共查询到20条相似文献，搜索用时 31 毫秒
1.
Masaki Yoshida Masayuki Takeda Momokazu Gotoh Shinji Nagai Takafumi Kurose 《European urology》2018,73(5):783-790
Background
Vibegron is a novel, potent, and selective β3-adrenoreceptor agonist for the treatment of patients with overactive bladder (OAB).Objective
To evaluate the efficacy and safety of vibegron versus placebo in Japanese OAB patients.Design, setting, and participants
Patients with OAB entered a 2-wk placebo run-in phase. Once eligibility (≥8 micturition/d and either ≥1 urgency episodes/d or ≥1 urgency incontinence episodes/d) was confirmed, patients entered a 12-wk double-blind treatment phase. The anticholinergic imidafenacin was used as an active reference.Intervention
A total of 1232 patients were randomly assigned to one of the four 12-wk treatment groups: vibegron (50 mg or 100 mg once daily), placebo, or imidafenacin (0.1 mg twice daily).Outcome measurements and statistical analysis
The primary endpoint was change in the mean number of micturitions/d at wk 12 from baseline. The secondary endpoints were changes from baselines in OAB symptom variables (daily episodes of urgency, urgency incontinence, incontinence, and nocturia, and voided volume/micturition). Quality of life (QoL) and safety were assessed. A constrained longitudinal data analysis model was used for analysis of efficacy.Results and limitations
Patients taking vibegron 50 mg and 100 mg orally for 12 wk had significant improvements over the placebo in the primary and secondary endpoints. The proportions of patients with normalization of micturition, resolution of urgency, urgency incontinence, and incontinence were significantly greater than placebo. Vibegron significantly improved QoL, with high patient satisfaction. Incidences of drug-related adverse events with vibegron 50 mg and 100 mg were 7.6%, 5.4%, similar to placebo (5.1%), and less than imidafenacin (10.3%). Treatment was for just 12 wk and a long-term study is needed.Conclusions
The 12-wk treatment with vibegron is effective and well tolerated in patients with OAB.Patient summary
This randomized study demonstrated that vibegron is clinically useful for treatment of patients with OAB.Trial registration ?JapicCTI-152936. http://www.clinicaltrials.jp/user/cteDetail.jsp. 相似文献2.
Olivier Wegelin Leonie Exterkate Marloes van der Leest Jean A. Kummer Willem Vreuls Peter C. de Bruin J.L.H.Ruud Bosch Jelle O. Barentsz Diederik M. Somford Harm H.E. van Melick 《European urology》2019,75(4):582-590
Background
Guidelines advise multiparametric magnetic resonance imaging (mpMRI) before repeat biopsy in patients with negative systematic biopsy (SB) and a suspicion of prostate cancer (PCa), enabling MRI targeted biopsy (TB). No consensus exists regarding which of the three available techniques of TB should be preferred.Objective
To compare detection rates of overall PCa and clinically significant PCa (csPCa) for the three MRI-based TB techniques.Design, setting, and participants
Multicenter randomised controlled trial, including 665 men with prior negative SB and a persistent suspicion of PCa, conducted between 2014 and 2017 in two nonacademic teaching hospitals and an academic hospital.Intervention
All patients underwent 3-T mpMRI evaluated with Prostate Imaging Reporting and Data System (PIRADS) version 2. If imaging demonstrated PIRADS ≥3 lesions, patients were randomised 1:1:1 for one TB technique: MRI-transrectal ultrasound (TRUS) fusion TB (FUS-TB), cognitive registration TRUS TB (COG-TB), or in-bore MRI TB (MRI-TB).Outcome measurements and statistical analysis
Primary (overall PCa detection) and secondary (csPCa detection [Gleason score ≥3 + 4]) outcomes were compared using Pearson chi-square test.Results and limitations
On mpMRI, 234/665 (35%) patients had PIRADS ≥3 lesions and underwent TB. There were no significant differences in the detection rates of overall PCa (FUS-TB 49%, COG-TB 44%, MRI-TB 55%, p = 0.4). PCa detection rate differences were ?5% between FUS-TB and MRI-TB (p = 0.5, 95% confidence interval [CI] ?21% to 11%), 6% between FUS-TB and COG-TB (p = 0.5, 95% CI ?10% to 21%), and ?11% between COG-TB and MRI-TB (p = 0.17, 95% CI ?26% to 5%). There were no significant differences in the detection rates of csPCa (FUS-TB 34%, COG-TB 33%, MRI-TB 33%, p > 0.9). Differences in csPCa detection rates were 2% between FUS-TB and MRI-TB (p = 0.8, 95% CI ?13% to 16%), 1% between FUS-TB and COG-TB (p > 0.9, 95% CI ?14% to 16%), and 1% between COG-TB and MRI-TB (p > 0.9, 95% CI ?14% to 16%). The main study limitation was a low rate of PIRADS ≥3 lesions on mpMRI, causing underpowering for primary outcome.Conclusions
We found no significant differences in the detection rates of (cs)PCa among the three MRI-based TB techniques.Patient summary
In this study, we compared the detection rates of (aggressive) prostate cancer among men with prior negative biopsies and a persistent suspicion of cancer using three different techniques of targeted biopsy based on magnetic resonance imaging. We found no significant differences in the detection rates of (aggressive) prostate cancer among the three techniques. 相似文献3.
