European urology focus最新文献

Background and objective: The widespread adoption and rapid integration of new technologies and techniques in endoscopic and laser bladder interventions, particularly endoscopic enucleation, have led to new types of bladder injuries. This underscores the need for an intraoperative injury classification system. This study aims to develop and validate the Bladder Injury Classification System for Endoscopic Procedures (BICEP), which standardizes the classification of complications and intervention requirements.

Methods: This mixed-methods study involved experts from the European Association of Urology Section of Urotechnology to standardize and validate the BICEP classification system. An iterative process involving focus groups, expert surveys, and revisions assessed clarity, relevance, comprehensiveness, and practicality. Validity was confirmed through expert surveys conducted in two rounds for face and content validity, using a 5-point Likert scale to correlate ratings with expected outcomes.

Key findings and limitations: The novel BICEP classification system categorizes bladder injuries into ten subcategories with scores ranging from 0 to 4, reflecting injury severity and management requirements. Face validity was demonstrated by a 95% consensus on the system's clarity, relevance, and comprehensiveness. Content validity was supported by high acceptance rates in expert surveys, with average scores of 4.53 and 4.58 in the first and second rounds, respectively. This demonstrates strong support for its applicability in clinical practice. However, the primary limitation is the lack of external validation.

Conclusions and clinical implications: Our study demonstrates that the BICEP system is a robust and comprehensive classification system, with strong support for its face and content validity. The BICEP system is a proposal based on expert opinion, and additional studies are necessary to ensure its widespread adoption and efficacy.

Patient summary: Our study addressed the critical need for standardized classification in the increasingly widespread context of urology endoscopic technologies by focusing on intraoperative evaluation, reporting, and standardization of bladder injuries. This study provides a globally standardized basis for the classification and treatment of bladder injuries in urology endoscopic procedures.

Background and objective: Prostate biopsy, conducted frequently through the transrectal route, is associated with significant risks of infectious complications. This study aimed to compare the efficacy of various strategies to reduce these complications, using a network meta-analysis approach.

Methods: Our study included randomized controlled trials (RCTs) identified from PubMed/MEDLINE, Embase, and the Cochrane database as of March 1, 2024. We included studies that involved adults undergoing transrectal or transperineal prostate biopsy with either standard empirical antibiotic prophylaxis or alternative interventions. The primary outcomes were assessment of sepsis, fever, urinary tract infections (UTIs), and readmissions. The study was registered with PROSPERO (CRD42024532225).

Key findings and limitations: Our search yielded 28 RCTs eligible for analysis, encompassing a total of 10 179 participants. Rectal cleansing had the highest rankogram score to reduce infectious complications such as sepsis (odds ratio 0.40, 95% confidence interval [0.28-0.58]; rankogram, p score = 0.917), followed by transperineal biopsy (p score = 0.496). The overall analysis also highlighted a lower incidence of UTIs and readmissions with this method. Heterogeneity among studies was minimal (I² < 50% for all outcomes).

Conclusions and clinical implications: Rectal cleansing might be the most effective strategy to reduce infectious complications following transrectal prostate biopsy and could be more effective than rectal culture-based antibiotic prophylaxis and transperineal biopsy. Given the indirect nature of our comparisons, further RCTs are needed to determine the safest approach for prostate biopsy, particularly between transperineal biopsy and transrectal biopsy with rectal cleansing or rectal culture-based antibiotic prophylaxis.

Patient summary: In this review, we analyzed different techniques to reduce infectious complications after a prostate biopsy. We found that rectal cleansing prior to performing a transrectal prostate biopsy reduced infectious complications and might be the most effective strategy. We conclude that either transperineal or transrectal prostate biopsies are acceptable approaches, albeit with rectal cleansing or rectal culture-based antibiotic prophylaxis, respectively.

Urinary tract infection (UTI) is among the most common human bacterial infections. In the context of increasing antibiotic resistance, there are many research efforts to improve the pathophysiological understanding, diagnosis, and treatment of UTI. Despite the high clinical relevance of UTI, there is high variability in definitions in the literature, making interpretation and comparison of research studies difficult, and even impossible in some cases. A recent Delphi consensus study generated a new reference standard definition for UTI that incorporates symptoms, pyuria, and urine culture results. This definition allows for designation of systemic involvement, and no longer categorizes UTIs as complicated or uncomplicated. The definition aligns with guidance from regulatory bodies for approval of UTI drugs. Implementation of a reference standard definition in the design and reporting of future investigations will allow better research design and interpretability within and outside the urology field. The new reference standard resolves some issues and offers a suitable way to unify methodology, and hence increase the potential strength of research in this area. There are some limitations and challenges for implementation, such as difficulties in establishing sensitivity and specificity values for the various settings in which the definition will be used. The inclusion of "probable" and "possible" UTI categories could be a problem in studies that require dichotomous outcomes. Nonetheless, the reference standard should be recommended until new developments become available, notably a more specific UTI biomarker than pyuria. Approaches to standardized diagnosis of catheter-associated UTIs remain unresolved. PATIENT SUMMARY: A new research definition for urinary tract infection (UTI) has been developed. Use of a single standardized definition in research will help in better design of research studies and comparison of results. Although the new definition will help in reducing the variability in UTI research reports, it has some limitations and there may be challenges to overcome before it is widely used.

