Urinary Incontinence Treatment Network

描述(由申请人提供)：提案概述本提案是根据RFA-DK-06-501继续实施尿失禁治疗网络(UITN)而提交的。UITN第二阶段将包括继续进行TOMUS试验，以及继续对第一阶段进行的SISTER和BE-DRI研究(称为E-SISTER和E-BE-DRI)进行观察性后续研究。由于第二阶段的主要工作将针对进行TOMUS试验，本提案详细描述了这项试验的科学依据和进行。这项试验的方案是应NIDDK于2004年年中提出的要求制定的，即由国际技联进行第三项研究。该议定书随后在2005年5月由全国数据和数据中心组成的特设咨询委员会进行审查，然后在2005年秋季由UITN数据业务和数据中心进行审查。在每一次审查中，UITN调查员都仔细考虑了各自委员会的建议，并在认为有必要和适当的情况下对议定书进行了修订。UITN DSMB于2006年2月批准了该议定书，该试验的招募工作将于2006年3月下旬开始。本提案还说明了E-SISTER和E-BE-DRI研究的目的和方法(第D.7节)。完整的方案，包括SISTER和BE-DRI研究的研究目标、设计和方法的说明，载于附录B。

DESCRIPTION (provided by applicant): OVERVIEW OF PROPOSAL This proposal is submitted in response to RFA-DK-06-501 for continuation of the Urinary Incontinence Treatment Network (UITN). Phase II of the UITN will include continued conduct of the TOMUS trial as well as continuation of the observational follow-up studies for the SISTEr and BE-DRI studies (called E-SISTEr and E-BE-DRI) conducted in Phase I. Because the primary effort of Phase II will be directed toward conduct of the TOMUS trial, this proposal describes in detail the scientific rationale for and the conduct of this trial. The protocol for this trial was developed in response to a request from NIDDK in mid-2004 for development of a third study to be conducted by the UITN. The protocol was subsequently reviewed in May 2005 by an Ad Hoc Advisory Committee constituted by the NIDDK and then by the UITN DSMB in the fall of 2005. At each point of review, recommendations by the respective committees were considered carefully by the UITN investigators and revisions to the protocol were made where considered indicated and appropriate. The UITN DSMB approved the protocol in February 2006 and recruitment for the trial will start in late March 2006. This proposal also describes the Study Aims and methods for the E-SISTEr and E-BE-DRI studies (section D.7). The full protocols, including a description of the Study Aims, designs and methods for the SISTEr and BE-DRI studies are included in Appendix B.