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大前列腺患者的水蒸气热疗法(Rezūm系统):一项前瞻性对比研究的结果

Water vapor thermal therapy (Rezūm System) in patients with large prostates: results from a prospective comparative study.

作者信息

Balsamo Raffaele, Tammaro Simone, Trivellato Massimiliano, Crocetto Felice, Barone Biagio, Fusco Ferdinando, Arcaniolo Davide, Manfredi Celeste, Cindolo Luca, Ranavolo Raffaele, Uricchio Francesco

机构信息

Urology Unit, Department of Surgical Sciences, AORN dei Colli, Monaldi Hospital, Naples, Italy -

Urology Unit, Department of Woman, Child and General and Specialized Surgery, Luigi Vanvitelli University of Campania, Naples, Italy.

出版信息

Minerva Urol Nephrol. 2024 Dec;76(6):759-767. doi: 10.23736/S2724-6051.24.05883-X. Epub 2024 Nov 4.

DOI:10.23736/S2724-6051.24.05883-X
PMID:39494943
Abstract

BACKGROUND

Rezūm is a novel minimally invasive surgical technique (MIST) useful for BPH patients with medium-sized prostate (30-80 cm) refractory to medical treatment. The aim of this study was to evaluate the efficacy and safety of Rezūm as a treatment option in large-sized prostates (>80 cm).

METHODS

We performed a prospective, comparative, single-center study from June 2022 to June 2023, including consecutive patients undergoing surgery with the Rezūm System. Enrolled men were classified into two subgroups based on prostate size: medium prostate (MP) (30-80 cm) and large prostate (LP) (≥80 cm). Inclusion criteria included an International Prostate Symptom Score (IPSS) Total score of ≥ 8 points. International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post-void residual (PVR), and International Index of Erectile Function 5-item version (IIEF-5) were collected at baseline and at three, six, and 12 months post-procedure. Ejaculation presence was assessed at 3 months. Post-operative complications were described using the Clavien-Dindo (CD) classification. The primary outcome was the IPSS-Total score, with intraoperative and postoperative CD grade ≥III complications as secondary outcomes.

RESULTS

One hundred and twenty-one patients (PV 78.2±32.1 mL) were included in the study, 51 large prostate (LP) and 70 medium prostate (MP). The IPSS-Total score and Qmax showed a statistically significant (P<0.0001) improvement at 3, 6, and 12 months respectively. PVR decreased at 3, 6, and 12 months; however, only at 3 months this variation was statistically significant (P<0.0001). At 3-month follow-up, anejaculation was detected in (3; 5.8% and 1; 1.4%) patients in LP and MP group respectively (P=0.86). IIEF-5 significantly improved 3 months after surgery in the LP subgroup (P<0.0001).

CONCLUSIONS

Rezūm water vapor therapy appears to be effective for treating BPH in larger prostates. Additionally, it demonstrates a low risk of impairing sexual function, indicating a favorable safety profile.

摘要

背景

Rezūm是一种新型微创手术技术(MIST),对药物治疗无效的中度前列腺(30 - 80立方厘米)良性前列腺增生(BPH)患者有用。本研究的目的是评估Rezūm作为大尺寸前列腺(>80立方厘米)治疗选择的疗效和安全性。

方法

我们在2022年6月至2023年6月进行了一项前瞻性、对比性、单中心研究,纳入连续接受Rezūm系统手术的患者。根据前列腺大小将入选男性分为两个亚组:中度前列腺(MP)(30 - 80立方厘米)和大前列腺(LP)(≥80立方厘米)。纳入标准包括国际前列腺症状评分(IPSS)总分≥8分。在基线以及术后3个月、6个月和12个月收集国际前列腺症状评分(IPSS)、最大尿流率(Qmax)、残余尿量(PVR)和国际勃起功能指数5项版本(IIEF - 5)。在3个月时评估射精情况。使用Clavien - Dindo(CD)分类描述术后并发症。主要结局是IPSS总分,术中及术后CD分级≥III级并发症为次要结局。

结果

本研究纳入了121例患者(前列腺体积78.2±32.1毫升),其中51例大前列腺(LP)患者和70例中度前列腺(MP)患者。IPSS总分和Qmax在3个月、6个月和12个月时分别显示出统计学显著改善(P<0.0001)。PVR在3个月、6个月和12个月时下降;然而,仅在3个月时这种变化具有统计学显著性(P<0.0001)。在3个月随访时,LP组和MP组分别有(3例;5.8%)和(1例;1.4%)患者出现无射精情况(P = 0.86)。LP亚组术后3个月IIEF - 5显著改善(P<0.0001)。

结论

Rezūm水蒸气疗法似乎对治疗大尺寸前列腺的BPH有效。此外,它显示出性功能受损风险低,表明安全性良好。

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