Background: In an era of Bacillus of Calmette-Guérin (BCG) shortages, the comparative efficacy from different adjuvant intravesical BCG strains in non-muscle invasive bladder cancer (NMIBC) has not been clearly elucidated. We aim to compare, through a systematic review and meta-analysis, the cumulative BC recurrence rates and the best efficacy profile of worldwide available BCG strains over the last forty years. Methods: PubMed, Scopus, Web of Science, Embase, and Cochrane databases were searched from 1982 up to 2022. A meta-analysis of pooled BC recurrence rates was stratified for studies with ≤3-y vs. >3-y recurrence-free survival (RFS) endpoints and the strain of BCG. Sensitivity analysis, sub-group analysis, and meta-regression were implemented to investigate the contribution of moderators to heterogeneity. A random-effect network meta-analysis was performed to compare BCG strains on a multi-treatment level. Results: In total, n = 62 series with n = 15,412 patients in n = 100 study arms and n = 10 different BCG strains were reviewed. BCG Tokyo 172 exhibited the lowest pooled BC recurrence rate among studies with ≤3-y RFS (0.22 (95%CI 0.16–0.28). No clinically relevant difference was noted among strains at >3-y RFS outcomes. Sub-group and meta-regression analyses highlighted the influence of NMIBC risk-group classification and previous intravesical treated categories. Out of the n = 11 studies with n = 7 BCG strains included in the network, BCG RIVM, Tice, and Tokyo 172 presented with the best-predicted probability for efficacy, yet no single strain was significantly superior to another in preventing BC recurrence risk. Conclusion: We did not identify a BCG stain providing a clinically significant lower BC recurrence rate. While these findings might discourage investment in future head-to-head randomized comparison, we were, however, able to highlight some potential enhanced benefits from the genetically different BCG RIVM, Tice, and Tokyo 172. This evidence would support the use of such strains for future BCG trials in NMIBCs.
OPon behalf of European Association of Urology (EAU)—Young Academic Urologists (YAU) Urothelial Cancer Working Party
on behalf of European Association of Urology (EAU)—Young Academic Urologists (YAU) Urothelial Cancer Working Party
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Background: Intravesical immunotherapy with bacillus Calmette–Guerin (BCG) is the standard therapy for high-risk non-muscle invasive bladder cancer (NMIBC). The superiority of any BCG strain over another could not be demonstrated yet. Methods: Patients with NMIBCs underwent adjuvant induction ± maintenance schedule of intravesical immunotherapy with either BCG TICE or RIVM at two high-volume tertiary institutions. Only BCG-naïve patients and those treated with the same strain over the course of follow-up were included. One-to-one (1:1) propensity score matching (PSM) between the two cohorts was utilized to adjust for baseline demographic and tumor characteristics imbalances. Kaplan–Meier estimates and multivariable Cox regression models according to high-risk NMIBC prognostic factors were implemented to address survival differences between the strains. Sub-group analysis modeling of the influence of routine secondary resection (re-TUR) in the setting of the sole maintenance adjuvant schedule for the two strains was further performed. Results: 852 Ta-T1 NMIBCs (n = 719, 84.4% on TICE; n = 133, 15.6% on RIVM) with a median of 53 (24–77) months of follow-up were reviewed. After PSM, no differences at 5-years RFS, PFS, and CSS at both Kaplan–Meier and Cox regression analyses were detected for the whole cohort. In the sub-group setting of full adherence to European/American Urology Guidelines (EAU/NCCN), BCG TICE demonstrated longer 5-years RFS compared to RIVM (68% vs. 43%, p = 0.008; HR: 0.45 95% CI 0.25–0.81). Conclusion: When routinely performing re-TUR followed by a maintenance BCG schedule, TICE was superior to RIVM for RFS outcomes. However, no significant differences were detected for PFS and CSS, respectively.
Background: Transurethral resection of the prostate (TURP) is the gold-standard treatment for benign prostatic hyperplasia (BPH). However, laser surgery techniques (e.g., photoselective vaporization of the prostate (PVP), holmium laser, thulium laser enucleation of the prostate (HoLEP or ThuLEP)), and minimally invasive treatment options (e.g., UroLift) are increasingly replacing TURP. This study seeks to report the annual incidence, management trends, and costs of BPH procedures in the U.S. Methods: Data analyses of U.S. health insurance claims from 2004 to 2017, collected from the de-identified Optum Clinformatics Claims Database, were performed to determine the number of BPH patients and the treatment selected. Results: A total of 51,448 patients underwent BPH procedures from 2004 to 2017. There was a significant increase in the annual rate from 770 in 2004 to 6571 in 2017. The mean patient age (±SD) increased from 67.6 years old (±8.4) in 2004 to 73.4 years old (±8.4) in 2017. More than 60% of patients underwent cystourethroscopy and a post-void residual urine check for workup prior to surgical management. TURP was the most-common, and PVP was the second-most-common BPH procedure. Medical and total treatment costs increased, while the detection rate of prostate cancer after BPH surgery gradually decreased from 19.87% in 2004 to 5.78% in 2017. Conclusions: Our study demonstrates a recent trend in BPH management that replaces the traditional TURP technique with alternative methods. Due to rising costs, future studies should assess whether these newer methods are cost effective over the long term.
