UTAH URINARY INCONTINENCE TREATMENT NETWORK (UUITN)

犹他州尿失禁治疗网络 (UUITN)

• 批准号: 7214284
• 负责人: PEGGY A NORTON
• 金额: $ 26.58万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7214284
• 关键词: clinical research; clinical trials; cooperative study; female; human subject; human therapy evaluation; longitudinal human study; patient oriented research; postoperative state; quality of life; stress; urinary incontinence; urinary tract surgery; women' s health

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.

描述（由申请人提供）：本提案是根据RFA-DK-06-501提交的，旨在继续犹他大学尿失禁治疗网络（UITN）临床中心（CC）。II期将重点进行TOMUS试验，并继续对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悬吊手术（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。经闭锁入路避开耻骨后空间，为改善与原始耻骨后手术相关的罕见但显著的风险提供了最大的潜力。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；E-SISTEr的主要目的是在655名女性随机队列中比较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多）；E-BE-DRI的主要目的是在307名女性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，犹他中心负责患者的入组、随访、治疗、数据收集和管理。犹他州CC调查人员参与网络活动，包括协议制定，常设委员会和工作组，手稿和演示。具体来说，犹他州通过倡导SISTEr的随机手术设计、联合主持BE-Dri协议委员会、在并发症和尿动力学等重要工作组以及出版物和报告等重要常设委员会中为unitn做出了贡献。UITN是一个多学科、多中心的研究小组，致力于有关uui的预防、评估和管理的高影响力临床研究，以提高成人的生活质量。