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.

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 #
2UG1HD054215-11
Application #
9178015
Study Section
Special Emphasis Panel (ZHD1-DSR-L (MB)1)
Program Officer
Halvorson, Lisa M
Project Start
2006-09-12
Project End
2021-06-30
Budget Start
2016-09-13
Budget End
2017-06-30
Support Year
11
Fiscal Year
2016
Total Cost
$19,020
Indirect Cost
$7,020
Name
Cleveland Clinic Lerner
Department
Surgery
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
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
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:
Visco, Anthony G; Zyczynski, Halina; Brubaker, Linda et al. (2016) Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial. Female Pelvic Med Reconstr Surg 22:311-6
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
Lukacz, Emily S; Warren, Lauren Klein; Richter, Holly E et al. (2016) Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse. Obstet Gynecol 127:1071-9
Sung, Vivian W; Rogers, Rebecca G; Bann, Carla M et al. (2014) Symptom outcomes important to women with anal incontinence: a conceptual framework. Obstet Gynecol 123:1023-30