Robert Geraghty , Amelia Pietropaolo , Lazaros Tzelves , Riccardo Lombardo , Helene Jung , Andreas Neisius , Ales Petrik , Bhaskar K. Somani , Niall F. Davis , Giovanni Gambaro , Romain Boissier , Andreas Skolarikos , Thomas Tailly
{"title":"Which Measure of Stone Burden is the Best Predictor of Interventional Outcomes in Urolithiasis: A Systematic Review and Meta-analysis by the YAU Urolithiasis Working Group and EAU Urolithiasis Guidelines Panel","authors":"Robert Geraghty , Amelia Pietropaolo , Lazaros Tzelves , Riccardo Lombardo , Helene Jung , Andreas Neisius , Ales Petrik , Bhaskar K. Somani , Niall F. Davis , Giovanni Gambaro , Romain Boissier , Andreas Skolarikos , Thomas Tailly","doi":"10.1016/j.euros.2024.10.024","DOIUrl":"10.1016/j.euros.2024.10.024","url":null,"abstract":"<div><h3>Background and objective</h3><div>Stone size has traditionally been measured in one dimension. This is reflected in most of the literature and in the EAU guidelines. However, recent studies have shown that multidimensional measures provide better prediction of outcomes.</div></div><div><h3>Methods</h3><div>We performed a systematic review and meta-analysis of the prognostic accuracy of measures of stone size (PROSPERO reference CRD42022346967). We considered all studies reporting prognostic accuracy statistics on any intervention for kidney stones (extracorporeal shockwave lithotripsy [ESWL], ureterorenoscopy [URS], or percutaneous nephrolithotomy [PCNL]; Population) using multiplane measurements of stone burden (area in mm<sup>2</sup> or volume in mm<sup>3</sup>; Intervention) in comparison to single-plane measurements of stone burden (size in mm; Intervention) for the study-defined stone-free rate (Outcome) in a PICO-framed question. We also assessed complication rates (overall and by Clavien-Dindo grade) and the operative time as secondary outcomes. Searches were made between 1970 and August 2023. We used the DeLong method to compare receiver operating characteristic (ROC) curves.</div></div><div><h3>Key findings and limitations</h3><div>Of 24 studies included in the review, 12 were eligible for comparative analysis with the DeLong test following meta-analysis of prognostic accuracy. For prediction of stone-free status, the area under the ROC curve (AUC) was significantly higher for stone volume than for stone size (0.71 vs 0.67; <em>p</em> < 0.001). Subanalyses confirmed this for ESWL and URS, but not for PCNL. For URS, the AUC was also significantly higher for stone area than for stone size (0.79 vs 0.77; <em>p</em> < 0.001). Throughout all analyses, there was no difference in AUC between stone area and stone volume. There was high risk of bias for all analyses apart from the URS subanalyses.</div></div><div><h3>Conclusions and clinical implications</h3><div>According to the limited data currently available, stone-free rates are predicted with significantly higher accuracy using multidimensional measures of stone burden in comparison to a single linear measurement.</div></div><div><h3>Patient summary</h3><div>We reviewed different ways of measuring the size of stones in the kidney or urinary tract and compared their accuracy in predicting stone-free rates after treatment. We found that measurement of the stone area (2 dimensions) or stone volume (3 dimensions) is better than stone diameter (1 dimension) in predicting stone-free status after treatment.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 22-30"},"PeriodicalIF":3.2,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giuseppe Salfi , Martino Pedrani , Selin Candan , Vasile Urechie , Sara Merler , Lorenzo Ruinelli , Amos Colombo , Luis Castelo-Branco , Irene Testi , Fabio Turco , Luigi Tortola , Ursula Vogl , Luca Gabutti , Silke Gillessen , Ricardo Pereira Mestre
{"title":"Treatment-related Hypertension as a Prognostic Factor for De Novo Metastatic Hormone-sensitive Prostate Cancer: A Retrospective Real-world Evidence Study","authors":"Giuseppe Salfi , Martino Pedrani , Selin Candan , Vasile Urechie , Sara Merler , Lorenzo Ruinelli , Amos Colombo , Luis Castelo-Branco , Irene Testi , Fabio Turco , Luigi Tortola , Ursula Vogl , Luca Gabutti , Silke Gillessen , Ricardo Pereira Mestre","doi":"10.1016/j.euros.2024.10.023","DOIUrl":"10.1016/j.euros.2024.10.023","url":null,"abstract":"<div><h3>Background and objective</h3><div>Hypertension (HTN) has been linked to an elevated risk of prostate cancer (PC) development and poorer prognosis in localized cases, and is a common side effect of hormonal PC treatments. However, its relationship with the prognosis of metastatic PC is still unclear. We assessed the prognostic role of treatment-related HTN in patients with de novo metastatic hormone-sensitive PC (mHSPC) undergoing androgen deprivation therapy (ADT) alone or in combination with docetaxel or androgen receptor pathway inhibitors (ARPIs).