Background and objective: Belzutifan, a hypoxia-inducible factor 2 alpha inhibitor, was approved initially for patients with von Hippel-Lindau disease and more recently for sporadic, metastatic clear cell renal cell carcinoma (ccRCC) based on the results of LITESPARK-005. There is a paucity of data regarding real-world experience with belzutifan in patients with sporadic, metastatic ccRCC. This study aims to describe clinical outcomes with belzutifan in patients with sporadic, metastatic ccRCC.

Methods: A retrospective study of 22 patients who received belzutifan at MD Anderson Cancer Center prior to the Food and Drug Administration approval was conducted. Progression-free survival (PFS) and objective response rate (ORR) were assessed by a blinded radiologist using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. PFS and overall survival (OS) were measured from belzutifan initiation.

Key findings and limitations: The median follow-up time was 14.9 mo. Most patients had International Metastatic RCC Database Consortium intermediate-risk disease, more than three metastatic sites, and a median of five prior lines of treatment at initiation of belzutifan; all patients received prior immune checkpoint therapy (ICT) and vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs). The median PFS was 8.51 mo (95% confidence interval [CI] 0-18.4) and ORR was 36.4%. The median OS was 14.72 mo (95% CI 7.34-22.10). Of 22 patients, four (18.2%) patients required dose reductions and three (13.6%) patients discontinued belzutifan because of adverse drug events (ADEs). The most common ADEs were anemia (77.3%; 17/22) and hypoxia (36.4%; 8/22). There were no treatment-related deaths.

Conclusions and clinical implications: In a heavily pretreated cohort of patients with sporadic, metastatic ccRCC, belzutifan had meaningful clinical activity and was well tolerated. These real-world results add to the results of LITESPARK-005 and support the use of belzutifan after progression on ICT and VEGFR-TKIs.

Patient summary: Belzutifan is a new medicine used to treat a type of clear cell kidney cancer that has spread to other parts of the body (metastasized). A study at MD Anderson Cancer Center followed 22 patients who were treated with belzutifan, and found that it worked to control the cancer for almost 9 mo and caused the cancer to shrink in 36% of patients. This study confirms that belzutifan can be effective and safe, even after other treatments have not worked.

Background and objective: It is unclear whether cytoreductive nephrectomy (CN) practices have changed in the USA after the publication of the Cancer du Rein Métastatique Nephrectomie et Antiangiogéniques (CARMENA) trial in 2018. Our primary objective is to determine the effect of the CARMENA trial on CN rates in the USA.

Methods: Patients were identified in the National Cancer Database from 2004 to 2020. A quasiexperimental difference-in-differences analysis was used to test the primary outcome, as follows: the change in CN rate was assessed among metastatic clear cell renal cell carcinoma (ccRCC) patients diagnosed before versus after 2018, while using the localized nephrectomy (LN) rate performed in the setting of nonmetastatic ccRCC as a control group.

Key findings and limitations: The difference-in-differences analysis identified a statistically significant decrease in CN rate after CARMENA (β-coefficient [standard error]: -0.06 [0.025], p = 0.028), with a 10.2% absolute and a 31.8% relative rate reduction when compared with the counterfactual (expected) value (34.7% → 21.9% [actual] vs 32.1% [expected]). Primarily, relative differences in CN and LN rates before and after 2018 may be attributable to additional factors, aside from CARMENA publication, not tested in this quasiexperimental model.

Conclusions and clinical implications: CN rates decreased significantly after the publication of the CARMENA trial in 2018, with a minimal difference in regional or demographic practice patterns. Overall, the publication of the CARMENA trial results is seemingly associated with substantial alteration of clinical practice in the USA, with relatively broad and nonspecific adoption across facilities, regions, and demographics.

Patient summary: For decades, the immediate surgical removal of the kidney tumor (cytoreductive nephrectomy) was a mainstay of metastatic kidney cancer treatment. In 2018, the CARMENA study showed that patients treated with systemic therapy alone had similar outcomes to patients who underwent cytoreductive nephrectomy first. In this study, we show that fewer cytoreductive nephrectomies were performed after the CARMENA trial results were published.

