The faculty of the University of Pittsburgh School of Medicine Departments of Gynecology, Urology, Geriatric Medicine, Gastroenterology and Colon and Rectal Surgery have collaborated to form the UPMC Center for Continence and Pelvic Floor Disorders. Our health care system with over 25 hospitals and outpatients facilities is an outstanding resource for research subject recruitment. Our proven ability to hold leadership positions in the NIH sponsored multicenter surgical trials and to perform a large number of reconstructive pelvic surgeries per year make us a valuable contributor to the Clinical Trials Network for Female Pelvic Floor Disorders. We propose a study protocol assessing two commonly performed reconstructive approaches to posthysterectomy pelvic organ prolapse PH-POP: the transabdominal abdominal sacral colpopexy with paravaginal defect repair and Burch vs. the transvaginal sacrospinous ligament suspension of the vaginal apex with colporrhaphies and sling. Surgical success will be determined by a satisfactory and sustained support of the prolapsing vagina and pelvic visceral function. This proposed randomized trial with three year follow-up will 1) assess the short and long-term outcomes of the two approaches, 2) determine specific patient characteristics that predispose patients to surgical failure, 3) assess the components of an optimal cost effective preoperative workup. In addition, we will study the impact of adjuvant Pelvic Floor Muscle Exercises on postoperative support and continence, improvement in quality of life and patient satisfaction with the surgical procedure. This data will yield valuable clinical information and will help address the regional and specialty variation in the evaluation and treatment of women with PH-POP. We are committed to adhering to the final protocol of the network. Our investigators have unique expertise in assessment of bladder dysfunction and pelvic floor physical therapy. The surgical team is proficient in both surgical approaches and comfortable with the concept of a randomized surgical trial.

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 #
5U10HD041263-02
Application #
6536433
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
2002-07-01
Budget End
2003-06-30
Support Year
2
Fiscal Year
2002
Total Cost
$569,084
Indirect Cost
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
058625146
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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Nygaard, Ingrid; Brubaker, Linda; Zyczynski, Halina M et al. (2013) Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA 309:2016-24
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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
Hoyte, Lennox; Ye, Wen; Brubaker, Linda et al. (2011) Segmentations of MRI images of the female pelvic floor: a study of inter- and intra-reader reliability. J Magn Reson Imaging 33:684-91
Handa, Victoria L; Whitcomb, Emily; Weidner, Alison C et al. (2011) Sexual function before and after non-surgical treatment for stress urinary incontinence. Female Pelvic Med Reconstr Surg 17:30-35
Gutman, Robert E; Bradley, Catherine S; Ye, Wen et al. (2010) Effects of colpocleisis on bowel symptoms among women with severe pelvic organ prolapse. Int Urogynecol J 21:461-6
Heilbrun, Marta E; Nygaard, Ingrid E; Lockhart, Mark E et al. (2010) Correlation between levator ani muscle injuries on magnetic resonance imaging and fecal incontinence, pelvic organ prolapse, and urinary incontinence in primiparous women. Am J Obstet Gynecol 202:488.e1-6

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