The Pelvic Floor Disorders Registry (PFDR), the American Urogynecologic Society’s (AUGS) national patient registry, is a multi-centered prospective cohort of patients undergoing treatment for pelvic organ prolapse (POP) to evaluate the effectiveness, quality of life and safety associated with both surgical therapy (transvaginal/transabdominal native tissue repair, transvaginal mesh repair and sacrocolpopexy) and non-surgical management (pessary). The PFDR, managed by the PFDR Committee, is designed to collect both provider and patient reported outcomes through broad participation by physicians providing treatment for POP.
The PFDR is a web-based platform designed to collect, store and analyze both provider and patient reported outcomes through broad participation from specialists and generalists performing surgery for prolapse. The Registry will also provide a framework for stakeholders in cooperation with AUGS to conduct research to improve knowledge in the field.
The data collection phase of this project is closed. Data from the registry is being analyzed and will meaningful data be published. Registry data is planned to be available to AUGS members in late 2024.
The primary objectives of the registry are to:
- Evaluate the effectiveness, quality of life and safety associated with surgical options (transvaginal/transabdominal native tissue repair, transvaginal mesh repair and sacrocolpopexy) for POP
- Assess the effectiveness and quality of life associated with non-surgical management (pessary) for POP
- Provide a framework for clinical studies to be conducted within the registry, including industry-sponsored studies required to fulfill the FDA’s request for postmarket surveillance for transvaginal mesh for POP
- Allow healthcare providers to track surgeon volume, patient outcomes, and quality measures for quality improvement activities and fulfill upcoming Centers for Medicaid and Medicare Services (CMS), Physician Quality and Reporting Systems (PQRS) and maintenance of certification requirements
The secondary objectives of the registry are to:
- Identify modifiable and non-modifiable risk factors associated with complications and reduced effectiveness of PFD treatments
- Capture comprehensive data that includes those elements required by the FDA’s requirement for postmarketing surveillance of transvaginal mesh use for POP
- Function as resource for additional PFD research, whereby stakeholders and participants may propose and conduct analyses of registry data (as approved by registry’s Scientific Committee) and in cooperation with AUGS
The PFD Registry is thankful for the generous support provided by: