Pelvic Floor Disorders Network 2015

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Pelvic Floor Disorders Network Cycle IV Renewal – UT Southwestern PROJECT SUMMARY / ABSTRACT Our primary goal is to actively engage in the Pelvic Floor Disorders Network (PFDN) through efficient patient recruitment, participation, and retention of a racially and ethnically diverse patient population in all studies examining pelvic floor disorders (PFDs) in women. Our second goal is to bring innovative research proposals to this Network with emphasis on translational aims that explore the pathophysiology and prevention of PFDs in well-defined clinical study populations. To accomplish these aims, we describe the qualifications and experience of the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) faculty and research teams at the University of Texas Southwestern Medical Center and Parkland Hospital, the facilities and patient population available to carry out clinical protocols, and our state-of-the-art scientific approaches to the study of PFDs. The clinical research team described in this application actively participated in Cycle II of the PFDN and achieved robust recruitment and retention for every PFDN clinical trial, including leading site enrollment and randomization for anticholinergic vs Botox® comparison (“ABC”). Our clinical and research clinics serve both medically indigent patients (Parkland Hospital) and private, insured patients (university practice). These clinics provide a diverse patient population which allowed us to be the leading recruiter of Hispanic women in the PFDN (Cycle II). We were active in all aspects of the PFDN including concept proposal, committee participation, and manuscript preparation. Unique to our research team is a urogynecology basic and translational scientist whereby our site led the effort to develop and implement the ABC Biorepository for the PFDN, which has remained housed at UT Southwestern in Cycle III and has become integral to other translational research endeavors. Further, the scientific resources and infrastructure within our Ob/Gyn department are centrally focused on the role of genomics, epigenetics and gene regulation in various aspects of women's health. Throughout Cycle III, while not a full clinical site, we have remained committed to the successful retention and long-term follow-up of our PFDN study participants; 80% of E-OPTIMAL patients (5- year postoperative study) have been retained. Moreover, we continue to contribute scientifically with multiple publications and ongoing writing team participation. In 2015, new hospitals have opened for both UT Southwestern and Parkland, and the FPMRS clinic population base is surging. The FPMRS physicians at UT Southwestern remain dedicated to rigorous controlled trials intended to objectively evaluate principles of non- surgical and surgical care consistent with the mission of the PFDN. With a growing, diverse clinical patient population, a committed and seasoned research team with a pedigree of successful internal and external collaborations, and the resources and expertise to champion additional translational PFD research, UT Southwestern is ready and energized to return to the PFDN as a full clinical site.