Minimally invasive transperitoneal partial versus radical nephrectomy in obese patients: perioperative and long-term functional outcomes from a large perspective contemporary series (RECORd2 project).

BACKGROUND: The aim of this study is to evaluate the perioperative and long-term functional outcomes of laparoscopic (LPN) and robot-assisted partial nephrectomy (RAPN) in comparison to laparoscopic radical nephrectomy (LRN) in obese patients diagnosed with renal cell carcinoma. METHODS: Clinical data of 4325 consecutive patients from The Italian REgistry of COnservative and Radical Surgery for cortical renal tumor Disease (RECORD 2 Project) were gathered. Only patients treated with transperitoneal LPN, RAPN, or LRN with Body Mass Index (BMI) ≥30 kg/m2, clinical T1 renal tumor and preoperative estimated glomerular filtration rate (eGFR) ≥60 mL/min, were included. Perioperative, and long-term functional outcomes were examined. RESULTS: Overall, 388 patients were included, of these 123 (31.7%), 120 (30.9%) and 145 (37.4%) patients were treated with LRN, LPN, and RAPN, respectively. No significant difference was observed in preoperative characteristics. Overall, intra and postoperative complication rates were comparable among the groups. The LRN group had a significantly increased occurrence of acute kidney injury (AKI) compared to LPN and RAPN (40.6% vs. 15.3% vs. 7.6%, P=0.001). Laparoscopic RN showed a statistically significant higher renal function decline at 60-month follow-up assessment compared to LPN and RAPN. A significant renal function loss was recorded in 30.1% of patients treated with LRN compared to 16.7% and 10.3% of patients treated with LPN and RAPN (P=0.01). CONCLUSIONS: In obese patients, both LPN and RAPN showcased comparable complication rates and higher renal function preservation than LRN. These findings highlighted the potential benefits of minimally invasive PN over radical surgery in the context of obese individuals.

Partial nephrectomy for renal tumors: recommendations of the Italian Society of Urology RCC working group.

INTRODUCTION: Partial nephrectomy (PN) aims to remove renal tumors while preserving renal function without affecting oncological and perioperative surgical outcomes. Aim of this paper is to summarize the current evidence on PN and to provide evidence-based recommendations on indications, surgical technique, perioperative management and postoperative surveillance of PN for renal tumors in the Italian clinical and health care system context. EVIDENCE ACQUISITION: This review is the result of an interactive peer-reviewing process of the recent literature on PN for renal tumors carried out by an expert panel composed of members of the Italian Society of Urology (SIU) Renal Cell Carcinoma Working Group. EVIDENCE SYNTHESIS: PN for localized renal tumors is not inferior to radical nephrectomy in terms of survival outcomes while significantly better preserving renal function. Loss of renal function after PN is influenced by medical comorbidities/preoperative renal function and surgical variables such volume of parenchyma preserved and ischemia time. Urologists should select the clamping strategy during PN based on their experience and patient-specific factors. PN can be performed with any surgical approach based on surgeon's expertise and skills. Robotic PN has the potential to expand the minimally invasive indications without interfering with oncological outcomes. The use of 3D virtual models, real time ultrasound and fluorescence tools to assess the anatomy and vascularization of renal tumors during PN may allow a more accurate preoperative planning and intraoperative guidance. Proper postoperative surveillance protocols are essential to detect tumor recurrences and assess functional outcomes. CONCLUSIONS: PN is the standard of care for treatment of localized T1 renal tumors. Recent data supports PN also for selected T2-T3a tumors in experienced institutions. Careful preoperative planning, adequate surgical skills and volumes and appropriate postoperative management and surveillance are paramount to optimize PN oncological and functional outcomes.

Open questions on lower urinary tract infections: Results of a Delphi consensus study.

