简介:前列腺尿道抬高(PUL)的证据,在治疗男性梗阻性中叶(OML)的下尿路症状/良性前列腺增生(BPH)中,长大了。在这项研究中,我们向相关比较者(接受经尿道前列腺电切术[TURP]和随机对照试验[RCT]假手术治疗的受试者)首次详细比较了在对照和现实环境中接受PUL治疗的OML患者的结局,以证明症状相似。安全,和患者体验结果。材料和方法:在12个月的对照PUL研究中,比较了症状和安全性结果以及患者满意度:BPH6RCT(35名男性随机接受TURP);L.I.F.T.侧叶梗阻患者的关键RCT(66例随机分为假手术组)和MedLift,美国食品药品监督管理局批准的研究设备豁免(IDE)扩展L.I.F.T.审判(45名男性患有OML)。症状改善,导管插入术,我们比较了MedLift受试者和OML患者(n=187)之间的不良事件发生率,该研究是根据基线特征进行PUL过滤的大型真实世界回顾性(RWR)研究,以接近MedLift人群.结果:治疗后,MedLift受试者的国际前列腺症状评分(IPSS)改善比3个月时的假手术高170%,生活质量(QoL)明显更好。Qmax,良性前列腺增生影响指数(BPHII)。与TURP相比,在PUL后的1个月和3个月时,MedLiftIPSS和QoL显着改善,并且在所有时间点射精功能评分均较好。IPSS,QoL,后空隙残留物(PVR),MedLift组和RWROML组在3、6和12个月时的Qmax结果相当。与MedLift相比,RWROML患者没有经历更高的总体不良事件发生率。结论:对照和真实世界的结果证实,对于有和没有OML的BPH患者,PUL是一种安全有效的治疗方法。
Introduction: 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. Materials and Methods: 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 (n = 187) from the large real-world retrospective (RWR)
study of PUL filtered on baseline characteristics to approximate the MedLift population. Results: 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. Conclusion: Controlled and real-world outcomes confirm PUL is a safe and effective treatment for BPH patients with and without OML.