Urinary Incontinence Treatment Network

概述：该提案是根据RFA-DK-06-501提交的，旨在继续尿失禁治疗网络（UITN）。UITN的第二阶段将包括TOMUS试验的继续进行，以及在第一阶段进行的SISTEr和be - dri研究（称为E-SISTEr和E-BE-DRI）的观察性随访研究的继续进行。因为第二阶段的主要工作将直接针对TOMUS试验的进行，本提案详细描述了该试验的科学依据和进行。该试验的方案是应NIDDK在2004年年中提出的由联合国开展第三项研究的要求而制定的。该议定书随后在2005年5月由NIDDK组成的特设咨询委员会进行了审查，然后在2005年秋季由itu DSMB组成。在每一次审查时，训研所的调查人员都仔细审议了各委员会的建议，并在认为有必要和适当的情况下对议定书进行了修订。itu DSMB在2006年2月批准了该方案，为试验招募人员将在2006年3月底开始。本提案还描述了E-SISTEr和E-BE-DRI研究的研究目标和方法（第D.7节）。完整的方案，包括对SISTEr和BE-DRI研究的研究目的、设计和方法的描述，都包含在附录B中。

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.