BACKGROUND AND OBJECTIVE: This is a Delphi study that aims to explore expert consensus regarding open questions in current literature evidence on lower urinary tract infections (UTIs). This manuscript deals with adults and analyzed the most recent guidelines and meta-analysis on the topic. METHODS: A panel of leading urologists and urogynaecologists participated in a consensus-forming project using a Delphi method to reach consensus on gray zone issues on recurrent lower UTIns (rUTIs), asymptomatic bacteriuria (AB) in pregnant women, and catheter-associated UTIs (CAUTI) in adults. All the panelists were invited to participate the four phases consensus. Consensus was defined as ≥75% agreement. An ordinal scale (0-10) was used. A systematic literature review was analyzed for diagnostic workup and prevention of rUTIs, AB, and CAUTI. RESULTS: In total, 37 experts participated. All panelists participated in the four phases of the consensus process. Consensus was reached if ≥75% of the experts agreed on the proposed topic. Online meetings and a face-to-face consensus meeting was held in Milan in March 2023. Formal consensus was achieved for 12/13 items. CONCLUSIONS: This manuscript is a Delphi survey of experts that showed interest on some debated points on rUTIs, AB in pregnancy, and prevention of CAUTI. There is still little data on nonantibiotic prevention of UTIs and CAUTI; quite old studies have been reported on AB in pregnancy. The emerging problem of antibiotic resistance is relevant and nonantibiotic prophylaxis may play a role in its prevention.

Combined spinal and epidural anaesthesia for open radical cystectomy: A controlled study.

Objectives: To evaluate the feasibility of loco-regional anaesthesia and to compare perioperative outcomes between loco-regional and standard general anaesthesia in patients with bladder cancer undergoing open radical cystectomy (ORC). Patients and Methods: A single-surgeon cohort of 60 consecutive patients with bladder cancer undergoing ORC with an enhanced recovery after surgery protocol between May 2020 and December 2021 was analysed. A study group of 15 patients operated on under combined spinal and epidural anaesthesia was compared with a control group of 45 patients receiving standard general anaesthesia. Intraoperative outcomes were haemodynamic stability, estimated blood loss, intraoperative red blood cell transfusion rate, and anaesthesia time. Postoperative outcomes were pain assessment 24 h after surgery, time to mobilisation, return to oral diet, time to bowel function recovery, length of stay and rate of 90-day complications. Results: No patients required conversion from loco-regional to general anaesthesia. All patients in both groups were haemodynamically stable. No significant differences between groups were observed for all other intraoperative outcomes, except for a shorter anaesthesia time in the study versus control group (250 vs. 290 min, p = 0.01). Pain visual score 24 h after surgery was significantly lower in the study versus control group (0 vs. 2, p < 0.001). No significant differences were observed for all other postoperative outcomes, with a comparable time to bowel function recovery (5 days in each group for stool passage), and 90-day complication rate (46.6% vs. 42.2% for the study vs. control group, p = 0.76). Conclusion: Our exploratory, controlled study confirmed the feasibility, safety and effectiveness of a pure loco-regional anaesthesia in patients with bladder cancer undergoing ORC. No significant differences were observed in intra- and postoperative outcomes between loco-regional and general anaesthesia, except for a significantly shorter anaesthesia time and greater pain reduction in the early postoperative period for the former.

Impacts on functional and oncological outcomes of Robotic-assisted Radical Prostatectomy 10 years after the US Preventive Service Taskforce recommendations against PSA screening.

OBJECTIVE: In the following years after the United States Preventive Service Task Force (USPSTF) recommendation against prostate cancer screening with PSA in 2012, several authors worldwide described an increase in higher grades and aggressive prostate tumors. In this scenario, we aim to evaluate the potential impacts of USPSTF recommendations on the functional and oncological outcomes in patients undergoing robotic-assisted radical prostatectomy (RARP) in a referral center. MATERIAL AND METHODS: We included 11396 patients who underwent RARP between 2008 and 2021. Each patient had at least a 12-month follow-up. The cohort was divided into two groups based on an inflection point in the outcomes at the end of 2012 and the beginning of 2013. The inflection point period was detected by Bayesian regression with multiple change points and regression with unknown breakpoints. We reported continuous variables as median and interquartile range (IQR) and categorical variables as absolute and relative percent frequencies. RESULTS: Group 1 had 4760 patients, and Group 2 had 6636 patients, with a median follow-up of 109 and 38 months, respectively. In the final pathology, Group 2 had 9.5% increase in tumor volume, 24% increase on Gleason ≥ 4+3 (ISUP 3) , and 18% increase on ≥ pT3. This translated to a 6% increase in positive surgical margins and 24% reduction in full nerve sparing in response to the worsening pathology. There was a significant decline in post-operative outcomes in Group 2, including a 12-month continence reduction of 9%, reduction in potency by 27%, and reduction of trifecta by 22%. CONCLUSIONS: The increasing number of high-risk patients has led to worse functional and oncologic outcomes. The initial rapid rise in PSM was leveled by the move towards more partial nerve sparing. Among some historical changes in prostate cancer diagnosis and management in the period of our study, the USPSTF recommendation coincided with worse outcomes of prostate cancer treatment in a population who could benefit from PSA screening at the appropriate time.

Double-Layered Hand-Sewn versus Stapled Intestinal Anastomosis in Patients Who Underwent Ileal Urinary Diversion in Radical Cystectomy: A Comparative and Cost Effective Study.

INTRODUCTION: Intestinal anastomosis can be performed by hand suturing (single layer or double layer) or by a mechanical suturing machine. The aim of the study was to compare complications, operative time, and costs of the intestinal anastomosis techniques. METHODS: A retrospective comparative study was conducted including patients who underwent radical cystectomy and uretero-ileo-cutaneostomy or vescica ileale Padovana orthotopic neobladder. Double-layered hand-sewn intestinal anastomosis (HS-IA) were performed using Vicryl stitches. Mechanical-stapled intestinal anastomosis (MS-IA) were performed with a mechanical stapler. RESULTS: Data of 195 patients who underwent were collected. 100 (51.3%) patients underwent HS-IA and 95 (48.7%) patients underwent MS-IA. Considering the complications classified according to Clavien-Dindo, a statistical difference with higher incidence for grade one in the HS-IA both in the ileal conduit group and in the neobladder one than the MS-IA (15.8% and 8.7%, respectively, in HS-IA vs. 1.7% and none in MS-IA). There is not a significant difference in time to flatus and time to defecation. Difference is recorded in the ileal conduit groups for the length of stay (10 days, range 9-12 with HS-IA vs. 13 days range 12-16 days with MS-IA (p < 0.001). The cost of the suture thread used for a single operation was 0.40 euros, whereas the overall cost of a disposable mechanical stapler and one refill was 350.00 €. CONCLUSION: Both HS-IA and MS-IA are safe and effective for patients. The cost for the stapling device is 350 €, in contrast, the cost for Vicryl sutures is negligible.

Diagnosis of prostate cancer with magnetic resonance imaging in men treated with 5-alpha-reductase inhibitors.

PURPOSE: The primary aim of this study was to evaluate if exposure to 5-alpha-reductase inhibitors (5-ARIs) modifies the effect of MRI for the diagnosis of clinically significant Prostate Cancer (csPCa) (ISUP Gleason grade ≥ 2). METHODS: This study is a multicenter cohort study including patients undergoing prostate biopsy and MRI at 24 institutions between 2013 and 2022. Multivariable analysis predicting csPCa with an interaction term between 5-ARIs and PIRADS score was performed. Sensitivity, specificity, and negative (NPV) and positive (PPV) predictive values of MRI were compared in treated and untreated patients. RESULTS: 705 patients (9%) were treated with 5-ARIs [median age 69 years, Interquartile range (IQR): 65, 73; median PSA 6.3 ng/ml, IQR 4.0, 9.0; median prostate volume 53 ml, IQR 40, 72] and 6913 were 5-ARIs naïve (age 66 years, IQR 60, 71; PSA 6.5 ng/ml, IQR 4.8, 9.0; prostate volume 50 ml, IQR 37, 65). MRI showed PIRADS 1-2, 3, 4, and 5 lesions in 141 (20%), 158 (22%), 258 (37%), and 148 (21%) patients treated with 5-ARIs, and 878 (13%), 1764 (25%), 2948 (43%), and 1323 (19%) of untreated patients (p < 0.0001). No difference was found in csPCa detection rates, but diagnosis of high-grade PCa (ISUP GG ≥ 3) was higher in treated patients (23% vs 19%, p = 0.013). We did not find any evidence of interaction between PIRADS score and 5-ARIs exposure in predicting csPCa. Sensitivity, specificity, PPV, and NPV of PIRADS ≥ 3 were 94%, 29%, 46%, and 88% in treated patients and 96%, 18%, 43%, and 88% in untreated patients, respectively. CONCLUSIONS: Exposure to 5-ARIs does not affect the association of PIRADS score with csPCa. Higher rates of high-grade PCa were detected in treated patients, but most were clearly visible on MRI as PIRADS 4 and 5 lesions. TRIAL REGISTRATION: The present study was registered at ClinicalTrials.gov number: NCT05078359.

Outcomes and treatment failure after open or robotic ureteral reconstruction for iatrogenic injuries.

Objectives: The aim of this study is to assess the aetiology, perioperative outcomes and treatment failure of contemporary patients undergoing open or robot-assisted ureteral reconstruction for iatrogenic injuries. Patients and methods: We retrospectively analysed consecutive patients who underwent ureteral reconstruction for iatrogenic injuries at two academic centres 07/2013 and 06/2022. A variety of open or robot-assisted procedures were performed, including uretero-cystoneostomy, Boari bladder flap, uretero-ureterostomy, ileal replacement and pyelo-ureteroplasty. All procedures were performed by a single surgeon with extensive experience in open and robot-assisted surgery and preference-based management. Outcome measures were aetiology, estimated blood loss, length of stay, postoperative complications and treatment failure, defined as upper tract obstruction requiring permanent urinary drainage. We also planned a subgroup analysis comparing the outcomes between open and robot-assisted procedures. Results: Fifty-nine patients were included. Most injuries were consequent to endourological procedures (44%). The most frequently performed procedures were uretero-cystoneostomy (49.2%) and Boari bladder flap (32.2%). Forty (67.8%) were open, and 19 (32.2%) were robot-assisted procedures. Major postoperative complications were recorded in seven (11.9%) patients. After a median follow-up of 42 months (interquartile range 12-24), treatment failure was observed in seven (11.9%) cases. Robot-assisted versus open procedures were associated with decreased estimated blood loss (p = 0.01), length of stay (p < 0.001) and treatment failure (0/19 vs. 7/36, p = 0.04). Conclusion: In our series of iatrogenic ureteral lesions requiring reconstructive surgery, endourological procedures were the most frequent cause. Major postoperative complications were infrequent, and treatment failure rate was low. The robot-assisted approach was associated with improved perioperative outcomes and lower failure rate compared with open.

Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence.

The nature of alpha-D-mannose-natural aldohexose sugar, C-2 glucose epimer, whose intended use is for preventing urinary tract infections-in the interaction with E. coli is addressed in order to drive the issue of its regulatory classification as a medicinal product or medical device. PRISMA systematic review approach was applied; Delphi Panel method was used to target consensus on statements retrieved from evidence. Based on regulatory definitions and research evidence, the mechanism of D-mannose does not involve a metabolic or immunological action while there is uncertainty regarding the pharmacological action. Specific interaction between the product and the bacteria within the body occurs, but its nature is inert: it does not induce a direct response activating or inhibiting body processes. Moreover, the action of D-mannose takes place, even if inside the bladder, outside the epithelium on bacteria that have not yet invaded the urothelial tissue. Therefore, its mechanism of action is not directed to host structures but to structures (bacteria) external to the host's tissues. On the basis of current regulation, the uncertainty as regard a pharmacological action of alpha-D-mannose makes possible its medical device classification: new regulations and legal judgments can add further considerations. From a pharmacological perspective, research is driven versus synthetic mannosides: no further considerations are expected on alpha-D-mannose.

Incidence of Rectal Injury After Radical Prostatectomy: A Systematic Review and Meta-analysis.

