Minimally Invasive Surgical Therapies Treatment Consort*

描述(由申请人提供)： 良性前列腺增生症引起的下尿路症状 (BPH)是老年男性中非常常见的发现，并表现出相当健康的状态 在发病率和卫生保健资源方面的护理负担 利用率。除了标准的治疗方法外，经尿道电切术 前列腺(TURP)、内科治疗和微创外科治疗 (雾化)是在过去十年中发展起来的，它被用来改变 有学位的。从根本上讲，关于相对有效性和安全性的信息， 以及这些手术在门诊环境下的耐受性 局部麻醉，重要的是，初步结果的持久性超过 缺乏中间的随访期。此外，由于缺乏 了解一些治疗的作用机制，有以下几种 没有已知的基线参数可用作成功预测 结果。MIST研究小组将开发几个临床试验方案来 在5年内解决这些问题。一项四臂随机试验 TURP与TUMT、金枪鱼与ILTT的安全性和有效性比较 建议招募600名中到重度LUTS患者进行随访 15个中心的良性前列腺增生症是MIST研究小组与 目标如下：(1)。测定三种不同最低限度的药效 侵入性外科治疗(雾化：TUMT、金枪鱼、组织间激光热疗 治疗)与标准治疗TURP的疗效比较 通过标准化的症状严重程度评估来衡量电灼术 仪器(2)。确定三种不同药物的安全性和耐受性 微创疗法(TUMT、金枪鱼、组织间激光热疗) 对LUTS和临床BPH与标准治疗TURP的比较 电灼术(3)。确定再治疗或二次治疗的比率 雾化干预后与标准治疗TURP的比较 电灼疗法。(4)确定治疗前的尿流动力学状态是否影响 根据症状改善定义的治疗结果。(五)确定 排尿后最大尿流率测定的相对疗效 剩余尿量、前列腺体积变化、血清PSA变化。在.期间 在这一初审过程中，MIST研究小组将定期开会，以 进行第二次、第三次和后续试验。这些额外试验的性质 将取决于需求评估、新的雾化干预措施的开发、 初审结果及其他因素。迷雾研究 小组将是适用于其他部门的技术评估小组的蓝图 泌尿科和其他内科或外科专科领域。

DESCRIPTION (provided by applicant): Lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) are very common findings in aging men and present a considerable health care burden both in terms of morbidity as well as health care resource utilization. Aside from the standard therapy transurethral resection of the prostate (TURP), medical therapies and minimally invasive surgical therapies (MIST) have been developed over the past decade, which are utilized to varying degreed. Fundamentally, information regarding the relative efficacy and safety, as well as tolerability of these procedures in an outpatient setting under local anesthesia, and importantly, durability of the initial results over intermediate follow-up periods is lacking. Further, due to a lack of understanding of the mechanism of action of some of the treatments, there are no known baseline parameters that could be used as predictors of a successful outcome. The MIST Study Group will develop several clinical trial protocols to address these issues over a 5 year time period. A four-arm randomized trial comparing the safety and efficacy of TURP vs TUMT vs TUNA vs ILTT with a 3 year follow-up is proposed enrolling 600 patients with moderate to severe LUTS and BPH at 15 centers as the first study done by the MIST Study Group with the following objectives: (1). Determine the efficacy of three different minimally invasive surgical therapies (MIST: TUMT, TUNA, Interstitial Laser Thermal Therapy) for LUTS and clinical BPH compared with the standard treatment TURP by electrocautery as measured by a standardized symptom severity assessment instrument (2). Determine the safety and tolerability of three different minimally invasive therapies (TUMT, TUNA, Interstitial Laser Thermal Therapy) for LUTS and clinical BPH compared with the standard treatment TURP by electrocautery (3). Determine the rate of retreatment or secondary treatments following the MIST intervention compared with the standard treatment TURP by electrocautery. (4) Determine whether pre-treatment urodynamic status impacts upon the treatment outcome as defined by symptomatic improvement. (5) Determine the relative efficacy as measured by maximum urinary flow rate, post-void residual urine volume, prostate volume changes, and serum PSA changes. During the course of this first trial, the MIST Study Group will meet regularly to develop a 2nd, 3rd and subsequent trials. The nature of these additional trials will depend on a needs assessment, the development of new MIST interventions, the findings obtained in the first trial and other factors. The MIST Study Group will be a blueprint for a technology assessment group applicable to other areas of urology and other medical or surgical subspecialties.