Vincenzo Ficarra Gianluca Giannarini Alessandro Crestani Vito Palumbo Marta Rossanese Claudio Valotto Antonino Inferrera Vito Pansadoro 《European urology》2019,75(2):294-299
Background
Ureteroileal anastomotic stricture (UAS) after ileal conduit diversion occurs in a non-negligible proportion of patients undergoing radical cystectomy (RC). Surgical techniques aimed at preventing this potential complication are sought.Objective
To describe our surgical technique of retrosigmoid ileal conduit, and to assess perioperative outcomes and postoperative complications with a focus on UAS rate.Design, setting, and participants
A prospective single-centre, single-surgeon cohort of 67 consecutive patients undergoing open RC with ileal conduit urinary diversion between July 2013 and April 2017 was analysed. A study group of 30 patients receiving retrosigmoid ileal conduit was compared with a control group of 37 patients receiving standard Wallace ileal conduit.Surgical procedure
Retrosigmoid versus Wallace ileal conduit diversion after open RC.Measurements
Operative room (OR) time, estimated blood loss (EBL), transfusion rate, and 90-d postoperative complications were recorded and compared between the two groups. In particular, rate of UAS, defined as upper collecting system dilatation requiring endourological or surgical management, was assessed and compared.Results and limitations
The two groups were comparable with regard to all demographic, clinical, and pathological variables. No differences were observed in terms of OR time (p = 0.35), EBL (p = 0.12), and transfusion rate (p = 0.81). Ninety-day postoperative complications were observed in 11 (36.7%) patients who underwent a retrosigmoid ileal conduit and 20 (54.1%) patients who received a traditional ileal conduit (p = 0.32). Major complications (grade 3–4) were observed in three (10%) cases in the former group and in 12 (32.4%) cases in the latter group (p = 0.08). Mean (standard deviation) follow-up time was 10.8 ± 4.0 mo in the study group and 27.5 ± 9.5 mo in the control group (p < 0.001). No single case of UAS was observed in the study group, whereas six (16.2%) cases of UAS occurred in the control group (p = 0.02). The main limitation is a nonrandomised comparison of a relatively small cohort with short-term follow-up.Conclusions
In our study, we observed a significantly reduced rate of UAS and no increase in postoperative complications with the retrosigmoid ileal conduit diversion compared with standard Wallace ileal conduit diversion after open RC.Patient summary
We describe our surgical technique of retrosigmoid ileal conduit as urinary diversion after open radical cystectomy. Compared with traditional techniques, our technique for ileal conduit was found to be safe and reduce the risk of ureteric strictures. 相似文献4.
Farrukh Aslam Khalid Muhammad Younas Mehrose Muhammad Saleem Muhammad Amin Yousaf Abdul Malik Mujahid Saif Ur Rehman Sania Ahmad Moazzam Nazeer Tarar 《Burns : journal of the International Society for Burn Injuries》2019,45(1):69-75
The treatment of keloid and hypertrophic scar is challenging with no universally accepted mode for permanent ablation. Conventional therapies yield unpredictable results, significant complications and require elaborate hardware.
Objective
The objective was to establish the safety and efficacy of intralesional 5-fluorouracil (5-FU) for the treatment of keloids and hypertrophic scars.Study design
Randomized controlled trial (RCT).Place and duration
It was conducted at the Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Lahore, Pakistan from May 2012 to March 2013.Subjects and methods
We included 120 patients divided in two groups. The group A patients received intralesional triamcinolone acetonide (TAC) and the group B patients received both 5-FU and TAC. 8 injections at a week interval were given and patients were evaluated at the start of treatment and then at 4th and at 8th week during the treatment and then 4 weeks after the end of treatment. Patents were assessed for mean reduction in scar height, efficacy and complications.Results
Total of 108 patients completed the study. The mean reduction in the scar height in group B (5-FU + TAC) 1.144 + .4717 was markedly better than that of group A (TAC alone) 1.894 + 1.0751 (t = 4.781, p = .000). The efficacy (defined previously as >50% reduction in initial scar height) was superior in group B 44 (77.2%) than that of group A 25 (49.0% (X2 = 9.260, p = .002). Recurrence was seen in 39.2% (20) of patients of the group A while in only 17.5% (10) of the cases of group B (P = 0.012). Mean follow up was of 22 months.Conclusion
5-FU + TAC is safe, easy to administer and effective treatment for problematic scars and has the lower rate of recurrence on larger follow up. 相似文献5.
