The Pelvic Floor Disorders Registry: Purpose and Development.
Pelvic organ prolapse (POP) is a common problem that negatively impacts women's quality of life. A variety of surgeries exist for POP treatment, including procedures performed with and without mesh augmentation. The growing use of mesh in prolapse surgeries in the 2000s was associated with increasing reports of complications, resulting in Food and Drug Administration (FDA) Safety Notifications, and in 2012, the FDA ordered transvaginal mesh manufacturers to conduct prospective studies to evaluate longer-term outcomes. These requirements provided incentives and an environment conducive to collaboration. American Urogynecologic Society leaders collaborated with device manufacturers, the FDA, and other professional organizations to establish the Pelvic Floor Disorders Registry (PFDR), a collection of interrelated registries, which could meet manufacturers' needs but also allow surgeons to track individual and aggregate outcomes for quality improvement. The PFDR was developed and launched by American Urogynecologic Society with objectives of (1) collecting, storing, and analyzing clinical data related to POP treatment; (2) establishing common data elements and quality metrics; and (3) providing a framework for external stakeholders to conduct POP research. The PFDR includes industry-sponsored studies, as well as 2 options for volunteer registry participation, the PFDR-Quality Improvement and PFDR-Research. The PFDR promotes quality improvement and national benchmarking and will provide real-world comparative safety and effectiveness data for prolapse surgeries. The PFDR can serve as a model for collaboration between medical practitioners, researchers, industry, and federal agencies and may allow progress toward our similar goal of high-quality surgical care of women with prolapse.
Bradley, CS; Visco, AG; Weber LeBrun, EE; Barber, MD
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