The purpose of this proposal is to demonstrate the capabilities of the University of Pittsburgh to participate as a clinical site in the NICHD-sponsored Pelvic Floor Disorders Network (PFDN). Our site has a longstanding track record of successful contribution to multicenter studies of urinary and fecal incontinence, and pelvic organ prolapse. We are particularly well suited to be a clinical site in the PFDN because of our volume, research infrastructure and track record, basic and translational experience and expertise. Access to large numbers of nulliparous women enables us to contribute uniquely to studies of the role of pregnancy and parturition in the etiology and prevention of pelvic floor disorders (PFDs). Magee-Womens Hospital (MWH) is the central resource for gynecologic specialty care for the 19 hospital University of Pittsburgh Health System serving a very large aging population. Our site brings expertise in urogynecology, physical therapy, geriatrics, urology, gastroenterology and mental health. We offer unique technical expertise in genomics, proteomics, tissue regenerative techniques, biochemical and biomechanical impact of meshes on the vagina and central neuronal control of bladder function. We propose to establish a comprehensive, scientifically rigorous clinical and translational research program within the PFDN for prospective comparative studies of mesh materials used in prolapse and incontinence procedures. The program will generate data of immediate clinical relevance as it will present scientifically sound, vendor independent evidence to guide surgeons'selection of specific graft materials and evidence-based practice guidelines for management of mesh complications. The 3 major components of the proposal are: 1) mesh specific infrastructure for implementation in PFDN clinical trials employing mesh inclusive of the development of a Mesh Morbidity Index and establishment of a Biospecimen Repository 2) the first RCT of meshes selected through rigorous analyses of biomechanical and biochemical properties and 3) translational studies on the cellular response to mesh materials and pathophysiology of mesh complications. The RCT will serve to pilot the database, compare clinical outcomes of meshes whilst providing specimens for translational studies.

Public Health Relevance

Though prosthetic mesh enhances durability of prolapse and incontinence repairs, escalating complications have prompted public health warnings. Understanding the pathophysiology of mesh related morbidity and identifying modifiable risk factors through comparative and translational studies will inform on complications, support guidelines on mesh selection and route of delivery, and direct innovations in mesh technologies.

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 #
5U10HD069006-03
Application #
8501605
Study Section
Special Emphasis Panel (ZHD1-DSR-N (02))
Program Officer
Parrott, Estella C
Project Start
2011-08-01
Project End
2016-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2013
Total Cost
$307,207
Indirect Cost
$74,643
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Nager, Charles W; Zyczynski, Halina; Rogers, Rebecca G et al. (2016) The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial). Female Pelvic Med Reconstr Surg 22:182-9
Sung, Vivian W; Borello-France, Diane; Dunivan, Gena et al. (2016) Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial. Int Urogynecol J 27:1479-90
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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
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
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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
Richter, Holly E; Whitehead, Nedra; Arya, Lily et al. (2015) Genetic contributions to urgency urinary incontinence in women. J Urol 193:2020-7
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

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