Search Results (105)

Background/Objectives: Robot-assisted radical cystectomy (RARC) has become the primary approach for treating bladder cancer, replacing the traditional open procedure. The robotic approach, when combined with ureterocutaneostomy (UCS), offers significant advantages for octogenarians, who are at increased risk for perioperative complications. Methods: This observational, prospective, multicenter analysis is based on data from the Italian Radical Cystectomy Registry (RIC), collected from January 2017 to June 2020 across 28 major urological centers in Italy. We analyzed consecutive male and female patients undergoing radical cystectomy (RC) and urinary diversion via the open, laparoscopic, or robot-assisted technique. Inclusion criteria: patients aged 80 years or older, with a WHO Performance Status (PS) of 2–3, an American Society of Anesthesiologist score ≥3, a Charlson Comorbidity Index (CCI) ≥ 4, and a glomerular filtration rate (GFR) <60 mL/min. Results: A total of 128 consecutive patients were included: 41 underwent RARC with UCS (Group 1), 65 open RC (ORC) with UCS (Group 2), and 22 laparoscopic RC (LRC) with UCS (Group 3). The cystectomy operative time was longer in robotic surgeries, while the lymph node dissection time was shorter. RARC with UCS showed statistically significant advantages in terms of lower median estimated blood loss (EBL), transfusion rate, and length of hospital stay (LOS) compared to open and laparoscopic procedures. Intra- and postoperative complications were also lower in the RARC groups. Conclusions: Robotic cystectomy in high-volume referral centers (≥20 cystectomies per year) provides the best outcome for fragile patients. Beyond addressing the baseline pathology, RARC with UCS may represent a leading option, offering oncological control while reducing complications in this vulnerable age group. Full article

Introduction: Radical cystectomy (RC) is the gold standard for urothelial cT2-4a, N0, M0 muscle-invasive bladder cancer (MIBC). However, bladder-sparing strategies (BSS) such as Trimodality Therapy (TMT) have emerged as alternative treatments for a select group of localized muscle-confined (cT2) urothelial bladder cancers. Accordingly, reliable preoperative staging and a reliable risk factor assessment linked to pathological upstaging play a key role in adequate counselling and patient selection for BSS. Patients and Methods: cT2 MIBC patients undergoing RC at our institution from 2014 to 2024 were reviewed. Preoperative staging modalities, demographics, and tumour and patient characteristics were assessed. Multivariable logistic regression was applied to explore the relative effect of confounders on any pathological upstaging from robot-assisted or open RC specimens. Subgroup analysis according to the local upstaging (>pT2) or nodal dissemination (pN+) was also performed. Results: N = 275 RCs were included (73.5% males, 26.5% females). Upstaging was documented in n = 141 (51%) cases. Of these, n = 125 (45.5%) were upstaged locally (>pT2) and n = 35 (23%) yielded pN+ disease. Preoperative parameters like gender, the number of TURBTs, previous BCG exposure, and concomitant CIS did not significantly influence the risk of any kind of upstaging (p > 0.05). At multivariable analysis, neoadjuvant chemotherapy (NAC) and multi-disciplinary team (MDT) discussion were found protective (odds ratio [OR]: 0.4, 95%CI 0.2–0.7, p = 0.001 and OR: 0.51, 95%CI 0.2–0.9, p = 0.01). Preoperative FDG-PET assessment yielded higher risk for later pN upstaging (OR: 1.8, 95%CI 1–3, p = 0.05). HG/G3 features at TURBT along with mixed/pure histology variants in RC specimens were the most relevant independent predictors for both any and pT upstaging (OR: 4.3, 95%CI 1–34, p = 0.04 and OR: 2.3, 95%CI 1.1–4.6, p = 0.02 for any upstaging and OR: 5.6, 95%CI 1.3–36, p = 0.02 and OR: 2.5, 95%CI 1.3–5, p = 0.01 for pT upstaging, respectively). Conclusions: In this study, over half of the patients undergoing RC for cT2 were upstaged at the final pathology. Therefore, adequate counselling and examining the non-conventional criteria for prognosis is mandatory in the contemporary era of bladder-preservation strategies. Full article