Sami Hamid Ian A. Donaldson Yipeng Hu Rachael Rodell Barbara Villarini Ester Bonmati Pamela Tranter Shonit Punwani Harbir S. Sidhu Sarah Willis Jan van der Meulen David Hawkes Neil McCartan Ingrid Potyka Norman R. Williams Chris Brew-Graves Alex Freeman Caroline M. Moore Hashim U. Ahmed 《European urology》2019,75(5):733-740
Background
Multiparametric magnetic resonance imaging (mpMRI)-targeted prostate biopsies can improve detection of clinically significant prostate cancer and decrease the overdetection of insignificant cancers. It is unknown whether visual-registration targeting is sufficient or augmentation with image-fusion software is needed.Objective
To assess concordance between the two methods.Design, setting, and participants
We conducted a blinded, within-person randomised, paired validating clinical trial. From 2014 to 2016, 141 men who had undergone a prior (positive or negative) transrectal ultrasound biopsy and had a discrete lesion on mpMRI (score 3–5) requiring targeted transperineal biopsy were enrolled at a UK academic hospital; 129 underwent both biopsy strategies and completed the study.Intervention
The order of performing biopsies using visual registration and a computer-assisted MRI/ultrasound image-fusion system (SmartTarget) on each patient was randomised. The equipment was reset between biopsy strategies to mitigate incorporation bias.Outcome measurements and statistical analysis
The proportion of clinically significant prostate cancer (primary outcome: Gleason pattern ≥3 + 4 = 7, maximum cancer core length ≥4 mm; secondary outcome: Gleason pattern ≥4 + 3 = 7, maximum cancer core length ≥6 mm) detected by each method was compared using McNemar's test of paired proportions.Results and limitations
The two strategies combined detected 93 clinically significant prostate cancers (72% of the cohort). Each strategy detected 80/93 (86%) of these cancers; each strategy identified 13 cases missed by the other. Three patients experienced adverse events related to biopsy (urinary retention, urinary tract infection, nausea, and vomiting). No difference in urinary symptoms, erectile function, or quality of life between baseline and follow-up (median 10.5 wk) was observed. The key limitations were lack of parallel-group randomisation and a limit on the number of targeted cores.Conclusions
Visual-registration and image-fusion targeting strategies combined had the highest detection rate for clinically significant cancers. Targeted prostate biopsy should be performed using both strategies together.Patient summary
We compared two prostate cancer biopsy strategies: visual registration and image fusion. A combination of the two strategies found the most clinically important cancers and should be used together whenever targeted biopsy is being performed. 相似文献6.
H. Ballentine Carter Brian Helfand Mufaddal Mamawala Yishuo Wu Patricia Landis Hongjie Yu Kathleen Wiley Rong Na Zhuqing Shi Jacqueline Petkewicz Sameep Shah Richard J. Fantus Kristian Novakovic Charles B. Brendler S. Lilly Zheng William B. Isaacs Jianfeng Xu 《European urology》2019,75(5):743-749
Background
Mutations in DNA repair genes are associated with aggressive prostate cancer (PCa).Objective
To assess whether germline mutations are associated with grade reclassification (GR) in patients undergoing active surveillance (AS).Design, setting, and participants
Two independent cohorts of PCa patients undergoing AS; 882 and 329 patients from Johns Hopkins and North Shore, respectively.Outcome measurements and statistical analysis
Germline DNA was sequenced for DNA repair genes, including BRCA1/2 and ATM (three-gene panel). Pathogenicity of mutations was defined according to the American College of Medical Genetics guidelines. Association of mutation carrier status and GR was evaluated by a competing risk analysis.Results and limitations
Of 1211, 289 patients experienced GR; 11 of 26 with mutations in a three-gene panel and 278 of 1185 noncarriers; adjusted hazard ratio (HR) = 1.96 (95% confidence interval [CI] = 1.004–3.84, p = 0.04). Reclassification occurred in six of 11 carriers of BRCA2 mutations and 283 of 1200 noncarriers; adjusted HR = 2.74 (95% CI = 1.26–5.96, p = 0.01). The carrier rates of pathogenic mutations in the three-gene panel, and BRCA2 alone, were significantly higher in those reclassified (3.8% and 2.1%, respectively) than in those not reclassified (1.6% and 0.5%, respectively; p = 0.04 and 0.03, respectively). Carrier rates for BRCA2 were greater for those reclassified from Gleason score (GS) 3 + 3 at diagnosis to GS ≥4 + 3 (4.1% vs 0.7%, p = 0.01) versus GS 3 + 4 (2.1% vs 0.6%; p = 0.03). Results are limited by the small number of mutation carriers and an intermediate end point.Conclusions
Mutation status of BRCA1/2 and ATM is associated with GR among men undergoing AS.Patient summary
Men on active surveillance with inherited mutations in BRCA1/2 and ATM are more likely to harbor aggressive prostate cancer. 相似文献7.
Markos Karavitakis Iason Kyriazis Muhammad Imran Omar Stavros Gravas Jean-Nicolas Cornu Marcus J. Drake Mauro Gacci Christian Gratzke Thomas R.W. Herrmann Stephan Madersbacher Malte Rieken Mark J. Speakman Kari A.O. Tikkinen Yuhong Yuan Charalampos Mamoulakis 《European urology》2019,75(5):788-798
Context
Practice patterns for the management of urinary retention (UR) secondary to benign prostatic obstruction (BPO; UR/BPO) vary widely and remain unstandardized.Objective
To review the evidence for managing patients with UR/BPO with pharmacological and nonpharmacological treatments included in the European Association of Urology guidelines on non-neurogenic male lower urinary tract symptoms.Evidence acquisition
Search was conducted up to April 22, 2018, using CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform. This systematic review included randomized controlled trials (RCTs) and prospective comparative studies. Methods as detailed in the Cochrane handbook were followed. Certainty of evidence (CoE) was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.Evidence synthesis
Literature search identified 2074 citations. Twenty-one studies were included (qualitative synthesis). The evidence for managing patients with UR/BPO with pharmacological or nonpharmacological treatments is limited. CoE for most outcomes was low/very low. Only α1-blockers (alfuzosin and tamsulosin) have been evaluated in more than one RCT. Pooled results indicated that α1-blockers provided significantly higher rates of successful trial without catheter compared with placebo [alfuzosin: 322/540 (60%) vs 156/400 (39%) (odds ratio {OR} 2.28, 95% confidence interval {CI} 1.55 to 3.36; participants = 940; studies = 7; I2 = 41%; low CoE); tamsulosin: 75/158 (47%) vs 40/139 (29%) (OR 2.40, 95% CI 1.29 to 4.45; participants = 297; studies = 3; I2 = 30%; low CoE)] with rare adverse events. Similar rates were achieved with tamsulosin or alfuzosin [51/87 (59%) vs 45/84 (54%) (OR 1.28, 95% CI 0.68 to 2.41; participants = 171; studies = 2; I2 = 0%; very low CoE)]. Nonpharmacological treatments have been evaluated in RCTs/prospective comparative studies only sporadically.Conclusions
There is some evidence that usage of α1-blockers (alfuzosin and tamsulosin) may improve resolution of UR/BPO. As most nonpharmacological treatments have not been evaluated in patients with UR/BPO, the evidence is inconclusive about their benefits and harms.Patient summary
There is some evidence that alfuzosin and tamsulosin may increase the rates of successful trial without catheter, but little or no evidence on various nonpharmacological treatment options for managing patients with urinary retention secondary to benign prostatic obstruction. 相似文献8.
