Urinary Incontinence Treatment Network (UITN)

描述(由申请人提供)：本提案是为了响应RFA-DK-06-501，继续在马里兰大学巴尔的摩分校(UMB)建立尿失禁治疗网络(UITN)临床中心而提交的。第二阶段将集中于进行尿道中间吊带(TOMUS)试验，以及对第一阶段的SISTER和BE-DRI研究(即E-SISTER和E-BE-DRI)的观察性随访研究的继续。TOMUS的主要目标是比较12个月和24个月耻骨后和经膀胱膀胱吊带(MUS)手术的压力性尿失禁的客观和主观治愈率。耻骨后入路是历史最长、所有MUS手术的有效性和安全性方面可获得最多数据的方法，被公认为黄金标准。经耻骨上突入路远离耻骨后间隙，最有可能改善与原始耻骨后手术相关的罕见但重大的风险。这些程序的性能正在迅速提高，有关安全性和有效性的现有数据有限。因此，本研究将比较双臂RCT中耻骨后和经耻骨后(由内向外和由外向内)手术的有效性和安全性。588名有应激性UL的女性将被纳入研究；65名患者在该临床中心(CC)。E-SISTER的主要目的是比较Burch悬吊术和自体筋膜悬吊术治疗应激性尿失禁的长期有效性和耐用性(60个月)，随机选择655名女性作为研究对象。参加了这项研究。E-BE-DRI的主要目的是在307名妇女的随机队列中检验在药物治疗的基础上加用行为疗法治疗UL的长期持久性(26个月)；26名妇女在这项CC中登记。对于所有研究，CC负责患者登记和随访、治疗、数据收集和管理。协调委员会调查员参加网络活动，包括制订礼仪、常设委员会和工作组、手稿和陈述。基于UMB在第一个资助周期成功招募和保留研究对象，UMB拥有在TOMUS取得成功的经验、资源、人员和临床数量。UITN是一个多学科、多中心的研究小组，致力于UL的预防、评估和管理方面的高影响力临床研究，以提高成年人的生活质量。

DESCRIPTION (provided by applicant): This proposal is submitted in response to RFA-DK-06-501 for continuation of the Urinary Incontinence Treatment Network (UITN) Clinical Center at University of Maryland Baltimore (UMB). Phase II will focus on conduct of the Trial of Mid-Urethral Slings (TOMUS) trial as well as continuation of the observational follow- up studies for the SISTEr and BE-DRI studies (i.e. E-SISTEr and E-BE-DRI) of Phase I. Primary Aims of TOMUS are to compare objective and subjective cure rates for stress incontinence at 12 and 24 months between the retropubic and transobturator midurethral sling (MUS) procedures.The retropubic approach, with the longest history and most available data on efficacy and safety of all MUS procedures, is generally accepted as the gold standard. The transobturator approach stays out of the retropubic space and offers the most potential for improving the rare but significant risks associated with the original retorpubic procedure. Performance of these procedures is increasing rapidly with limited data available on safety and efficacy. Therefore, this study will compare the efficacy and safety of the retropubic and transobturator (inside-out and outside-in) procedures in a 2-arm RCT. 588 women with stress Ul will be enrolled; 65 patients at this clinical center (CC). The Primary Aim of E-SISTEr is to compare long-term effectiveness and durability (60 mos) of the Burch colposuspension and autologous fascial sling for treatment of stress Ul in a randomized cohort of 655 women; 64 are enrolled at this CC. The Primary Aim of E-BE-DRI is to examine long-term durability (26 mos) of the addition of behavioral treatment to drug therapy for treatment of urge Ul in a randomized cohort of 307 women; 26 are enrolled at this CC. For all studies, the CC is responsible for patient enrollment and follow-up, treatment, data collection and management. CC investigators participate in network activities, including protocol development, standing committees and work groups, manuscripts and presentations. Based on UMB's successful recruitment and retention of study subjects in the first funding cycle, UMB has the experience, resources, personnel and clinical volume to be successful in TOMUS. The UITN is a multi- disciplinary, multi-center group of Investigators dedicated to high impact clinical research regarding the prevention, evaluation and management of Ul to improve the quality of life for adults.