Pelvic floor disorders research at Duke University Medical Center (DUMC) is sophisticated and comprehensive with committed investigators addressing issues of great importance to women. DUMC has a tradition of excellence in clinical care, training and research in pelvic floor disorders and includes one of the nation's first accredited fellowship programs in the field. DUMC offers detailed evaluation and treatment in a high-volume, multidisciplinary setting that serves as a tertiary referral center for women across the southeast US. Each of the five Duke urogynecology investigators is fellowship-trained with expertise in both surgical and non-surgical management of urinary incontinence (Ul), pelvic organ prolapse (POP), fecal incontinence, and defecatory dysfunction. Last year, our Division cared for more than 1550 new patients and performed more than 400 surgical procedures for Ul and 270 for POP. Our patient population is 80% Caucasian, 15% African American, 2% Asian and 2% Hispanic, from both suburban and rural communities with stable care and follow-up patterns. DUMC is the hub of a multidisciplinary team of outstanding collaborative investigators in urogynecology, urology, colorectal surgery, gastroenterology, maternal-fetal medicine, physical therapy and epidemiology. DUMC offers a wide range of diagnostic resources: multi-channel urodynamic testing, video urodynamics, cystoscopy, defecography, pelvic MRI, endoanal ultrasound, and needle electromyography. During the current PFDN cycle, DUMC-initiated three active RCTs: 1. Anticholinergic vs Botox RCT (ABC, Dr. Visco, currently enrolling), Interstim vs Botox RCT (ROSETTA, Dr. Amundsen, full protocol), and a RCT evaluating transvaginal mesh for prolapse repair (Dr. Weidner, mini-protocol planned for fall of 2010. DUMC has consistently been a high recruitment site across a wide range of non-surgical and surgical studies with unparalleled retention rates. We have proven our ability to support and successfully complete large-scale, multi-centered investigations through our robust clinical practice and exceptional research infrastructure. Accordingly, Duke University Medical Center is well equipped and uniquely qualified to continue as a valuable and productive member of the Pelvic Floor Disorders Network.

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
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD041267-15
Application #
8699793
Study Section
Special Emphasis Panel ()
Program Officer
Parrott, Estella C
Project Start
2001-09-01
Project End
2016-06-30
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
15
Fiscal Year
2014
Total Cost
$315,033
Indirect Cost
$114,375
Name
Duke University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
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
Amundsen, Cindy L; Richter, Holly E; Menefee, Shawn A et al. (2016) OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA 316:1366-1374
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
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
Lukacz, Emily S; Warren, Lauren Klein; Richter, Holly E et al. (2016) Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse. Obstet Gynecol 127:1071-9
Markland, Alayne; Wang, Lu; Jelovsek, J Eric et al. (2015) Symptom improvement in women after fecal incontinence treatments: a multicenter cohort study of the pelvic floor disorders network. Female Pelvic Med Reconstr Surg 21:46-52
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 :
Jelovsek, J Eric; Chagin, Kevin; Brubaker, Linda et al. (2014) A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstet Gynecol 123:279-87
Grimes, Cara L; Lukacz, Emily S; Gantz, Marie G et al. (2014) What happens to the posterior compartment and bowel symptoms after sacrocolpopexy? evaluation of 5-year outcomes from E-CARE. Female Pelvic Med Reconstr Surg 20:261-6

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