TUMT verses Medical Therapy in Treatment of BPH

描述（由申请人提供）： 提示良性前列腺梗阻的下尿路症状 (LUTS) (BPO) 在老年男性中很常见。很少有精心设计的、长期的、 比较主观和客观的多中心随机临床试验 微创手术治疗（MIST）的结果。 目的1.参与协作前列腺评估和治疗 中心（PETC）将开发： a) 标准化评估工具 50 岁以上男性有症状 BPH 的诊断和分类； b) 临床试验方案，将治疗结果与 改善症状性良性前列腺增生。目标 1 的主要重点是将我们的 BPH 纳入 研究团队为PETC。 PI 和 BPH 研究团队为此集结 项目的设计、实施和分析方面拥有丰富的经验 良性前列腺增生研究。我们已成功参与 10 项 BPH 试验，其中包括 2 项 VA 合作试验、药物赞助试验、当地研究者 启动试验，前列腺症状药物治疗的两个阶段 试验（MTOPS）。我们的患者保留率和依从性一直保持在 前 25%。医疗中心医院提供充足的医疗服务 满足招募目标的患者数量。 目标 2. 建立并实施一项前瞻性随机对照试验 BPH 的治疗将： a) 确定医疗治疗结果 治疗与微创治疗作为主要治疗方式； b) 确定以下哪一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）确定实现目标的成本 治疗结果。目标 2 的目标是一项随机临床试验 (RCT) 评估微创治疗的疗效和有效性 经尿道微波热疗（TUMT）。我们的假设是 TUMT 继发于 BPH 的轻度或中度症状的患者会更容易 比药物治疗有效有效并减少整体医疗保健 美元支出。 RCT将比较当前MTOPS的最佳手臂 试用 TUMT。 TUMT 被选为 MIST，因为它满足以下标准： 真正做到“微创”。不幸的是，缺乏统一的 准入标准、缺乏一致的后续行动以及长期数据稀缺 结果（有效性）和成本。 RCT 将比较假 TUMT 和 以双盲方式进行药物治疗和TUMT治疗。药物治疗是 选择 TURP 进行比较，因为 TUMT 有更多“重叠” 这种疗法优于经尿道前列腺电切术 (TURP) （图1）。医疗保健经济学决定了短期和长期成本 BPH 治疗需要解决。 PI 已获得以下机构的支持 将协助这项重要评估的顾问。这样做的结果 分析对于分配医疗保健资源至关重要。

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.