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.
PFDR Timeline
- Oct 2008 – FDA issues first Public Health Notice
- July 2011 – FDA issues second Public Health Notice
- January 2012 – FDA issues 522 Orders for TVM
- January 2012- AUGS expressed interest to FDA to serve as host; FDA initiated initial conference call about a multi-sponsored registry with industry, societies, NIH and others
- April 2012 – Quintiles Outcome selected as technology platform
- July 2012 – Announced to AUGS members; ACell, ASTORA Women’s Health, Boston Scientific, Coloplast confirmed sponsors
- October 2012 – Registry build kick-off
- Second Quarter of 2014 – Launch of PFDR-Industry Sponsored Research
- First Quarter of 2015 – Launch of PFDR-Research to Pioneer Sites
- October 2015- PFDR-R enrolling Pioneer sites only
- February 2016- Approved to meet MOC Part IV Improvement in Medical Practice requirements for 2016 & 2017