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Patient experience of bladder cancer: A data linkage study 膀胱癌患者的经历:数据关联研究
Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-01-31 DOI: 10.1002/bco2.325
Snehadhar Shah, Jonathan Ince, Roger Kockelbergh
<div> <section> <h3> Introduction</h3> <p>Bladder cancer is one of the most common cancers worldwide and can be managed with a range of approaches, including conservative, medical and surgical therapies. Treatment may be associated with considerable morbidity, but despite this, little data exist to reflect patients' subsequent experience. This study aims to evaluate patients' experiences of bladder cancer care by linking data from a national cancer experience survey with data routinely collected from National Health Service (NHS) sources. This study considers patient perspectives and makes recommendations to improve the patient experience of bladder cancer care.</p> </section> <section> <h3> Methods</h3> <p>Anonymised data from the National Cancer Patient Experience Survey (NCPES) for patients who had received care for bladder cancer were collated and linked with demographic and treatment data. Questions from the NCPES were then categorised into different themes based on their content. This study focused on themes relating to lifestyle, activities of daily living (ADL), symptoms, psychological impact and body perception. Statistical analyses were used to investigate the relationship between patient reported experience, demographics and type of care received.</p> </section> <section> <h3> Results</h3> <p>NCPES data from 673 patients (487 male, 29 undisclosed) with at least T1 bladder cancer were analysed. Statistically significant differences were identified across the five investigated patient experience themes. No significant difference was seen in patient reported experience between bladder cancer drug treatments (such as intravesical BCG vs. intravesical chemotherapy vs. systemic chemotherapy) and radiotherapy types (curative vs. palliative). Patients treated with cystectomy had significantly worse experiences relating to body image and ADL but not when compared with patients treated with radical radiotherapy. Patients with long-term health conditions reported worse experiences for all five themes compared with those without.</p> </section> <section> <h3> Conclusion</h3> <p>The literature surrounding the experience of patients with bladder cancer is limited. This data linkage study demonstrates the impact of bladder cancer care on five patient experience themes, including the effect of different treatment types and the presence of long-term health conditions. While limited by sample size and data comprehensiveness, this study aims to inform clinicians and service providers of factors affecting patient experience of bladder cancer care, to stimul
简介:膀胱癌是全球最常见的癌症之一,可通过一系列方法进行治疗,包括保守治疗、药物治疗和手术治疗。治疗可能会导致相当高的发病率,但尽管如此,反映患者后续经历的数据却很少。本研究旨在通过将全国癌症经验调查的数据与国民健康服务系统(NHS)定期收集的数据联系起来,评估患者的膀胱癌治疗经验。本研究考虑了患者的观点,并提出了改善患者膀胱癌治疗体验的建议。 方法 对全国癌症患者体验调查(NCPES)中有关接受过膀胱癌治疗的患者的匿名数据进行整理,并将其与人口统计学和治疗数据联系起来。然后将 NCPES 中的问题根据其内容分为不同的主题。本研究侧重于与生活方式、日常生活活动 (ADL)、症状、心理影响和身体感知有关的主题。统计分析用于研究患者报告的经历、人口统计学特征和所接受的护理类型之间的关系。 结果 对 673 名至少患有一级膀胱癌的患者(487 名男性,29 名未披露)的 NCPES 数据进行了分析。在五个调查的患者体验主题中发现了统计学上的重大差异。在膀胱癌药物治疗(如膀胱内卡介苗与膀胱内化疗与全身化疗)和放疗类型(根治性与姑息性)之间,患者报告的体验无明显差异。接受膀胱切除术治疗的患者在身体形象和日常活动能力方面的体验明显较差,但与接受根治性放疗的患者相比,情况并非如此。与无长期健康状况的患者相比,有长期健康状况的患者在所有五个主题方面的体验都较差。 结论 有关膀胱癌患者经历的文献十分有限。这项数据关联研究证明了膀胱癌治疗对五个患者体验主题的影响,包括不同治疗类型的影响和是否存在长期健康状况。虽然受到样本量和数据全面性的限制,但本研究旨在让临床医生和服务提供者了解影响膀胱癌患者护理体验的因素,从而促进服务的审查和发展。
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引用次数: 0
The impact of pre-biopsy MRI and additional testing on prostate cancer screening outcomes: A rapid review 活检前核磁共振成像和附加检查对前列腺癌筛查结果的影响:快速回顾
Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-01-31 DOI: 10.1002/bco2.321
Abel Tesfai, Natalia Norori, Thomas A. Harding, Yui Hang Wong, Matthew David Hobbs

Objective

This work aims to examine the latest evidence on the impact of pre-biopsy MRI, in addition to prostate-specific antigen (PSA) testing, on health outcomes and quality of life.

Methods

We conducted a literature search including PubMed and Cochrane Central Register of Controlled Trials (CENTRAL) databases, with a limited scan of (i) guidelines and (ii) references from trial reports, from January 2005 to 25th January 2023. Two independent reviewers selected randomised controlled trials (RCT) and cohort studies which met our inclusion criteria.

