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.

Public Health Relevance

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.

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 #
5UG1HD041267-19
Application #
9517979
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Halvorson, Lisa M
Project Start
2001-09-01
Project End
2021-06-30
Budget Start
2018-07-01
Budget End
2019-06-30
Support Year
19
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Duke University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Komesu, Yuko M; Amundsen, Cindy L; Richter, Holly E et al. (2018) Refractory urgency urinary incontinence treatment in women: impact of age on outcomes and complications. Am J Obstet Gynecol 218:111.e1-111.e9
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
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
Weidner, Alison C; Barber, Matthew D; Markland, Alayne et al. (2017) Perioperative Behavioral Therapy and Pelvic Muscle Strengthening Do Not Enhance Quality of Life After Pelvic Surgery: Secondary Report of a Randomized Controlled Trial. Phys Ther 97:1075-1083
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
Visco, Anthony G; Zyczynski, Halina; Brubaker, Linda et al. (2016) Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial. Female Pelvic Med Reconstr Surg 22:311-6
Nager, Charles W; Zyczynski, Halina; Rogers, Rebecca G et al. (2016) The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial). Female Pelvic Med Reconstr Surg 22:182-9
Sung, Vivian W; Borello-France, Diane; Dunivan, Gena et al. (2016) Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial. Int Urogynecol J 27:1479-90
Visco, Anthony G; Brubaker, Linda; Jelovsek, J Eric et al. (2016) Adherence to Oral Therapy for Urgency Urinary Incontinence: Results from the Anticholinergic Versus Botox Comparison (ABC) Trial. Female Pelvic Med Reconstr Surg 22:24-8
Eric Jelovsek, J; Markland, Alayne D; Whitehead, William E et al. (2015) Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods. Contemp Clin Trials 44:164-174

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