Minimally Invasive Surgery For BPH

描述(由申请人提供)： 这项申请的目标是梅奥泌尿外科 明尼苏达州罗切斯特的诊所将成为前列腺评估和 微创外科治疗的一部分--治疗中心(S) (雾状)RFA DK-01-024中描述的BPH治疗联盟。目的 MIST联盟将开展微创技术的合作研究 下尿路症状(LUTS)和良性疾病的外科治疗 未来五年的前列腺增生症(BPH)。微创 近年来，手术治疗前列腺增生症被认为是一种有效和 替代标准经尿道前列腺电切术的高性价比选择 经尿道前列腺电切术(TURP)和开放前列腺切除术治疗某些典型症状的前列腺癌 前列腺增生症。大多数泌尿科医生现在认识到，微创手术 治疗方法在药物治疗和外科治疗之间占据了一个有用的位置。 需要住院治疗的程序。然而，正如 RFA，已发表的关于微创疗法的报告具有很高的可变性 入院标准和跟踪时间短，文件不充分 随访和不良事件，以及缺乏关于手术后的信息 药物疗法。大多数研究都是由设备制造商资助的， 可能不像由独立小组进行的研究那样客观 比如MIST财团。因为有据可查的执行兴趣 本机构治疗良性前列腺增生症的微创手术治疗 过去成为合作联盟学习有用成员的经验 我们相信，我们可以为前列腺疾病的研究做出有益的贡献 前列腺增生症的微创手术治疗等。 作为可以在此中执行的雾研究类型的一个例子 倡议，我们提出了前瞻性的多中心随机阶段III 高功率KTP激光前列腺汽化电切术(LVP)与传统手术的比较 Urologix Targis T3经尿道微波热疗 设备。170名患者将被随机分配到每个治疗组。 随访期为治疗后2年。

DESCRIPTION (provided by applicant): The objective of this application is for the Department of Urology, Mayo Clinic, Rochester, Minnesota, to become one of the Prostate Evaluation and Treatment Centers (PETC?s) as part of the Minimally Invasive Surgical Therapies (MIST) Treatment Consortium for BPH described in RFA DK-01-024. The purpose of the MIST consortium is to carry out collaborative studies of minimally invasive surgical treatments for lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH) over the next five years. Minimally invasive surgical therapies for BPH recently have been recognized as an efficient and cost-effective alternative to standard transurethral resection of the prostate (TURP) and open prostatectomy for certain patients with typical symptoms of prostatism. Most urologists now recognize that minimally invasive surgical therapies occupy a useful niche between pharmacologic therapy and surgical procedures which require inpatient hospitalization. However, as stated in the RFA, published reports about minimally invasive therapies are highly variable in entry criteria and have short periods of follow-up, inadequate documentation of follow-up and adverse events, and absence of information on post-surgical pharmacologic therapy. Most studies have been funded by the device makers and are probably not as objective as studies carried out by an independent group such as the MIST consortium. Because of documented interest in carrying out minimally invasive surgical therapies for BPH at this institution as well as past experience of being a useful member of collaborative consortia studying prostate diseases, we believe we can make a useful contribution to the study of Minimally Invasive Surgical Therapies for BPH as a PETC. As an example of the type of MIST research which could be performed in this initiative, we propose a prospective multicenter randomized Phase III comparison of high power KTP laser vaporization prostatectomy (LVP) versus transurethral microwave thermotherapy (TUMT) using the Urologix Targis T3 device. One hundred seventy patients would be randomized to each treatment arm. Follow-up period would be 2 years post-treatment.