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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK060397-08S2
Application #
8147970
Study Section
Special Emphasis Panel (ZDK1-GRB-R (O1))
Program Officer
Kusek, John W
Project Start
2010-09-30
Project End
2012-08-31
Budget Start
2010-09-30
Budget End
2012-08-31
Support Year
8
Fiscal Year
2010
Total Cost
$190,000
Indirect Cost
Name
University of Maryland Baltimore
Department
Surgery
Type
Schools of Medicine
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
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
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
Guthrie, Katherine A; LaCroix, Andrea Z; Ensrud, Kristine E et al. (2015) Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms. Obstet Gynecol 126:413-22
Sirls, Larry T; Tennstedt, Sharon; Brubaker, Linda et al. (2015) The minimum important difference for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form in women with stress urinary incontinence. Neurourol Urodyn 34:183-7
Zyczynski, Halina M; Albo, Michael E; Goldman, Howard B et al. (2015) Change in Overactive Bladder Symptoms After Surgery for Stress Urinary Incontinence in Women. Obstet Gynecol 126:423-30
Brubaker, Linda; Litman, Heather J; Kim, Hae-Young et al. (2015) Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women. Int Urogynecol J 26:1155-9
Subak, Leslee L; Goode, Patricia S; Brubaker, Linda et al. (2014) Urinary incontinence management costs are reduced following Burch or sling surgery for stress incontinence. Am J Obstet Gynecol 211:171.e1-7

Showing the most recent 10 out of 76 publications