</div></div><div><h3>Methods</h3><div>Our retrospective analysis included 100 patients with de novo mHSPC treated with ADT, ADT + docetaxel, or ADT + ARPI between 2014 and 2021. Data on clinical variables, antihypertensive drugs, and blood pressure were collected from treatment initiation to 7 mo from ADT start. HTN development within 7 mo from hormonal treatment initiation was graded according to the Common Toxicity Criteria for Adverse Events version 5.0, and Cox analyses were performed for time to castration resistance (TTCR) and overall survival (OS).</div></div><div><h3>Key findings and limitations</h3><div>In the overall population, grade (G) 2–3 HTN development within 7 mo from hormonal treatment initiation was associated with improved TTCR and OS at both univariate (TTCR: 19.8 vs 7.9 mo, hazard ratio [HR]: 0.35, 95% confidence interval [CI]: 0.20–0.63, <em>p</em> < 0.001; OS: 42 vs 18.4 mo, HR: 0.48, 95% CI: 0.26–0.87, <em>p</em> = 0.017) and multivariate (TTCR: HR: 0.41, 95% CI: 0.18–0.91, <em>p</em> = 0.029; OS: HR: 0.42, 95% CI: 0.18–0.97, <em>p</em> = 0.042) analyses. A subgroup analysis of the ADT + ARPI–treated population revealed 7-mo treatment-related G2–3 HTN to be an independent positive prognostic factor in terms of both TTCR and OS multivariate survival analyses (HR: 0.30, 95% CI: 0.09–0.95, <em>p</em> = 0.040, and HR: 0.12, 95% CI: 0.02–0.57, <em>p</em> = 0.008, respectively).</div></div><div><h3>Conclusions and clinical implications</h3><div>The early development or worsening of HTN under hormonal treatment may be associated with longer TTCR and OS in de novo mHSPC patients. Larger studies are needed to validate these findings and explore the potential underlying mechanisms.</div></div><div><h3>Patient summary</h3><div>In this report, we examined the outcomes of patients with metastatic hormone-sensitive prostate cancer and their correlation with hypertension toxicities. We found that patients who developed clinically significant blood pressure toxicity early in oncological treatment experienced longer survival.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 1-10"},"PeriodicalIF":3.2,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jacob Schmidt , Jorien Krediet , Holger Beutel , Ayoub Hidayat Allah , Nella Gagel , Isabel Lichy , Bernhard Ralla , Maha Ullmann , Robert Peters , Frank Friedersdorff , Martin Kanne
{"title":"Comparison of Perioperative Outcomes of Holmium Laser Enucleation of the Prostate for Standard (≤149 ml) Versus Very Large (≥150 ml) Prostate Glands: Retrospective Analysis of a Propensity Score Matched Cohort of 326 Patients","authors":"Jacob Schmidt , Jorien Krediet , Holger Beutel , Ayoub Hidayat Allah , Nella Gagel , Isabel Lichy , Bernhard Ralla , Maha Ullmann , Robert Peters , Frank Friedersdorff , Martin Kanne","doi":"10.1016/j.euros.2024.10.019","DOIUrl":"10.1016/j.euros.2024.10.019","url":null,"abstract":"<div><h3>Background and objective</h3><div>Our objective was to evaluate whether a very large prostate volume significantly affects the incidence of perioperative complications and compromises outcomes among patients undergoing holmium laser enucleation of the prostate (HoLEP).</div></div><div><h3>Methods</h3><div>We retrospectively analyzed data for 1815 adult patients who underwent HoLEP at Evangelisches Krankenhaus Königin Elisabeth Herzberge, Berlin, between January 2019 and May 2024. Patients were divided into two groups according to their prostate volume: ≤149 ml (group A) and ≥150 ml (group B). Propensity score matching on age, body mass index, American Society of Anesthesiologists physical status, and the presence of an indwelling catheter was used to balance baseline differences. A Mann-Whitney <em>U</em> test was used for comparison of continuous variables between the groups, and a χ<sup>2</sup> test for comparison of categorical variables, with <em>p</em> < 0.05 considered statistically significant. Postoperative complications were assessed according to the Clavien-Dindo classification.