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而提交的，旨在延续马里兰州大学巴尔的摩（UMB）的泌尿系统疾病治疗网络（UMN）临床中心。II期将重点开展中段尿道吊带试验（TOMUS）以及继续I期SISTEr和BE-DRI研究（即E-SISTEr和E-BE-DRI）的观察性随访研究。TOMUS的主要目的是比较耻骨后和经闭孔尿道中段悬吊术（MUS）在12个月和24个月时压力性尿失禁的客观和主观治愈率。耻骨后入路是所有MUS手术中历史最长、有效性和安全性数据最多的方法，被普遍接受为金标准。经闭孔肌入路远离耻骨后间隙，最有可能改善与原始耻骨上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，但有关安全性和有效性的数据有限。因此，本研究将在一项2组RCT中比较耻骨后和经闭孔（由内向外和由外向内）手术的有效性和安全性。将招募588名患有应激性UI的女性; 65名患者在该临床中心（CC）。E-SISTEr的主要目的是在655名女性的随机队列中比较Burch阴道悬吊术和自体筋膜吊带治疗压力性Ul的长期有效性和耐久性（60个月）; 64名女性入组该CC。E-BE-DRI的主要目的是在307名女性的随机队列中检查在药物治疗基础上增加行为治疗急迫性Ul的长期持久性（26个月）; 26名女性入组该CC。对于所有研究，CC负责患者入组和随访、治疗、数据收集和管理。CC研究人员参与网络活动，包括方案制定、常设委员会和工作组、手稿和演示文稿。基于UMB在第一个资助周期成功招募和保留研究受试者，UMB拥有在TOMUS中取得成功的经验、资源、人员和临床数量。UCN是一个多学科、多中心的研究者小组，致力于关于Ul的预防、评估和管理的高影响力临床研究，以改善成人的生活质量。

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.