As a vanguard center in this important multisite clinical research infrastructure we have demonstrated our credible, creative, productive, multidisciplinary clinical approach, to the evaluation and treatment, both surgically and non-surgically, of women with pelvic floor disorders including urinary and fecal incontinence, pelvic organ prolapse and other sensory and emptying abnormalities of the lower urinary and gastrointestinal tracts. We have a well-established research and multi-disciplinary clinical infrastructure including long-standing clinical and research relationships with urology, radiology, geriatrics, behavioral medicine, colorectal surgery, gastroenterology, maternal fetal medicine, advanced practice nursing, basic sciences and epidemiology and extensive experience in performing relevant clinical trials and observational studies both within and outside the PFDN Network. We have substantially contributed to the Network activities by participating at all levels of clinical trial design, implementation, recruitment, intervention implementation, retention and scientific reporting and have an excellent track record of facilitation and cooperation with other network sites, the Data Coordinating Center, Advisory and Data Safety Monitoring Boards. Our site was the first to propose the addition of a translational aim a priori which served to complement the clinical component of an index trial (ROSETTA Urinary Marker Study-RUM). We have reported outcomes and implications for care of these research initiatives at national and international scientific meetings and we are committed to continuing these activities. In this application we wish to highlight our ability and continued commitment to perform these meaningful research activities with the result of increasing understanding of the best evidence-based approaches to the care of women with these disorders.

Public Health Relevance

In order to improve on the care and individualized treatment for the 1 in 4 US women with symptoms of quality of life altering pelvic floor disorders, it is important that that a credible research program exists to provide information for the evidence-based management of women with these conditions. The Pelvic Floor Disorders Network supported by the Eunice Kennedy Shriver NICHD performs such research and we are submitting a competetive proposal to highlight our abilities in order to continue to participate in this important initiative. As a part of this application, we provide information regarding our credible multi-disciplinary investigators and research experience, available clinical population, including the addition of a sub-site and affiliate site, track record of excellence in clinical research and strengths of our institutional infrastructure.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
2UG1HD041261-16
Application #
9176538
Study Section
Special Emphasis Panel (ZHD1-DSR-L (50)1)
Program Officer
Halvorson, Lisa M
Project Start
2001-09-01
Project End
2021-06-30
Budget Start
2016-09-13
Budget End
2017-06-30
Support Year
16
Fiscal Year
2016
Total Cost
$241,448
Indirect Cost
$77,198
Name
University of Alabama Birmingham
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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
Markland, Alayne D; Jelovsek, J Eric; Rahn, David D et al. (2017) Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence. Female Pelvic Med Reconstr Surg 23:179-183
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
Wei, John T; Dunn, Rodney; Nygaard, Ingrid et al. (2017) Development and Validation of a Quantitative Measure of Adaptive Behaviors in Women With Pelvic Floor Disorders. Female Pelvic Med Reconstr Surg 23:232-237
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:
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
Amundsen, Cindy L; Richter, Holly E; Wallace, Dennis et al. (2017) OnabotulinumtoxinA vs Sacral Neuromodulation for Urgency Incontinence-Reply. JAMA 317:535-536
Amundsen, Cindy L; Richter, Holly E; Menefee, Shawn A et al. (2016) OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA 316:1366-1374

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