Urinary Incontinence Treatment Network (UITN)

描述（由申请人提供）：本提案是根据RFA-DK-06-501提交的，旨在继续马里兰大学巴尔的摩分校（UMB）尿失禁治疗网络（UITN）临床中心。II期将重点进行中尿道吊带试验（TOMUS），以及继续对i期的SISTEr和BE-DRI研究（即E-SISTEr和E-BE-DRI）进行观察性随访研究。TOMUS的主要目的是比较耻骨后和经闭锁尿道中吊带（MUS）手术在12个月和24个月时压力性尿失禁的客观和主观治愈率。耻骨后入路在所有MUS手术中具有最悠久的历史和最有效的有效性和安全性数据，被普遍接受为金标准。经闭锁入路避开了耻骨后空间，提供了最大的潜力来改善与原始再造手术相关的罕见但显著的风险。这些程序的性能正在迅速提高，但有关安全性和有效性的可用数据有限。因此，本研究将在一项2臂随机对照试验中比较耻骨后和经闭器（由内到外和由外到内）手术的有效性和安全性。588名有压力的女性将被招募；该临床中心（CC） 65例患者。E-SISTEr的主要目的是比较655名女性随机队列中Burch阴道悬吊和自体筋膜悬吊治疗应激性溃疡的长期有效性和持久性（60个月）；E-BE-DRI的主要目的是在307名妇女的随机队列中检查在药物治疗的基础上增加行为治疗的长期持久性（26个）；在所有的研究中，CC负责患者的入组、随访、治疗、数据收集和管理。CC调查员参与网络活动，包括协议制定、常设委员会和工作组、手稿和演示。基于UMB在第一个资助周期成功招募和保留研究对象，UMB拥有成功开展TOMUS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，致力于对Ul的预防、评估和管理进行高影响力的临床研究，以提高成人的生活质量。

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.