The broad long-term objective of the NICHD Pelvic Floor Disorders Network (PFDN) is to perform multicenter research to study clinical and health aspects of pelvic floor disorders (PFD) with an emphasis on performing randomized clinical trials in order to reduce the burden of these conditions on women and their families. The Cleveland Clinic is seeking to successfully compete in the fourth cycle of the PFDN. The Cleveland Clinic PFDN Clinical Site joined the Network as one of its seven Clinical Sites at the beginning of the Network's 2nd 5- year cycle (2006) and has continued as a highly productive clinical site through its 2nd and 3rd cycles (2006- 2015).
The specific aims of this application are to: 1) demonstrate that the Cleveland Clinic PFDN Site has contributed substantially to the academic, administrative, and clinical aspects of the PFDN during its 2nd and 3rd 5-year cycles; 2) demonstrate that we possess the personnel, patient, clinical and administrative resources needed for successful participation; and that our continued participation would be advantageous to the successful attainment of the Network's scientific goals, and 3) describe the unique strengths of the Cleveland Clinic Site relevant to PFD research. The Cleveland Clinic offers a stable, research-oriented environment for the conduct of Network studies includes highly experienced investigators with complementary clinical and research backgrounds with expertise in urogynecology, urology, colorectal surgery, physical therapy, epidemiology, radiology and biomedical engineering. Additionally, our site offers unique expertise in PFD outcome measure development and validation, development of clinical risk prediction models, and basic and translational research of PFDs. The Cleveland Clinic Center for Female Pelvic Medicine and Reconstructive Surgery provides care to a large volume of women with the full spectrum of PFD including urinary incontinence, fecal incontinence and pelvic organ prolapse and other sensory and emptying abnormalities of the lower urinary and gastrointestinal tracts with approximately 3,200 new patients seen and 3,900 surgeries performed annually. Our research team has a long and successful history of conducting clinical and translational research including clinical trials evaluating both surgical and non-surgical therapies for women with PFD. We have developed an infrastructure and environment conducive to the conduct of clinical studies of the PFDN and have made substantial contributions towards PFDN productivity including taking leadership in the design, implementation and publications of many PFDN studies and analyses. The unique strengths of the Cleveland Clinic Site have expanded and strengthened PFDN activities in the 2nd and 3rd cycle and will continue to be advantageous to the Network in the future. The health-relatedness of the PFDN and our application is that on-going and future Network studies will significantly advance the field by filling important gaps in our knowledge to expand evidence-based treatments for women with PFD.

Public Health Relevance

Pelvic floor disorders including urinary incontinence, pelvic organ prolapse, and fecal incontinence affect nearly one quarter of all women and more than one-third of older women. The Pelvic Floor Disorders Network conducts multicenter research to study the clinical and health aspect of these highly prevalent conditions in order to reduce their burden on women and their families.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Clinical Research Cooperative Agreements - Single Project (UG1)
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Special Emphasis Panel (ZHD1)
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Halvorson, Lisa M
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Cleveland Clinic Lerner
Schools of Medicine
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