPSI pain domain, -2.14±0.51, P<0.001; QoL scores, P=0.002). All patients were negative at the Meares-Stamey test evaluation. Adverse events were less frequent in the DEPROX 500® group than in the ibuprofen group. The DEPROX 500® treatment significantly improved total symptoms, pain and quality of life compared with ibuprofen in patients with CP/CPPS, without severe side-effects.

Concordance and clinical significance of uncommon variants of bladder urothelial carcinoma in transurethral resection and radical cystectomy specimens.

OBJECTIVE: To evaluate the concordance and prognostic role of histologic variants of bladder urothelial carcinoma in transurethral resection of bladder tumor (TURBT) and radical cystectomy (RC) specimens. METHODS: Clinicopathologic information available at the time of RC and follow-up data from 4110 RC specimens, collected between January 2000 and December 2009 at 17 tertiary referral centers were retrospectively analyzed and evaluated for the presence or absence of uncommon variants of bladder urothelial carcinoma. The presence or absence of uncommon variants of bladder urothelial carcinoma was evaluated on previous TURBT specimens of patients undergoing RC. Cox regression was used to assess the impact of these parameters on cancer-specific survival, and the Kaplan-Meier test for disease-free survival was plotted for survival estimate. RESULTS: Of 4110 patients, 579 were found to have uncommon variants of bladder urothelial carcinoma at RC (14.1%), whereas 266 (6.4%) at TURBT. A lack of agreement about uncommon variants was observed between TURBT and RC specimens in the entire population (P <.001). The presence of uncommon variants at TURBT was associated with an increased risk of pathologic upstage (hazard ratio, 3.24; confidence interval, 1.19-6.37; P <.003) and significant decrease in cancer-specific survival and recurrence-free survival (P <.001). CONCLUSION: Although the concordance of presence of uncommon histologic variants of urothelial bladder carcinoma between TURBT and RC is low, the presence of uncommon histologic variants of urothelial bladder carcinoma at TURBT is associated with a less favorable clinical outcome.

Effects of pollen extract in association with vitamins (DEPROX 500®) for pain relief in patients affected by chronic prostatitis/chronic pelvic pain syndrome: results from a pilot study.

BACKGROUND: The therapeutic efficacy of CP/CPPS is not very satisfactory and the impact on young male's quality of life is considerable. The aim of the present study is to evaluate the efficacy of pollen extract associated with vitamins (DEPROX 500®) in order to improve the quality of life of young patients affected by chronic prostatitis type IIIb (CP/CPPS) by pain relieving. METHODS: All patients with clinical and instrumental diagnosis of CP/CPPS (class b) underwent DEPROX 500® 2 tablets in a single dose daily for 30 days. Clinical and microbiological analyses were carried out at the enrolment and after 1 month. NIH-CPSI and IPSS questionnaires have been used. The main outcome measure was the improvement of quality of life at the end of the whole study period, evaluated by questionnaires results. RESULTS: 20 men (mean age 32.8 ± 6.78) were enrolled in this pilot study. The baseline questionnaire mean scores were 25.90 ± 2.1 and 8.01 ± 3.64 for NIH-CPSI and IPSS, respectively. At the follow-up examination (1 month after treatment), 18 out of 20 patients (90.0%) reported an improvement of quality of life, in terms of pain reduction. The questionnaire results after 1 month from treatment were as follows: NIH-CPSI 12.8 ± 2.20, IPSS 7.6 ± 1.58. Statistically significant differences were then reported between the two visits, in terms of NIH-CPSI scores (p<0.001). No statistically significant differences have been reported in terms of IPSS between the two groups. All patients were negative at the Meares-Stamey test evaluation. The compliance to the study protocol was 100%. CONCLUSIONS: The pollen extract associated with vitamins (DEPROX 500®) significantly improved total symptoms, pain, and QoL in patients with non-inflammatory CP/CPPS without severe side effects.

Prediction of response to bacillus Calmette-Guérin treatment in non-muscle invasive bladder cancer patients through interleukin-6 and interleukin-10 ratio.

This study aimed to evaluate whether the interleukin-6 (IL-6) and interleukin-10 (IL-10) ratio (IL-6/IL-10) can be used as a prognostic marker of recurrence following bacillus Calmette-Guérin (BCG) therapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC). One hundred and twenty-one consecutive urological patients (72 affected by high-risk NMIBC and 49 controls) were selected for this prospective study. Urine samples for dipstick and interleukin analyses were collected from each subject before surgery. All patients underwent transurethral resection of bladder tumours (TUR-BT), followed by six weekly BCG instillations. IL-6 and IL-10 concentrations in urine were determined by solid phase ELISA Quantikine IL-6 and IL-10 Immunoassay. Patients with NMIBC were stratified in accordance with IL-6/IL-10: group A ≤0.09 and group B >0.10. The main outcome measures were time to first recurrence and recurrence rate following BCG therapy. At enrolment, IL-6/IL-10 was not statistically different between patients and controls (p=0.763, degrees of freedom (df)=1, F-test result (F)=0.092). Of the 72 patients with NMIBC, 38 (52.7%) had an IL-6/IL-10 of ≤0.09 (group A), while 34 (47.3%) had an IL-6/IL-10 of >0.10 (group B). A significant difference between IL-6/IL-10 and status at follow-up was found (p=0.016, df=1, χ(2)=5.800). The Kaplan-Meier curves demonstrated that group B patients had a significantly higher probability of being recurrence-free than group A patients [p=0.003; recurrence rate (RR)=3.1]. At multivariate analysis, IL-6/IL-10 (p<0.003) and the number of lesions (p<0.001) were identified as independent predictors of BCG response probability. In conclusion, this study highlights the feasible role of IL-6/IL-10 in predicting recurrence following BCG therapy in high-risk NMIBC.