Context: Rectal injury (RI) is a dreaded complication after radical prostatectomy (RP), increasing the risk of early postoperative complications, such as bleeding and severe infection/sepsis, and late sequelae, such as a rectourethral fistula (RUF). Considering its traditionally low incidence, uncertainty remains as to predisposing risk factors and management. Objective: To examine the incidence of RI after RP in contemporary series and to propose a pragmatic algorithm for its management. Evidence acquisition: A systematic literature search was performed using the Medline and Scopus databases. Studies reporting data on RI incidence were selected. Subgroup analyses were conducted to assess the differential incidence by age, surgical approach, salvage RP after radiation therapy, and previous benign prostatic hyperplasia (BPH)-related surgery. Evidence synthesis: Eighty-eight, mostly retrospective noncomparative, studies were selected. The meta-analysis obtained a pooled RI incidence of 0.58% (95% confidence interval [CI] 0.46-0.73) in contemporary series with significant across-study heterogeneity (I2 = 100%, p < 0.00001). The highest RI incidence was found in patients undergoing open RP (1.25%; 95% CI 0.66-2.38) and laparoscopic RP (1.25%; 95% CI 0.75-2.08) followed by perineal RP (0.19%; 95% CI 0-276.95) and robotic RP (0.08%; 95% CI 0.02-0.31). Age ≥60 yr (0.56%; 95% CI 0.37-06) and salvage RP after radiation therapy (6.01%; 95% CI 3.99-9.05), but not previous BPH-related surgery (4.08%, 95% CI 0.92-18.20), were also associated with an increased RI incidence. Intraoperative versus postoperative RI detection was associated with a significantly decreased risk of severe postoperative complications (such as sepsis and bleeding) and subsequent formation of a RUF. Conclusions: RI is a rare, but potentially devastating, complication following RP. RI incidence was higher in patients ≥60 yr of age, and in those who underwent open/laparoscopic approach or salvage RP after radiation therapy. Intraoperative RI detection and repair apparently constitute the single most critical step to significantly decrease the risk of major postoperative complications and subsequent RUF formation. Conversely, intraoperatively undetected RI can lead more often to severe infective complications and RUF, the management of which remains poorly standardised and requires complex procedures. Patient summary: Accidental rectum tear is a rare, but potentially devastating, complication in men undergoing prostate removal for cancer. It occurs more often in patients aged 60 yr or older as well as in those who underwent prostate removal via an open/laparoscopic approach and/or prostate removal after radiation therapy for recurrent disease. Prompt identification and repair of this condition during the initial operation are the key to reduce further complications such as the formation of an abnormal opening between the rectum and the urinary tract.

Is EMA warning on quinolones and fluoroquinolones really assessed? An EudraVigilance database analysis.

BACKGROUND: On March 11th 2019, European Medicines Agency (EMA) issues a warning after a review of serious, disabling and potentially permanent adverse events (AEs), particularly on musculoskeletal and nervous system, with quinolone (QN) and fluoroquinolone (FQ) antibiotics. Aim of this study was to evaluate the effect of the EMA warning on the rate of AEs after QN and FQ treatments, reported in the EudraVigilance (EV) database. METHODS: EV database is the system for managing and analyzing information on suspected AEs to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We retrospectively explored the effect of FQs and QNs on musculoskeletal and nervous system from the EMA warning up to now (21 months) and compared these results with the 21 months before the EMA warning. RESULTS: Main part of AEs in EV database were reported for ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin. Ciprofloxacin total AEs before 21 months till 12 months of EMA warning were 2763. 12 months before EMA Warning they were 2935. Twelve months after EMA Warning they were 3419. Between 12 months till 21 months they were 3174. Musculoskeletal disorders were respectively 574 (21% of the total) 21 months before, 558 (19%) 12 months before, 1048 (31%) after 12 months, 540 (17%) after 21 months of EMA Warning. Nervous system disorders were respectively 606 (22% of the total) 21 months before, 517 (18%) 12 months before, 680 (20%) after 12 months, 560 (18%) after 21 months of EMA Warning (respectively OR 1,16 95%CI 1,10 -1,22, P 0,12 ; OR 0,76 95%CI 0,69-0,83, P 0,27 ; OR 1,01 95%CI 0,96-1,06 P 0,05). CONCLUSIONS: Our analysis clearly showed no significant differences before and after EMA warning, opening new insights in the role of the EMA warning in clinical practice.

Retzius-sparing vs. standard robot-assisted radical prostatectomy for clinically localised prostate cancer: a comparative study.