Qiang Fu Le Xu Yiwei Wang Qi Jiang Zheng Liu Junyu Zhang Quan Zhou Han Zeng Shanyou Tong Tao Wang Yangyang Qi Baoying Hu Hangcheng Fu Huyang Xie Lin Zhou Yuan Chang Yu Zhu Bo Dai Jiejie Xu 《European urology》2019,75(5):752-763
Background
Glutamine addiction is a hallmark of clear cell renal cell carcinoma (ccRCC); yet whether glutamine metabolism impacts local immune surveillance is unclear. This knowledge may yield novel immunotherapeutic opportunities.Objective
To seek a potential therapeutic target in glutamine-addicted ccRCC.Design, setting, and participants
Tumors from ccRCC patients from a Shanghai cohort and ccRCC tumor data from The Cancer Genome Atlas (TCGA) cohort were analyzed. In vivo and in vitro studies were conducted with fresh human ccRCC tumors and murine tumor cells.Outcome measurements and statistical analysis
Immune cell numbers and functions were analyzed by flow cytometry. Glutamine and cytokine concentrations were determined. Survival was compared between different subpopulations of patients using Kaplan-Meier and Cox regression analyses.Results and limitations
We found that in ccRCC, high interleukin (IL)-23 expression was significantly associated with poor survival in both TCGA (overall survival [OS] hazard ratio [HR] = 2.04, cancer-specific survival [CSS] HR = 2.95; all p < 0.001) and Shanghai (OS HR = 2.07, CSS HR = 3.92; all p < 0.001) cohorts. IL-23 blockade prolongs the survival of tumor-bearing mice, promotes T-cell cytotoxicity in in vitro cultures of human ccRCC tumors, and augments the therapeutic benefits of anti-PD-1 antibodies. Mechanistically, glutamine consumption by ccRCC tumor cells results in the local deprivation of extracellular glutamine, which induces IL-23 secretion by tumor-infiltrating macrophages via the activation of hypoxia-inducible factor 1α (HIF1α). IL-23 activates regulatory T-cell proliferation and promotes IL-10 and transforming growth factor β expression, thereby suppressing tumor cell killing by cytotoxic lymphocytes. The positive correlations between glutamine metabolism, IL-23 levels, and Treg responses are confirmed in both TCGA cohort and tumors from Shanghai ccRCC patients. Study limitations include the unclear impacts of glutamine deprivation and IL-23 on other immune cells.Conclusions
Macrophage-secreted IL-23 enhanced Treg functions in glutamine-addicted tumors; thus, IL-23 is a promising target for immunotherapy in ccRCC.Patient summary
In this study, we analyzed the immune components in glutamine-addicted clear cell renal cell carcinoma (ccRCC) tumors from two patient cohorts and conducted both in vitro and in vivo studies. We found that ccRCC tumor cell-intrinsic glutamine metabolism orchestrates immune evasion via interleukin (IL)-23, and IL-23–high patients had significantly poorer survival than IL-23–low patients. IL-23 should thus be considered a therapeutic target in ccRCC, either alone or in combination with immune checkpoint inhibitors. 相似文献9.
