Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical Site

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ABSTRACT The Pelvic Floor Disorders Network (PFDN) has provided the framework for landmark clinical trials that utilize rigorous methodology to change clinical practice. The Duke University Medical Center (DUMC) PFDN Clinical Site has been a significant and consistent contributor since 2007. We are excited to offer our dedicated faculty, experienced research team, and established track-record of high patient recruitment with this re-application to the PFDN. DUMC has a rich tradition of excellence in clinical care, training and research in pelvic floor disorders, offering detailed evaluation and treatment in a high-volume, multidisciplinary setting with broad institutional resources, and serving as a tertiary southeastern US referral center. Our eight fellowship- trained urogynecology investigators have expertise in both surgical and non-surgical management of the full spectrum of pelvic floor disorders including urinary urgency/frequency, urinary incontinence (UI), fecal incontinence (FI), and pelvic organ prolapse (POP). Last year, our Urogynecology Division cared for 3165 new patients, performed 191 surgical procedures for UI and 377 for POP. This is in addition to 474 non-surgical procedures (including bulking injection, bladder Botox, and percutaneous tibial nerve stimulation) for UI. The Urogynecology Division is a hub of multidisciplinary collaboration including urology, colorectal surgery, gastroenterology, radiology, physical therapy, and multiple basic research laboratories across our campus. DUMC provides comprehensive diagnostic evaluation including multi-channel urodynamic testing, video urodynamics, cystoscopy, defecography, static and dynamic MRI, as well as and endoanal ultrasound. We have expertise in study design, recruitment, retention, adverse event reporting, and data analysis. We have unique and substantial expertise in translational sciences and prediction modeling that we aim to leverage in innovative translational aims embedded in PFDN clinical trials. Our clinical patient population is 72% White, 19% African American, 0.4% Latina, 0.3% Asian, and 0.01% American Indian, from suburban and rural communities with stable care and follow-up patterns. We recognize that our clinical population is skewed as Durham County statistics report that our local community is 50% White, 37% African American, 13% Latina, 4% Asian, and 4% American Indian. Thus, in the current cycle we will actively engage with new institutional resources that provide bilingual coordinators and community-based engagement for research. The long-term objective of the DUMC PFDN Clinical Site is to improve the evidence-based clinical care of women with pelvic floor disorders. To accomplish this objective, we propose to provide meaningful scientific contributions to the PFDN by collaborating with other sites and the data coordinating center, implementing all approved protocols in a manner that maximizes faculty engagement and participant recruitment and retention, and involving collaborators with a range of clinical, basic science, and methodological expertise, when appropriate.