UTAH URINARY INCONTINENCE TREATMENT NETWORK (UUITN)

犹他州尿失禁治疗网络 (UUITN)

• 批准号: 7289803
• 负责人: PEGGY A NORTON
• 金额: $ 38.74万
• 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/7289803
• 关键词: Adult; Advocate; Autologous; Behavior Therapy; Classification; Client satisfaction; Clinical; Clinical Research; Data; Data Collection; Effectiveness; Enrollment; Follow-Up Studies; Frequencies; Functional disorder; Gold; Guidelines; Incontinence; Industry; Injury; Invasive; Literature; Manuscripts; Marketing; Medical; Morbidity - disease rate; Numbers; Observational Study; Operative Surgical Procedures; Pain; Patient Self-Report; Patients; Performance; Pharmacotherapy; Phase; Procedures; Protocols documentation; Ptosis; Publications; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Rate; Recommendation; Recording of previous events; Research Personnel; Risk; Safety; Sister; Standards of Weights and Measures; Stress; Stress Urinary Incontinence; Symptoms; Time; Transplanted tissue; Universities; Upper arm; Urge Incontinence; Urinary Incontinence; Urination; Urodynamics; Utah; Woman; Work; World Health Organization; cohort; design; efficacy evaluation; follow-up; improved; prevention evaluation; protocol development; repaired; response; uptake

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）：本提案是为了响应RFA-DK-06-501而提交的，旨在继续犹他州大学的泌尿外科治疗网络（UCN）临床中心（CC）。II期将重点关注TOMUS试验的开展以及I期SISTe和BE-DRI研究（即E-SISTe和E-BE-DRI）的观察性随访研究的继续。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。耻骨后入路在所有MUS手术中具有最长的历史和最多的有效性和安全性数据，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，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）; 71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中添加行为治疗以治疗急迫性Ul的长期持久性（26个月）; 22名女性入组该CC。对于所有研究，犹他州CC负责患者入组和随访、治疗、数据收集和管理。犹他州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。具体而言，犹他州通过倡导SISEr的随机手术设计、共同主持BE-Dri方案委员会、参与并发症和尿动力学等重要工作组以及沿着出版物和演示文稿等重要常设委员会，为美国临床试验协会做出了贡献。UCN是一个多学科、多中心的研究小组，致力于关于UI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。