Results

One hundred thirty-seven articles were identified, and seven trial articles were selected. Trial interventions were as follows: (i) PSA blood test, (ii) additional tests such as pre-biopsy multiparametric magnetic resonance imaging (mpMRI) and Biparametric MRI (bpMRI), and (iii) MRI targeted biopsy and standard biopsy. Compared with standard biopsy, MRI-based interventions led to increased detection of clinically significant cancers in three studies and decreased detection of clinically insignificant cancer (Gleason grade 3 + 3) in four studies. However, PROstate Magnetic resonance Imaging Study (PROMIS) and Stockholm3 with MRI (STHLM3-MRI) studies reported different trends depending on the scenario studied in PROMIS (MRI triage and MRI directed biopsy vs. MRI triage and standard biopsy) and thresholds used in STHLM3-MRI (≥0·11 and ≥0·15). MRI also helped 8%–49% of men avoid biopsy, in six out of seven studies, but not in STHLM3-MRI at ≥0.11. Interestingly, the proportion of men who experienced sepsis and UTI was low across studies.

Conclusion

This review found that a combination of approaches, centred on the use of pre-biopsy MRI, may improve the detection of clinically significant cancers and reduce (i) the diagnosis of clinically insignificant cancers and (ii) unnecessary biopsies, compared with PSA testing and standard biopsy alone. However, the impact of such interventions on longer term outcomes such as prostate cancer-specific mortality has not yet been assessed.

目的 本文旨在研究除前列腺特异性抗原 (PSA) 检测外,活检前磁共振成像对健康结果和生活质量影响的最新证据。 方法 我们对 2005 年 1 月至 2023 年 1 月 25 日期间的文献进行了检索,包括 PubMed 和 Cochrane 对照试验中央注册数据库 (CENTRAL),并对 (i) 指南和 (ii) 试验报告中的参考文献进行了有限扫描。两位独立审查员筛选出符合纳入标准的随机对照试验 (RCT) 和队列研究。 结果 确定了 137 篇文章,并筛选出 7 篇试验文章。试验干预措施如下(i) PSA 血液检测,(ii) 活检前多参数磁共振成像 (mpMRI) 和双参数磁共振成像 (bpMRI) 等附加检测,以及 (iii) 磁共振成像靶向活检和标准活检。与标准活检相比,在三项研究中,基于磁共振成像的干预措施提高了临床意义癌症的检出率,而在四项研究中,降低了临床意义不明显癌症(Gleason 3 + 3 级)的检出率。不过,前列腺磁共振成像研究(PROMIS)和斯德哥尔摩3 MRI(STHLM3-MRI)研究报告了不同的趋势,这取决于PROMIS研究的情况(MRI分流和MRI引导活检与MRI分流和标准活检)和STHLM3-MRI使用的阈值(≥0-11和≥0-15)。在七项研究中的六项中,核磁共振成像还帮助8%-49%的男性避免了活检,但在STHLM3-MRI中,≥0.11的阈值则没有帮助男性避免活检。有趣的是,各项研究中出现败血症和UTI的男性比例都很低。 结论 本综述发现,与单纯的 PSA 检测和标准活检相比,以活检前 MRI 的使用为中心的综合方法可提高对有临床意义的癌症的检出率,并减少(i)对临床意义不大的癌症的诊断和(ii)不必要的活检。然而,此类干预措施对前列腺癌特异性死亡率等长期结果的影响尚未得到评估。
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引用次数: 0
Testosterone nadir and clinical outcomes in patients with advanced prostate cancer: Post hoc analysis of triptorelin pamoate Phase III studies 晚期前列腺癌患者的睾酮最低值与临床疗效:帕莫酸曲普瑞林III期研究的事后分析
Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-01-10 DOI: 10.1002/bco2.318
Laurence Klotz, Tri Tat

Objective

The objective of the study is to evaluate whether low nadir testosterone during treatment with triptorelin pamoate, a luteinising hormone-releasing hormone (LHRH) agonist, is associated with improved clinical outcomes in patients with advanced prostate cancer using a retrospective analysis of clinical trial data.

Patients and methods

Data were pooled from three prospective, 9–12-month Phase III studies of triptorelin monotherapy in patients with advanced prostate cancer (including NCT00751790). The serum testosterone concentration suppression targets evaluated were <0.35 nmol/L (<10 ng/dl), <0.7 nmol/L (<20 ng/dl), <1.7 nmol/L (<50 ng/dl) and ≥1.7 nmol/L. Overall survival (OS) and disease-specific survival (DSS) by testosterone suppression group were assessed by Kaplan–Meier analysis, with log-rank test. The time frame for the primary analysis was Days 1–518 (median OS follow-up 254 days [range, 29–518 days]) and for the sensitivity analyses was Days 1–262. Supplementary analyses combined the ≥0.7- to <1.7-nmol/L and ≥1.7-nmol/L groups.

Results

The sample size comprised 592 patients (most received triptorelin monotherapy; four reported concomitant androgen receptor-axis–targeted therapy). Nadir testosterones of <0.35, ≥0.35 to <0.7, ≥0.7 to <1.7 and ≥1.7 nmol/L were achieved by 96%, 3.2%, 0.34% and 0.17% of patients, respectively. Better OS with decreasing level of nadir testosterone was observed (p < 0.001) and this persisted after sensitivity/supplemental analyses (all p < 0.001). Differences in DSS with decreasing levels of nadir testosterone were not statistically significant in the primary analysis. Sensitivity/supplemental analysis showed better DSS with decreasing level of nadir testosterone (Days 1–262, p = 0.01; combined groups Days 1–518, p = 0.03; combined groups Days 1–262, p = 0.005).

