Eastern Health Clinical School, Monash University, Level 2, 5 Arnold St, Box Hill, VIC, 3128, Australia.
Department of Urology, Eastern Health, Box Hill, VIC, Australia.
World J Urol. 2024 Mar 4;42(1):115. doi: 10.1007/s00345-024-04800-0.
Non-muscle-invasive bladder cancer (NMIBC) can recur, partly due to seeding of free tumour cells after transurethral resection of bladder tumour (TURBT). Intravesical chemotherapy post-TURBT can reduce the risk but is used infrequently and inconsistently due to cost, complexity and side effects. The objective of this study was to prospectively assess continuous bladder irrigation using water, which may be a safer and easier alternative with comparable effectiveness.
WATIP was a prospective, single-arm phase 2 study of water irrigation during and for at least 3 h after TURBT for bladder tumours noted on imaging or flexible cystoscopy. Participants were assessed clinically for adverse effects and with blood tests within 24 h for sodium, haemoglobin and lactate dehydrogenase. The primary endpoints were safety (defined as < 10% adverse events of CTCAE grade ≥ 3), and feasibility (defined as the intervention being delivered as planned in > 90% of cases) and secondary endpoint was recurrence-free rates (RFR).
Water irrigation was delivered as planned in 29 (97%) of 30 participants (median age 67 years, 25 (83%) males). The only adverse event (grade 2) was clot retention in one (3.3%) participant. Water irrigation significantly reduced urothelial cell counts in catheter effluent over time, unlike saline irrigation which did not. RFR was 56.2% (9/16 participants with low-risk NMIBC) at first cystoscopy (median interval 108 days) and 62.5% (5/8 evaluable low-risk NMIBC) at 12 months.
Water irrigation during and after TURBT is feasible and safe. Prospective assessment of its effect on NMIBC recurrence compared to post-TURBT intravesical chemotherapy is needed before recommending its use in routine clinical practice. Trial registration ANZCTR registration ID ACTRN12619000517178 on 1 April 2019.
非肌肉浸润性膀胱癌（NMIBC）会复发，部分原因是经尿道膀胱肿瘤切除术（TURBT）后游离肿瘤细胞的播种。TURBT 后膀胱内化疗可以降低风险，但由于成本、复杂性和副作用，该方法的使用并不频繁且不一致。本研究的目的是前瞻性评估使用水进行连续膀胱冲洗的效果，这种方法可能更安全、更容易，且效果相当。
WATIP 是一项前瞻性、单臂 2 期研究，对影像学或软性膀胱镜检查发现的膀胱肿瘤，在 TURBT 期间和 TURBT 后至少 3 小时内使用水进行冲洗。通过临床评估参与者的不良反应，并在 24 小时内通过血液检查评估钠、血红蛋白和乳酸脱氢酶。主要终点是安全性（定义为<10%的 CTCAE 分级≥3 的不良事件）和可行性（定义为干预计划在>90%的病例中完成），次要终点是无复发生存率（RFR）。
在 30 名参与者（中位年龄 67 岁，25 名男性）中，有 29 名（97%）按计划进行了水冲洗。唯一的不良反应（2 级）是 1 名（3.3%）参与者的血块滞留。与生理盐水冲洗不同，水冲洗可随时间显著减少导尿管流出物中的尿路上皮细胞计数。RFR 在首次膀胱镜检查时为 56.2%（16 名低危 NMIBC 患者中的 9 名），在 12 个月时为 62.5%（8 名可评估的低危 NMIBC 患者中的 5 名）。
TURBT 期间和之后进行水冲洗是可行且安全的。在推荐其在常规临床实践中使用之前，需要前瞻性评估其对 NMIBC 复发的影响，与 TURBT 后膀胱内化疗进行比较。试验注册：2019 年 4 月 1 日，澳大利亚临床试验注册中心（ANZCTR）注册号 ACTRN12619000517178。