BACKGROUND: Retzius-sparing robot-assisted radical prostatectomy (RARP) is not yet universally accepted due to still limited functional data and some concerns on oncological safety compared to the standard one. We assessed perioperative, pathological and early functional outcomes in patients with clinically localised prostate cancer treated with Retzius-sparing versus standard RARP. METHODS: A single-surgeon cohort of 207 consecutive patients undergoing RARP was analysed. A later study group of 102 patients receiving the Retzius-sparing approach was compared with an earlier control group of 105 patients receiving the standard one. Urinary continence recovery 1 week after catheter removal was the primary study outcome. Urinary continence recovery 1, 2, 3 and 6 months after catheter removal, potency recovery 6 months postoperatively, rate of perioperative complications and positive surgical margins were secondary study outcomes. RESULTS: Patients in the study group reported significantly higher urinary continence recovery rates 1 week (91.2% vs. 54.3%, p < 0.001), 1 month (92.2% vs. 66.7%, p < 0.001), 2 months (95.1% vs. 74.3%, p < 0.001), 3 months (96.1% vs. 83.8%, p = 0.01), but not 6 months (97% vs 90.5%, p = 0.09) after catheter removal compared to controls. Potency recovery rates 6 months after catheter removal were significantly higher in the study than the control group (68.2% vs 51.6%, p = 0.03). On multivariable analyses, the Retzius-sparing approach was an independent predictor of 1-week urinary continence recovery, but not of 6-month potency recovery. There were significant differences neither in perioperative complication rate (9.8% in the study vs. 14.3% in the control group, p = 0.28) nor in positive surgical margin rate (9.8% in the study vs. 8.6% in the control group, p = 0.75). CONCLUSIONS: In a comparative study, we observed a significant improvement in immediate urinary continence, but not in early potency recovery, using the Retzius-sparing compared to the standard approach for RARP, with no increase in perioperative complication and positive surgical margin rate.

Impact of anabolic androgenic steroids on male sexual and reproductive function: a systematic review.

INTRODUCTION: Anabolic-androgenic steroids (AASs) are a complex cluster of synthetic derivatives of testosterone. AAS abuse is considered a major public health issue since it has increased among young/adolescent males. The use of steroids has a prevalence rate of 14% in young athletes and 30-75% in professional athletes or bodybuilders. AASs simulate the testosterone mechanism, binding the intracellular androgen receptor, and dysregulating the normal hypothalamic-pituitary-gonadal axis in the same way as exogenous testosterone. Abuse can produce several side effects on organs, such as the genital system. The physio-pathological mechanisms that cause AAS abuse-related, genital system disorders in humans are still not completely known. EVIDENCE ACQUISITION: This study focuses on the effect of AASs on the male reproductive organs in humans and animals. EVIDENCE SYNTHESIS: A systematic review was performed using SCOPUS, PubMed, Google Scholar, and Web of Sciences database up to 31 December 2021 using the keywords: "anabolic-androgenic steroids," "erectile dysfunction," "spermatogenesis" and "infertility;" (anabolic agents) "erectile dysfunction," "spermatogenesis" and "infertility." The review of the literature identified 66 articles published until 2021. Sixty-two articles were included. The use of AASs induces testicular atrophy and azoospermia known as "anabolic steroid-induced hypogonadism." Anabolic steroid induced infertility is characterized by oligo or azoospermia and abnormalities in sperm motility and morphology. Although sperm quality recovers in most cases within 4 months of stopping anabolic steroid abuse, the negative consequences on spermatogenesis can take up to 3 years to disappear. Human studies reported a positive correlation between AAS abuse in athletes and an increase in morphologically abnormal spermatozoa. Animal studies showed the destruction of Leydig cells and testicular atrophy in animals treated with cycles of AASs. CONCLUSIONS: The present review of the literature highlights how little is known about the action of AASs on the male genital system. However, although their use is prohibited in many countries, the black market for these substances is still very frequent. The scientific landscape still has a lot to invest in the research of AAS on the male genital system to make young people even more aware of the negative aspects of these substances, contributing to the reduction of these products in an inappropriate way.

The Role of Combination Therapy with α-Blockers and Hexanic Extract of Serenoa repens in the Treatment of LUTS/BPH.