Conclusion

Low nadir testosterone achieved during treatment with the LHRH agonist triptorelin was associated with improved OS and DSS in patients with advanced prostate cancer.

该研究的目的是通过对临床试验数据的回顾性分析,评估黄体生成素释放激素(LHRH)激动剂帕莫酸曲普瑞林治疗期间的低睾酮是否与晚期前列腺癌患者临床预后的改善有关。数据来自三项针对晚期前列腺癌患者的曲普瑞林单药治疗的前瞻性、为期9-12个月的III期研究(包括NCT00751790)。评估的血清睾酮浓度抑制目标为<0.35 nmol/L(<10 ng/dl)、<0.7 nmol/L(<20 ng/dl)、<1.7 nmol/L(<50 ng/dl)和≥1.7 nmol/L。睾酮抑制组的总生存期(OS)和疾病特异性生存期(DSS)通过卡普兰-梅耶分析和对数秩检验进行评估。主要分析的时间范围为第1-518天(中位OS随访254天[范围为29-518天]),敏感性分析的时间范围为第1-262天。补充分析合并了≥0.7-<1.7-nmol/L组和≥1.7-nmol/L组。样本量包括592例患者(大多数接受曲普瑞林单药治疗;4例报告同时接受雄激素受体轴靶向治疗)。96%、3.2%、0.34%和0.17%的患者体内睾酮含量分别为<0.35、≥0.35至<0.7、≥0.7至<1.7和≥1.7 nmol/L。随着睾酮最低水平的降低,观察到更好的OS(p < 0.001),在进行敏感性/补充性分析后,这种情况依然存在(所有p < 0.001)。在主要分析中,随着最低睾酮水平的降低,DSS的差异无统计学意义。LHRH激动剂曲普瑞林治疗期间达到的低睾酮水平与晚期前列腺癌患者OS和DSS的改善有关。
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引用次数: 0
A study protocol of a comparative mixed study of the T-Control catheter T-Control 导管混合比较研究的研究方案
Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-01-02 DOI: 10.1002/bco2.313
José Medina-Polo, Ana Belén Salamanca-Castro, Yolanda Ramallo-Fariña, Max Mòdol-Vidal, Cristina Valcárcel-Nazco, Clara Armas-Moreno, Lilisbeth Perestelo-Pérez, Lidia García-Pérez, Miguel Ángel García-Bello, Manuel Luque-González, Marta Serrano-Muñoz, Santiago Pérez-García

Background

Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterization by a multifactorial approach. The general purpose of this study is to determine the effectiveness, comfort, and experience of the patient catheterized with T-Control® compared with patients with a conventional Foley catheter.

Study Design

This trial is a mixed-method study comprising a two-arm, pilot comparative study with random allocation to T-Control catheter or traditional Foley catheter in patients with long-term catheterization and a study with qualitative methodology, through discussion groups.

Endpoints

The comfort and acceptability of the T-Control® device (qualitative) and the quality of life related to self-perceived health (quantitative) will be analysed as primary endpoints. As secondary endpoints, the following will be analysed: magnitude and rate of infections (symptomatic and asymptomatic); days free of infection; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterization's healthcare resources; and level of satisfaction and workload of health professionals.

Patients and Methods

Eligible patients are male and female adults aged ≥18 years, who require a change of long-term bladder catheter. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 4 weeks later, plus the time until the discussion groups take place.

