Two requests for applications (RFAs) with set asides are proposed for the Pelvic Floor Disorders Network. They are entitled “Pelvic Floor Disorders Network Clinical Sites,” and “Pelvic Floor Disorders Network Data Coordinating Center.” This network has received support from the Office of Research on Women’s Health for studies. Both RFAs will use the cooperative agreement mechanism, which includes substantial NICHD programmatic involvement among the Clinical Sites and Data Coordinating Center.
The NICHD established the Pelvic Floor Disorders Network in 2001 to support a multicenter network in response to the growing public health need for high quality clinical trials in this area. The purpose of this request is to recompete the Pelvic Floor Disorders Network. The network consists of eight Clinical Sites and one Data Coordinating Center along with NICHD to perform clinical trials and observational research. The goal of the Pelvic Floor Disorders Network is to conduct multicenter clinical research designed to investigate problems in pelvic floor disorders, including urinary incontinence, fecal incontinence, and pelvic organ prolapse, as well as other sensory and emptying abnormalities of the lower urinary and gastrointestinal tracts. One objective of the Pelvic Floor Disorders Network is to facilitate resolution of these problems by establishing a network of academic centers that can study the required numbers of patients under rigorous common protocols and then provide answers more rapidly than individual centers acting alone.
The scope of research of this concept includes clinical problems in urinary incontinence, fecal incontinence, and pelvic organ prolapse. The scientific knowledge to be achieved through research supported by the Pelvic Floor Disorders Network will include accumulation of quality evidence to inform specific rather than empiric methods for prevention, diagnosis, and treatment of pelvic floor disorders. This knowledge will be obtained by incorporating research on standard treatments as well as testing new therapies and approaches to move the research agenda forward in unique directions. The Data Coordinating Center will be the critical component for novel study designs, secure statistical analyses, and data management and reporting processes. The network will continue to conduct prospective randomized trials of interventions for pelvic floor disorders, observational studies, and long term follow up on high risk cohorts. The proposed network would include 6-9 clinical sites, a data coordinating center, and NICHD.
The objective of this concept is to design and carry out high quality research to benefit women with pelvic floor disorders by expanding a network of academic centers that can study the required numbers of patients under rigorous common protocols. Particular attention will be paid to develop inventive solutions to the challenging problems in women with pelvic floor disorders and to reduce the burden of pelvic floor disorders for women and their families. The goal of the Pelvic Floor Disorders Network is to expand multicenter clinical trials to better understand the pathophysiology that leads to these conditions, and then be able to better assess treatment and prevention strategies.
Estella Parrott, MD, MPH
Gynecologic Health and Disease Branch
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