Background/Objectives: While cytoskeleton-associated protein 4 (CKAP4) has been associated with prognosis in various malignancies, its prognostic value for bladder cancer (BCa) remains unclear. The aim of this study was to evaluate CKAP4 expression in tumor cells and cancer-associated fibroblasts (CAFs) following radical cystectomy (RC) in patients with BCa. Methods: In this study, CKAP4 in tumor cells was defined as CKAP4-1, while CKAP4 expressed in CAFs was defined as CKAP4-2. CKAP4-2 expression was evaluated to explore its potential association with tumor aggressiveness and patient outcomes. CKAP4 expression in 86 RC specimens was assessed using immunohistochemistry. CKAP4-1 positivity was considered when ≥5% cytoplasmic staining of cancer cells, with at least moderate staining intensity, was observed. CKAP4-2 positivity was evaluated using a point scale (0–3), with scores based on the number of CKAP4 positive CAFs in the tumor stroma. Scores of 2 (moderate number of CAFs) and 3 (significant number of CAFs) were considered to indicate positivity. Results: CKAP4-1 and CKAP4-2 were expressed in 53 (61.6%) and 34 (39.5%) patients, respectively. Kaplan–Meier analysis showed that patients with CKAP4-1 had significantly shorter cancer-specific survival and recurrence-free survival (RFS; p = 0.046 and p = 0.0173, respectively). Multivariate analysis showed that CKAP4-1 positivity was an independent predictor of RFS (p = 0.041, hazard ratio: 2.09, 95% confidence interval: 1.03–4.25). Conclusions: This study showed that CKAP4 expression in tumor cells may serve as a useful prognostic biomarker for patients with BCa who undergo RC. Full article

An accurate histopathological evaluation of radical cystectomy (RC) specimens is crucial for optimal tumor staging, prognosis, and therapeutic decision making. The increasing demand for precision medicine and multidisciplinary oncological management emphasizes the necessity for standardized protocols in the handling and sampling of bladder cancer specimens. The effective processing of RC specimens begins with the integration of clinical and anamnestic data, along with appropriate formalin fixation methods to meet diagnostic needs. The pathologist must meticulously document the macroscopic characteristics and dimensions of the surgical specimen, especially in post-neoadjuvant chemotherapy (post-NAC) cases where the primary tumor may not be macroscopically visible. Sampling strategies should ensure a comprehensive assessment of the primary tumor and any extra-organ or metastatic involvement. Despite international guidelines, variability in pathology practices persists, particularly concerning prostate sampling in RC and the use of frozen sections for margin assessment. Addressing these challenges necessitates a consensus-driven, standardized approach to improve the reproducibility and quality of histopathological data. By addressing gaps in current pathology practices, this review advocates for uniform protocols that enhance diagnostic accuracy, ultimately improving patient care and clinical decision making. Full article

Background/Objectives: The aim of this study was to identify response prediction and prognostic biomarkers in muscle-invasive bladder cancer (MIBC) patients undergoing neoadjuvant chemotherapy (NAC). Methods: A retrospective multicentre study including 191 patients with MIBC who received NAC previous to radical cystectomy (RC) between 1996 and 2013. Gene expression patterns were analysed in 34 samples from transurethral resection of the bladder (TURB) using Illumina microarrays. The expression levels of 45 selected differentially expressed genes between responders and non-responders to NAC were validated by quantitative PCR in an independent cohort of 157 patients. Regression analysis was used to identify predictors of downstaging and relapse. A nomogram for predicting downstaging and relapse—including clinicopathological and gene expression variables—was developed. Results: The expression levels of 1352 transcripts differed between responders and non-responders to NAC. A nomogram based on the most predictive clinical variables (age, Tis (in situ), gender, history of NMIBC, and lymphadenopathy) and genes selected following the Akaike information criterion (AIC) (CBTB16, CHMP6, DDX54, CASP8, LOR, and PLEC) was then created. In addition, a three-gene expression prognostic model to predict tumour relapse was generated. This model was able to discriminate between two groups of patients with a significantly different probability of tumour relapse (HR: 2.11; CI: 1.16–3.83, p = 0.01). Conclusions: Our nomogram based on gene expression and clinical data is a useful tool to predict downstaging and tumour relapse after NAC in MIBC patients. Further validation is warranted. Full article

