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
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
Jelovsek, John Eric; Chen, Zhen; Markland, Alayne D et al. (2014) Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence. Female Pelvic Med Reconstr Surg 20:342-8
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
Barber, Matthew D; Brubaker, Linda; Burgio, Kathryn L et al. (2014) Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA 311:1023-34
Amundsen, Cindy L; Richter, Holly E; Menefee, Shawn et al. (2014) The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial. Contemp Clin Trials 37:272-83
Gutman, Robert E; Nygaard, Ingrid E; Ye, Wen et al. (2013) The pelvic floor complication scale: a new instrument for reconstructive pelvic surgery. Am J Obstet Gynecol 208:81.e1-9
Nygaard, Ingrid; Brubaker, Linda; Zyczynski, Halina M et al. (2013) Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA 309:2016-24
Brubaker, Linda; Richter, Holly E; Barber, Matthew D et al. (2013) Pelvic floor disorders clinical trials: participant recruitment and retention. Int Urogynecol J 24:73-9
Kenton, Kimberly; Barber, Matthew; Wang, Lu et al. (2012) Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence. Female Pelvic Med Reconstr Surg 18:118-21
Visco, Anthony G; Brubaker, Linda; Richter, Holly E et al. (2012) Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial. Contemp Clin Trials 33:184-96

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