The hexanic extract of Serenoa repens (HESr) has been in use for decades as an effective, safe and well-tolerated therapy for relieving bothersome lower urinary tract symptoms (LUTS) associated with benign prostate hyperplasia (BPH). This manuscript gives an overview of HESr as monotherapy for LUTS/BPH treatment and focuses on the currently available literature investigating the possible clinical benefits of HESr combination therapy with α-blockers. Combination therapy of HESr with α-blockers has been gaining significant interest in recent years, as an increasing body of evidence shows the beneficial pharmacological effects that HESr treatment can add to standard first-line treatment with α-blockers. By reducing persistent Prostatic Inflammatory Status (PIS), commonly present in LUTS/BPH patients, HESr complements the relaxation of prostate smooth muscle induced by α-blockers, thus providing additional symptom relief. Data suggest that patients harbouring PIS and having a specific clinical profile might especially benefit from the combination therapy. Future therapeutic efforts may take advantage of more personalised strategies for LUTS/BPH management.

A systematic review and meta-analysis on delaying surgery for urothelial carcinoma of bladder and upper tract urothelial carcinoma: Implications for the COVID19 pandemic and beyond.

Purpose: The COVID-19 pandemic has led to competing strains on hospital resources and healthcare personnel. Patients with newly diagnosed invasive urothelial carcinomas of bladder (UCB) upper tract (UTUC) may experience delays to definitive radical cystectomy (RC) or radical nephro-ureterectomy (RNU) respectively. We evaluate the impact of delaying definitive surgery on survival outcomes for invasive UCB and UTUC. Methods: We searched for all studies investigating delayed urologic cancer surgery in Medline and Embase up to June 2020. A systematic review and meta-analysis was performed. Results: We identified a total of 30 studies with 32,591 patients. Across 13 studies (n = 12,201), a delay from diagnosis of bladder cancer/TURBT to RC was associated with poorer overall survival (HR 1.25, 95% CI: 1.09-1.45, p = 0.002). For patients who underwent neoadjuvant chemotherapy before RC, across the 5 studies (n = 4,316 patients), a delay between neoadjuvant chemotherapy and radical cystectomy was not found to be significantly associated with overall survival (pooled HR 1.37, 95% CI: 0.96-1.94, p = 0.08). For UTUC, 6 studies (n = 4,629) found that delay between diagnosis of UTUC to RNU was associated with poorer overall survival (pooled HR 1.55, 95% CI: 1.19-2.02, p = 0.001) and cancer-specific survival (pooled HR of 2.56, 95% CI: 1.50-4.37, p = 0.001). Limitations included between-study heterogeneity, particularly in the definitions of delay cut-off periods between diagnosis to surgery. Conclusions: A delay from diagnosis of UCB or UTUC to definitive RC or RNU was associated with poorer survival outcomes. This was not the case for patients who received neoadjuvant chemotherapy.

Robot-assisted Bladder Diverticulectomy Using a Transperitoneal Extravesical Approach.

Background: Acquired bladder diverticula (BD) are a possible complication of bladder outlet obstruction (BOO) due to benign prostate enlargement (BPE). Robot-assisted bladder diverticulectomy (RABD) has been proposed as an alternative to open removal; however, only a few small series have been published. Objective: To describe our surgical technique for RABD and to assess perioperative results and functional outcomes at 6-mo follow-up. Design setting and participants: A prospective single-centre, single-surgeon cohort of 16 consecutive men with posterior or posterolateral BD due to BOO/BPE undergoing RABD between May 2017 and December 2021 was analysed. Surgical procedure: RABD was performed with a four-arm robotic system via a transperitoneal approach. BD were identified intraoperatively via bladder distension with saline solution through an indwelling catheter with or without concomitant illumination using flexible cystoscopy and fluorescence imaging. Extravesical BD dissection and removal were performed. Outcome measurements and statistical analysis: Operating room time, estimated blood loss, intraoperative and postoperative complications, indwelling catheter time, and timing of associated procedures for BOO/BPE were assessed. The International Prostate Symptom Score (IPSS) and postvoid residual volume (PVR) were compared between baseline and 6 mo after surgery. Results and limitations: Median age and maximum BD diameter were 68 yr (interquartile range [IQR] 54-74) and 69 mm (IQR 51-82), respectively. The median operative time was 126 min (IQR 92-167) and the median estimated blood loss was 20 ml (IQR 15-40). No intraoperative complications were recorded. The urethral catheter was removed on median postoperative day 5 (IQR 5-7). Two men experienced 90-d postoperative complications (persistent urinary infection requiring prolonged antimicrobial therapy). Bipolar transurethral resection of the prostate was performed 3 wk before RABD in seven men and concomitant to RABD in nine men. Median IPSS significantly decreased from 25 (IQR 21-30) to 5 (IQR 5-6), and median PVR from 195 ml (IQR 140-210 ml) to 30 (IQR 28-40) ml (both p < 0.001) at 6-mo follow-up in comparison to baseline. A limitation is the rather small cohort with no control group. Conclusions: RABD is a safe and effective minimally invasive option for treatment of acquired BD in men with BOO/BPE. Validation of our results in larger series with longer follow-up is warranted. Patient summary: We describe our surgical technique for robot-assisted removal of pouches in the bladder wall (called diverticula) in men with bladder outlet obstruction caused by benign prostate enlargement, and report functional results at 6 months after the operation. This minimally invasive technique was found to be safe and effective.