Objective: The objective was to evaluate the impact of perioperative immunonutrition (IN) on postoperative complications in patients undergoing radical cystectomy (RC) for bladder cancer (BC). Methods: A prospective case series of 19 patients treated with perioperative IN between October 2022 and July 2023 was conducted. Patients received preoperative IN based on nutritional risk and postoperative IN with gradual recovery of normal feeding. The inclusion criteria encompassed clinically node-negative patients without metastatic disease. The outcomes were assessed using Clavien–Dindo classification and included infectious complications, wound healing disorders, ileus, anemia, genitourinary issues, recovery time, and compliance with the nutritional regimen. Results: Sixteen patients (84.2%) experienced complications. Most were low-grade (CD 1–2), with no CD > 3a. Wound disorders affected 10.5% and anemia requiring transfusion occurred in 47.4% of patients, infectious complications were reported in 26.3%, and ileus in 36.8%. The median time to first flatus was 2 days (IQR 2–3), while resumption of oral feeding occurred after 4 days (IQR 2–5), like mobilization (IQR 2–5). The median hospital stay was 14 days (IQR 11–18). Compliance with IN was 78.9%, with gastrointestinal intolerance being the primary cause of discontinuation. Conclusions: Patients with RC undergoing perioperative IN showed low rates of high-grade complications and promising results in bowel function recovery and infection rates. Further randomized controlled trials are required to validate these results. Full article

Purpose: Bacillus Calmette–Guérin (BCG) has long been the standard treatment for preventing recurrence and progression following resection of high-risk non-muscle invasive bladder cancer (NMIBC). Unfortunately, recurrence or progression despite BCG induction and maintenance treatment have significant prevalence—a persistent issue in urologic oncology. Notable advancements in the development of alternative therapeutic options have become available and are in the pipeline. This review aims to provide an overview of the current treatment landscape for patients with BCG-unresponsive NMIBC, highlighting both existing and emerging therapies that are expected to become more widely available. Methods: A narrative review based on data collected through the end of 2024. Results: Several treatment options, aside from radical cystectomy (RC), are currently available or in promising stages of clinical trials. Many of these treatment modalities were granted Fast Track and Breakthrough Therapy status due to their initial success. These include novel chemotherapy regimens, immune checkpoint inhibitors, device-assisted therapies, and new intravesical and systemic agents. Combination therapies combining traditional treatments and newer approaches were explored. Conclusions: The next few years promise to offer patients a variety of new, effective therapies for BCG-unresponsive NMIBC. These advancements hold significant potential for improving patient outcomes and providing more targeted, organ-sparing treatment options. Full article

Objectives: To investigate neoadjuvant chemotherapy (NAC) eligibility, utilization, and survival outcomes for muscle-invasive bladder cancer patients undergoing radical cystectomy (RC) in a Finnish population. Materials and Methods: Data from the Finnish National Cystectomy Database (2005–2017) was combined with Finnish Cancer Registry survival data. NAC utilization rates were reported, and downstaging rates were calculated based on final pathological staging. Logistic regression analyzed NAC usage and complete response (CR) predictors. Results: Since 2011, 29% of 1157 patients received NAC. Its usage remained consistent, and the number of eligible patients not receiving NAC decreased during the study period. Among NAC patients, pathology T-category was pT0 (34%), pT1-Ta-Tis (16%), pT2 (23%), pT3 (20%), and pT4 (7%) tumors, with pN0 in 82%. In the RC + NAC group, the 5-year overall survival (OS) rates were 89% for patients with no residual disease (pT0N0), 82% for those with organ-confined residual disease (pT1, Tis, Ta, T2/N0), and 49% for patients with non-organ-confined residual disease (pT3+/N+). The corresponding cancer-specific survival (CSS) rates were 93%, 86%, and 57%, respectively. Patients with organ-confined residual disease after NAC had survival outcomes comparable to those who underwent RC alone. Higher age; odds ratio (OR) 0.93, [95% Confidence Interval (CI): 0.90–0.95] and Charlson Co-morbidity Index–score [OR 0.88 (0.79–0.98)] reduced the likelihood of receiving NAC, while a smaller center size increased the probability [OR 1.82 (1.02–3.28)]. More treatment cycles [OR 0.70, (95% CI: 0.51–0.93)] and a favorable GFR [OR 0.38 (0.16–0.88)] were associated with achieving CR. Conclusion: We report that NAC is well-utilized across Finland, with CR rates comparable to recent trials. Additionally, our survival rates are reasonable, and even with organ-confined residual disease after NAC, survival outcomes are similar to those who underwent RC alone. Full article