Background and objective: Sequential intravesical gemcitabine/docetaxel (Gem/Doce) has emerged as a potential alternative to bacillus Calmette-Guérin (BCG) for the treatment of non-muscle-invasive bladder cancer (NMIBC). Our aim was to determine the comparative effectiveness of BCG and Gem/Doce for patients with intermediate-risk (IR) NMIBC, composed mainly of high-grade (HG) Ta disease.

Methods: Patients with IR-NMIBC who received either BCG or Gem/Doce during 2013-2023 were included. Maintenance BCG (as per the Southwest Oncology Group protocol) and monthly Gem/Doce maintenance for 1 yr were offered to patients with no evidence of recurrence after induction. Routine surveillance with cystoscopy was performed according to the American Urological Association guidelines. The Kaplan-Meier method was used to assess high-grade and any-grade recurrence-free survival (RFS). Cox regression analysis was performed to find predictors of recurrence.

Key findings and limitations: Of 483 patients, 127 had IR-NMIBC; 66 patients received BCG and 61 received Gem/Doce. Median age was 69 yr (interquartile range [IQR] 61-76) for the BCG group and 72 yr (IQR 62-76) for the Gem/Doce group. Median follow-up was 53.1 mo (IQR 25.3-71.2) for the BCG group and 20.2 mo (IQR 8.28-33.1) for the Gem/Doce group. The 2-yr high-grade RFS rates for primary high-grade tumors for BCG versus Gem/Doce groups were 81% versus 61%, with corresponding any-grade RFS rates of 60% versus 41%. Induction with Gem/Doce predicted any-grade recurrence (hazard ratio [HR] 1.87, 95% confidence interval [CI] 1.1-3.2) and high-grade recurrence for primary high-grade tumors (HR 3.4 95% CI 1.27-9.13), while receipt of maintenance therapy decreased the risk of any-grade recurrence (HR 0.4, 95% CI 0.22-0.72). This study is limited by its retrospective design.

Conclusions and clinical implications: For patients with IR-NMIBC, BCG was associated with superior any-grade RFS and high-grade RFS for primary high-grade tumors. Maintenance therapy was associated with better RFS when receiving Gem/Doce. Standardization and longer maintenance therapy protocols should be considered for Gem/Doce treatment.

Patient summary: We compared outcomes for patients who received two different in-bladder treatments for intermediate-risk bladder cancer. Bacillus Calmette-Guérin (BCG) led to better outcomes than gemcitabine + docetaxel (Gem/Doce). Monthly maintenance therapy improved recurrence-free survival for patients who received Gem/Doce. We conclude that maintenance therapy is essential for patients receiving Gem/Doce to avoid bladder cancer recurrence after treatment.

Background and objective: Understanding the learning curve for the da Vinci single-port (SP) surgical robot is crucial for adoption, training, and enhancement of surgical safety and efficiency. Our aim was to assess the impact of both overall experience (O-EXP) and procedure-specific experience (PS-EXP) on perioperative outcomes across various SP surgeries.

Methods: We analyzed data for 387 consecutive SP surgeries conducted by a high-volume surgeon from December 2018 to July 2023. These included SP robot-assisted radical prostatectomy (SP-RARP), robot-assisted simple prostatectomy (SP-RASP), and robot-assisted nephrectomy (SP-RANP). We used multivariable logistic regression to evaluate the relationship between surgeon experience and outcomes, and locally weighted scatterplot smoothing analysis to graphically explore the risk of postoperative complications according to O-EXP.

Key findings and limitations: The 387 SP procedures assessed included 172 (44%) SP-RARP, 53 (14%) SP-RASP, and 162 (42%) SP-RANP cases. Overall, 17% of patients had a complication of any grade, 6% experienced severe complications (Clavien-Dindo grade ≥3), and 8% required readmission. Both O-EXP and PS-EXP were associated with a lower risk of complications. The odds ratios for the incidence of complications per increment of 10 procedures were 0.83 (95% confidence interval [CI] 0.76-0.89) for PS-EXP and 0.93 (95% CI 0.90-0.96) for O-EXP. PS-EXP was also associated with a shorter operative time (β = -3.9, 95% CI -4.9 to -2.9). The risk of complications reached a minimum at 30 SP-RASP, 70 SP-RANP, and 150 SP-RARP cases. Our study is limited by its retrospective design, single-surgeon experience, and lack of functional outcome assessment.

Conclusions and clinical implications: Robot-assisted surgery with the da Vinci SP robot has a distinctive learning curve that is influenced by the platform and procedure-specific characteristics. For surgeons new to SP surgery, RASP and renal procedures had the earliest learning curve success and should be approached first, with RARP attempted only when the surgeon has become accustomed to the SP platform.

Patient summary: We investigated the learning curve for a surgical robot that uses just one keyhole incision. We found that the time to reach proficiency for urological surgeries with this specific robot, measured as the rate of complications, is faster for some procedures than for more complex operations. This information can help in improving surgeon training and patient safety.