在过去几十年中,福里导尿管的发展受到了限制。这些导尿管虽然实现了将尿液从膀胱排出的基本功能,但却引发了其他相关问题。T-Control 是一种集成了液体控制阀的新型硅胶 Foley 导管,其设计旨在通过多因素方法降低膀胱导尿的相关风险。这项研究的总体目的是确定使用 T-Control® 导管的患者与使用传统 Foley 导管的患者相比,其有效性、舒适性和体验如何。该试验是一项混合方法研究,包括一项双臂试验性比较研究,在长期导尿患者中随机分配使用 T-Control 导管或传统 Foley 导管,以及一项通过讨论小组进行的定性方法研究。T-Control® 设备的舒适度和可接受性(定性)以及与自我感觉健康相关的生活质量(定量)将作为主要终点进行分析。作为次要终点,将对以下内容进行分析:感染(无症状和无症状)的程度和比率;无感染天数;相关抗生素治疗指征;生物膜的测定;导尿管相关不良事件的数量;每种导尿方式的医疗资源使用情况;医疗专业人员的满意度和工作量。预计样本量为 50 名患者。患者随访包括插入导尿管的时间和 4 周后拔出或更换导尿管的时间,以及参加讨论小组的时间。
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引用次数: 0
Expanding the usage of cryoablation as focal therapy for prostate tumour near the rectum 扩大冷冻消融术在直肠附近前列腺肿瘤病灶治疗中的应用
Q3 UROLOGY & NEPHROLOGY Pub Date : 2023-12-27 DOI: 10.1002/bco2.283
Yiu Chung Lam, Chi Man Ng
<p>Since radical treatment yields no major advantages in terms of prostate cancer specific and overall survival comparing with expectant management,<span><sup>1</sup></span> focal therapy (FT) is becoming more popular, providing a balance of oncological control and functional outcomes.<span><sup>2</sup></span> Cryotherapy is one of the most commonly use focal treatment for intermediate risk localized prostate cancer. It involves freezing and thawing the target areas of the prostate and ultimately inducing an extremely cold temperature within the prostate tumour. It results in cell death by tissue ablation. At the same time, it is mandatory to keep a certain distance between the rectal wall and the prostate ablative area during cryoablation for not only protecting the rectal wall from thermal injury but also allowing a more powerful ablative energy output. So prostate cancer in peripheral zone near the rectum is relatively contraindicated for cryotherapy.</p><p>In order to expand the usage of cryotherapy in prostate cancer near the rectum, different innovative methods have been used including saline displacement of the rectal wall,<span><sup>3</sup></span> proactive rectal warming using cryoprobe<span><sup>4</sup></span> and Hydrogel spacer (absorbable gel) injection into the Denovilliers' space to widen the distance between the rectum and the prostate.<span><sup>5</sup></span> Barrigel® is a new rectal spacer that can be sculpted in place to create a custom fit to the anatomy for minimizing the complications associated with radiation therapy in prostate cancer treatment. It is made from Non-Animal Stabilized Hyaluronic Acid (NASHA®) and is fully absorbable by the body. It is used in prostate cancer radiotherapy but not in ablative therapy, to the best of our knowledge. Therefore, our study aimed at assessing the feasibility and safety of using SpaceOAR™ Hydrogel and Barrigel® as a spacer between the rectum and the prostate in cryoablation for prostate cancer near the rectum.</p><p>We conducted the experimental study in operating theatre. A porcine model of pork belly size 20 × 20 × 10 cm was used for the study. Nonetheless, porcine model had been used in transurethral and percutaneous bladder cryoablation experimental studies.<span><sup>6, 7</sup></span> Under ultrasound (USG) guidance (High resolution 3D side fire USG probe, KOELIS Trinity®), 10 cc of saline was injected into the fascial plane of muscles as hydrodissection. Then two injections (5 cc per injection) of SpaceOAR™ Hydrogel were carried out to create a 10 mm thickness space between two muscle layers. A cryoprobe (14G, IcePearl™ 2.1CX straight, Boston Scientific) was placed at a target point 10 mm superior to upper margin of the SpaceOAR™ Hydrogel. The IcePearl™ cryoprobe can form iceball with −40°C isothermal area 10 mm distant from the distal portion of the needle. Then two temperature sensors were placed at superior (TS1) and inferior (TS2) margin of the SpaceOAR™ Hydrogel (Figure 
最近发表的一项关于冷冻消融治疗前列腺肿瘤而不使用直肠间隔器的研究显示,在18个月的磁共振引导下前列腺活检(MRGB)中,后方肿瘤男性(21/48,43.7%)比前方肿瘤男性(4/23,17.4%)患临床重大前列腺癌(csPCa)的几率更高。9 因此,当冷冻消融是唯一可用的能量模式时,在冷冻消融治疗前列腺后部肿瘤时使用直肠间隔器作为辅助手段,以最大限度地减少直肠热损伤,同时确保病灶得到充分治疗,这是令人鼓舞的。在整个研究过程中,使用 Barrigel® 的模型测得的最低温度远高于 SpaceOAR™ Hydrogel(13°C 对 -3°C)。这一结果可能是由于间隔物的物理和化学性质不同造成的。首先,SpaceOAR™ 水凝胶主要由水(90%)和聚乙二醇(PEG)组成,注射后 10 秒内就会固定成一定形状。注射前需要用生理盐水进行水切割,以便在目标区域形成空间。因此,要在几秒钟内将凝胶状液态水凝胶变成厚度均匀的蜡状固态物质,植入过程中良好的注射技术至关重要。因此,水凝胶的某些部分厚度不够,无法有效阻挡 "暴风雪 "也就不足为奇了。相比之下,Barrigel® 由非动物稳定透明质酸(NASHA®)制成,与人体中天然存在的透明质酸相似。它的内部结构工程既能精确定位,又能提高提拉力。同时,Barrigel® 的果冻状物理特性在制作任何形状的植入体时都更加灵活,从而达到最佳的间距效果。在 De Castro Abreu 等人的研究中,他们使用了四次注射(共 20 毫升)水凝胶来达到满意的间距效果,5 因此成本效益(20 毫升 SpaceOAR™ 水凝胶:港币 24000 元 vs. 9 毫升 Barrigel®:港币 13000 元)是一个值得关注的问题。此外,在水凝胶中检测到的 TS2 最低温度约为 0°C,这可能是由于注射前生理盐水的水化作用和水凝胶的高含水量造成的。由于水在达到 0°C 时会凝结成冰,水凝胶垫片在接触膨胀的冰球时可能会形成冰晶。因此,水凝胶垫片的环境温度可能为零或更低。因此,与主要成分为透明质酸的 Barrigel® 相比,SpaceOAR™ 水凝胶可能不是一种有效的隔冷剂。在前列腺后部肿瘤的冷冻消融术中,通过向 Denovilliers 空间注射间隔物来增加前列腺和直肠壁之间的距离,是提高手术安全性的可行方法。富含水分的凝胶还能提供额外的绝缘效果。两种间隔物的温度分布图和宏观外观都显示了这项技术的安全性:概念化(牵头);数据整理(牵头);形式分析(牵头);调查(等同);方法论(牵头);项目管理(牵头);资源(牵头);可视化(牵头);写作-原稿(牵头);写作-审阅和编辑(等同)。吴志文:实验中使用的 SpaceOAR™ 和 ICEFX™ 低温消融系统由波士顿科学公司提供,而 Barrigel® 则由嘉里医疗公司提供。
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引用次数: 0
Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial Optilume 药物涂层球囊治疗前尿道狭窄:ROBUST III 试验的两年结果
Q3 UROLOGY & NEPHROLOGY Pub Date : 2023-12-18 DOI: 10.1002/bco2.312
Maia E. VanDyke, Allen F. Morey, Karl Coutinho, Kaiser J. Robertson, Richard D'Anna, Kent Chevli, Christopher H. Cantrill, Michael J. Ehlert, Alexis E. Te, Jeffrey Dann, Jessica M. DeLong, Ramón Virasoro, Judith C. Hagedorn, Richard Levin, Euclid DeSouza, David DiMarco, Brad A. Erickson, Carl Olsson, Sean P. Elliott

