Effect of vacation on urinary symptoms in health care workers: an Italian multicenter study.

BACKGROUND: Aim of our study was to assess the impact of vacation on urinary symptoms in health care workers. METHODS: Between March 2018 to October 2019 a survey was carried out by enrolling health care system workers in three centers. Demographic and clinical characteristics of health care workers (i.e. age, smoking status, medical history) were collected. Lower urinary tract symptoms (LUTS) and work related quality of life were assessed before and after vacation with validated questionnaires: Overactive Bladder Questionnaire Short Form (OABq-sf), International Prostate Symptom Score (IPSS), Work-related Quality of Life (WRQOL) and SF-36 questionnaires. As well, night shift workers (NSWs), defined as working at least one time a week from 8 pm to 8 am, were compared to traditional workers (TWs). RESULTS: A total of 236 participants (118 males and 118 females) with a median of 41 (32/49 IQR) years old were included in the survey. Healthcare workers presented after vacation an improvement in LUTS, in work related quality of life and overall health. Overall, 89 (37%) were NSWs and 147 (62%) subjects were TWs. NSWs reported a significant higher median OABq Total Score and IPSS than TWs: respectively, 27 (IQR 23-34) vs. 20 (IQR 19-24) P=0.01, 2 (0/6) vs. 0 (0/2) (P<0.01). No significative differences were found for WRQOL and SF36, respectively 66 (IQR 59/77) vs. 67 (IQR 61/82) (P<0.29) and 98 (97/101) vs. 98 (97/100) (P<0.79). CONCLUSIONS: NSWs present worst urinary symptoms when compared to TWs. Vacation has a beneficial effect, particularly in NSWs, on urinary symptoms and work-related quality of life.

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database.

BACKGROUND: The aim of our study was to analyze adverse events (AEs) associated with radium-223 using real life data from Eudra-Vigilance (EV) database. METHODS: EV database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European economic area (EEA). We recorded number of AEs for radium-223 per category and severity from 2013 to May 2019. We recorded AEs per age group (<65 years old; between 65 and 85 years; >85 years old) pooled relative risk (PRR) were used to compare groups. The number of individual cases identified in EV database was 4339. RESULTS: According to the registry study the most frequent AEs in patients treated with radium-223 were hematological, general and gastrointestinal disorders and they were confirmed as the most frequent AEs in the EV database. In the EV database over 90% of the reported AEs were defined as serious and 8% were fatal. Older patients (>85 years) treated with radium-223 were at increased risk of cardiac, infectious, and metabolism disorders when compared to younger patients (<65). However, we have no information on the number of patients under treatment in the EV database. CONCLUSIONS: EV database highlights several AEs which are not reported in registry studies as well as different AEs profiles according to age. Clinicians should consider these data when treating patients with radium-223.

Laparoscopic simple prostatectomy: a large single-center prospective cohort study.

BACKROUND: The aim of our study was to analyze outcomes and safety of laparoscopic simple prostatectomy (LSP) in a high-volume center. METHODS: A consecutive series of men with lower urinary tract symptoms and large prostates (>80 cc) prospectively enrolled between November 2015 and December 2017 in one center. All patients underwent laparoscopic simple prostatectomy. Outcomes were evaluated considering the trifecta favorable outcome which was defined as a combination of the following items: 1) no perioperative complications; 2) postoperative IPSS <8; 3) postoperative Qmax >15 mL/s. Complications were evaluated according to the modified Clavien classification system. Univariate and multivariate binary logistic regression was performed to identify predictors of a positive trifecta outcome. RESULTS: Overall 272 patients were enrolled. At three months after surgery median IPSS total score was 4 (IQR: 3-7), median IPSS QoL was 1 (IQR:1-2), median prostate-specific antigen was 0.53 (IQR: 0.33-1.00) ng/ml and median Qmax was 23 (IQR: 17-30) mL/s. All these parameters improved statistically when compared to baseline (P<0.001). The overall complication rate was 21% however most of the complications were low grade complications according to modified Clavien-Dindo classification (grade ≤2). Overall, 68% of the patients presented a positive trifecta outcome. On multivariate analysis only preoperative hemoglobin and hospital stay were confirmed predictors of positive trifecta outcome. CONCLUSIONS: LSP represents a safe and effective procedure in the treatment of large adenomas. Although RCTs are needed before reaching definitive conclusions, LSP is a promising technique for patients with LUTS and large prostates.

Night shift workers refer higher urinary symptoms with an impairment quality of life: a single cohort study.

