This application describes the qualifications and experience of the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) faculty and research teams at the University of Texas 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 (PFDN). UT Southwestern's Division of FPMRS includes 4 full-time faculty physicians, 1 full-time basic scientist and 4 full-time urogynecology nurse-practitioners. Additionally, the Departments of Urology, Colorectal Surgery and Physical Therapy care for many patients with pelvic floor disorders and maintain an active clinical and research collaboration with the Division of FPMRS. In 2009, there were 2160 women with pelvic floor disorders seen in the FPMRS clinics. Three hundred seventy eight women underwent surgical procedures for correction of pelvic floor disorders and 1782 women were managed with non-surgical techniques. The clinical research team described in this application has participated in the previous 5 year cycle of the PFDN and has had robust recruitment for every PFDN clinical trial. Our clinical and research clinics are targeted at both private patients (UT Southwestern) and medically indigent patients (Parkland Hospital). These clinics provide a diverse patient population which has allowed us to be the leading recruiter of Hispanic patients in the PFDN. Unique to our research team is an urogynecology basic and translational scientist. Through this collaboration, our site has led the effort to develop and implement the ABC Biorepository for the PFDN, which is now housed at UT Southwestern. In the last 5 year cycle we have been active in all aspects of the PFDN including concept proposal, committee participation and manuscript preparation. Importantly, the FPMRS physicians at UT Southwestern are philosophically dedicated to rigorous controlled trials intended to objectively evaluate principles of non-surgical and surgical care consistent with the mission of the PFDN. Included in this application is a concept proposal for a randomized placebo-controlled trial of intravaginal estrogen therapy as an adjunct to sacrocolpopexy for prevention of recurrent pelvic organ prolapse. We believe this trial builds on the previous work of the PFDN and addresses several key research topics including postoperative management to maximize recovery and minimize recurrence of pelvic floor disorders. We are of the view that this trial is ideally suited for the PFDN and has the potential to improve the care of patients with 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 #
5U10HD054241-09
Application #
8700429
Study Section
Special Emphasis Panel (ZHD1-DSR-N (02))
Program Officer
Parrott, Estella C
Project Start
2006-09-12
Project End
2016-06-30
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
9
Fiscal Year
2014
Total Cost
$100,022
Indirect Cost
$37,115
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
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
Richter, Holly E; Nager, Charles W; Burgio, Kathryn L et al. (2015) Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women. Female Pelvic Med Reconstr Surg 21:182-9
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
Pearce, Meghan M; Zilliox, Michael J; Rosenfeld, Amy B et al. (2015) The female urinary microbiome in urgency urinary incontinence. Am J Obstet Gynecol 213:347.e1-11
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
Brubaker, Linda; Nager, Charles W; Richter, Holly E et al. (2014) Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery. Am J Obstet Gynecol 211:554.e1-7

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