Minimally Invasive Surgical Therapies Treatment Consort*

微创手术治疗治疗组合*

• 批准号: 6524643
• 负责人: CLAUS G ROEHRBORN
• 金额: $ 30.92万
• 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 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6524643
• 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）： 良性前列腺增生引起的下尿路症状（LUTS） （BPH）是老年男性中非常常见的症​​状，对健康状况有很大影响 发病率和医疗保健资源方面的护理负担 利用率。除了标准治疗外，还有经尿道切除术 前列腺（TURP）、药物治疗和微创手术治疗 （MIST）在过去十年中得到了发展，它被用于不同的 获得学位。从根本上讲，有关相对功效和安全性的信息， 以及这些手术在门诊环境中的耐受性 局部麻醉，重要的是，初步结果的持久性 缺乏中期随访期。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以用作成功的预测因素 结果。 MIST 研究小组将制定多项临床试验方案 在 5 年时间内解决这些问题。四组随机试验 比较 TURP、TUMT、TUNA、ILTT 3 年的安全性和有效性 建议招募 600 名中度至重度 LUTS 患者进行随访 MIST 研究小组与 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的功效 侵入性手术疗法（MIST：TUMT、TUNA、间质激光热疗 LUTS 和临床 BPH 治疗）与标准治疗 TURP 的比较 通过标准化症状严重程度评估来测量电灼 仪器 (2).确定三种不同药物的安全性和耐受性 微创疗法（TUMT、TUNA、间质激光热疗） 对于 LUTS 和临床 BPH 与标准治疗 TURP 的比较 电灼（3）。确定再治疗或二次治疗的比率 MIST 干预与标准治疗 TURP 的比较 电灼术。 (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功效 残余尿量、前列腺体积变化和血清PSA变化。期间 在首次试验过程中，MIST 研究小组将定期开会，以 开展第二次、第三次及后续试验。这些额外试验的性质 将取决于需求评估、新的 MIST 干预措施的开发， 第一次试验中获得的结果和其他因素。迷雾研究 小组将成为适用于其他小组的技术评估蓝图 泌尿外科和其他医学或外科亚专业领域。