This application is submitted in response to NOT-OD-09-058, Recovery Act Funds for Competitive Revision Applications. Based on both clinical experience and empirical data from our own studies and those of others, the multidisciplinary investigators of the Urinary Incontinence Treatment Network (UITN) have identified the need for a comparative effectiveness trial of surgical procedures for the treatment of persistent or recurring stress urinary incontinence (SUI) following a prior continence surgery. Recurrent or persistent SUI after a continence procedure occurs in up to 10-40% of women. Few data are available to guide surgical treatment of recurrent or persistent SUI, although it is commonly accepted that repeat continence procedures are associated with higher failure rates and that failure rates increase over time. We propose a competitive revision to the UITN award to conduct a 12-month pilot and feasibility study for a 2-arm randomized controlled comparative effectiveness trial of the autologous rectus fascia pubovaginal sling and the synthetic mesh midurethral sling procedures for the treatment of recurrent or persistent SUI. The NIH and NIDDK have placed a high priority on such a comparative effectiveness study, as evidenced by inclusion in the list of Highest Priority Challenge Topics for NIH Challenge Grants in Health and Science Research (RFA-OD-09- 003). Secondary Procedures for Incontinence: Comparative Effectiveness (SPICE) Is consistent with the initial scope and aims of the UITN parent grant, as well as the scope of the competitive revision (NOT-OD- 09-0058). The proposed pilot and feasibility study will allow us to refine and implement the secondary continence protocol and the study procedures to ensure that the full study can be conducted in a timely and cost-efficient manner. University of California, San Diego will be a participating clinical center in the UITN SPICE study. This application reflects both the success and esprit de corps of the UITN. The 9 clinical centers and the data coordinating center have collaborated to develop the SPICE protocol and are submitting a common Competitive Revision Application.
In direct response to the intent of ARRA funding mechanisms, these funds will speed up the tempo of scientific research in the field of urinary incontinence and provide employment opportunities for professional and administrative staff.
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