Preliminary Results of ERAS Protocol in a Single Surgeon Prospective Case Series.

Background and Objectives: The aim was to compare the intra and postoperative outcomes between the Enhanced Recovery After Surgery (ERAS) protocol versus the standard of care protocol (SCP) in patients who underwent radical cystectomy performed by a single surgeon. Materials and Methods: A retrospective comparative study was conducted including patients who underwent radical cystectomy from 2017 to 2020. Length of stay (LOS), incidence of ileus, early postoperative complications, and number of re-hospitalizations within 30 days were considered as primary comparative outcomes of the study. Results: Data were collected for 91 patients who underwent cystectomy, and 70 and 21 patients followed the SCP and ERAS protocol, respectively. The mean age of the patients was 70.6 (SD 9.5) years. Although there was a statistically significant difference in time to flatus (TTF) [3 (2.7−3) vs. 1 (1−2 IQR) days, p < 0.001, in the SC hospital and in the ERAS center respectively], no difference was reported in time to first defecation (TTD) [5 (4−6) vs. 4 (3−5.8), p = 0.086 respectively]. The median LOS in the SCP group was 12 (IQR 11−13) days vs. 9 (IQR 8−13 p = 0.024). In the postoperative period, patients reported 22 complications (37% in SCP and 42.8% in ERAS group, p = 0.48). Conclusions: The study reveals how even partial adherence to the ERAS protocols leads to similar outcomes when compared to SCP. As a single surgeon series, our study confirmed the role of surgeons in reducing complications and improving surgical outcomes.

Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study.

The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.

Antibiotic prophylaxis in patients who had undergone to prostate biopsy in between the EMA warning era: effects of fluoroquinolones in diabetic and non-diabetic patients. Results of an observational cohort study.

PURPOSE: To investigate the effects of different antibiotic prophylaxis regimens in patients with diabetes mellitus (DM) candidates to trans-rectal ultrasound-guided prostate biopsy (TRUSPB). METHODS: 143 outpatients with DM who underwent TRUSPB during the period 2018-2020 were selected from a cohort of 1150 patients in 3 different institutions. Exclusion criteria were allergies, concomitant anti-platelet therapies and uncontrolled DM. Different antibiotic prophylaxis regimens were adopted. Bacterial resistance levels to fluoroquinolones into the different communities were also collected. Univariable and multivariable binomial logistic regression analyses were used to assess the odds ratio (OR) with 95% confidence intervals (CIs) testing the risk of infective complications' occurrence after adjusting for clinical covariates. RESULTS: Overall, DM patients were significantly associated with infective complications' occurrence (p < 0.001). No differences on the event of sepsis were found between diabetic and non-diabetic patients. Clinically relevant infections with fever > 37 °C were found in 9.1% and 1.5% (p < 0.001) in diabetic and non-diabetic patients, respectively. Trimethoprim-sulphametoxazole and fluoroquinolones were six times more efficient than Cefixime in non-diabetic patients. Fluoroquinolones confirmed the same effect in diabetic patients although the level of resistance in the period of study decreased only from 56 to 46%. CONCLUSION: Fluoroquinolones were active in antibiotic prophylaxis of diabetic patients who had undergone to TRUSPB independently from the level of bacterial resistance found in the community. These results conflict with the recent European warning and support the Japanese and American guidelines on the topic.