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水喷射消融疗法治疗中小体积前列腺良性梗阻患者:首个法国 Aquablation 临床注册研究 12 个月结果。

Waterjet Ablation Therapy for Treating Benign Prostatic Obstruction in Patients with Small- to Medium-size Glands: 12-month Results of the First French Aquablation Clinical Registry.

机构信息

Department of Urology, Clinique Pasteur, Toulouse, France.

Department of Urology, Hospital Quirón Salud, Barcelona, Spain.

出版信息

Eur Urol. 2019 Nov;76(5):667-675. doi: 10.1016/j.eururo.2019.06.024. Epub 2019 Jul 5.

Abstract

BACKGROUND

Aquablation has emerged as a novel ablative therapy combining image guidance and robotics for targeted waterjet adenoma resection.

OBJECTIVE

To describe a standardised technique of aquablation in the treatment of benign prostatic obstruction (BPO), and to report the perioperative and 1-yr functional outcomes obtained by multiple surgeons with no previous experience of the technique.

DESIGN, SETTING, AND PARTICIPANTS: Between September 2017 and January 2018, patients referred to three different urological centres for BPO surgical management were prospectively enrolled to undergo an aquablation procedure.

SURGICAL PROCEDURE

Aquablation was performed using the Aquabeam system (Procept BioRobotics, Redwood Shores, CA, USA) that combines transrectal prostatic image guidance and robotics bespoke tissue resection with a high-pressure saline jet. The surgeon defines the area of treatment, and the resection is executed automatically.

MEASUREMENTS

The primary endpoint was the change in total International Prostate Symptom Score (IPSS) score at 6 and 12mo. Functional outcomes were assessed at 1, 3, 6, and 12mo with IPSS, International Index of Erectile Function (IIEF)-15, Sexual Health Inventory for Men, and Male Sexual Health Questionnaire questionnaires and uroflowmetry.

RESULTS AND LIMITATIONS

Thirty patients were enrolled in the study. The median operative time and resection time were 30.5 (24-35) and 4 (3.1-4.9)min, respectively. The median catheterisation time was 43 (23-49)h. The median hospitalisation stay was 2 (2-4)d. The IPSS score improved to 3 (1-6) at the 6mo, with a mean change of 15.6 points (95% confidence interval 13-18.2). IPSS improvements persisted at month 12. The maximum urinary flow rate improved to 20.4 (17-26)ml/s at 12mo. The 6-mo rates of Clavien-Dindo grade 2 and 3 events were 13.3%. There were no reports of incontinence or de novo erectile dysfunction. Postoperative de novo ejaculatory dysfunction was observed in 26.7% of patients.

CONCLUSIONS

This clinical registry confirmed that aquablation was feasible, safe, and effective, and provided immediate good functional results and similar outcomes to those of prior studies despite the lack of surgeons' previous experience with the technique.

PATIENT SUMMARY

Aquablation is feasible, safe, and reproducible with promising outcomes for treating benign prostatic enlargement.

摘要

背景

水动力消融术作为一种新的消融治疗方法,结合了图像引导和机器人技术,用于靶向水射流腺瘤切除术。

目的

描述一种标准化的水动力消融技术在治疗良性前列腺梗阻(BPO)中的应用,并报告多位之前没有该技术经验的外科医生在围手术期和 1 年的功能结果。

设计、设置和参与者:2017 年 9 月至 2018 年 1 月,3 家不同的泌尿科中心的患者被前瞻性纳入本研究,接受水动力消融术治疗。

手术过程

水动力消融术使用 Aquabeam 系统(Procept BioRobotics,加利福尼亚州雷德伍德海岸)进行,该系统结合经直肠前列腺图像引导和机器人定制组织切除与高压盐水射流。外科医生定义治疗区域,然后自动执行切除。

测量

主要终点是在 6 个月和 12 个月时总国际前列腺症状评分(IPSS)的变化。功能结果在 1、3、6 和 12 个月通过 IPSS、国际勃起功能指数(IIEF)-15、男性健康调查和男性性健康问卷以及尿流率进行评估。

结果和局限性

本研究纳入了 30 名患者。中位手术时间和切除时间分别为 30.5 分钟(24-35 分钟)和 4 分钟(3.1-4.9 分钟)。中位导尿管留置时间为 43 小时(23-49 小时)。中位住院时间为 2 天(2-4 天)。IPSS 评分在 6 个月时改善至 3(1-6),平均改善 15.6 分(95%置信区间 13-18.2)。在 12 个月时 IPSS 仍有改善。最大尿流率在 12 个月时改善至 20.4ml/s(17-26ml/s)。6 个月时 Clavien-Dindo 分级 2 和 3 级事件的发生率为 13.3%。没有报告尿失禁或新发勃起功能障碍。术后新发射精功能障碍在 26.7%的患者中观察到。

结论

本临床研究证实,水动力消融术是可行、安全且有效的,并且提供了即时良好的功能结果,与既往研究相似,尽管外科医生缺乏该技术的经验。

患者总结

水动力消融术治疗良性前列腺增生是可行、安全和可重复的,具有良好的治疗效果。

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