Ramos Pedro, Brás João P, Dias Carolina, Bessa-Gonçalves Mafalda, Botelho Francisco, Silva João, Silva Carlos, Pacheco-Figueiredo Luís
Departamento de Urologia, Centro Hospitalar e Universitário São João, Porto, Portugal.
Instituto de Investigação em Ciências da Vida e Saúde-ICVS/3bs Laboratório Associado, Escola de Medicina, Universidade do Minho, Braga, Portugal.
J Urol. 2025 Mar;213(3):304-312. doi: 10.1097/JU.0000000000004335. Epub 2024 Nov 19.
Alternative, noninvasive, cost-effective methods to complement or serve as substitutes to current standard-of-care (SOC) procedures in nonmuscle-invasive bladder cancer (NMIBC) follow-up are needed. Uromonitor is a urine biomarker test detecting bladder cancer recurrence through the screening of , , and hotspot mutations. The aim of this study was to assess Uromonitor performance by comparing it with the current SOC methods.
Four hundred thirty-nine patients with 528 NMIBC surveillances were enrolled in this study. All patients underwent SOC methods and provided a urine sample for Uromonitor analysis before undergoing cystoscopy. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for recurrence and compared with the gold standard cystoscopy plus transurethral resection of bladder tumor histopathology.
Uromonitor displayed a sensitivity of 87% (95% CI, 74-95), with only 6 of 47 recurrences failing to be detected; specificity of 99% (98-100); PPV of 93% (82-98); and an NPV of 99% (97-99). Cystoscopy showed a total of 22 false positives (32%) not confirmed by transurethral resection of bladder tumor, whereas Uromonitor presented only 3 positive tests where no lesions were found. Overall recurrence rate was 8.9% (n = 47) among 528 total screenings. Sensitivity, specificity, PPV, and NPV values for Uromonitor remained high across all NMIBC grades and stages.
Uromonitor represents a reliable tool in the detection of NMIBC recurrence in patients undergoing routine surveillance, regardless of stage and grade. To our knowledge, this is the largest single-center study assessing Uromonitor's performance, thus validating its usefulness in clinical practice.
需要有替代的、非侵入性的、具有成本效益的方法来补充或替代目前非肌肉浸润性膀胱癌（NMIBC）随访中的现行标准治疗（SOC）程序。Uromonitor是一种尿液生物标志物检测方法，通过筛查 、 和 热点突变来检测膀胱癌复发。本研究的目的是通过将Uromonitor与现行SOC方法进行比较来评估其性能。
本研究纳入了439例接受528次NMIBC监测的患者。所有患者均接受了SOC方法，并在膀胱镜检查前提供了一份尿液样本用于Uromonitor分析。计算复发的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV），并与金标准膀胱镜检查加膀胱肿瘤组织病理学经尿道切除术进行比较。
Uromonitor的敏感性为87%（95%CI，74 - 95），47例复发中仅6例未被检测到；特异性为99%（98 - 100）；PPV为93%（82 - 98）；NPV为99%（97 - 99）。膀胱镜检查显示共有22例假阳性（32%）未被膀胱肿瘤经尿道切除术证实，而Uromonitor仅出现3次阳性检测结果但未发现病变。在528次总筛查中，总体复发率为8.9%（n = 47）。Uromonitor的敏感性、特异性、PPV和NPV值在所有NMIBC分级和分期中均保持较高水平。
Uromonitor是在接受常规监测的患者中检测NMIBC复发的可靠工具，无论其分期和分级如何。据我们所知，这是评估Uromonitor性能的最大规模单中心研究，从而验证了其在临床实践中的实用性。
