UTAH URINARY INCONTINENCE TREATMENT NETWORK (UUITN)

描述(由申请人提供)：本提案是针对犹他州大学尿失禁治疗网络(UITN)临床中心(CC)的延续RFA-DK-06-501而提交的。第二阶段将集中于TOMUS试验的进行以及对第一阶段的SISTER和BE-DRI研究(即E-SISR和E-BE-DRI)的观察性后续研究的继续。TOMUS的主要目标是比较12个月和24个月时耻骨后和经膀胱尿道悬吊术(MU)的压力性尿失禁的客观和主观治愈率。耻骨后入路是所有MU手术中历史最长、获得的有效性和安全性数据最多的，被公认为黄金标准。经鼻大嘴入路远离耻骨后间隙，为改善最初耻骨后手术罕见但重大的风险提供了最大的潜力。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名患有应激性UL的女性将被纳入；65名患者在这个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UL的长期有效性和耐用性(60个月)，随机选择655名女性；71名参加这项CC。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)；22名妇女在这项CC中登记。对于所有研究，犹他州CC负责患者登记和随访、治疗、数据收集和管理。犹他州CC调查员参加网络活动，包括制定协议、常设委员会和工作组、手稿和演示文稿。具体地说，犹他州为UITN做出了贡献，倡导SISTER的随机手术设计，共同主持BE-DRI方案委员会，并在重要的工作组，如并发症和尿动力学，以及重要的常设委员会，如出版物和演示。UITN是一个多学科、多中心的研究小组，致力于关于尿失禁的预防、评估和管理的高影响力临床研究，以改善成年人的生活质量。

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 (CC) at the University of Utah. Phase II will focus on conduct of the 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 procedures (MUS).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 retropubis 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 CC. 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; 71 are enrolled at this CC. 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; 22 are enrolled at this CC. For all studies, the Utah CC is responsible for patient enrollment and follow-up, treatment, data collection and management. Utah CC investigators participate in network activities, including protocol development, standing committees and work groups, manuscripts and presentations. Specifically, Utah has contributed to the UITN by advocating the randomized surgical design of SISTEr, by co-chairing the BE-Dri protocol committee, and in important work groups such as complications and urodynamics, along with important standing committees such as Publications and Presentations. The UITN is a multi-disciplinary, multi-center group of investigators dedicated to high impact clinical research regarding the prevention, evaluation, and management of UI to improve the quality of life for adults.