有证据表明,前列腺尿道抬高(PUL)在低发病率的症状性BPH中显着改善,仅基于侧叶(LL)增大的受试者。MedLift是L.I.F.T.的FDAIDE扩展。随机研究旨在检查PUL治疗梗阻性中叶(OML)的安全性和有效性。此非随机队列的纳入标准与L.I.F.T.随机研究,除了要求OML:≥50岁,IPSS≥13,Qmax≤12ml/s。主要终点分析量化IPSS相对于基线的改善和术后严重并发症的发生率。量化症状缓解,生活质量,流量,性功能持续12个月。将结果与历史L.I.F.TLL结果进行比较,并结合起来证明了PUL的全部有效性。在71名筛选的受试者中,45人报名参加。在1、3、6和12个月时,平均IPSS比基线改善至少13.5个百分点(p<0.0001)。生活质量和BPHII也得到了类似的改善(>60%和>70%,分别在3、6和12个月时,p<0.0001)。平均Qmax改善范围为90%至129%(p<0.0001)。在1个月,86%(CI73-94%)在回收质量量表上报告≥70,80%(CI66-89%)报告“好多了”或“好多了”,89%(CI76-95%)会推荐该程序。与LL科目相比,OML受试者的症状在每个时间点改善至少一样多(OML范围13.5-15.9,LL范围9.9-11.1,p≤0.01)。在结合OML和LL数据时,>70%(范围CI63-81%)的受试者在12个月内表现出IPSS改善≥8点。对组合数据集的分析表明,≥40%(CI30-51%)的性活跃男性在12个月内改善了勃起功能的最小临床重要差异。前列腺,包括患有中叶梗阻的人,可以安全有效地使用PUL程序进行治疗。
Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized
study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized
study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73-94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66-89%) reported being \"much\" or \"very much better,\" and 89% (CI 76-95%) would recommend the procedure. Compared to LL subjects, OML subjects\' symptoms improved at least as much at every time point (OML range 13.5-15.9, LL range 9.9-11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63-81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30-51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.