经会阴激光消融与 TURP 治疗良性前列腺梗阻后射精功能的比较：一项随机试验。

Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial.

机构信息

Department of Urology, San Carlo di Nancy Hospital, Rome, Italy.

Department of Life, Health and Environmental Sciences, Urology Unit, University of L'Aquila, Coppito, Italy.

出版信息

BJU Int. 2023 Jul;132(1):100-108. doi: 10.1111/bju.16008. Epub 2023 Mar 30.

DOI:10.1111/bju.16008

PMID:36917033

Abstract

OBJECTIVES

To evaluate the reliability of transperineal interstitial laser ablation of the prostate (TPLA) in preserving antegrade ejaculation compared to transurethral resection of the prostate (TURP).

PATIENTS AND METHODS

In this single-centre, prospective, randomized, open-label study, consecutive patients with indication for surgical treatment for benign prostatic obstruction (BPO) were enrolled between January 2020 and September 2021 (NCT04781049). Patients were randomized to one of two treatment arms: Group A: TPLA (experimental group) and Group B: TURP (reference standard group). The primary endpoint was change in ejaculatory function (assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain [EJ-MSHQ]) at 1 month after surgery. Secondary endpoints included comparison of visual analogue scale (VAS) scores, changes in sexual function (assessed using the five-item International Index of Erectile Function [IIEF-5]), change in International Prostate Symptom Score [IPSS], change in quality of life score, and maximum urinary flow rate [Q ] improvement at 1-6 months, as appropriate.

RESULTS

Fifty-one patients (26 TPLA vs 25 TURP) were analysed. No differences in the perception of pain assessed by VAS and no differences in IIEF-5 score were found between the groups. The distribution of ejaculatory function assessed by the EJ-MSHQ remained unmodified after TPLA (P = 0.2), while a median 30% decrease in EJ-MSHQ score was observed after TURP (P = 0.01). Absence of antegrade ejaculation was reported in one patient in the TPLA group (vs 18 patients in the TURP group). A statistically significant difference between the treatment groups was found in terms of postoperative Q (TPLA vs TURP: 15.2 [interquartile range 13.5-18.3] mL/s vs 26.0 [interquartile range 22.0-48.0] mL/s; P < 0.001). Both treatments significantly improved Q , with a mean 23.9 mL/s improvement after TURP (95% confidence interval [CI] 17.1-30.7) vs 6.0 mL/s after TPLA (95% CI 5.0-7.0), and IPSS, with a mean decrease of 11.6 (95% CI 9.7-13.5) vs 5.8 after TPLA (95% CI.2-9.6) with respect to baseline.

CONCLUSION

In our study, TPLA preserved ejaculatory function in 96% of cases in addition to providing significant relief from BPO.

摘要

目的

评估经会阴前列腺间质激光消融术（TPLA）在保留顺行射精方面的可靠性，与经尿道前列腺切除术（TURP）相比。

患者和方法

在这项单中心、前瞻性、随机、开放标签研究中，2020 年 1 月至 2021 年 9 月间连续纳入有手术治疗良性前列腺梗阻（BPO）指征的患者（NCT04781049）。患者被随机分配到以下两个治疗组之一：A 组：TPLA（实验组）和 B 组：TURP（参考标准组）。主要终点是术后 1 个月时射精功能的变化（通过男性性健康问卷-射精功能域[EJ-MSHQ]评估）。次要终点包括比较视觉模拟量表（VAS）评分、性功能变化（使用五分量表国际勃起功能指数[IIEF-5]评估）、国际前列腺症状评分[IPSS]变化、生活质量评分变化和最大尿流率[Q]改善在 1-6 个月内，视情况而定。

结果

分析了 51 例患者（26 例 TPLA 与 25 例 TURP）。两组之间 VAS 评估的疼痛感知没有差异，IIEF-5 评分也没有差异。TPLA 后 EJ-MSHQ 评估的射精功能分布保持不变（P=0.2），而 TURP 后 EJ-MSHQ 评分中位数下降 30%（P=0.01）。TPLA 组有 1 例患者报告无顺行射精（与 TURP 组的 18 例患者相比）。两组间术后 Q 存在统计学显著差异（TPLA 与 TURP：15.2 [四分位距 13.5-18.3] mL/s 与 26.0 [四分位距 22.0-48.0] mL/s；P<0.001）。两种治疗方法均显著改善 Q，TURP 后平均改善 23.9 mL/s（95%置信区间[CI] 17.1-30.7），TPLA 后 6.0 mL/s（95% CI 5.0-7.0），IPSS 分别平均下降 11.6（95% CI 9.7-13.5）和 5.8（95% CI.2-9.6）。