Objective

The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture.

Materials and Methods

Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs).

Results

A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2–10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, p < 0.001). During the follow-up period, there were 15 treatment failures and two non-study-related deaths. Treatment-related AEs were rare and generally self-limited (haematuria, dysuria and urinary tract infection).

Conclusion

The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.

本研究旨在报告 ROBUST III 随机试验干预组的最新两年结果,该试验评估了 Optilume 药物涂层球囊 (DCB) 与标准内窥镜治疗复发性男性前尿道狭窄的安全性和有效性。符合条件的患者包括复发性前尿道狭窄长度≤3 cm、直径≤12Fr、国际前列腺症状评分 (IPSS) ≥11、峰值流速 (Qmax) <15 mL/s的男性。患者随机接受 Optilume DCB 治疗或标准内镜治疗。2年后测量的主要疗效终点包括不再干预、IPSS、Qmax和排尿后残余物(PVR)的变化。次要终点是国际勃起功能指数(IIEF)对性功能的影响。美国和加拿大的 22 个研究机构共招募了 127 名患者(48 人随机接受标准护理扩张术,79 人接受 DCB 扩张术)。DCB治疗组的75名患者在6个月后进入开放标签阶段。参与者之前平均接受过 3.2 次内镜干预(2-10 次不等);大多数(89.9%)患者有球部狭窄,平均狭窄长度为 1.63 厘米(标清 0.76)。患者的 IPSS、平均 Qmax 和 PVR 在 2 年后仍有显著改善。与对照组相比,Optilume DCB 治疗组在 2 年后不再重复干预的比例明显更高(77.8% 对 23.6%,P < 0.001)。在随访期间,共有 15 例治疗失败和 2 例非研究相关死亡。Optilume DCB在2年随访中显示出客观和主观排尿参数的持续改善。Optilume似乎为那些希望避免或推迟正式尿道成形术的男性提供了一种安全有效的内窥镜治疗方法,可用于治疗短小的复发性前尿道狭窄。
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引用次数: 0
Combining theranostic/particle therapy with immunotherapy for the treatment of GU malignancies 将治疗仪/粒子疗法与免疫疗法结合起来治疗上咽部恶性肿瘤
Q3 UROLOGY & NEPHROLOGY Pub Date : 2023-12-13 DOI: 10.1002/bco2.316
Karin A. Skalina, Beata Małachowska, Kunal K. Sindhu, Marcher Thompson, Anthony D. Nehlsen, Lucas Resende Salgado, Zachary Dovey, Shaakir Hasan, Chandan Guha, Justin Tang

Particle therapy and radiopharmaceuticals are emerging fields in the treatment of genitourinary cancers. With these novel techniques and the ever-growing immunotherapy options, the combinations of these therapies have the potential to improve current cancer cure rates. However, the most effective sequence and combination of these therapies is unknown and is a question that is actively being explored in multiple ongoing clinical trials. Here, we review the immunological effects of particle therapy and the available radiopharmaceuticals and discuss how best to combine these therapies.