BACKGROUND: The aim of the present study is to assess the impact of night shift work (NSW) on urinary symptoms. METHODS: Between March 2018 to October 2018, we evaluated a group of National Health care system workers. Urinary symptoms and quality of life were measured by Overactive Bladder Questionnaire Short Form (OABq-sf). Clinical variables (i.e. age, smoking status, medical history) were collected and analyzed according to be NS workers (NSWs) from subjects working at least one time from 8 pm to 8 am or from traditional workers (TWs). Univariate and multivariate analysis was performed to identify predictive variables of worse OAB outcomes (OABq-sf>30, OABq-SB≥12, OABq HRQL≥18). RESULTS: A total of 136 participants (68 males and 68 females) were included in the study. On OABq-sf, total score, symptoms bother (OABq-SB) and health related quality of life (OABq-HRQL) domains were significantly (P<0.05) higher in NSWs group, respectively: 31 (IQR 26-35) vs. 19 (IQR 19-20); 11 (IQR 10-13) vs. 6 (IQR 6-7); 19 (IQR 16-22) vs. 13 (13-14). Finally, seven NSWs (10.6%) referred nocturia respect to only one (1%) TWs, (P=0.02). On multivariate analysis NSW was an independent predictor of OABq-sf>30 units (OR:30; CI: 9-111, P=0.001), OABq-SB ≥12 units (OR:16, CI: 6-43, P=0.001) and OABq HRQL≥18 units (OR:20, CI: 6-70, P=0.001). CONCLUSIONS: Night shift workers presented worst OAB Score and poor QL when compared to similar traditional workers. Long-term data on NSWs patients are also needed to further clarify this relationship.

Adverse events related to abiraterone and enzalutamide treatment: analysis of the EudraVigilance database and meta-analysis of registrational phase III studies.

BACKGROUND: Data from clinical trials do not always provide adequate information to judge the impact of new treatments when used in a real-world setting. The aim of our study was to analyze adverse events (AEs) associated with enzalutamide (ENZ) and abiraterone (ABI) using real-life data from the EudraVigilance (EV) database. METHODS: The EV database is the system for managing and analyzing information on suspected adverse reactions to medicines, which have been authorized or are being studied in clinical trials in the European Economic Area. We recorded the number of AEs for ABI and ENZ per category and severity from January 2013 to January 2019. In addition, we recorded AEs per age group. A meta-analysis of AEs reported in registrational phase III studies (AFFIRM, PREVAIL, COU-AA) was performed. RESULTS: The number of individual cases identified in EV database was 13,562 for ABI and 40,599 for ENZ. Over 90% of the reported AEs were defined as serious for both drugs. Older patients (>85 years and 65-85 years) treated with ABI or ENZ are at increased risk of cardiac, infectious, metabolic, and respiratory disorders when compared with younger patients (<65). According to registrational phase III studies, the most frequent AEs in patients treated with ABI are hepatobiliary disorders, while the most frequent AEs in patients treated with ENZ are psychiatric and vascular disorders. Several AEs present in the EV database are not reported in the registrational phase III studies. It is important to note that we have no information on the number of patients under treatment in the EV database. CONCLUSIONS: The EV database highlights several AEs that are not reported in registrational phase III studies as well as different AEs profiles according to age. Clinicians should consider these data when treating patients with castration-resistant prostate cancer with ABI or ENZ.

Smoking reduces PSA accuracy for detection of prostate cancer: results from an Italian cross-sectional study.

BACKGROUND: The aim of our study is to evaluate the diagnostic accuracy of prostate-specific antigen (PSA) according to the smoking status in a cohort of European men undergoing prostate biopsy. METHODS: From 2008 onwards, we consecutively enrolled, at a single institution in Italy, men undergoing 12 core transrectal ultrasound-guided prostate needle biopsy. Demographic, clinical and histopathological data were collected. We excluded men who had PSA >30 ng/mL. Patients were classified in three groups: non-smokers, smokers and former smokers. Receiver-operator characteristics (ROC) curve analysis were used to compare predictive properties of PSA across smoking categories for the final histopathological diagnosis of prostate cancer. RESULTS: 872 patients were enrolled. with a median age and PSA of 67 years (IQR: 61/74) and 6.2 ng/mL (IQR: 4.4/9.7) respectively.402/872 patients (46%) were non-smokers; 151 of 872 were smokers (17%) and 319 of 872 were former smokers (36%); 374 of 872 (43%) had cancer on biopsy. PSA accuracy for smokers (AUC= 0.47, P=0.490) was lower when compared to non-smokers (AUC=0.59, P=0.003) and former smokers (AUC=0.59, P=0.005). CONCLUSIONS: In a cohort of Italian men undergoing prostate biopsy, the performance accuracy of PSA, as a predictor of prostate cancer, is lower in smokers. Although the molecular link behind our findings is still unknown, our study firstly showed that the PSA accuracy for PCa diagnosis is significantly influential by smoking.