Minimally Invasive Surgery For BPH

描述（由申请人提供）： 本申请的目的是为马约泌尿科 诊所，罗切斯特，明尼苏达州，成为前列腺评估和 治疗中心（PETC？s）作为微创外科治疗的一部分 RFA DK-01-024中描述的BPH（MIST）治疗联盟。的目的 MIST联盟将开展微创的合作研究， 下尿路症状（LUTS）和良性疾病的手术治疗 前列腺增生症（BPH）在未来五年。微创 前列腺增生症的外科治疗最近被认为是一种有效的， 经尿道前列腺切除术的一种经济有效的替代方法 （TURP）和开放性前列腺切除术对于某些具有典型症状的患者， prophylm.大多数泌尿科医生现在认识到， 治疗占据了药物治疗和手术治疗之间的一个有用的利基 需要住院治疗的程序。然而，正如《世界人权宣言》所述， RFA，已发表的关于微创治疗的报告具有高度可变性 在进入标准中，后续行动时间短，文件不足， 随访和不良事件，以及缺乏术后信息 药物治疗大多数研究都由设备制造商资助， 可能不像一个独立小组进行的研究那样客观 如MIST联盟。因为有文件证明他们有兴趣 该机构对BPH的微创手术治疗以及 过去作为合作财团的有用成员的经验 前列腺疾病，我们相信我们可以作出有益的贡献， BPH的微创手术治疗作为PETC。 作为一个例子，MIST研究的类型，可以在这个 我们提出了一项前瞻性多中心随机III期研究， 高功率KTP激光汽化膀胱切除术（LVP）与 使用Urologix Targis T3的经尿道微波热疗（TUMT） 设备. 170例患者将被随机分配至每个治疗组。 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.