Pelvic Floor Disorders Network

盆底疾病网络

• 批准号: 7162309
• 负责人: CHARLES William NAGER
• 金额: $ 24.01万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-11 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7162309
• 关键词: clinical research; clinical trials; cooperative study; data collection methodology /evaluation; exercise; experimental designs; female; female reproductive system disorder; human subject; human therapy evaluation; information dissemination; medical outreach /case finding; muscle strength; outcomes research; patient oriented research; pelvis; physical therapy; preoperative state; quality of life; urinary incontinence; women' s health

DESCRIPTION (provided by applicant): The objectives and aims of this application are for San Diego to become the first western United States clinical site in the Pelvic Floor Disorders Network (PFDN). The San Diego Clinical Site is a collaboration of three medical centers: 1) the University of California, San Diego (UCSD), 2) Kaiser Permanente, San Diego (Kaiser) and the 3) Naval Medical Center, San Diego (NMCSD). This same collaboration in the Urinary Incontinence Treatment Network (UITN) led all sites in patient recruitment for the UITN SISTEr (Stress Incontinence Surgery Treatment Efficacy) trial. The efficiency of the San Diego Clinical Site's efforts was recognized by the PFDN and we were asked to become a subcontract site for the University of Alabama for the Colpopexy and Reduction Efforts (CARE) study. In the brief nine months available before the CARE study ended, San Diego (UCSD and Kaiser only) recruited 19 patients to CARE. This total was more than all but one center during those nine months. We were the third UITN site to reach recruitment goals in the UlTN's BE-DRI (Behavior Enhances Drug Reduction Incontinence) study. Additionally in the UITN, our site has led efforts in the design, protocol development, and workgroup leadership for the UlTN's current study, TOMUS (Trial Of Mid-Urethral Slings). Urodynamic studies are commonly performed in the United States at an annual cost of approximately 400 million dollars. These urodynamic studies are routine preoperative investigations in most centers that have urodynamic capability, yet we do not have evidence that these tests improve outcomes. Our concept proposal is a randomized trial of preoperative urodynamic studies in women with predominant stress urinary incontinence. The primary aim is to determine if preoperative urodynamic studies improve treatment success rates in all women considered candidates for SUI surgery after an office evaluation. We believe that this proposed urodynamics study requires a multi-center randomized clinical trial and has significant relevance to the appropriate evaluation and care of women with pelvic floor disorders, namely urinary incontinence. The proposed study also has potential significant importance for national health care resource allocation and expenditures. The work that the San Diego investigators have done for the UITN in the last five years to develop standardized, quality urodynamic studies make them the ideal investigators to lead this effort. We believe that the PFDN will benefit greatly by the proven ability of the San Diego Clinical Site's demonstrated energy, skills, and leadership.

描述（由申请人提供）：本申请的目的和目标是使圣地亚哥成为骨盆底疾病网络（PFDN）中的第一个美国西部临床研究中心。圣地亚哥临床研究中心是三个医疗中心的合作：1）加州大学圣地亚哥分校（UCSD），2）Kaiser Permanente，圣地亚哥（Kaiser）和3）海军医疗中心，圣地亚哥（NMCSD）。泌尿外科治疗网络（UNAN）中的这一相同合作导致了UNAN SISTEr（压力抑制手术治疗疗效）试验的患者招募的所有研究中心。圣地亚哥临床研究中心的工作效率得到了PFDN的认可，我们被要求成为亚拉巴马大学Colpopexy and Reduction Efforts（CARE）研究的研究中心。在CARE研究结束前的短短9个月内，圣地亚哥（仅UCSD和Kaiser）招募了19名患者参加CARE。这一总数超过了这九个月内除一个中心外的所有中心。我们是第三个在UlTN的BE-DRI（行为增强药物减少抑制）研究中达到招募目标的CNON网站。此外，在UTN中，我们的研究中心在UlTN当前研究TOMUS（中段尿道吊带试验）的设计、方案开发和临床试验领导方面发挥了主导作用。尿动力学研究通常在美国进行，每年花费约4亿美元。这些尿动力学检查是大多数有尿动力学能力的中心的常规术前检查，但我们没有证据表明这些检查改善了结果。我们的概念建议是一项随机试验，术前尿动力学研究的妇女占主导地位的压力性尿失禁。主要目的是确定术前尿动力学检查是否能提高所有经门诊评估后被认为是SUI手术候选人的女性的治疗成功率。我们认为，这项建议的尿动力学研究需要一个多中心的随机临床试验，并有显着的相关性，以适当的评估和照顾妇女盆底疾病，即尿失禁。这项研究对国家卫生保健资源分配和支出也具有潜在的重要意义。圣地亚哥的研究人员在过去五年中为CNON所做的工作，开发了标准化的，高质量的尿动力学研究，使他们成为领导这项工作的理想研究者。我们相信，PFDN将受益于圣地亚哥临床研究中心所展示的能量、技能和领导能力。