Background: The advantage of a robotic-assisted (RARP) over a laparoscopic (LRP) approach in radical prostatectomy (RP) remains to be demonstrated. Aim: The aim of the study is to use a homogeneous population in real life and single primary surgeon surgery to analyze the oncological and functional results based on the type of surgical approach and pathological features. Methods: This is a prospective trial on non-metastatic prostate cancer (PCa) patients considered after a multidisciplinary decision to conduct a RP, using a RARP or LRP approach. A real-life setting was analyzed at our Urological Departments using homogeneous criteria for the management of PCa cases and a single surgeon experience on 444 cases (284 LRP and 160 RARP). Results: Mean operating time was significantly lower in RARP (153.21 ± 25.1 min) than in LRP (173.33 ± 44.3 min) (p < 0.001). In cases submitted to an extended lymph node dissection (eLND), the mean number of lymph nodes removed was 15.16 ± 7.83 and 19.83 ± 4.78, respectively, in LRP and RARP procedures (p < 0.001), but positive lymph nodes (pN1) were similarly found in 15.8% of LRP patients and 13.6% of RARP patients (p = 0.430). Surgical margins (SM) positivity was not significantly higher in the RARP group (20.0%) when compared to the LRP group (15.9%) (p = 0.145). During the postoperative follow-up, a biochemical recurrence (BCR) was detected in 14.4% and 7.5% of cases in the LRP and RARP group, respectively, (p = 0.014). Better results of PAD tests at 3-month intervals using the RARP approach (mean pad weight 75.57 ± 122 g and 14 ± 42 g, respectively, in LRP and RARP (p < 0.01)) were described. Conclusions: In the comparison between the RARP and LRP approach, a clear advantage of the robotic approach is a significant reduction in operating times, days of hospitalization, and postoperative catheterization compared to laparoscopic surgery. It is not possible to describe any certain oncological advantage both in terms of surgical margins and pathological lymph nodes removed. In RARP cases a reduction to the limit of significance is described in terms of biochemical recurrence. RARP produces a more rapid recovery of urinary continence at 3 months postoperatively without significant advantages in terms of erective potency recovery.
Background/Objectives: The da Vinci Single-Port (SP) system represents a recent evolution in robotic-assisted surgery, offering enhanced articulation and access through a single incision. The SP system was approved by the European Medicine Agency (EMA) in January 2024. Methods: This review synthesizes current clinical evidence on the feasibility, safety, and versatility of SP-assisted procedures across multiple surgical specialties to date based on a comprehensive literature search conducted through major databases (MEDLINE, EMBASE, and Cochrane) according to PRISMA and PICOS guidelines. Results: A total of 14 studies were included, highlighting that the SP platform has been successfully adopted in complex procedures such as cervical esophagectomy, radical prostatectomy, nephrectomy, gynecologic procedures, and wall surgery. Across indications, the SP approach is associated with reduced blood loss, shorter hospital stays, and low complication rates. On the other hand, limitations include restricted working space and the steep learning curve. Conclusions: Overall, the da Vinci SP platform expands the scope of minimally invasive surgery, but European centers lag behind international trends, particularly when compared to new, less-invasive techniques adopted in high-volume SP centers in the US. Urology remains the main field of application.
To identify the characteristics of patients with sepsis or acute pyelonephritis (APN) combined with ureteral calculi and to analyze the risk factors in its causation. Methods: We included patients with sepsis or APN caused by ureteral calculi who received treatment in the United States from January 2003 to December 2017 using the Optum® deidentified Clinformatics® Datamart. Demographic factors and risk factors for the receipt of sepsis or APN were subsequently analyzed for statistical significance. Results: Of 467,502 urinary stone patients, age-matched multivariate analysis revealed that a history of urinary tract infection (OR 11.31, 95% CI 10.68–11.99, p < 0.0001) and female gender (OR 2.73, 95% CI 2.62–2.84, p < 0.0001) were significantly related to an increased risk of sepsis or APN. Conversely, a previous past medical history of urolithiasis (OR 0.91, 95% CI 0.87–0.95, p < 0.0001) and cancer (OR 0.91, 95% CI 0.87–0.95, p < 0.0001) were associated with a decreased risk of sepsis or APN. With regards to comorbidities, when more than one comorbidity was present, there was an additive effect with higher OR point estimates, rising to 11.31 (10.68–11.99) when three or more comorbidities present. History of urinary tract infection and female gender are risk factors for sepsis or APN in patients with ureteral calculi. Conclusions: This large national cohort reveals the characteristics of sepsis or APN combined with ureteral stone and provides an important baseline for the treatment of urolithiasis in the future.