Utah Continence Treatment Center (CTC)

犹他州失禁治疗中心 (CTC)

• 批准号: 7093706
• 负责人: PEGGY A NORTON
• 金额: $ 57.28万
• 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 2006-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7093706
• 关键词: clinical trials; cooperative study; data collection methodology /evaluation; female; human subject; human therapy evaluation; longitudinal human study; outcomes research; patient /disease registry; patient care management; patient oriented research; urinary incontinence; urinary tract surgery; women' s health

Urinary incontinence constitutes a common and significant public health challenge in the United States, a challenge that is continuously compounded by the "graying" of America and by the ever improving life expectancy for women. Outcomes following surgery for urinary incontinence have not been ,adequately evaluated. As a result, objective, rigorously-obtained data, required to fully inform patients and on which to base important policy decisions, are unavailable. The long-term objective of the Urinary Incontinence Treatment Network (UITN) is to systematically evaluate the long-term outcomes of commonly utilized therapeutic approaches for urinary incontinence. This proposal describes the strengths that the University of Utah Continence Center would bring if it were to become a member Continence Treatment Center (CTC) of the UITN. Specifically, we will demonstrate the extensive expertise of the Utah Continence Center in the evaluation and treatment of urinary incontinence, including non-surgical and surgical approaches. We will further document that the Utah Continence Center has the- necessary ability to participate in or lead multicenter clinical trials, and that the Department of Obstetrics and Gynecology at the University of Utah Health Sciences Center, 14th'in the nation in NIH awards, has a proven track record in participating and managing NIH-driven multicenter network studies. Finally, we propose to carry out a prospective, randomized clinical trial for the two proposed surgical procedures (Bunch colposuspension versus pubovaginal sling) rather than a prospective cohort study, since the three investigators-surgeons for the Utah CTC can perform both procedures with equal expertise. Thus, inclusion of the proposed Utah CTC will increase the likelihood that the UITN will be in a position to complete a randomized controlled trial as the final outcome.

尿失禁是美国一项常见且重大的公共卫生挑战，这一挑战因美国的“老龄化”和女性预期寿命的不断延长而不断加剧。尿失禁手术后的结果尚未得到充分评估。因此，无法获得充分告知患者所需的客观、严格获得的数据，并以此作为重要政策决策的基础。尿失禁治疗网络 (UITN) 的长期目标是系统评估尿失禁常用治疗方法的长期结果。该提案描述了犹他大学失禁中心成为 UITN 失禁治疗中心 (CTC) 成员后将带来的优势。具体来说，我们将展示犹他州失禁中心在尿失禁评估和治疗方面的广泛专业知识，包括非手术和手术方法。我们将进一步证明犹他州节制中心具有参与或领导多中心临床试验的必要能力，并且犹他大学健康科学中心妇产科在 NIH 奖项中排名全国第 14 位，在参与和管理 NIH 驱动的多中心网络研究方面拥有良好的记录。最后，我们建议对两种拟议的手术程序（束阴道悬吊术与耻骨阴道悬吊术）进行前瞻性、随机临床试验，而不是前瞻性队列研究，因为犹他州 CTC 的三名研究外科医生可以以同等的专业知识执行这两种手术。因此，纳入拟议的犹他州 CTC 将增加 UITN 能够完成随机对照试验作为最终结果的可能性。