John D. Kelly Wei Shen Tan Nuria Porta Hugh Mostafid Robert Huddart Andrew Protheroe Richard Bogle Jane Blazeby Alison Palmer Jo Cresswell Mark Johnson Richard Brough Sanjeev Madaan Stephen Andrews Clare Cruickshank Stephanie Burnett Lauren Maynard Emma Hall 《European urology》2019,75(4):593-601
Background
Non–muscle-invasive bladder cancer (NMIBC) has a significant risk of recurrence despite adjuvant intravesical therapy.Objective
To determine whether celecoxib, a cyclo-oxygenase 2 inhibitor, reduces the risk of recurrence in NMIBC patients receiving standard treatment.Design, setting, and participants
BOXIT (CRUK/07/004, ISRCTN84681538) is a double-blinded, phase III, randomised controlled trial. Patients aged ≥18 yr with intermediate- or high-risk NMIBC were accrued across 51 UK centres between 1 November 2007 and 23 July 2012.Intervention
Patients were randomised (1:1) to celecoxib 200 mg twice daily or placebo for 2 yr. Patients with intermediate-risk NMIBC were recommended to receive six weekly mitomycin C instillations; high-risk NMIBC cases received six weekly bacillus Calmette-Guérin and maintenance therapy.Outcome measurements and statistical analysis
The primary endpoint was time to disease recurrence. Analysis was by intention to treat.Results and limitations
A total of 472 patients were randomised (236:236). With median follow-up of 44 mo (interquartile range: 36–57), 3-yr recurrence-free rate (95% confidence interval) was as follows: celecoxib 68% (61–74%) versus placebo 64% (57–70%; hazard ratio [HR] 0.82 [0.60–1.12], p = 0.2). There was no difference in high-risk (HR 0.77 [0.52–1.15], p = 0.2) or intermediate-risk (HR 0.90 [0.55–1.48], p = 0.7) NMIBC. Subgroup analysis suggested that time to recurrence was longer in pT1 NMIBC patients treated with celecoxib compared with those receiving placebo (HR 0.53 [0.30–0.94], interaction test p = 0.04). The 3-yr progression rates in high-risk patients were low: 10% (6.5–17%) and 9.7% (6.0–15%) in celecoxib and placebo arms, respectively. Incidence of serious cardiovascular events was higher in celecoxib (5.2%) than in placebo (1.7%) group (difference +3.4% [–0.3% to 7.2%], p = 0.07).Conclusions
BOXIT did not show that celecoxib reduces the risk of recurrence in intermediate- or high-risk NMIBC, although celecoxib was associated with delayed time to recurrence in pT1 NMIBC patients. The increased risk of cardiovascular events does not support the use of celecoxib.Patient summary
Celecoxib was not shown to reduce the risk of recurrence in intermediate- or high-risk non–muscle-invasive bladder cancer (NMIBC), although celecoxib was associated with delayed time to recurrence in pT1 NMIBC patients. The increased risk of cardiovascular events does not support the use of celecoxib. 相似文献10.
Wei Shen Tan Anesh Panchal Laura Buckley Adam J. Devall Laurence S. Loubière Ann M. Pope Mark R. Feneley Jo Cresswell Rami Issa Hugh Mostafid Sanjeev Madaan Rupesh Bhatt John McGrath Vijay Sangar T.R. Leyshon Griffiths Toby Page Dominic Hodgson Shibendra N. Datta John D. Kelly 《European urology》2019,75(1):63-71
Background
There is no effective intravesical second-line therapy for non–muscle-invasive bladder cancer (NMIBC) when bacillus Calmette-Guérin (BCG) fails.Objective
To compare disease-free survival time (DFS) between radiofrequency-induced thermo-chemotherapy effect (RITE) and institutional standard second-line therapy (control) in NMIBC patients with recurrence following induction/maintenance BCG.Design, settings, and participants
Open-label, phase III randomised controlled trial accrued across 14 centres between May 2010 and July 2013 (HYMN [ClinicalTrials.gov: NCT01094964]).Intervention
Patients were randomly assigned (1:1) to RITE (60 min, 40 mg mitomycin-C, 42 ± 2 °C) or control following stratification for carcinoma in situ (CIS) status (present/absent), therapy history (failure of previous induction/maintenance BCG), and treatment centre.Outcome measurements and statistical analysis
Primary outcome measures were DFS and complete response (CR) at 3 mo for the CIS at randomisation subgroup. Analysis was based on intention-to-treat.Results and limitations
A total of 104 patients were randomised (48 RITE: 56 control). Median follow-up for the 31 patients without a DFS event was 36 mo. There was no significant difference in DFS between treatment arms (hazard ratio [HR] 1.33, 95% confidence interval [CI] 0.84–2.10, p = 0.23) or in 3-mo CR rate in CIS patients (n = 71; RITE: 30% vs control: 47%, p = 0.15). There was no significant difference in DFS between treatment arms in non-CIS patients (n = 33; RITE: 53% vs control: 24% at 24 mo, HR 0.50, 95% CI 0.22–1.17, p = 0.11). DFS was significantly lower in RITE than in control in CIS with/without papillary patients (n = 71; HR 2.06, 95% CI 1.17–3.62, p = 0.01; treatment-subgroup interaction p = 0.007). Disease progression was observed in four patients in each treatment arm. Adverse events and health-related quality of life between treatment arms were comparable.Conclusions
DFS was similar between RITE and control. RITE may be a second-line therapy for non-CIS recurrence following BCG failure; however, confirmatory trials are needed. RITE patients with CIS with/without papillary had lower DFS than control. HYMN highlights the importance of the control arm when evaluating novel therapies.Patient summary
This study did not show a difference in bladder cancer outcomes between microwave-heated chemotherapy and standard of care treatment. Papillary bladder lesions may benefit from microwave-heated chemotherapy treatment; however, more research is needed. Both treatments are similarly well tolerated. 相似文献11.