Background: Pelvic lymph node dissection during standard radical cystectomy (stdRC) for muscle invasive bladder cancer is performed as separate templates. In the modernized en bloc radical cystectomy (mEbRC), the bladder is removed together with all its associated lymphatic tissue as one specimen. Our aim was to evaluate the oncological and surgical outcomes of mEbRC with a propensity-matched national cohort of stdRC cases. Methods: 935 patients (mEbRC: 214 and stdRC: 721) were eligible for analysis, and 1:2 propensity score matching was performed regressing mEbRC treatment on the variables age, gender, neoadjuvant chemotherapy, Charlson Comorbidity Index, lymph node metastases at final pathology, carcinoma in situ, and pT-stage. The primary outcome was recurrence-free survival (RFS). Secondary endpoints were overall survival (OS) and cancer-specific survival (CSS), survival for female patients. and perioperative measures. Results: There were no significant differences between the groups regarding complications, 30-day readmission rates, and 30- and 90-day mortality rates. In the propensity score matched groups, the 5-year RFS was 83% in the mEbRC group vs. 67% in the stdRC group (p < 0.001), the CSS was 89% and 78% (p ≤ 0.001), and OS 81% vs. 68% (p < 0.001) in the same groups, respectively. The results were confirmed by Cox regression analyses with hazard ratios ranging from 0.41 to 0.50 and p-values ≤ 0.001, favoring mEbRC. The 5-year OS for female patients was 86% for mEbRC and 60% for stdRC (p = 0.022). Conclusions: Performing mEbRC over stdRC might yield significantly better oncological outcomes, with equal survival rates for both genders. Full article

Background/Objectives: Radical cystectomy (RC) is the standard treatment for muscle-invasive and high-risk non-muscle-invasive bladder cancer, but it often results in significant functional impairments, including sexual and urinary dysfunction, adversely affecting quality of life (QoL). Sexual-sparing robotic-assisted radical cystectomy (RARC) has been introduced to mitigate these effects. This review evaluates the oncological and functional outcomes of sexual-sparing RARC in male and female patients. Methods: A systematic literature search identified 15 studies including 793 patients who underwent sexual-sparing RARC using techniques such as nerve-sparing, capsule-sparing, and pelvic organ-preserving approaches. Data on oncological and functional outcomes were analyzed. Results: Sexual-sparing RARC achieves oncological outcomes comparable to open RC, with negative surgical margin (NSM) rates exceeding 95% in most studies. RFS and CSS rates were robust, often surpassing 85% at intermediate follow-ups. Functional outcomes were also favorable, with continence rates exceeding 90% and erectile function recovery surpassing 70% in well-selected male patients. Female patients undergoing pelvic organ-preserving techniques demonstrated improved continence, preserved sexual function, and enhanced QoL. Patient selection emerged as critical, favoring those with organ-confined disease and good baseline function. Conclusions: Sexual-sparing RARC offers a promising balance between oncological control and functional preservation, making it an effective option for selected patients. Further research is needed to refine techniques and establish standardized protocols for broader adoption. Full article

Introduction: Intravenous fluid management is integral to perioperative care, particularly under enhanced recovery after surgery (ERAS) protocols. In radical cystectomy (RC), which carries high risks of complications and mortality, optimizing fluid management poses a significant challenge due to the absence of definitive guidelines. Aim: the purpose of this study was to investigate the effects of intravenous fluid administration on postoperative complications in patients undergoing RC. Material and methods: This study involved 288 patients who underwent laparoscopic RC and urinary diversion from 2018 to 2022. ERAS protocols were implemented for all patients. Participants were divided into four groups based on the type of urinary diversion (ureterocutaneostomy vs. ileal conduit) and the intraoperative fluid volume input (less than 1000 mL vs. more than 1000 mL). Postoperative complications were evaluated at 30 and 90 days post-surgery using the Clavien-Dindo scale. The fluid management effectiveness was measured using the absolute Vascular Bed Filling Index (aVBFI) and the adjusted Vascular Bed Filling Index (adjVFBI). Results: The UCS is associated with a lower risk of increased severity of postoperative complications. The administration of more than 1000 mL of fluids was associated with a higher risk of complications (p = 0.035). However, after adjusting for the duration of the surgery and BMI, this association did not hold statistical significance, indicating that fluid volume alone is not a direct predictor of postoperative complications. At aVBFI values between zero and eight, urinary diversion using the UCS method is associated with a lower risk of complications compared to the IC. When aVBFI equals eight, the differences in the severity of complications between the UCS and the IC are minimal. However, when aVBFI exceeds eight, the IC is associated with fewer complications during the 30 days post-operation compared to the UCS. The correlation between the adjVFBI (B = −0.27; 95% CI: −0.45 to −0.08; p = 0.005) and the severity of complications up to 30 days postoperatively is similar to that seen with the aVBFI. Similarly, the correlation of the adjVFBI with the method of urinary diversion (B = 0.24; 95% CI: 0.06 to 0.43; p = 0.011) resembles that of the aVBFI. The volume of fluids administered and the indices aVBFI and adjVFBI did not influence the occurrence of complications 90 days postoperatively. Conclusions: The volume of fluids administered is not a factor directly affecting the occurrence of complications following RC when the ERAS protocol is used. The amount of intraoperative fluid administration should be adjusted according to the intraoperative blood loss. Our findings endorse the utility of aVBFI and adjVFBI as valuable tools in guiding fluid therapy within the framework of ERAS protocols. However, further multicenter randomized trials are needed to definitively determine the best fluid therapy regimen for patients undergoing RC. Full article

