Department of Urology, Urology of Virginia, Virginia Beach, Virginia, USA.
Prisma Health USC Medical Group, Division of Urology, 300 Palmetto Health Pkwy, Columbia.
J Endourol. 2023 Jan;37(1):50-59. doi: 10.1089/end.2022.0324. Epub 2022 Sep 9.
The evidence for prostatic urethral lift (PUL), in treating lower urinary tract symptoms/benign prostatic hyperplasia (BPH) in men with obstructive median lobes (OMLs), has grown. In this study, we present the first detailed comparison of outcomes between OML patients treated with PUL in controlled and real-world settings to relevant comparators (subjects treated with transurethral resection of the prostate [TURP] and sham in randomized controlled trials [RCTs]) to demonstrate similar symptom, safety, and patient experience outcomes. Symptom and safety outcomes and patient satisfaction were compared through 12 months among controlled PUL studies: BPH6 RCT (35 men randomized to TURP); L.I.F.T. pivotal RCT in subjects with lateral lobe obstruction (66 subjects randomized to sham) and MedLift, an U.S. Food and Drug Administration-approved Investigational Device Exemption (IDE) extension of the L.I.F.T. trial (45 men with OML). Symptom improvement, catheterization, and adverse event rates were compared between MedLift subjects and OML patients ( = 187) from the large real-world retrospective (RWR) study of PUL filtered on baseline characteristics to approximate the MedLift population. Posttreatment, International Prostate Symptoms Score (IPSS) improvement for MedLift subjects was 170% greater compared with sham at 3 months with significantly better quality of life (QoL), Qmax, and benign prostatic hyperplasia impact index (BPHII). Compared with TURP, MedLift IPSS and QoL improved significantly better at 1 and 3 months and with superior ejaculatory function scores at all time points after PUL. IPSS, QoL, postvoid residual (PVR), and Qmax outcomes were equivalent between MedLift and RWR OML groups at 3, 6, and 12 months. RWR OML patients did not experience higher rates of overall adverse events compared with MedLift. Controlled and real-world outcomes confirm PUL is a safe and effective treatment for BPH patients with and without OML.
前列腺尿道提升术（PUL）在治疗伴有阻塞性中叶（OML）的男性下尿路症状/良性前列腺增生（BPH）方面的证据不断增加。在这项研究中，我们首次详细比较了在对照和真实环境中接受 PUL 治疗的 OML 患者与相关对照（接受经尿道前列腺切除术 [TURP] 和随机对照试验 [RCT] 中的假手术）的结果，以证明相似的症状、安全性和患者体验结果。通过对照 PUL 研究的 12 个月比较了症状和安全性结局以及患者满意度：BPH6 RCT（35 名随机分配至 TURP 的男性）；L.I.F.T. 关键 RCT 中侧叶阻塞患者（66 名随机分配至假手术）和 MedLift，L.I.F.T. 试验的美国食品和药物管理局批准的研究性器械豁免（IDE）扩展（45 名 OML 男性）。MedLift 受试者与来自大型真实世界回顾性（RWR）研究的 OML 患者（ = 187）比较了症状改善、导尿和不良事件发生率，该研究基于基线特征对 PUL 进行了过滤，以近似 MedLift 人群。治疗后，MedLift 受试者的国际前列腺症状评分（IPSS）在 3 个月时较 sham 组改善了 170%，生活质量（QoL）、最大尿流率（Qmax）和良性前列腺增生影响指数（BPHII）显著改善。与 TURP 相比，MedLift 在 1 个月和 3 个月时 IPSS 和 QoL 改善明显更好，并且在 PUL 后所有时间点的射精功能评分均更高。在 3、6 和 12 个月时，MedLift 和 RWR OML 组的 IPSS、QoL、剩余尿量（PVR）和 Qmax 结局均相当。RWR OML 患者与 MedLift 相比，并未经历更高的总体不良事件发生率。对照和真实世界的结果证实，PUL 是治疗伴有和不伴有 OML 的 BPH 患者的安全有效的治疗方法。