A. David D. Le Touze K. Warin-Fresse P. Paul-Gilloteaux F. Bonnefoy J. Idier S. Moussaoui P. Guerin J.-M. Serfaty 《Diagnostic and interventional imaging》2019,100(1):17-23
Purpose
The purpose of this study was to assess the precision of four-dimensional (4D) phase-contrast magnetic resonance imaging (PCMRI) to measure mean flow and peak velocity (Vmax) in a pulsatile flow phantom and to test its sensitivity to spatial resolution and Venc.Material and methods
The pulsatile flow phantom consisted of a straight tube connected to the systemic circulation of an experimental mock circulatory system. Four-dimensional-PCMR images were acquired using different spatial resolutions (minimum pixel size: 1.5 × 1.5 × 1.5 mm3) and velocity encoding sensitivities (up to three times Vmax). Mean flow and Vmax calculated from 4D-PCMRI were compared respectively to the reference phantom flow parameters and to Vmax obtained from two-dimensional (2D)-PCMRI.Results
4D-PCI measured mean flow with a precision of ?0.04% to + 5.46%, but slightly underestimated Vmax when compared to 2D-PCMRI (differences ranging from ?1.71% to ?3.85%). 4D PCMRI mean flow measurement was influenced by spatial resolution (P < 0.001) with better results obtained with smaller voxel size. There was no effect of Venc on mean flow measurement. Regarding Vmax, neither spatial resolution nor Venc did influence the precision of the measurement.Conclusion
Using an experimental pulsatile flow model 4D-PCMRI is accurate to measure mean flow and Vmax with better results obtained with higher spatial resolution. We also show that Venc up to 3 times higher than Vmax may be used with no effect on these measurements. 相似文献12.
Jacob A. Burns Adam B. Weiner William J. Catalona Eric V. Li Edward M. Schaeffer Stephen B. Hanauer Scott Strong James Burns Maha H.A. Hussain Shilajit D. Kundu 《European urology》2019,75(5):846-852
Background
There are limited data examining the risk of prostate cancer (PCa) in patients with inflammatory bowel disease (IBD).Objective
To compare the incidence of PCa between men with and those without IBD.Design, setting, and participants
This was a retrospective, matched-cohort study involving a single academic medical center and conducted from 1996 to 2017. Male patients with IBD (cases = 1033) were randomly matched 1:9 by age and race to men without IBD (controls = 9306). All patients had undergone at least one prostate-specific antigen (PSA) screening test.Outcome measurements and statistical analysis
Kaplan-Meier and multivariable Cox proportional hazard models, stratified by age and race, evaluated the relationship between IBD and the incidence of any PCa and clinically significant PCa (Gleason grade group ≥2). A mixed-effect regression model assessed the association of IBD with PSA level.Results and limitations
PCa incidence at 10 yr was 4.4% among men with IBD and 0.65% among controls (hazard ratio [HR] 4.84 [3.34–7.02] [3.19–6.69], p < 0.001). Clinically significant PCa incidence at 10 yr was 2.4% for men with IBD and 0.42% for controls (HR 4.04 [2.52–6.48], p < 0.001). After approximately age 60, PSA values were higher among patients with IBD (fixed-effect interaction of age and patient group: p = 0.004). Results are limited by the retrospective nature of the analysis and lack of external validity.Conclusions
Men with IBD had higher rates of clinically significant PCa when compared with age- and race-matched controls.Patient summary
This study of over 10 000 men treated at a large medical center suggests that men with inflammatory bowel disease may be at a higher risk of prostate cancer than the general population. 相似文献13.
Daniel J. Canter Julia Reid Maria Latsis Margaret Variano Shams Halat Saradha Rajamani Kristen E. Gurtner Zaina Sangale Michael Brawer Steven Stone Stephen Bardot 《European urology》2019,75(3):515-522
Background
Better prostate cancer risk stratification is necessary to inform medical management, especially for African American (AA) men, for whom outcomes are particularly uncertain.Objective
To evaluate the utility of both a cell cycle progression (CCP) score and a clinical cell-cycle risk (CCR) score to predict clinical outcomes in a large cohort of men with prostate cancer highly enriched in an AA patient population.Design, setting, and participants
Patients were diagnosed with clinically localized adenocarcinoma of the prostate and treated at The Ochsner Clinic (New Orleans, LA, USA) from January 2006 to December 2011. CCP scores were derived from archival formalin-fixed, paraffin-embedded biopsy tissue. CCR scores were calculated as the combination of molecular (CCP score) and clinical (Cancer of the Prostate Risk Assessment [CAPRA] score) components.Intervention
Active treatment (radical prostatectomy, radiation therapy alone, or radiation and hormone therapy) or watchful waiting.Outcome measurements and statistical analysis
The primary outcome was progression to metastatic disease. Association with outcomes was evaluated via Cox proportional hazards survival analysis and likelihood ratio tests.Results and limitations
The final cohort included 767 men, of whom 281 (36.6%) were AA. After accounting for ancestry, treatment, and CAPRA in multivariable analysis, the CCP score remained a significant predictor of metastatic disease (hazard ratio [HR] 2.04; p < 0.001), and there was no interaction with ancestry (p = 0.20) or treatment (p = 0.09). The CCR score was highly prognostic (HR 3.86; p < 0.001), and as with the CCP score, there was no interaction with ancestry (p = 0.24) or treatment (p = 0.32). Limitations include the retrospective study design and the use of self-reported ancestry information.Conclusions
A CCR score provided significant prognostic information regardless of ancestry. The findings demonstrate that AA men in this study cohort appear to have similar prostate cancer outcomes to non-AA patients after accounting for all available molecular and clinicopathologic variables.Patient summary
In this study we evaluated the ability of a combined molecular and clinical score to predict the progression of localized prostate cancer. We found that the combined molecular and clinical score predicted progression to metastasis regardless of patient ancestry or treatment. This suggests that the combined molecular and clinical score may be a valuable tool for determining the risk of metastasis in men with newly diagnosed prostate cancer in order to make appropriate treatment decisions. 相似文献14.