粒子疗法和放射性药物是治疗泌尿生殖系统癌症的新兴领域。有了这些新技术和不断增加的免疫疗法选择,这些疗法的组合有可能提高目前的癌症治愈率。然而,这些疗法的最有效序列和组合尚不清楚,也是多个正在进行的临床试验中积极探索的问题。在此,我们回顾了粒子疗法和现有放射性药物的免疫学效应,并讨论了如何最好地结合这些疗法。
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引用次数: 0
Impact of androgen deprivation therapy on cognitive function in men with prostate cancer 雄激素剥夺疗法对男性前列腺癌患者认知功能的影响
Q3 UROLOGY & NEPHROLOGY Pub Date : 2023-12-11 DOI: 10.1002/bco2.319
Yutaka Yamamoto, Yasunori Akashi, Keisuke Kiba, Akihide Hirayama, Hirotsugu Uemura
<p>While the benefits of androgen deprivation therapy (ADT) have been well established for prostate cancer (PC) patients, it is also known to cause various adverse events as a consequence of testosterone deficiency.<span><sup>1</sup></span> Recently, there has been growing interest in the association between ADT and cognitive function, but no consensus has yet been reached.<span><sup>2</sup></span> Androgen receptors are highly expressed in the prefrontal cortex and hippocampus in the brain cortices and these regions are considered to responsible for memory and higher order cognitive functions.<span><sup>3</sup></span> ADT for suppressing androgen release may lead to cause decreased activity in these regions, resulting in cognitive decline.<span><sup>4</sup></span> Given that both the prevalence of cognitive decline and the number of ADT users increase with age,<span><sup>5</sup></span> it is important to articulate the impact of ADT on cognitive function. The aim of this study was to evaluate the impact of ADT on cognitive function over a 36-month follow-up, including changes in serum testosterone levels.</p><p>The following two cohorts were enrolled in this study between July 2017 and April 2019 from Kindai University Nara Hospital in Nara, Japan: men with newly diagnosed PC who received ADT and healthy controls (HCs) without PC. Of those, 43 with PC and 34 HCs were evaluated in this analysis. All men with PC received a luteinizing hormone–releasing hormone (LH–RH) agonist. The addition of anti-androgen was administered at the discretion of the attending physician. The vast majority of localized or locally advanced PC received intensity-modulated radiotherapy (IMRT) in combination with ADT. Cognitive function was assessed using the mini-mental state examination (MMSE),<span><sup>6</sup></span> and a score of less than 24 out of 30 were excluded from this study. MMSE and blood samples for total testosterone were collected at baseline, 6 months, 12 months and 36 months. We also examined the percentage of MMSE domains in each cohort that had a change of 1 standard deviation (SD) (improved or worsened) from baseline to 36 months. Changes in cognitive function and serum testosterone levels between baseline and each follow-up visit were compared by linear mixed effect models. An analysis of changes in the percentage of MMSE domains in each cohort was performed using an unadjusted chi-square test. This study was approved by the Institutional Review Board of our hospital.</p><p>Figure 1A shows the baseline characteristics. Median age, baseline MMSE score, Charlson comorbidity index, education level and serum testosterone levels were well matched between the two cohorts. The median duration of ADT was 36 (range 18–36) months. The rate of change in MMSE score from baseline is shown in Figure 1B. From baseline to 36 months, there was no significant difference in cognitive function between the two cohorts at each observation point (<i>p =</i> 0.38). We als
虽然雄激素剥夺疗法(ADT)对前列腺癌(PC)患者的益处已得到公认,但众所周知,它也会因睾酮缺乏而导致各种不良反应。雄激素受体在大脑皮质的前额叶皮层和海马体中高度表达,这些区域被认为负责记忆和高阶认知功能。3 用于抑制雄激素释放的 ADT 可能会导致这些区域的活性降低,从而导致认知功能下降。本研究旨在评估 ADT 在 36 个月随访期间对认知功能的影响,包括血清睾酮水平的变化。2017 年 7 月至 2019 年 4 月期间,日本奈良的健大奈良医院招募了以下两个队列:接受 ADT 的新诊断 PC 男性患者和无 PC 的健康对照组(HCs)。其中,43名PC患者和34名健康对照者接受了本次分析评估。所有 PC 患者都接受了促黄体生成素释放激素(LH-RH)激动剂治疗。抗雄激素的使用由主治医生决定。绝大多数局部或局部晚期 PC 患者在接受 ADT 的同时还接受了调强放射治疗 (IMRT)。认知功能采用小型精神状态检查(MMSE)6 进行评估,满分 30 分,得分低于 24 分者不在本研究范围内。我们在基线、6 个月、12 个月和 36 个月时采集了 MMSE 和总睾酮的血液样本。我们还检查了每个队列中从基线到 36 个月期间 MMSE 领域变化达到 1 标准差 (SD) (改善或恶化)的百分比。通过线性混合效应模型比较了认知功能和血清睾酮水平在基线和每次随访之间的变化。使用未调整的卡方检验对每个队列中 MMSE 领域的百分比变化进行分析。图 1A 显示了基线特征。两组患者的中位年龄、基线 MMSE 评分、Charlson 合并症指数、教育程度和血清睾酮水平完全匹配。ADT 的中位持续时间为 36 个月(18-36 个月)。图 1B 显示了 MMSE 评分与基线相比的变化率。从基线到 36 个月,两个队列在每个观察点的认知功能均无显著差异(P = 0.38)。我们还根据抗雄激素的使用情况对 PC 组群进行了分层,并研究了与 MMSE 变化的相关性,但未观察到显著差异(p = 0.54 [其他数据未显示])。图 1C 显示了血清睾酮水平的变化。在 PC 中观察到血清睾酮水平明显降低至阉割水平(50 ng/dL)以下,而在 HC 中未观察到,在 6、12 和 36 个月时分别存在显著差异(p &lt;0.01)。图 1D 展示了从基线到 36 个月期间每个队列中每个认知功能领域的受试者百分比分析。在 36 个月的随访中,我们发现即使血清睾酮水平维持在阉割水平以下,ADT 也与认知功能下降无关。据我们所知,只有 Alibhai 等人报道了接受 ADT 超过一年的男性认知功能的变化。7 他们的结论是,使用 ADT 长达 36 个月与认知功能下降无关,这与我们的结果一致。鉴于在实际临床实践中,大多数男性接受 ADT 的时间长达数年,我们的研究结果可为评估 ADT 的风险和益处提供有价值的信息。我们的研究有几个优点,包括 3 年的纵向评估和详细的血清睾酮评估。不过,我们的研究也存在一些局限性,包括样本量相对较小,对照组中没有未接受 ADT 治疗的 PC 患者。我们的研究还有一个很大的局限性,那就是我们只通过一项神经心理学测试进行评估。Yutaka Yamamoto和Akihide Hirayama提出并设计了实验;Yutaka Yamamoto、Yasunori Akashi和Keisuke Kiba进行了实验;Yutaka Yamamoto和Keisuke Kiba分析了数据;Yutaka Yamamoto撰写了手稿;Akihide Hirayama和Hirotsugu Uemura指导了本研究。所有作者都批准了最终手稿。 所有作者声明不存在利益冲突。
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引用次数: 0
Clinical variables associated with major adverse cardiac events following radical cystectomy 根治性膀胱切除术后与主要心脏不良事件相关的临床变量
Q3 UROLOGY & NEPHROLOGY Pub Date : 2023-12-05 DOI: 10.1002/bco2.315
Aaron A. Gurayah, Ruben Blachman-Braun, Christopher J. Machado, Matthew M. Mason, Helen Y. Hougen, Ali Mouzannar, Mark L. Gonzalgo, Bruno Nahar, Sanoj Punnen, Dipen J. Parekh, Chad R. Ritch

