Benign prostate hyperplasia: minimally invasive surgery

良性前列腺增生：微创手术

• 批准号: 6439416
• 负责人: CLAUS G ROEHRBORN
• 金额: $ 10万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6439416
• 关键词: adult human (21+); benign prostate hyperplasia; blood tests; clinical trials; cooperative study; disease /disorder prevention /control; human subject; human therapy evaluation; hyperthermia therapy; laser therapy; longitudinal human study; magnetic resonance imaging; male; microwave radiation; outcomes research; patient oriented research; prostate surgery; relapse /recurrence; statistics /biometry; ultrasound; urinary catheterization

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.

描述（由申请人提供）： 前列腺增生引起的下尿路症状（LUTS） (BPH)在老年男性中非常常见， 在发病率和卫生保健资源方面的保健负担 利用率除了标准治疗外， 前列腺（TURP），药物治疗和微创手术治疗 （MIST）在过去十年中已经开发出来，用于不同的 度。从根本上讲，关于相对有效性和安全性的信息， 以及这些程序在门诊环境中的耐受性， 局部麻醉，重要的是，最初结果的持久性超过 缺乏中期后续行动。此外，由于缺乏 了解一些治疗的作用机制，有 没有已知的基线参数可用作成功的 结果。MIST研究小组将制定几项临床试验方案， 在5年时间内解决这些问题。一项四臂随机试验 比较TURP与TUMT与TUNA与ILTT的安全性和有效性， 拟对600例中度至重度LUTS患者进行随访， 作为MIST研究组与15个中心的BPH进行的第一项研究， 以下目标：（1）。确定三种不同的最低限度 侵入性外科治疗（MIST：TUMT、TUNA、组织间激光热疗 治疗）与标准治疗TURP相比， 通过标准化症状严重程度评估测量的电烙术 仪器（2）。确定三种不同药物的安全性和耐受性 微创治疗（TUMT、TUNA、组织间激光热疗） 对于LUTS和临床BPH与标准治疗TURP相比， 电烙术（3）。确定再治疗或二次治疗的比率 MIST干预后与标准治疗TURP相比， 电烙术(4)确定治疗前尿动力学状态是否影响 根据症状改善定义的治疗结果。(5)确定 通过排尿后最大尿流率测量的相对疗效 残余尿量、前列腺体积变化和血清PSA变化。期间 在第一次试验过程中，MIST研究小组将定期开会， 进行第二、第三次和随后的试验。这些额外审判的性质 将取决于需求评估，新的MIST干预措施的制定， 第一次审判的结果和其他因素。MIST研究 技术评估小组将是一个适用于其他 泌尿科和其他内科或外科专科领域。