</div></div><div><h3>Key findings and limitations</h3><div>After propensity score matching, 163 matched cases per group were analyzed. Group B had significantly longer median total operative time (76 vs 47 min; <em>p</em> < 0.001), enucleation time (42 vs 26 min; <em>p</em> < 0.001), coagulation time (11 vs 6 min; <em>p</em> < 0.001), and morcellation time (15 vs 7 min; <em>p</em> < 0.001). Clavien-Dindo grade ≥IIIb complications (8.7% vs 1.2%; <em>p</em> = 0.02) and blood transfusion (2.5% vs 0%; <em>p</em> = 0.045) were significantly more frequent in group B. Catheterization time (1.9 vs 2.0 d; <em>p</em> = 0.01) and the proportion of patients with postoperative residual urine volume ≤50 ml (85.2% vs 80.2%; <em>p</em> = 0.18) were comparable between the groups. Limitations include the retrospective and single-center study design.</div></div><div><h3>Conclusions and clinical implications</h3><div>Prostate volume ≥150 ml is associated with a longer operative time, a higher rate of major complications, and a more frequent need for blood transfusion. Therefore, HoLEP for prostate glands ≥150 ml should be performed in experienced high-volume centers.</div></div><div><h3>Patient summary</h3><div>We compared outcomes of laser surgery for enlarged prostate glands of different sizes. We found that while the surgery is generally effective for very large prostates, it takes longer and has a higher risk of complications in comparison to more typical prostate sizes. However, this procedure is still the best treatment available for prostate enlargement and should be carried out in high-volume hospitals specializing in this treatment.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 15-21"},"PeriodicalIF":3.2,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sebastiaan Remmers , Ivo I. de Vos , Frederique B. Denijs , Renée C.A. Leenen , Tycho M.T.W. Lock , Arjen Noordzij , Wim J. Kirkels , Chris H. Bangma , Monique J. Roobol , ERSPC Rotterdam Study Group
{"title":"Assessing the Cause of Death for Men with Prostate Cancer Using Official Mortality Statistics or a Dedicated Cause of Death Committee: Results from 30-year ERSPC Rotterdam Data","authors":"Sebastiaan Remmers , Ivo I. de Vos , Frederique B. Denijs , Renée C.A. Leenen , Tycho M.T.W. Lock , Arjen Noordzij , Wim J. Kirkels , Chris H. Bangma , Monique J. Roobol , ERSPC Rotterdam Study Group","doi":"10.1016/j.euros.2024.10.021","DOIUrl":"10.1016/j.euros.2024.10.021","url":null,"abstract":"<div><div>For men with prostate cancer (PCa) within the European Randomized Study of Screening for Prostate Cancer (ERSPC), the cause of death is determined by a Cause of Death Committee (CODC) that evaluates all medical records using a fixed algorithm. The aim of this study was to compare the classification of PCa-specific mortality (PCSM) between the CODC and Statistics Netherlands. We calculated the sensitivity (PCSM agreement divided by total PCSM deaths according to the CODC) and specificity (agreement for other-cause mortality [OCM] divided by total OCM deaths according to the CODC) using the last 21-yr follow-up data from ERSPC Rotterdam. For the core age group (age 55–69 yr at randomization; <em>n</em> = 1732), the sensitivity was 86% (95% CI 83-89) and specificity was 93% (95% CI 91-94), with no statistical difference between the youngest ages and the oldest ages. Extrapolation of our findings to 30 yr of follow-up would result in an expected risk reduction of PCSM of 30% using data from the CODC and 33% using official statistics in favor of screening. In conclusion, our results support the use of official statistics in determining the cause of death, without compromising the main outcome of ERSPC Rotterdam.</div></div><div><h3>Patient summary</h3><div>We compared the classification of prostate cancer death between a dedicated trial committee and official statistics in the Netherlands. We found that official statistics are an accurate representation in determining the cause of death.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 11-14"},"PeriodicalIF":3.2,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142656245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ek Leone Oh , Wade Huish , Sara El-Gamil , Tim Benson , Thomas Ferguson
