This proposal is submitted in response to RFA-DK-06-501 for continuation of the Urinary Incontinence Treatment Network (UITN) Clinical Center at University of Maryland Baltimore (UMB). Phase II will focus on conduct of the Trial of Mid-Urethral Slings (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 (MUS) 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 retorpubic 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 clinical center (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; 64 are enrolled at this CC. The 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; 26 are enrolled 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. Based on UMB's successful recruitment and retention of study subjects in the first funding cycle, UMB has the experience, resources, personnel and clinical volume to be successful in TOMUS. The UITN is a multi- disciplinary, multi-center group of Investigators dedicated to high impact clinical research regarding the prevention, evaluation and management of Ul to improve the quality of life for adults. ? ?
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