Duke University Medical Center (DUMC) is dedicated to continued active participation in the NICHD Pelvic Floor Disorders Network (PFDN) by using our growing patient volume, sophisticated research structure, extensive quality improvement systems, and successful track record of high recruitment in clinical and translational research. 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 and serving as a tertiary southeastern US referral center. Our seven fellowship-trained and board certified urogynecology (5) and urology (2) investigators have expertise in both surgical and non-surgical management of urinary (UI) and fecal incontinence, and pelvic organ prolapse (POP) including vaginal native tissue repair, vaginal mesh placement and robotic sacrocolpopexy. Last year, our Urogynecology Division cared for 2087 new patients and performed more than 252 surgical procedures for UI and 465 for POP. Our diverse patient population is 82% Caucasian, 14% African American, 1% Asian and 2% Hispanic, from suburban and rural communities with stable care and follow-up patterns. DUMC is the hub of a multidisciplinary team of outstanding collaborators from urogynecology, urology, colorectal surgery, gastroenterology, radiology, epidemiology and physical therapy. DUMC provides comprehensive diagnostic evaluation including multi-channel urodynamic testing, video urodynamics, cystoscopy, defecography, pelvic MRI, and endoanal ultrasound. We have expertise in study design, recruitment, retention, adverse event reporting, and data and cost-effectiveness analysis. Our substantial basic science and translational capabilities, including a robust divisional biorepository, are supported by experts in bladder physiology and epigenetics. Committed to data quality, we built robust systems for the prevention, early detection, and correction of errors, and have shared these with the PFDN to enhance data quality. We are harnessing our sophisticated electronic health record to integrate source documentation with research data, minimize paper case report forms, maximize electronic data collection, and include quality checks at multiple levels to improve both efficiency and data integrity. DUMC has consistently been a high recruitment site across a wide range of research studies. During the current cycle, the PFDN completed two DUMC-initiated RCTs: Anticholinergic vs Botox (ABC, Dr. Visco, PI) and Interstim vs Botox (ROSETTA, Dr. Amundsen, PI). The DUMC clinical site actively participated in all other trials with outstanding recruitment in SUPER (native tissue vs vaginal mesh for uterine prolapse). Our proven ability to enroll for SUPER strongly suggests equally high performance in the upcoming ASPIRE trial (3-arm RCT: vaginal native tissue vs vaginal mesh vs sacrocolpopexy). As we have proven our ability to successfully complete large-scale, multi-centered trials through our robust clinical practice and exceptional research infrastructure, Duke University Medical Center is uniquely qualified to continue as a valuable and productive member of the PFDN.
Female pelvic floor disorders represent a major public health burden given their high prevalence, impairment of quality of life, and substantial economic costs. As part of the Pelvic Floor Disorders Network, Duke University Medical Center is committed to actively participating in innovative clinical trials aimed at improving the evaluation and treatment of pelvic floor disorders through high-quality, high-impact clinical research.
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