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.
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.
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