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. ? ?
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