Aly-Khan A. Lalani Bradley A. McGregor Laurence Albiges Toni K. Choueiri Robert Motzer Thomas Powles Christopher Wood Axel Bex 《European urology》2019,75(1):100-110
Context
Systemic therapy for metastatic clear cell renal cell carcinoma (mccRCC) has greatly evolved over the last 15 yr. More recently, combination strategies involving contemporary immunotherapy have emerged as key opportunities to further shift the treatment landscape.Objective
To review the evidence regarding the efficacy and safety of standard therapeutic options in mccRCC as well as combination immunotherapy options on the horizon.Evidence acquisition
PubMed/Medline, Embase, Web of Knowledge, and Cochrane Library databases were searched up to February 2018 and according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. A narrative review of studies was performed.Evidence synthesis
Twenty-six studies were included regarding therapies for metastatic RCC including vascular endothelial growth factor (VEGF)-directed therapy (n = 9), mTOR inhibitors (n = 2), cytokines (n = 3), vaccines (n = 3), and immune checkpoint inhibitors (ICIs, n = 9). VEGF tyrosine kinase inhibitor monotherapy had been the standard therapy, and its use is evolving in the front-line setting with ICIs; cabozantinib provides superior progression-free survival versus sunitinib in intermediate- and poor-risk patients, by International Metastatic RCC Database Consortium criteria. The mTOR therapy is largely inferior to VEGF-directed therapy, although it has a role in combination strategies. Cytokines have largely been replaced in current practice throughout most regions, and vaccines have failed to show improved survival in phase III studies to date. ICIs have now become standard care in untreated patients with intermediate and poor risks, given overall survival benefit seen with CheckMate-214 study; survival data from IMmotion 151 are not yet mature. Several ongoing phase III combination trials, with promising early-phase data, are due to be read out.Conclusions
The treatment landscape for mccRCC has evolved since the introduction of VEGF inhibitors. Combination therapies involving checkpoint inhibitors could be the next standard of care.Patient summary
With the expanding role of immune checkpoint inhibitors in metastatic renal cell carcinoma, the treatment paradigm has shifted to include combination therapy in the untreated setting. As the field advances, the bar has been raised in evaluating ongoing combination strategies. 相似文献15.
16.
Jürgen E. Gschwend Matthias M. Heck Jan Lehmann Herbert Rübben Peter Albers Johannes M. Wolff Detlef Frohneberg Patrick de Geeter Axel Heidenreich Tilman Kälble Michael Stöckle Thomas Schnöller Arnulf Stenzl Markus Müller Michael Truss Stephan Roth Uwe-Bernd Liehr Joachim Leißner Margitta Retz 《European urology》2019,75(4):604-611
Background
The extent of lymph node dissection (LND) in bladder cancer (BCa) patients at the time of radical cystectomy may affect oncologic outcome.Objective
To evaluate whether extended versus limited LND prolongs recurrence-free survival (RFS).Design, setting, and participants
Prospective, multicenter, phase-III trial patients with locally resectable T1G3 or muscle-invasive urothelial BCa (T2-T4aM0).Intervention
Randomization to limited (obturator, and internal and external iliac nodes) versus extended LND (in addition, deep obturator, common iliac, presacral, paracaval, interaortocaval, and para-aortal nodes up to the inferior mesenteric artery).Outcome measurements and statistical analysis
The primary endpoint was RFS. Secondary endpoints included cancer-specific survival (CSS), overall survival (OS), and complications. The trial was designed to show 15% advantage of 5-yr RFS by extended LND.Results and limitations
In total, 401 patients were randomized from February 2006 to August 2010 (203 limited, 198 extended). The median number of dissected nodes was 19 in the limited and 31 in the extended arm. Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR] = 0.84 [95% confidence interval 0.58–1.22]; p = 0.36), CSS (5-yr CSS 76% vs 65%; HR = 0.70; p = 0.10), and OS (5-yr OS 59% vs 50%; HR = 0.78; p = 0.12). Clavien grade ≥3 lymphoceles were more frequently reported in the extended LND group within 90 d after surgery. Inclusion of T1G3 tumors may have contributed to the negative study result.Conclusions
Extended LND failed to show a significant advantage over limited LND in RFS, CSS, and OS. A larger trial is required to determine whether extended compared with limited LND leads to a small, but clinically relevant, survival difference (ClinicalTrials.gov NCT01215071).Patient summary
In this study, we investigated the outcome in bladder cancer patients undergoing cystectomy based on the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce the rate of tumor recurrence in the expected range. 相似文献17.
Ibukunoluwa B. Araoye Yvonne E. Chodaba Kenneth S. Smith Ryan W. Hadden Ashish B. Shah 《Foot and Ankle Surgery》2019,25(1):2-7
Background
Current literature on carbon fiber implant use in foot and ankle surgery is scant. The purpose of this paper is to report medium-term outcomes of hindfoot fusion using a carbon fiber intramedullary nail.Methods
We retrospectively reviewed 30 cases of hindfoot fusion using carbon fiber intramedullary nail fixation between 2014 and 2017. We excluded revisions and cases with bulk allograft or ankle infection prior to surgery. We reviewed charts for length of followup, radiographic union, and complications.Results
Eleven patients were included (6 females, 5 males; mean age = 52 ± 15 years; mean BMI = 29.0 ± 6.4 kg/m2). Mean followup was 20 (range, 1.5–107) months. Nine of eleven cases achieved radiographic union while one case developed a complication requiring surgery. The mean time to union was 3 (range, 1.5–6) months.Conclusions
Carbon fiber implants offer several theoretical advantages over traditional metallic implants. They can be used safely in foot and ankle surgery without concern for high failure or complication rate. Larger scale studies with longer followup are needed on this topic. 相似文献18.
