TUMT verses Medical Therapy in Treatment of BPH

TUMT 与药物治疗治疗 BPH 的比较

• 批准号: 6524641
• 负责人: E DAVID CRAWFORD
• 金额: $ 30.94万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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/6524641
• 关键词: adult human (21+); antiadrenergic agents; benign prostate hyperplasia; blood tests; clinical trials; cooperative study; diagnosis design /evaluation; disease /disorder prevention /control; health care cost /financing; human subject; human therapy evaluation; hyperthermia therapy; longitudinal human study; male; microwave radiation; outcomes research; patient oriented research; prognosis; reproductive system disorder chemotherapy; statistics /biometry; ultrasonography; urinalysis; urinary catheterization

DESCRIPTION (provided by applicant): Lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) are common in the aging male. There are few well-designed, long-term, mufti-center randomized clinical trials comparing the subjective and objective outcomes of minimally invasive surgical therapies (MIST). AIM 1.To participate in the collaborative Prostate Evaluation and Treatment Centers (PETCs) that will develop: a) Standardized assessment instruments for the diagnosis and classification of symptomatic BPH in men above the age of 50; b) Clinical trial protocols that will compare the outcomes of treatments to improve symptomatic BPH. The primary focus of Aim 1 is to incorporate our BPH research team as PETC. The PI and the BPH research team assembled for this project have had broad experience in the design, implementation and analysis of BPH research. We have successfully participated in 10 BPH trials including 2 VA Cooperative trials, pharmaceutical sponsored trials, a local investigator initiated trial, and both phases of the Medical Therapy of Prostatic Symptoms trials (MTOPS). Our patient retention and adherence has consistently been in the top 25 percent. The medical center hospitals provide more than an adequate number of patients to meet recruitment goals. AIM 2. To establish and implement a prospective randomized controlled trial for treatment of BPH that will: a) establish the treatment outcome for medical therapy versus minimally invasive therapy as the primary mode of therapy; b) determine which of the following predict successful treatment outcomes: 1) Patient characteristics including AUA symptoms score, uroflow rate, and prostate size; 2) Urodynamic parameters; 3) determine the cost of achieving the treatment outcome. The goal of Aim 2 is a randomized clinical trial (RCT) to evaluate the efficacy and effectiveness of the minimally invasive therapy of transurethral microwave thermotherapy (TUMT). Our hypothesis is that TUMT in patients with minimal or moderate symptoms secondary to BPH will be both more efficicacious and effective than medical therapy and reduce overall health care dollars expenditures. The RCT will compare the best arm of the current MTOPS trial to TUMT. TUMT was chosen as the MIST, because it meets the criteria of being truly "minimally invasive." Unfortunately, there has been lack of uniform entry criteria, lack of consistent follow-up and scarce data on long-term outcomes (effectiveness) and costs. The RCT will compare a sham TUMT and medical therapy to TUMT treatment in a double blind manner. Medical therapy was chosen over TURP for the comparison because there is more "overlap" of TUMT with this therapy than with transurethral resection of the prostate (TURP) (Figure 1). Health care economics dictate that the short and long-term costs of BPH therapy need to be addressed. The PI has enlisted the support of consultants who will assist in this important evaluation. The results of this analysis will be critical in allocating health care resources.

描述(由申请人提供)： 下尿路症状(LUTS)提示良性前列腺梗阻 (BPO)在老年男性中很常见。很少有精心设计的、长期的、 主客观对照的多中心随机临床试验 微创手术治疗的结果(MIST)。 目的1.参与协作式前列腺评估和治疗 中心(PETC)将制定：a)标准化评估工具 50岁以上男性症状性前列腺增生症的诊断和分类； B)临床试验方案，将治疗结果与 改善症状性前列腺增生症。目标1的主要重点是将我们的BPH 研究团队，Pet等。PI和BPH研究小组为此聚集在一起 项目具有丰富的设计、实施和分析经验 前列腺增生症研究。我们已经成功地参与了10次BPH试验，其中包括2次VA 合作试验、药物赞助试验、当地研究人员 启动试验和前列腺癌症状药物治疗的两个阶段 试验(MTOPS)。我们的耐心保持和坚持不懈一直在 收入最高的25%。医疗中心医院提供了足够的 达到招募目标的患者数量。 目的2.建立和实施一项前瞻性随机对照试验 前列腺增生症的治疗将：a)确定医学上的治疗结果 治疗与微创治疗作为主要治疗模式的比较；b) 确定以下哪项可预测成功的治疗结果：1) 患者特征包括AUA症状评分、尿流率和 前列腺大小；2)尿动力学参数；3)决定实现 治疗结果。目标2的目标是一项随机临床试验(RCT) 评价微创治疗食管炎的疗效和疗效 经尿路微波热疗(TUMT)。我们的假设是TUMT在 继发于BPH的轻微或中度症状的患者 比药物治疗更有效和有效，减少整体医疗保健 美元支出。RCT将比较当前MTOPS的最佳ARM 审判到TUMT。TUMT之所以被选为雾，是因为它符合 做到真正的“微创”。不幸的是，一直没有统一的制服 进入标准、缺乏一致的后续行动和关于长期的稀缺数据 结果(有效性)和成本。随机对照试验将比较假TUMT和 内科治疗以双盲方式进行TUMT治疗。药物治疗是 选择TURP而不是TURP进行比较，因为TUMT有更多的重叠 这种治疗方法比经尿道前列腺电切术(TURP)更有效。 (图1)。医疗保健经济学规定，短期和长期成本 良性前列腺增生症的治疗需要解决。国际和平协会已争取到 将协助这一重要评估的顾问。这样做的结果 分析将是分配卫生保健资源的关键。