This application describes the qualifications and experience of the urogynecology and urology faculty and research teams at the University of Texas Southwestern (UT Southwestern) Medical Center and Parkland Hospital and the facilities and patient population available to carry out clinical protocols sponsored by the Pelvic Floor Disorders Network. In 2004, there were more than 2,100 women with pelvic floor disorders seen in our clinics and 617 women underwent surgical procedures for correction of pelvic floor disorders. The Departments of Obstetrics and Gynecology and Urology have increasingly collaborated since 1997 to offer comprehensive care of women with pelvic floor disorders. In addition to urogynecology and urology, collaboration includes faculty from colorectal surgery, radiology, physical therapy, and maternal-fetal medicine. The clinical research teams described in this application have successful prior as well as on-going experience in NIH sponsored national multi-center trials. Centerpieces in this application are two existing research clinics, one targeted at private patients (operated by the Urology Department) and the other focused on medically indigent patients (operated by the Obstetrics and Gynecology Department). Also included in this application is a concept application for a randomized trial designed to assess the efficacy of end-to-end versus overlapping repair of the external anal sphincter lacerated during childbirth. The primary outcome is anal incontinence which is a significant consequence of such lacerations. This trial would permit accurate evaluation of the outcome of specific surgical procedures which is one of the prime areas of interest leading to creation of the Pelvic Floor Disorders Network. We are of the view that along with strategies for prevention of anal sphincter laceration during childbirth, optimal management of the torn sphincter should also be studied since more than 200,000 women sustain such pelvic floor injuries each year in the United States.

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 #
5U10HD054241-05
Application #
7877889
Study Section
Special Emphasis Panel (ZHD1-DSR-A (19))
Program Officer
Woo, Jason
Project Start
2006-09-12
Project End
2011-06-30
Budget Start
2010-07-01
Budget End
2011-06-30
Support Year
5
Fiscal Year
2010
Total Cost
$233,906
Indirect Cost
Name
University of Texas Sw Medical Center Dallas
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
800771545
City
Dallas
State
TX
Country
United States
Zip Code
75390
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
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
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

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