Research focused on women's health at the University of North Carolina (UNC) is sophisticated and widespread with many committed investigators addressing issues of fundamental importance to women. UNC 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 Division of Urogynecology and Reconstructive Pelvic Surgery. We offer comprehensive evaluation and treatment options in a high-volume care setting that serves as a tertiary referral center for women from across the state. More than 2,000 women have sought care for pelvic floor disorders at UNC in the previous five years. Seventy-five percent are Caucasian and 22% are African American, predominantly from rural and suburban communities with stable care and follow-up patterns. Approximately 260 women have multi-channel urodynamic and fluoroscopic studies annually. Care providers have extensive expertise in both surgical and non-surgical management of urinary incontinence, pelvic organ prolapse and defecatory dysfunction. The Division of Urogynecology performs an average of 80 surgical procedures for the primary indication of urinary incontinence, 148 for prolapse and provides medical management for 137 women with these conditions each year. Both Urogynecology and Urology have recently added faculty which will further enhance clinical volume. The UNC Pelvic Floor Disorders Research Collaborative led by the Division of Urogynecology is pleased to submit this proposal to serve as a site in the Clinical Trials Network for Female Pelvic Floor Disorders. The Collaborative is a multidisciplinary team of outstanding investigators in tuogynecology, urology, gastroenterology, colorectal surgery, radiology, internal medicine, and clinical research methodologists. They have a history of strong clinical ties and dedication to interdisciplinary research. Diagnostic resources include multi-channel urodynamic testing, cystoscopy, defecography, pelvic MRI, 360-degree anal ultrasound, anal manometry and needle electromyography. Clinical services include surgical treatment of complex pelvic floor disorders and a wide range of non-surgical options including pelvic floor exercise programs with biofeedback, pessary management and behavioral and -pharmacologic therapies. A UNC network site will have access to research infrastructure with proven ability to support large-scale, multi-centered clinical research. The Collaborative is well-equipped and uniquely qualified to be an asset to the Clinical Trials Network. Given the exceptional quality of the research opportunities and resources available at UNC, the stable and diverse patient population, the strength of the investigator pool, the genuine willingness to collaborate and the commitment of the institution to the stated goals of this RFA, we look forward to making substantial contributions to advancing women's health in the area of pelvic floor disorders.

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 #
5U10HD041267-03
Application #
6613465
Study Section
Special Emphasis Panel (ZHD1-DRG-D (13))
Program Officer
Weber, Anne M
Project Start
2001-09-01
Project End
2006-06-30
Budget Start
2003-07-01
Budget End
2004-06-30
Support Year
3
Fiscal Year
2003
Total Cost
$470,810
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Jelovsek, J Eric; Chagin, Kevin; Lukacz, Emily S et al. (2018) Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery. Obstet Gynecol 132:298-309
Arya, Lily A; Richter, Holly E; Jelovsek, Eric et al. (2018) Metabolites and microbial composition of stool of women with fecal incontinence: Study design and methods. Neurourol Urodyn 37:634-641
Jelovsek, J Eric; Barber, Matthew D; Brubaker, Linda et al. (2018) Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA 319:1554-1565
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
Newman, Diane K; Borello-France, Diane; Sung, Vivian W (2018) Structured behavioral treatment research protocol for women with mixed urinary incontinence and overactive bladder symptoms. Neurourol Urodyn 37:14-26
Rogers, Rebecca G; Nolen, Tracy L; Weidner, Alison C et al. (2018) Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications. Int Urogynecol J 29:1101-1110
Amundsen, Cindy L; Komesu, Yuko M; Chermansky, Christopher et al. (2018) Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol 74:66-73
Markland, Alayne D; Jelovsek, J Eric; Rahn, David D et al. (2017) Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence. Female Pelvic Med Reconstr Surg 23:179-183
Komesu, Yuko M; Richter, Holly E; Dinwiddie, Darrell L et al. (2017) Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence. Int Urogynecol J 28:711-720
Wei, John T; Dunn, Rodney; Nygaard, Ingrid et al. (2017) Development and Validation of a Quantitative Measure of Adaptive Behaviors in Women With Pelvic Floor Disorders. Female Pelvic Med Reconstr Surg 23:232-237

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