This proposal is submitted in response to RFA-DK-06-501 for continuation of the Urinary Incontinence Treatment Network (UITN) Clinical Center at Loyola University Medical Center. Phase II will focus on conduct of the TOMUS trial as well as continuation of the observational follow-up studies for the SISTEr and BE-DRI studies (i.e. E-SISTEr and E-BE-DRI) of Phase I. Primary Aims of TOMUS are to compare objective and subjective cure rates for stress incontinence at 12 and 24 months between the retropubic and transobturator midurethral sling procedures.The retropubic approach, with the longest history and most available data on efficacy and safety of all MUS procedures, is generally accepted as the gold standard. The transobturator approach stays out of the retropubic space and offers the most potential for improving the rare but significant risks associated with the original retropubic procedure. Performance of these procedures is increasing rapidly with limited data available on safety and efficacy. Therefore, this study will compare the efficacy and safety of the retropubic and transobturator (inside-out and outside-in) procedures in a 2-arm RCT. 588 women with stress Ul will be enrolled; 65 patients at this CC. The Primary Aim of E-SISTEr is to compare long-term effectiveness and durability (60 mos) of the Burch colposuspension and autologous fascial sling for treatment of stress Ul in a randomized cohort of 655 women; 48 will participate at this CC. Primary Aim of E-BE-DRI is to examine long-term durability (26 mos) of the addition of behavioral treatment to drug therapy for treatment of urge Ul in a randomized cohort of 307 women; 21 will participate at this CC. For all studies, the CC is responsible for patient enrollment and follow-up, treatment, data collection and management. CC investigators participate in network activities, including protocol development, standing committees and work groups, manuscripts and presentations. The Loyola site now has extensive experience in the recruitment of patients to surgical trials and is well-poised to begin active recruitment to TOMUS. We have also demosntrated our ability to retain patients enrolled in SISTEr and BE-DRI until study completion, and our ability to successfully recruit and retain patients for E-SISTEr and E-BE-DRI. We believe that we can continue to be a productive member of the UITN, with the ultimate objective of improving quality of life for adults through the conduct of high impact clinical research in urinary incontinence. ? ?
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