Purpose: Bladder cancer is one of the most common malignancies worldwide with over 614,000 new cases and 220,000 deaths annually. Five percent of newly diagnosed patients have metastatic disease. Metastatic urothelial carcinoma (mUC) is primarily treated with cisplatin-based chemotherapy, immunotherapy, targeted therapy, or combinations. Cure from disease is rarely achieved, with the overall survival being between 12 and 15 months, and the 5-year survival in the range of 5–15%. Historically, mUC has been deemed surgically incurable. There are limited data available to assess survival benefit with surgical extirpation of the primary site or metastases. In this review, we summarize findings from previous studies regarding the role of surgery in patients with clinically node-positive bladder cancer or metastatic urothelial carcinoma, focusing on cytoreductive radical cystectomy (RC) and distant metastasectomy. Materials and Methods: A literature search was conducted on The Medical Literature Analysis and Retrieval System Online (Medline), Excerpta Medica dataBASE (Embase), preprints, and ClinicalTrials.gov for studies that discussed the role of surgery in patients with clinically node-positive bladder cancer or mUC, focusing on cytoreductive radical cystectomy (RC) and distant metastasectomy. The keywords used included transitional cell carcinoma, urothelial carcinoma, bladder cancer, bladder carcinoma, bladder metastasis, bladder tumor, lymph node metastasis, metastasis, and muscle-invasive bladder cancer. Results: The final analysis included 21 studies, including 17 retrospective reviews, 2 prospective phase II trials, and 2 meta-analyses. Of the studies that assessed patients with urothelial carcinoma (UC) with nodal involvement, 15 of 17 showed improved survival with chemotherapy followed by radical cystectomy (RC). To our knowledge, few studies have solely assessed surgery in patients with distant metastases. Most studies include patients with both UC with local LN involvement and patients with distant sites of metastasis. Of these studies, 12 of 13 indicated improved survival with metastasectomy. Conclusions: While it remains to be seen whether metastasectomy will have a role in patients with mUC, patient selection is an important factor when assessing the survival benefits. Patient characteristics correlated with improved survival include good performance status, good response to chemotherapy, and single site of metastasis. Further studies of mUC patients are required to clearly assess the survival impact of cytoreductive surgery. Full article

Background/Objectives: Radical cystectomy (RC) represents one of the most complex and morbid surgical procedures in the field of Urology. Extraperitoneal open RC has emerged as an alternative to the traditional transperitoneal approach for the treatment of muscle-invasive bladder cancer. Frailty is one of the most important risk factors for perioperative morbidity and mortality, and this category of patients can benefit the most from the extraperitoneal approach. The purpose of this study was to evaluate the feasibility and the safety of extraperitoneal open RC in our experience; Methods: We retrospectively collected the data of 75 frail patients who underwent an extraperitoneal open RC, performed by a single experienced surgeon. We assessed their frailty status using the simplified frailty index (sFI). We recorded data regarding general characteristics, intraoperative, pathological, and postoperative complications, and mortality (within 90 days); Results: We analyzed 61 males and 14 females with an sFI equal to or higher than 3. The median age was 77 years. Fifty-one patients had an ASA score of 3 or more. Sixty procedures were with radical intention, while fifteen were palliative. Cutaneous ureterostomy was performed in 70 cases and extraperitonized ileal conduit in five cases. The median operative time was 150 min. The median blood loss was 400 mL. The median time to flatus was 2 days. The median postoperative stay was 7 days. Thirteen patients had Clavien–Dindo III or IV complications. Two patients died in first 90 days postoperatively; Conclusions: The extraperitoneal open RC in frail patients was demonstrated to be a feasible and safe alternative approach in definitive treatment or a palliative setting in our experience. Full article