Objectives

The objective of this study is to investigate the association between major adverse cardiac events (MACE) and clinical factors of patients undergoing radical cystectomy (RC) for bladder cancer.

Materials and Methods

A retrospective analysis using the 2015–2020 National Surgical Quality Improvement Program database was performed on patients who underwent RC for bladder cancer. MACE was defined as any report of cerebrovascular accident, myocardial infarction, or thromboembolic events (pulmonary embolism or deep vein thrombosis). A multivariable-adjusted logistic regression was conducted to identify clinical predictors of postoperative MACE.

Results

A total of 10 308 (84.2%) patients underwent RC with incontinent urinary diversion (iUD), and 1938 (15.8%) underwent RC with continent urinary diversion (cUD). A total of 629 (5.1%) patients recorded a MACE, and on the multivariable-adjusted logistic regression, it was shown that MACE was significantly associated with increased age (OR = 1.035, 95% CI: 1.024–1.046, p < 0.001), obesity (OR = 1.583, 95% CI: 1.266–1.978, p < 0.001), current smokers (OR = 1.386, 95% CI: 1.130–1.700, p = 0.002), congestive heart failure before surgery (OR = 1.991, 95% CI: 1.016–3.900; p = 0.045), hypertension (OR = 1.209, 95% CI: 1.016–1.453, p = 0.043), and increase the surgical time (per 10 min increase, OR = 1.010, 95% CI: 1.003–1.017, p = 0.009). We also report that increased age, obesity, and patients undergoing cUD (OR = 1.368, 95% CI: 1.040–1.798; p = 0.025) are associated with thromboembolic events.

Conclusion

By considering the preoperative characteristics of patients, including age, obesity, smoking, congestive heart failure, and hypertension status, urologists may be able to decrease the incidence of MACE in patients undergoing RC. Urologists should aim for lower operative times as this was associated with a decreased risk of thromboembolic events.

