WATER 与 WATER II 5 年更新:比较水消融疗法治疗 30-80 立方厘米和 80-150 立方厘米前列腺良性前列腺增生。

IF 1.6 Q3 UROLOGY & NEPHROLOGY BJUI compass Pub Date : 2024-09-09 DOI:10.1002/bco2.430
Mohamad Baker Berjaoui, David-Dan Nguyen, Saud Almousa, Karim Daher, Neil Barber, Mo Bidair, Peter Gilling, Paul Anderson, Kevin C. Zorn, Gopal Badlani, Mitch Humphreys, Steven Kaplan, Ronald P. Kaufman Jr, Dean Elterman, Mihir Desai, Claus Roehrborn, Naeem Bhojani
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引用次数: 0

摘要

研究目的本研究旨在比较水刀消融术治疗中小型(30-80 立方厘米)前列腺的长期疗效和大型(80-150 立方厘米)前列腺的 5 年随访疗效:前列腺组织内窥镜切除水刀消融疗法(WATER;NCT02505919)是一项前瞻性、双盲、国际临床试验,共有 116 名患者参加,研究了水刀消融术与经尿道前列腺切除术(TURP)治疗 30 至 80 立方厘米前列腺大小的 LUTS/BPH。与此同时,WATER II (W-II; NCT03123250)是一项前瞻性、多中心、单臂国际临床试验,探讨了80至150立方厘米前列腺的水消融治疗效果。采用统计学分析方法对基线参数和 60 个月的疗效进行了仔细检查,包括连续变量的学生 t 检验、Wilcoxon 检验和二元变量的费雪检验:结果:从基线到60个月,WATER(22.9至7.0)和WATER II(23.2至6.8)的国际前列腺症状评分(IPSS)均有明显改善(P = 0.852)。从基线到 60 个月期间,两组患者的尿流率(Qmax)均有所增加(WATER:9.4 至 17.3 cc/s;WATER II:8.7 至 17.1 cc/s)(P = 0.933)。在 IPSS 和 Qmax 方面观察到了立竿见影的持续改善。5 年后,两组患者中均有显著比例的人不再服用良性前列腺增生药物(WATER:99%;WATER II:94%)(P = 0.0517),也不再接受手术治疗(WATER:95%;WATER II:97%)(P = 0.508):5年的随访结果证实,无论前列腺体积在30到150立方厘米之间,水消融疗法在治疗LUTS/BPH方面都具有持续的疗效、极少的不可逆并发症和较低的再治疗率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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WATER versus WATER II 5-year update: Comparing Aquablation therapy for benign prostatic hyperplasia in 30–80-cm3 and 80–150-cm3 prostates

Objective

This study aims to compare the long-term outcomes of Aquablation for small-to-moderate (30–80 cm3) prostates with the outcomes for large (80–150 cm3) prostates at 5-year follow up.

Methods

The Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER; NCT02505919) is a prospective, double-blind, international clinical trial encompassing 116 patients, examining Aquablation versus transurethral resection of the prostate (TURP) for LUTS/BPH in prostates sized between 30 and 80 cm3. In parallel, WATER II (W-II; NCT03123250), a prospective, multicentre, single-arm international clinical trial, explores Aquablation outcomes in prostates ranging from 80 to 150 cm3. Baseline parameters and 60-month outcomes were scrutinized using statistical analyses, including Students' t test, Wilcoxon tests for continuous variables, and Fisher's test for binary variables.

Results

There is a significant improvement in International Prostate Symptom Score (IPSS) from baseline to 60 months in both WATER (22.9 to 7.0) and WATER II (23.2 to 6.8) (P = 0.852). Urinary flow rate (Qmax) increased in both groups from baseline to 60 months (WATER: 9.4 to 17.3 cc/s; WATER II: 8.7 to 17.1 cc/s) (P = 0.933). Immediate and sustained enhancements were observed in IPSS and Qmax. At 5 years, a notable percentage of patients in both groups were BPH medication-free (WATER: 99%; WATER II: 94%) (P = 0.0517) and free from surgical retreatment (WATER: 95%; WATER II: 97%) (P = 0.508).

Conclusions

The 5-year follow-up affirms that Aquablation therapy exhibits sustained outcomes, minimal irreversible complications, and low retreatment rates for treating LUTS/BPH, irrespective of prostate volume ranging from 30 to 150 cm3.

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