{"title":"Assessment of Patient and Clinician Perspectives on Clinically Meaningful Extension of Progression-free Survival in Prostate Cancer","authors":"Ek Leone Oh , Wade Huish , Sara El-Gamil , Tim Benson , Thomas Ferguson","doi":"10.1016/j.euros.2024.10.018","DOIUrl":"10.1016/j.euros.2024.10.018","url":null,"abstract":"<div><h3>Background and objective</h3><div>It is widely accepted that the value of treatments for incurable metastatic cancer depends on their ability to improve overall survival (OS), quality of life (QoL), or both. Progression-free survival (PFS) is frequently used as a primary endpoint because of challenges in accurately assessing OS and QoL. The perceived value of extending PFS when there is uncertainty regarding the benefit to OS/QoL may vary between clinicians and patients. The aim of our study was to measure patient and clinician perspectives on what defines a clinically meaningful PFS benefit.</div></div><div><h3>Methods</h3><div>We conducted an observational study using a self-administered questionnaire. Participants included patients with advanced prostate cancer (PC) and medical oncology clinicians treating patients with PC. The questionnaire presented a hypothetical scenario of metastatic castrate-resistant PC (mCRPC). Participants were asked about their willingness to undergo or prescribe treatment offering PFS benefits despite uncertain OS outcomes. Participants specified the minimum extension of PFS (ePFS<sub>min</sub>) beyond the estimated 18-mo duration outlined in the scenario while considering varying toxicity levels.</div></div><div><h3>Key findings and limitations</h3><div>Between April and May 2024, 54 patient responses and 27 clinician responses were received. Some 50/54 patient participants (92.6%) and 22/27 clinician participants (81.5%) expressed willingness to accept a prospective treatment associated with longer PFS but uncertain OS benefit. For treatment with no or mild toxicity, the median ePFS<sub>min</sub> for treatment acceptance was >12 mo for patient participants and 3–6 mo for clinician participants. For treatment with severe toxicity, 40.7% of patients and 51.9% of clinicians would not accept treatment; the ePFS<sub>min</sub> for treatment acceptance was 3–6 mo for patient participants and >12 mo for clinician participants.</div></div><div><h3>Conclusions and clinical implications</h3><div>Most patients and clinicians are open to mCRPC treatment with evidence of PFS benefits despite OS uncertainty. Patients needed longer PFS extension to justify treatment but were more accepting of side effects and placed greater importance on a prostate-specific antigen or radiological response than clinicians. The relationship between ePFS<sub>min</sub> and treatment acceptance according to toxicity levels for patients was unclear, limited by the nature of the self-administered questionnaires.</div></div><div><h3>Patient summary</h3><div>We surveyed patients and doctors about their views on an imaginary treatment for advanced prostate cancer that could delay disease progression but with no certainty about whether it would extend life expectancy. Both patients and doctors were open to this treatment, but patients expected a longer delay in disease progression than doctors before being willing to accept this imaginary tr","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"70 ","pages":"Pages 175-182"},"PeriodicalIF":3.2,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142656742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vasileios Sakalis , Yagnaseni Bhattacharya , Katharina Beyer , Charlotte Murray , Emma Jane Smith , Peter-Paul M. Willemse , Giorgio Gandaglia , Romain Boissier , Angelika Borkowetz , Saeed Dabestani , Renee C.A. Leenen , Antoni Vilaseca , Gianluca Maresca , Jeremy Teoh , Juan Gómez Rivas , Pawel Rajwa , Michael Lardas , Nikolas Grivas , Thomas Van den Broeck , Benjamin Pradere , Muhammad Imran Omar
{"title":"AGREE II Quality Assessment of National and International Clinical Practice Guidelines on Prostate Cancer Management by the OPTIMA Consortium","authors":"Vasileios Sakalis , Yagnaseni Bhattacharya , Katharina Beyer , Charlotte Murray , Emma Jane Smith , Peter-Paul M. Willemse , Giorgio Gandaglia , Romain Boissier , Angelika Borkowetz , Saeed Dabestani , Renee C.A. Leenen , Antoni Vilaseca , Gianluca Maresca , Jeremy Teoh , Juan Gómez Rivas , Pawel Rajwa , Michael Lardas , Nikolas Grivas , Thomas Van den Broeck , Benjamin Pradere , Muhammad Imran Omar","doi":"10.1016/j.euros.2024.10.020","DOIUrl":"10.1016/j.euros.2024.10.020","url":null,"abstract":"<div><h3>Background and objective</h3><div> <!