Background: The incidence of urinary tract infections (UTIs) after radical cystectomy (RC) with urinary diversion (UD), the typical pathogens, and associated patient risk factors have not been well documented. In this study, we examined the incidence of post-op UTIs after RC to identify associated risk factors. Methods: Single-center, retrospective case series of 386 patients with bladder cancer who underwent RC with UD between 2012 and 2024. The primary objective was UTI incidence, defined by the frequency of patients with urine culture with >10⁵ colony-forming units per high-powered field, spanning from post-op day 0 (POD0) to 90 days after discharge. Isolated pathogens were reported. Risk factors for UTIs were assessed. Results: The average age was 69 years old at surgery, and patients were predominantly male (80%). The cumulative incidence of post-op UTIs was 14%, among which 12 patients had more than one UTI. The UTI incidence was 2%, 8%, and 7% during the immediate post-op period, within 30 days, and within 31–90 days, respectively. Isolated pathogens included Escherichia coli (26%), Enterococcus faecalis (24%), Klebsiella pneumoniae (21%), and Pseudomonas species (21%). In the immediate post-op period, female sex was the only significant risk factor. At 31 to 90 days, cutaneous ureterostomy UD was the predominant risk factor for UTIs. For ileal conduit patients, those with a Wallace ureteral anastomosis were associated with UTI 31–90 days from discharge for RC. Conclusions: Our retrospective data suggests the incidence of UTIs and their causative pathogens after RC differ based on post-operative time points and vary according to different patient risk factors. Full article

Purpose: Bladder cancer (BC) is a heterogeneous disease with varying outcomes, influenced by disease heterogeneity and variability in treatment and follow-up. Risk groups have been established for non–muscle-invasive BC (NMIBC) to standardize therapy, and several quality control indicators (QCIs) monitor adherence to these risk group-based guidelines. However, controversial results had been obtained regarding the oncological benefits of these QCIs until recent high-quality studies from large registries showed their usefulness. To improve adherence to the European Association of Urology (EAU) Guidelines and benchmark current care in Flemish hospitals within Vlaams Ziekenhuisnetwerk–KU Leuven (VZNKUL), a QCI program for NMIBC was initiated in 2013. This study aims to describe the demographic, clinical, and treatment data of patients enrolled in this program. Participants: The VZNKUL–NMIBC Quality Indicators Program Registry is a prospective cohort including patients treated and followed up with at seven academic and non-academic Flemish hospitals since June 2013. Data collection includes patient characteristics, tumor data, treatment, and oncological outcomes. Findings to date: From June 2013 to December 2020, 4744 transurethral resections of bladder tumors (TURBTs) from 2237 unique patients were analyzed. Most patients (80%) were men with a median age of 73. The median time from diagnosis to TURBT was 19 days. A single tumor was detected in 37% of TURBTs. Tumors larger than 3 cm were found in 20.8% of cases. In 46% of TURBTs, a reTURBT was scheduled according to guidelines. The complication rates were 7.5% and 2.4% for bladder perforation and bleeding, respectively. Postoperative single intravesical instillation of chemotherapy (SIVIC) was administered to 56.9% of 1533 indicated patients with a median time to administration of 4.7 h. Among the cohort, 60.4% had NMIBC, and 9.3% had muscle-invasive BC. Of 972 high-risk patients, 60.7% received adequate BCG induction, while 39.4% received adequate maintenance. After BCG induction ± maintenance, 39.7% were tumor-free, with 17.7% recurrence and 4% progression to muscle-invasive BC. BCG treatment was terminated early for 17% of patients due to intolerance. Early cystectomy was performed for 2.4% of the BCG-naïve patients, and 27.7% of patients with BCG failure underwent a BCG rechallenge. For intermediate-risk patients, 2.1% received adequate BCG, and 23% received intravesical chemotherapy. The median follow-up was 57 months. Five-year recurrence-free, progression-free, cancer-free, overall, and cancer-specific survival rates were 53%, 91.6%, 89%, 70.6%, and 95.6%, respectively, for the NMIBC patients. Of 400 non-metastatic MIBC patients, 217 (54.3%) underwent radical cystectomy (RC), of whom 46% received neoadjuvant chemotherapy, while 18 (4.5%) refused RC, and 74 (18.5%) were considered unfit for the surgery. Future plans: The VZNKUL–NMIBC Quality Indicators Program Registry will continue collecting data to evaluate QCIs and monitor treatment quality, enabling hospitals to benchmark their performance and improve patient care. Additionally, the registry’s real-world data can support research and international collaboration. Trial registration: The study was registered on ClinicalTrials.gov (NCT04167332). Full article