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比较 100 cc 以下和 100 cc 以上前列腺行 aquablation 治疗良性前列腺增生。

Comparison of < 100 cc prostates and > 100 cc prostates undergoing aquablation for benign prostatic hyperplasia.

机构信息

Division of Urology, University of Montreal Hospital Center, Université de Montréal, Montreal, Canada.

Faculty of Medicine, McGill University, Montreal, Canada.

出版信息

World J Urol. 2019 Jul;37(7):1361-1368. doi: 10.1007/s00345-018-2535-9. Epub 2018 Oct 28.

Abstract

INTRODUCTION

Surgical options for benign prostatic hyperplasia (BPH) become limited when treating large prostates due to steep learning curves and less effective treatment. Aquablation (AquaBeam System, PROCEPT BioRobotics, Inc., USA) could remedy this. We compare the effectiveness of Aquablation in large prostates between 80 cc and 100 cc and very large prostates > 100 cc.

METHODS

WATER II (NCT03123250) is a prospective, multicenter, international clinical trial of Aquablation for the surgical treatment of LUTS/BPH in men of age 45-80 years with prostates between 80 cc and 150 cc. Aquablation was performed using the AquaBeam System. The reported analysis compares the subgroup of patients with a baseline prostate size of < 100 cc versus those with a prostate size of > 100 cc. Students' t test was used for continuous variables and Fisher's test for ordinal/binary variables.

RESULTS

Of 114 screened patients, 101 meeting eligibility criteria were enrolled at 13 US and 3 Canadian sites between September and December 2017. Mean operative time was 31.2 ± 8 min in the < 100 cc subgroup and 41.7 ± 14.9 min in the > 100 cc subgroup. The average length of stay following the procedure for the < 100 cc subgroup was 1.5 ± 0.7 days versus 1.7 ± 1.1 days for the > 100 cc subgroup. Mean changes in International Prostate Symptom Score (IPSS), IPSS quality of life, and IPSS voiding and storage subscores were substantial, occurring soon after treatment and averaging (at 3 months) 16.5, 2.8, 10.6, and 5.8 points, respectively (all p < 0.0001).

CONCLUSION

Aquablation clinically normalizes outcomes between patients of the < 100 cc and > 100 cc prostate cohorts. It is safe and effective in patients with large prostate glands (> 100 cc) with a smoother learning curve.

摘要

介绍

由于学习曲线陡峭和治疗效果较差,治疗大型前列腺时,良性前列腺增生(BPH)的手术选择变得有限。水射流消融(AquaBeam 系统,PROCERP 生物机器人公司,美国)可以解决这个问题。我们比较了前列腺在 80cc 到 100cc 之间和大于 100cc 的大型前列腺中使用 Aquablation 的效果。

方法

WATER II(NCT03123250)是一项前瞻性、多中心、国际临床试验,采用 Aquablation 治疗年龄在 45-80 岁之间、前列腺在 80cc 到 150cc 之间的男性下尿路症状/良性前列腺增生(LUTS/BPH)。使用 AquaBeam 系统进行水射流消融。报告的分析比较了基线前列腺体积<100cc 的患者亚组与前列腺体积>100cc 的患者亚组。连续变量采用学生 t 检验,有序/二分类变量采用 Fisher 检验。

结果

在 114 名筛选患者中,有 101 名符合纳入标准,于 2017 年 9 月至 12 月在 13 个美国和 3 个加拿大地点入组。<100cc 亚组的平均手术时间为 31.2±8 分钟,>100cc 亚组为 41.7±14.9 分钟。<100cc 亚组术后平均住院时间为 1.5±0.7 天,>100cc 亚组为 1.7±1.1 天。国际前列腺症状评分(IPSS)、生活质量评分(IPSS-QoL)和 IPSS 排尿和储存子评分的平均变化显著,治疗后很快发生,平均(3 个月时)分别为 16.5、2.8、10.6 和 5.8 分(均 p<0.0001)。

结论

Aquablation 使<100cc 和>100cc 前列腺队列的患者的临床结果正常化。对于前列腺较大(>100cc)的患者,它是安全有效的,并且学习曲线更平稳。

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