title: Pelvic Floor Disorders Registry: Study Design and Outcome Measures.
abstract: Pelvic floor disorders affect up to 24% of adult women in the United States, and many patients with pelvic organ prolapse (POP) choose to undergo surgical repair to improve their quality of life. While a variety of surgical repair approaches and techniques are utilized, including mesh augmentation, there is limited comparative effectiveness and safety outcome data guiding best practice. In conjunction with device manufacturers, federal regulatory organizations, and professional societies, the American Urogynecologic Society developed the Pelvic Floor Disorders Registry (PFDR) designed to improve the quality of POP surgery by facilitating quality improvement and research on POP treatments. The PFDR will serve as a resource for surgeons interested in benchmarking and outcomes data and as a data repository for Food and Drug Administration-mandated POP surgical device studies. Provider-reported clinical data and patient-reported outcomes will be collected prospectively at baseline and for up to 3 years after treatment. All data elements including measures of success, adverse events, and surgeon characteristics were identified and defined within the context of the anticipated multifunctionality of the registry, and with collaboration from multiple stakeholders. The PFDR will provide a platform to collect high-quality, standardized patient-level data from a variety of nonsurgical (pessary) and surgical treatments of POP and other pelvic floor disorders. Data from this registry may be used to evaluate short- and longer-term treatment outcomes, patient-reported outcomes, and complications, as well as to identify factors associated with treatment success and failure with the overall goal of improving the quality of care for women with these conditions.
authors.affiliation: From the University of Florida College of Medicine, Gainesville, FL.
authors.forename: Emily
authors.initials: E
authors.lastname: Weber LeBrun
authors.forename: Rony A
authors.initials: RA
authors.lastname: Adam
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Barber
authors.forename: Sarah Hamilton
authors.initials: SH
authors.lastname: Boyles
authors.forename: Cheryl B
authors.initials: CB
authors.lastname: Iglesia
authors.forename: Emily S
authors.initials: ES
authors.lastname: Lukacz
authors.forename: Pamela
authors.initials: P
authors.lastname: Moalli
authors.forename: Michael D
authors.initials: MD
authors.lastname: Moen
authors.forename: Holly E
authors.initials: HE
authors.lastname: Richter
authors.forename: Leslee L
authors.initials: LL
authors.lastname: Subak
authors.forename: Vivian W
authors.initials: VW
authors.lastname: Sung
authors.forename: Anthony G
authors.initials: AG
authors.lastname: Visco
authors.forename: Catherine S
authors.initials: CS
authors.lastname: Bradley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008875:Middle Aged; D059952:Pelvic Floor Disorders / Q000628:therapy*; D056887:Pelvic Organ Prolapse / Q000628:therapy; D011446:Prospective Studies; D012042:Registries; D019233:Retreatment; D016896:Treatment Outcome; D055815:Young Adult