Liselotte M.S. Boevé Maarten C.C.M. Hulshof André N. Vis Aeilko H. Zwinderman Jos W.R. Twisk Wim P.J. Witjes Karl P.J. Delaere R. Jeroen A. van Moorselaar Paul C.M.S. Verhagen George van Andel 《European urology》2019,75(3):410-418
Background
The cornerstone of standard treatment for patients with primary bone metastatic prostate cancer (mPCa) is androgen deprivation therapy (ADT). Retrospective studies suggest a survival benefit for treatment of the primary prostatic tumour in mPCa, but to date, no randomised-controlled-trials (RCTs) have been published addressing this issue.Objective
To determine whether overall survival is prolonged by adding local treatment of the primary prostatic tumour with external beam radiation therapy (EBRT) to ADT.Design, setting, and participants
The HORRAD trial is a multicentre RCT recruiting 432 patients with prostate-specific antigen (PSA) >20 ng/ml and primary bone mPCa on bone scan between 2004 and 2014.Intervention
Patients were randomised to either ADT with EBRT (radiotherapy group) or ADT alone (control group).Outcome measurements and statistical analysis
Primary endpoint was overall survival. Secondary endpoint was time to PSA progression. Crude and adjusted analyses were applied to evaluate treatment effect.Results and limitations
Median PSA level was 142 ng/ml and 67% of patients had more than five osseous metastases. Median follow up was 47 mo. Median overall survival was 45 mo (95% confidence interval [CI], 40.4–49.6) in the radiotherapy group and 43 mo (95% CI: 32.6–53.4) in the control group (p = 0.4). No significant difference was found in overall survival (hazard ratio [HR]: 0.90; 95% CI: 0.70–1.14; p = 0.4). Median time to PSA progression in the radiotherapy group was 15 mo (95% CI: 11.8–18.2), compared with 12 mo (95% CI: 10.6–13.4) in the control group. The crude HR (0.78; 95% CI: 0.63–0.97) was statistically significant (p = 0.02).Conclusions
The current RCT comparing ADT to ADT with EBRT to the prostate in patients with primary bone mPCa did not show a significant difference in overall survival, although the CI cannot exclude a substantial survival benefit. Further research is needed to confirm our findings.Patient summary
This study investigated the effect of adding radiation therapy to the prostate to hormonal therapy in prostate cancer patients with metastasis to the bone at diagnosis. In our patient group, additional radiotherapy did not improve overall survival. Further research is needed to confirm our findings.Twitter summary
Adding radiotherapy to the prostate in patients with bone metastatic prostate cancer does not improve overall survival. 相似文献19.
Paolo Capogrosso Emily A. Vertosick Nicole E. Benfante James A. Eastham Peter J. Scardino Andrew J. Vickers John P. Mulhall 《European urology》2019,75(2):221-228
Background
The last decade has seen several advances in radical prostatectomy (RP) technique and post-RP care that are relevant to erectile function (EF) recovery.Objective
We examined whether these practice changes have led to observed improvements in EF rates over time.Design, setting, and participants
We identified 2364 patients treated with either open or minimally-invasive RP at a single academic center in 2008–2015. To mitigate confounding by the surgical learning curve, only patients treated by surgeons who performed at least 100 procedures were considered.Intervention
EF before and after RP was assessed by the International Index of Erectile Function 6 (IIEF-6), with recovery defined as IIEF-6 ≥24.Outcome measurements and statistical analysis
We analyzed EF recovery rates of patients treated with bilateral nerve-sparing surgery and free from adjuvant/salvage treatment at the time of EF assessment. Local polynomial regression analyses explored changes in the outcomes over time. Linear and logistic regression analyses were used to estimate the influence of year of surgery on baseline variables and EF recovery.Results and limitations
We observed a significant decrease over time of the EF recovery rates at both 12 and 24 mo post-RP (all p = 0.01). However, patient's age at surgery increased over time (mean increase of 0.5 per year; p < 0.01), with a resultant increase in risk of comorbidity (odds ratio [OR] = 1.1, 95% confidence interval [CI]: 1.02–1.15; p = 0.008) and thus decrease in baseline IIEF-6 score (0.35 points per year; p = 0.0003). After accounting for baseline and pathological characteristics, urinary function, and type of surgery in a multivariable analysis, year of surgery was not associated with EF recovery (12 mo: OR = 0.97, 95% CI: 0.91–1.03, p = 0.4; 24 mo: OR = 0.97, 95% CI: 0.91–1.03, p = 0.3).Conclusions
Findings from a high-volume center suggest that, despite the advancements in surgical and postoperative care, EF outcomes after RP have not improved over the last decade. Additional strategies are required to improve EF recovery after RP.Patient summary
The probability of regaining potency after surgery for prostate cancer did not improve over the last decade; more efforts are needed to improve patient's care after radical prostatectomy. 相似文献20.
Bahman SahraNavard Parke W. Hudson Cesar de Cesar Netto Bradley W. Wills Ibukunoluwa B. Araoye Shelby Bergstresser Brent M. Cone Ashish Shah 《Foot and Ankle Surgery》2019,25(1):84-89