-->Clinical practice guidelines for prostate cancer (PCa) are a valuable resource for everyday clinical practice. The clinical practice guidelines and recommendations produced by various societies should demonstrate a considerable level of consistency in terms of quality, regardless of the society that developed these given the common evidence base. However, to date, no study has assessed the quality of PCa clinical practice guidelines. As part of the Optimal Treatment for Patients with Solid Tumours in Europe Through Artificial intelligence (OPTIMA) project, we evaluated the quality of the most frequently used national and international clinical practice guidelines for PCa using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) tool.</div></div><div><h3>Methods</h3><div>The quality of the identified clinical practice guidelines was assessed independently by two assessors using the AGREE II tool. The AGREE II tool comprises 23 different items organised into six domains, rated on a 7-point scale (1: strongly disagree to 7: strongly agree). The total score of the appraisal was the mean value of the two assessments. The agreement between assessors’ scores was calculated using the interclass correlation coefficient (ICC). Four key recommendations were compared among the included clinical practice guidelines to assess consistency.</div></div><div><h3>Key findings and limitations</h3><div>Sixteen clinical practice guidelines were assessed using their latest available version (cut-off April 2024). The European Association of Urology, S3LL PCa, Belgian Health Care Knowledge Centre, National Comprehensive Cancer Network, and Prostatacancer—Nationellt vårdprogram guidelines received the highest overall scores with a mean domain score of 82.4% (range: 75.5–88.3%). The de<!--> <!-->l’Association Française d’Urologie (AFU), American Urological Association, and National Institute for Health and Care Excellence received a mean domain score of 77.6% (range: 73.7–84.0%). Below average were the European Society for Medical Oncology, localised (L) and systemic (S) CPPC American Society of Clinical Oncology, and Nederlandse Vereniging voor Urologie (NVU) with a mean domain score of 58.4% (range: 43.5–76.3%). The reasons for scoring below average included the following: inadequate information about the methodology applied, limited scope of the guideline, and limited patient engagement. The highest inter-rater variability was observed in NVU (ICC: 0.58) and the lowest in AFU-L (ICC: 0.84). When examining the scores of each domain, “clarity of presentation” (domain 4) achieved the highest score with a mean of 86.9% ± 12.6%. The domain with the lowest score was applicability (domain 5), with a mean of 48.3% ± 24.8%. The ICC was calculated to be 0.72 (±0.08).</div></div><div><h3>Conclusions and clinical implications</h3><div>This is the first study in which a comprehensive quality assessment of the major","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"70 ","pages":"Pages 183-193"},"PeriodicalIF":3.2,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142651319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Re: Emilio Arbelaez, Iris Zünti, Sarah Tschudin-Sutter, et al. Catheter-associated Urinary Tract Infections—Online Questionnaire: Status Quo in Central European Urological Management of Catheter-associated Urinary Tract Infection. Eur Urol Open Sci 2024;69:63–70","authors":"Amnuay Kleebayoon , Viroj Wiwanitkit","doi":"10.1016/j.euros.2024.10.017","DOIUrl":"10.1016/j.euros.2024.10.017","url":null,"abstract":"","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"70 ","pages":"Page 174"},"PeriodicalIF":3.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142656804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Wei Zhu , Chu Ann Chai , Jinxiang Ma , Mehmet İlker Gökce , Nariman Gadzhiev , Jaisukh Kalathia , Kehua Jiang , Xianzhong Duan , Jianwei Cao , Rongpei Wu , Rijin Song , Song Bai , Xuedong Li , Shusheng Liu , Guohua Zeng
