Pelvic Floor Disorders Registry: Study Design and Outcome Measures.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Weber LeBrun, E; Adam, RA; Barber, MD; Boyles, SH; Iglesia, CB; Lukacz, ES; Moalli, P; Moen, MD; Richter, HE; Subak, LL; Sung, VW; Visco, AG; Bradley, CS; American Urogynecologic Society Registry Scientific Committee,

Published Date

  • March 2016

Published In

Volume / Issue

  • 22 / 2

Start / End Page

  • 70 - 76

PubMed ID

  • 26825404

Pubmed Central ID

  • 26825404

Electronic International Standard Serial Number (EISSN)

  • 2154-4212

Digital Object Identifier (DOI)

  • 10.1097/SPV.0000000000000237

Language

  • eng

Conference Location

  • United States