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, urology, gastroenterology, geriatrics, and biomechanical engineering. We offer unique technical expertise in development of finite element models of the vagina and its supportive tissues after surgery, biochemical and biomechanical impact of meshes on the vagina, dynamic 3D MRI and transperineal ultrasound of the pelvic floor, tissue regenerative techniques, genomics, proteomics, and central neuronal control of bladder function. In this application we describe: 1. our experience and productivity in multicenter randomized trials and clinical trials networks, our available population for enrollment and the clinical expertise of investigators; 2. special strengths of our transdisciplinary translational investigators; 3. our research personnel staffing and management plan for recruitment and retention of subjects in PFDN trials.

Public Health Relevance

There is a pressing need to provide women and their health providers high quality clinical outcomes data on treatments for pelvic floor disorders, their associated complications and strategies for evaluations and prevention. This Magee-Womens Research Institute application to the PFDN will contribute to the depth and breadth of the clinical and translational expertise jointly striving to advance knowledge of these common burdensome conditions.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
2UG1HD069006-06
Application #
9178200
Study Section
Special Emphasis Panel (ZHD1-DSR-L (50)1)
Program Officer
Halvorson, Lisa M
Project Start
2011-08-01
Project End
2021-06-30
Budget Start
2016-09-12
Budget End
2017-06-30
Support Year
6
Fiscal Year
2016
Total Cost
$274,091
Indirect Cost
$69,026
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Komesu, Yuko M; Amundsen, Cindy L; Richter, Holly E et al. (2018) Refractory urgency urinary incontinence treatment in women: impact of age on outcomes and complications. Am J Obstet Gynecol 218:111.e1-111.e9
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
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
Markland, Alayne D; Jelovsek, J Eric; Rahn, David D et al. (2017) Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence. Female Pelvic Med Reconstr Surg 23:179-183
Arya, Lily A (2017) Rationale for Investigating Stool Metabolites and Microbiota in Women With Fecal Incontinence. Dis Colon Rectum 60:249-252
Komesu, Yuko M; Richter, Holly E; Dinwiddie, Darrell L et al. (2017) Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence. Int Urogynecol J 28:711-720
Richter, Holly E; Moalli, Pamela; Amundsen, Cindy L et al. (2017) Urinary Biomarkers in Women with Refractory Urgency Urinary Incontinence Randomized to Sacral Neuromodulation versus OnabotulinumtoxinA Compared to Controls. J Urol 197:1487-1495
Markland, A D; Jelovsek, J E; Whitehead, W E et al. (2017) Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol. Neurogastroenterol Motil 29:
Amundsen, Cindy L; Richter, Holly E; Wallace, Dennis et al. (2017) OnabotulinumtoxinA vs Sacral Neuromodulation for Urgency Incontinence-Reply. JAMA 317:535-536
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

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