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一项关于使用 Rezūm®蒸汽系统治疗良性前列腺增生症引起的下尿路症状的全国多中心研究的初步结果。

Preliminary results of a national multicenter study on the treatment of LUTS secondary to benign prostatic hyperplasia using the Rezūm® steam system.

机构信息

Servicio de Urología, Hospital Universitario Marqués de Valdecilla, Santander, Spain.

Servicio de Urología, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.

出版信息

Actas Urol Esp (Engl Ed). 2022 Jun;46(5):310-316. doi: 10.1016/j.acuroe.2021.11.003. Epub 2022 May 12.

Abstract

INTRODUCTION AND OBJECTIVE

Rezūm® system is a minimally invasive transurethral therapy that uses convective water vapor energy to ablate prostatic tissue. The objective is to report 1-year functional and security outcomes obtained by using this technique in real clinical practice.

MATERIAL AND METHODS

Prospective study conducted in 5 Spanish hospitals for the treatment of LUTS secondary to BPH using the Rezūm® system. Patients with prostatic medium lobe (ML) and urethral catheter carriers were also included. Pre- and post-operative data were collected using IPSS, IIEF-5 and QoL questionnaires, flowmetry and post-void residual volume. Complications and retreatment rate at one-year follow-up were also reported.

RESULTS

137 patients, including 64 with ML and 10 patients with urinary retention were treated. Median prostate volume was 50 cm (15-131). At 3 months follow-up, significant improvement was observed in IPSS (-6.37 points), Qmax (+4.95 mL/s) and QoL (-1.29); and was maintained until 12 months: -10.78 points, +4.62 mL/s and -2.73 respectively (p < 0.001). No significant changes were observed in the sexual sphere. All complications were mild (≤ Clavien II). Retreatment rate at one year was 4%.

CONCLUSION

Short-term results of this technique are promising, showing improvement in terms of functional outcomes, with no impact on the sexual sphere or complications. Longer term follow-up should include treatment durability and comparison to standard BPH treatments.

摘要

介绍和目的

Rezūm®系统是一种微创经尿道治疗方法,利用对流水蒸气能量来消融前列腺组织。本研究旨在报告在真实临床实践中使用该技术获得的 1 年功能和安全性结果。

材料和方法

对 5 家西班牙医院使用 Rezūm®系统治疗 BPH 引起的下尿路症状(LUTS)的患者进行前瞻性研究。还纳入了前列腺中叶(ML)和导尿管携带者的患者。使用 IPSS、IIEF-5 和 QoL 问卷、尿流率和残余尿量收集术前和术后数据。还报告了 1 年随访时的并发症和再治疗率。

结果

共治疗了 137 例患者,包括 64 例 ML 患者和 10 例尿潴留患者。前列腺体积中位数为 50cm³(15-131)。在 3 个月随访时,IPSS(-6.37 分)、Qmax(+4.95mL/s)和 QoL(-1.29)显著改善,并且持续到 12 个月:-10.78 分、+4.62mL/s 和-2.73(p<0.001)。性领域没有观察到显著变化。所有并发症均为轻度(≤Clavien II)。1 年再治疗率为 4%。

结论

该技术的短期结果很有前景,在功能结果方面显示出改善,对性领域或并发症没有影响。长期随访应包括治疗持久性,并与标准 BPH 治疗进行比较。

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