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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK058229-11
Application #
8137058
Study Section
Special Emphasis Panel (ZDK1-GRB-R (O1))
Program Officer
Kusek, John W
Project Start
2000-09-30
Project End
2013-06-30
Budget Start
2011-07-01
Budget End
2012-06-30
Support Year
11
Fiscal Year
2011
Total Cost
$1,280,000
Indirect Cost
Name
New England Research Institute
Department
Type
DUNS #
153914080
City
Watertown
State
MA
Country
United States
Zip Code
02472
Brubaker, Linda; Wolfe, Alan J (2017) The female urinary microbiota, urinary health and common urinary disorders. Ann Transl Med 5:34
Brubaker, Linda; Wolfe, Alan J (2017) The Female Urinary Microbiota/Microbiome: Clinical and Research Implications. Rambam Maimonides Med J 8:
Brubaker, Linda; Wolfe, Alan J (2017) Microbiota in 2016: Associating infection and incontinence with the female urinary microbiota. Nat Rev Urol 14:72-74
Mueller, Elizabeth R; Wolfe, Alan J; Brubaker, Linda (2017) Female urinary microbiota. Curr Opin Urol 27:282-286
Thomas-White, Krystal J; Kliethermes, Stephanie; Rickey, Leslie et al. (2017) Evaluation of the urinary microbiota of women with uncomplicated stress urinary incontinence. Am J Obstet Gynecol 216:55.e1-55.e16
Norton, Peggy A; Nager, Charles W; Brubaker, Linda et al. (2016) The cost of preoperative urodynamics: A secondary analysis of the ValUE trial. Neurourol Urodyn 35:81-4
Zimmern, Philippe E; Gormley, E Ann; Stoddard, Anne M et al. (2016) Management of recurrent stress urinary incontinence after burch and sling procedures. Neurourol Urodyn 35:344-8
Brubaker, Linda; Wolfe, Alan (2016) The urinary microbiota: a paradigm shift for bladder disorders? Curr Opin Obstet Gynecol 28:407-12
Mueller, Elizabeth R; Litman, Heather; Rickey, Leslie R et al. (2015) Comparison of flowrates and voided volumes during non-instrumented uroflowmetry and pressure-flow studies in women with stress incontinence. Neurourol Urodyn 34:549-53
Kenton, Kimberly; Stoddard, Anne M; Zyczynski, Halina et al. (2015) 5-year longitudinal followup after retropubic and transobturator mid urethral slings. J Urol 193:203-10

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