This proposal is submitted in response to RFA-DK-06-501 for continuation of the Urinary Incontinence Treatment Network (UITN) Data Coordinating Center (DCC) at New England Research Institutes, Inc. The DCC is responsible for the scientific management of the studies, including directing, training, and monitoring the performance of Clinical Centers in enrollment, data collection, and data management as well as for all data analysis, and reports to the DSMB. In Phase I and continuing to Phase II, NERI has provided several unique and innovative tools and capabilities, including a proprietary Web-based data management system, an automated patient randomization system, and an electronic repository for UDS tracings. The DCC is also responsible for network communications and meeting support and provides a secure study website and a public website. DCC scientists play a leadership role in all network activities, including protocol development, standing committees and work groups, manuscript development and presentations. 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. 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. Primary Aim of E-SISTEr is to compare long-term (60 mos.) effectiveness and durability of the Burch colposuspension and autologous fascial sling for treatment of stress Ul in a randomized cohort of 655 women. Primary Aim of E-BE-DRI is to examine long-term (26 mos.) durability of the addition of behavioral treatment to drug therapy for treatment of urge Ul in a randomized cohort of 307 women. 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. The UITN is conducting 3 studies of treatments for both stress and urge urinary incontinence.
NIH ExPorter
NIH ExPorter