Background and History
The Food & Drug Administration (FDA) has played an active role in leading discussions and recommendations related to the ongoing safety and effectiveness of FDA approved transvaginal placement of mesh for POP and stress urinary incontinence (SUI). In recent years, the FDA has ordered manufacturers of transvaginal mesh products for POP to conduct postmarketing surveillance of the product and related procedures.
In support of the FDA’s recommendations, AUGS initiated the national Pelvic Floor Disorders Registry (PFDR) to provide much needed information about the comparative effectiveness, quality of life and safety associated with various surgical and non-surgical treatments and ultimately to improve the quality of care for women with these conditions. As the leading professional organization dedicated to the treatment of pelvic floor disorders, the American Urogynecologic Society (AUGS) recognizes the current trend in medicine today of reporting outcomes and establishing credible methods of tracking and reporting outcomes that focus on the interest of patients and providers.
AUGS is working in collaboration with multiple partners to develop and implement the Registry. The PFDR is a necessity that was mandated at multiple institutional levels, including the FDA. The FDA has approved the PFDR and industry partners play an important role in supporting the PFDR, but governance and data management is maintained by AUGS. The governance structure will include a Steering Committee and a Stakeholder Advisory Board that will work closely together to ensure the integrity of the Registry. Available in Q1 2015, the PFDR will collect both provider and patient reported outcomes through broad participation from specialists and generalists performing surgery for prolapse.
The population for the PFDR will include adult female patients who have newly elected to receive surgical and non-surgical treatment for POP and will focus on following patients for up to 36-months after treatment.
The PFDR will evaluate the effectiveness of POP treatments on the basis of three criteria including subjective success (the patient does not report symptoms of vaginal bulging); anatomic success (no vaginal or uterine descent beyond the hymen on pelvic examination); and no retreatment (the patient has not received additional surgical treatment for POP or used a pessary since the index surgery.
The PFDR will evaluate the safety of POP treatments based on a review of post-treatment adverse events.