RTI proposes to continue to serve as the data coordinating center (DCC) for the NICHD Pelvic Floor Disorders Network (PFDN) in support of its mission to improve the care of women with pelvic floor disorders (PFDs) by conducting well-designed multicenter observational studies and clinical trials to inform diagnosis, prevention, and treatment. We will build on our work as DCC in the current PFDN cycle to provide the Network with statistical leadership in study design and data analysis and operational support through data management and logistical services. Specifically, we will (1) collaborate in developing, implementing, and monitoring Network protocols; (2) provide data management, including preparation of public data files; (3) prepare reports including safety reports for the Data and Safety Monitoring Board; (4) collaborate in the analysis of data and publication of study results; (5) coordinate manufacturing of study drugs and placebos, acquisition of study equipment and materials, and collection and transport of biological specimens; and (6) provide all other support, including management of capitation payments to clinical sites, and logistical coordination of meetings and communications necessary to run an efficient and productive Network. This application has specific strengths that will enhance the scientific productivity of the PFDN: (1) Continuity of DCC leadership with Dr. Marie Gantz as Principal Investigator (PI) and Dr. Dennis Wallace as Alternate PI overseeing a DCC team experienced in PFD research, including studies of pelvic organ prolapse, urinary incontinence, and fecal incontinence. (2) Multidisciplinary experts, from RTI and The University of North Carolina, Chapel Hill, in biostatistics, statistical genetics, clinical and quality of life outcomes, cost-effectiveness, program evaluation, and clinical PFD care, who will collaborate with PFDN investigators to (a) develop innovative trial designs including bench-to-bedside translational studies; (b) develop new outcome measures to fill current gaps, particularly for outcomes patients consider crucial; and (c) respond quickly to fluctuations in Network analytic needs. (3) State-of-the-art data collection systems including (a) a web-based clinical electronic data capture and management system with rapid error resolution and real-time reports and data monitoring tools; (b) advancements in the collection of high-quality patient-reported outcome data using mobile technology; and (c) automated reports to provide daily tracking of study enrollment and progress to enhance the scientific quality and efficiency of clinical site trial activities.

Public Health Relevance

The PFDN was established in 2001 to improve the care of women with PFDs by conducting well-designed multicenter observational studies and clinical trials to inform diagnosis, prevention, and treatment. A qualified, experienced DCC is critical in helping the PFDN optimize research productivity through effective study design, implementation, data collection, quality assurance, monitoring, and statistical analysis. RTI will continue to provide multidisciplinary expertise to support high-impact collaborative clinical research studies and provide communications and logistical support to optimize the efficiency and productivity of the Network.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
2U24HD069031-06
Application #
9177940
Study Section
Special Emphasis Panel (ZHD1-DSR-L (51)1)
Program Officer
Halvorson, Lisa M
Project Start
2011-08-08
Project End
2021-06-30
Budget Start
2016-09-13
Budget End
2017-06-30
Support Year
6
Fiscal Year
2016
Total Cost
$3,311,847
Indirect Cost
$844,687
Name
Research Triangle Institute
Department
Type
DUNS #
004868105
City
Research Triangle
State
NC
Country
United States
Zip Code
27709
Komesu, Yuko M; Amundsen, Cindy L; Richter, Holly E et al. (2018) Refractory urgency urinary incontinence treatment in women: impact of age on outcomes and complications. Am J Obstet Gynecol 218:111.e1-111.e9
Arya, Lily A; Richter, Holly E; Jelovsek, Eric et al. (2018) Metabolites and microbial composition of stool of women with fecal incontinence: Study design and methods. Neurourol Urodyn 37:634-641
Rogers, Rebecca G; Nolen, Tracy L; Weidner, Alison C et al. (2018) Surgical Outcomes After Apical Repair for Vault Compared With Uterovaginal Prolapse. Obstet Gynecol 131:475-483
Amundsen, Cindy L; Komesu, Yuko M; Chermansky, Christopher et al. (2018) Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol 74:66-73
Arya, Lily A (2017) Rationale for Investigating Stool Metabolites and Microbiota in Women With Fecal Incontinence. Dis Colon Rectum 60:249-252
Komesu, Yuko M; Richter, Holly E; Dinwiddie, Darrell L et al. (2017) Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence. Int Urogynecol J 28:711-720
Richter, Holly E; Moalli, Pamela; Amundsen, Cindy L et al. (2017) Urinary Biomarkers in Women with Refractory Urgency Urinary Incontinence Randomized to Sacral Neuromodulation versus OnabotulinumtoxinA Compared to Controls. J Urol 197:1487-1495
Markland, A D; Jelovsek, J E; Whitehead, W E et al. (2017) Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol. Neurogastroenterol Motil 29:
Weidner, Alison C; Barber, Matthew D; Markland, Alayne et al. (2017) Perioperative Behavioral Therapy and Pelvic Muscle Strengthening Do Not Enhance Quality of Life After Pelvic Surgery: Secondary Report of a Randomized Controlled Trial. Phys Ther 97:1075-1083
Richter, Holly E; Amundsen, C L; Erickson, S W et al. (2017) Characteristics Associated with Treatment Response and Satisfaction in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation for Refractory Urgency Urinary Incontinence. J Urol 198:890-896

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