本研究的目的是探讨膀胱癌根治性膀胱切除术(RC)患者的主要心脏不良事件(MACE)与临床因素的关系。使用2015-2020年国家手术质量改进计划数据库对膀胱癌患者进行了回顾性分析。MACE定义为任何脑血管意外、心肌梗死或血栓栓塞事件(肺栓塞或深静脉血栓形成)的报告。采用多变量调整logistic回归分析确定术后MACE的临床预测因素。共有10308例(84.2%)患者行RC合并尿失禁转流(iUD), 1938例(15.8%)患者行RC合并尿失禁转流(cUD)。共有629例(5.1%)患者记录了MACE,经多变量校正logistic回归分析显示,MACE与年龄增加(OR = 1.035, 95% CI: 1.024-1.046, p < 0.001)、肥胖(OR = 1.583, 95% CI: 1.266-1.978, p < 0.001)、当前吸烟者(OR = 1.386, 95% CI: 1.130-1.700, p = 0.002)、术前充血性心力衰竭(OR = 1.991, 95% CI: 1.016-3.900;p = 0.045),高血压(OR = 1.209, 95% CI: 1.016-1.453, p = 0.043),并增加手术时间(每10分钟增加,OR = 1.010, 95% CI: 1.003-1.017, p = 0.009)。我们还报道了年龄增加、肥胖和cUD患者(OR = 1.368, 95% CI: 1.040-1.798;P = 0.025)与血栓栓塞事件相关。通过考虑患者的术前特征,包括年龄、肥胖、吸烟、充血性心力衰竭和高血压状况,泌尿科医生可能能够降低接受RC患者MACE的发生率。泌尿科医生应该以减少手术时间为目标,因为这与降低血栓栓塞事件的风险有关。
{"title":"Clinical variables associated with major adverse cardiac events following radical cystectomy","authors":"Aaron A. Gurayah,&nbsp;Ruben Blachman-Braun,&nbsp;Christopher J. Machado,&nbsp;Matthew M. Mason,&nbsp;Helen Y. Hougen,&nbsp;Ali Mouzannar,&nbsp;Mark L. Gonzalgo,&nbsp;Bruno Nahar,&nbsp;Sanoj Punnen,&nbsp;Dipen J. Parekh,&nbsp;Chad R. Ritch","doi":"10.1002/bco2.315","DOIUrl":"10.1002/bco2.315","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>The objective of this study is to investigate the association between major adverse cardiac events (MACE) and clinical factors of patients undergoing radical cystectomy (RC) for bladder cancer.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>A retrospective analysis using the 2015–2020 National Surgical Quality Improvement Program database was performed on patients who underwent RC for bladder cancer. MACE was defined as any report of cerebrovascular accident, myocardial infarction, or thromboembolic events (pulmonary embolism or deep vein thrombosis). A multivariable-adjusted logistic regression was conducted to identify clinical predictors of postoperative MACE.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 10 308 (84.2%) patients underwent RC with incontinent urinary diversion (iUD), and 1938 (15.8%) underwent RC with continent urinary diversion (cUD). A total of 629 (5.1%) patients recorded a MACE, and on the multivariable-adjusted logistic regression, it was shown that MACE was significantly associated with increased age (OR = 1.035, 95% CI: 1.024–1.046, <i>p</i> &lt; 0.001), obesity (OR = 1.583, 95% CI: 1.266–1.978, <i>p</i> &lt; 0.001), current smokers (OR = 1.386, 95% CI: 1.130–1.700, <i>p</i> = 0.002), congestive heart failure before surgery (OR = 1.991, 95% CI: 1.016–3.900; <i>p</i> = 0.045), hypertension (OR = 1.209, 95% CI: 1.016–1.453, <i>p</i> = 0.043), and increase the surgical time (per 10 min increase, OR = 1.010, 95% CI: 1.003–1.017, <i>p</i> = 0.009). We also report that increased age, obesity, and patients undergoing cUD (OR = 1.368, 95% CI: 1.040–1.798; <i>p</i> = 0.025) are associated with thromboembolic events.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>By considering the preoperative characteristics of patients, including age, obesity, smoking, congestive heart failure, and hypertension status, urologists may be able to decrease the incidence of MACE in patients undergoing RC. Urologists should aim for lower operative times as this was associated with a decreased risk of thromboembolic events.</p>\u0000 </section>\u0000 </div>","PeriodicalId":72420,"journal":{"name":"BJUI compass","volume":"5 4","pages":"480-488"},"PeriodicalIF":0.0,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/bco2.315","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138599303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effectiveness of the T-Control catheter: A study protocol T-Control 导管的有效性:研究方案
Q3 UROLOGY & NEPHROLOGY Pub Date : 2023-12-04 DOI: 10.1002/bco2.285
Yolanda Ramallo-Fariña, Ana Toledo Chávarri, Adrián Amador Robayna, Max Mòdol Vidal, Cristina Valcárcel-Nazco, Clara Armas Moreno, Lilisbeth Perestelo-Pérez, Marta Serrano Muñoz, Manuel Luque González, Lidia García-Pérez, Miguel Ángel García-Bello, Pedro Serrano-Aguilar, Pedro Raúl Castellano Santana, Laura Vera Álamo

Background

Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterisation by a multifactorial approach. The general purpose of this study is to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the Foley-type catheter in patients with Acute Urine Retention (AUR).

Study design

This is a pragmatic, open, multicentre, controlled clinical trial with random allocation to the T-Control catheter or a conventional Foley-type catheter in patients with AUR.

Endpoints

The magnitude of infections will be analysed as a primary endpoint. While as secondary endpoint, the following will be analysed: rate of symptomatic and asymptomatic infections; days free of infection; quality of life-related to self-perceived health; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterisation's healthcare resources; level of satisfaction and workload of health professionals and acceptability of the T-Control device as well as the patient experience.

Patients and methods

Eligible patients are male adults aged ≥50 years, with AUR and with an indication of bladder catheterisation for at least 2 weeks. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 2 weeks later, plus 2 weeks after this time when the patient will be called for an in-depth interview.

福莱导尿管在过去的几十年里发展有限。它们完成膀胱排尿的基本功能,但也会引起其他相关问题。T‐Control是一种新型硅胶Foley导管,带有集成流体控制阀,其设计旨在通过多因素方法降低与膀胱导尿相关的风险。本研究的一般目的是评估T - Control导尿管与Foley型导尿管在急性尿潴留(AUR)患者中的有效性和成本效益。这是一项实用的、开放的、多中心的对照临床试验,在AUR患者中随机分配T - Control导管或传统Foley型导管。感染程度将作为主要终点进行分析。作为次要终点,将分析以下数据:有症状和无症状的感染率;无感染天数;与自我感知健康相关的生活质量;相关抗生素治疗的指征;生物膜的测定;导管相关不良事件数量;使用每种导尿的医疗资源;卫生专业人员的满意度和工作量水平、T - Control设备的可接受性以及患者的体验。符合条件的患者为年龄≥50岁、患有AUR且有至少2周膀胱导尿指征的男性成年人。估计样本量为50名患者。患者随访包括导管插入时间和2周后拔管或更换导管的时间,再加上2周后患者将被要求进行深入访谈。
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BJUI compass
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