ADVANCED POP AND THE URINARY CONTINENCE MECHANISM

描述(申请人提供)：Loyola团队计划参加 临床试验网络，以促进其对 女性盆底疾患的临床护理。多学科交叉 团队具有参与临床试验的数量和已被证明的能力。AS 在RFA中要求，提供了临床研究的概念方案 晚期女性尿失禁机制的相关研究 盆腔器官脱垂。具体地说，申请人提议将 女性固定术时常规与选择性尿路固定术的比较 患有晚期盆腔器官脱垂(POP)。该协议将补充 正在进行的NIDDK试验随机选择真性压力性尿失禁(GSI) Burch尿路固定术与阴部阴道吊带术的比较。女性与 高级流行音乐被排除在试验之外，但构成了大量 受影响的病人。 申请人寻求确定该药的疗效和副作用发生率 在这种情况下，伯奇的尿路固定术。概念性协议比较了两个常见 以确定临床治疗方法的最佳方法。在……里面 此外，申请人计划学习必要的测试水平，以 为个别患者选择最佳方案。 最后，概念方案将使用来自该临床试验的数据 网络提出了一个标准化的命名法来描述 晚期POP妇女的尿失禁状况。 简单地说，概念方案将：确定哪些晚期POP患者 需要哪种尿检，如果有的话；确定疗效和副作用 (横跨整个盆底)常规与选择性Burch尿路固定术； 并提出了一种基于数据的描述尿路的标准化命名法 高级流行音乐女性的可控性状况。

DESCRIPTION (provided by applicant): The Loyola team plans to participate in the Clinical Trials Network in order to advance its understanding of the clinical care of women with pelvic floor disorders. The multi-disciplinary team has the volume and proven ability to participate in clinical trials. As requested in the RFA, a concept protocol is offered that studies clinically relevant aspects of the urinary continence mechanism in women with advanced pelvic organ prolapse. Specifically, the applicant proposes to compare routine versus selective urethropexy at the time of sacrocolpopexy in women with advanced pelvic organ prolapse (POP). This protocol will complement the ongoing, NIDDK trial which randomized genuine stress incontinence (GSI) patients to the Burch urethropexy versus the pubovaginal sling. Women with advanced POP are excluded from that trial, yet constitute a large number of affected patients. The applicant seeks to determine the efficacy and side effect rates for the Burch urethropexy in this setting. The concept protocol compares two common clinical methods of treatment in order to determine the optimal method. In addition, the applicant is planning to study the level of testing necessary to select the best protocol for the individual patient. Finally, the concept protocol will use the data from this clinical trials network to propose a standardized nomenclature to describe the status of the urinary continence status in women with advanced POP. Simply put, the concept protocol will: Determine which advanced POP patients need which urinary testing, if any; Determine the efficacy and side effects (across the whole pelvic floor) of routine versus selective Burch urethropexy; and Propose a data-based standardized nomenclature to describe the urinary continence status of women with advanced POP.