{"title":"Flexible Ureteroscopy with a Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2–3-cm Renal Stones: Study Protocol for an International, Multicenter, Randomized, Parallel-group, Noninferiority Trial","authors":"Wei Zhu , Chu Ann Chai , Jinxiang Ma , Mehmet İlker Gökce , Nariman Gadzhiev , Jaisukh Kalathia , Kehua Jiang , Xianzhong Duan , Jianwei Cao , Rongpei Wu , Rijin Song , Song Bai , Xuedong Li , Shusheng Liu , Guohua Zeng","doi":"10.1016/j.euros.2024.10.014","DOIUrl":"10.1016/j.euros.2024.10.014","url":null,"abstract":"<div><div>Guidelines recommend percutaneous nephrolithotomy (PCNL) for larger renal stones, but advances in flexible ureteroscopy (f-URS) with a tip-bendable suction ureteral access sheath (S-UAS) have prompted further investigation. Our multicenter, international, randomized controlled trial is investigating whether f-URS with S-UAS is noninferior to mini-PCNL (mPCNL) for renal stones of 2–3 cm. The primary objective is the immediate stone-free rate (SFR). Secondary outcomes include the 3-mo SFR, complication rates, surgical time, hospital stay, auxiliary procedures, and improvements in quality of life. A total of 720 patients from 12 urological centers will be randomized to either f-URS with S-UAS or PCNL. Statistical analyses will include intention-to-treat and per-protocol approaches, with specific methods for normally and non-normally distributed data. Subgroup analyses will focus on stone location and lithotripter types. The significance threshold will be set at <em>p</em> < 0.05. The aim of this trial is to generate high-level evidence regarding the noninferiority of f-URS with S-UAS compared to mPCNL for medium-sized renal stones.</div><div>The trial is registered on ClinicalTrials.gov as NCT06526390.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"70 ","pages":"Pages 167-173"},"PeriodicalIF":3.2,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142578240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Diagnostic Performance of GeneXpert BC as a Triage Test for Patients Presenting with Macroscopic Hematuria Suspicious for Urinary Bladder Cancer: A Multicenter Prospective Case-Control Study","authors":"Suleiman Abuhasanein , Jonatan Radmann , Staffan Jahnson , Henrik Kjölhede","doi":"10.1016/j.euros.2024.10.016","DOIUrl":"10.1016/j.euros.2024.10.016","url":null,"abstract":"<div><h3>Background and objective</h3><div>Our objective was to assess whether GeneXpert BC can be used as a triage test to exclude urinary bladder cancer (UBC) for patients with macroscopic hematuria.</div></div><div><h3>Methods</h3><div>We conducted a prospective study that include consecutive patients being evaluated for macroscopic hematuria between September 2020 and December 2022. Before cystoscopy, study participants provided a voided urine sample for GeneXpert BC analysis according to a case-control design with an emphasis on UBC detection. Descriptive statistics are reported for patient and tumor characteristics. To assess the diagnostic accuracy of the GeneXpert BC test, the sensitivity, specificity, and negative predictive value (NPV) were calculated, using the histopathologically proven UBC as the ground truth.</div></div><div><h3>Key findings and limitations</h3><div>In total, 1505 subjects presenting with macroscopic hematuria were enrolled in the study. After randomization and exclusions, GeneXpert BC testing was carried out for 312 participants. Of these, 151 patients from the case arm had UBC, 122 patients from the control arm (random 10%) were negative for UBC, and 39 patients from the case arm did not have malignancy. Using a predefined linear discriminant analysis (LDA) threshold of ≥0.22, the test had sensitivity of 0.94 (95% confidence interval [CI] 0.90–0.97), specificity of 0.52 (95% CI 0.42–0.59), and NPV of 0.99 (95% CI 0.98–0.99). All false-negative tumors were of low grade (Ta grade 1–2). Cystoscopy and computed tomography urography could have been omitted in 44% of the patients with macroscopic hematuria. At a secondary LDA threshold of ≥0.45, the test had sensitivity of 0.79 (95% CI 0.73–0.86), specificity of 0.83 (95% CI 0.76–0.89), and NPV of 0.97 (95% CI 0.96–0.98).</div></div><div><h3>Conclusions and clinical implications</h3><div>GeneXpert BC is a reliable triage test for deciding on whether further investigations are necessary in patients with macroscopic hematuria.</div></div><div><h3>Patient summary</h3><div>We assessed a test called GeneXpert BC for the detection of bladder cancer in patients with blood in their urine. GeneXpert BC performed well in ruling out bladder cancer for patients who did not have cancer according to further tests. Use of GeneXpert BC could help in avoiding scans and invasive tests for patients with a negative result.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"70 ","pages":"Pages 158-166"},"PeriodicalIF":3.2,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142571738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}