Frequently Asked Questions
Q: What is the Pelvic Floor Disorders Registry?
A: Pelvic Floor Disorders, or PFDs, including urinary incontinence, pelvic organ prolapse (POP) and fecal incontinence, are prevalent conditions among women, particularly as they age. Treatment of PFDs is often complex, and yet there is very little systematically collected data regarding the safety and efficacy of various treatment options. Initiated by the American Urogynecologic Society (AUGS), the Pelvic Floor Disorders Registry (PFDR) is the first national registry for providers who care for patients with PFDs to provide much needed information about the comparative effectiveness, quality of life and safety associated with various surgical and nonsurgical treatments and ultimately to improve the quality of care for women with these conditions.
Q: What quality measures are included in the regsitry?
A: 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.
Q: Why is the Registry needed?
A: AUGS initiated PFDR to track patients who have undergone procedures using both mesh and non-mesh repairs and to provide evidence for best medical practices for the treatment of PFDs, including Pelvic Organ Prolapse (POP). POP is a prevalent condition and like many PFDs, impacts a woman’s daily living and quality of life by affecting body image, sexual function and family relationships. Currently, there is very little systematically collected data available to patients and providers to make informed decisions regarding both surgical and non-surgical treatment options for POP. The PFDR will provide women and their doctors with information that will enable more informed discussions regarding the likely benefits and potential risks of all treatment options.
The PFDR will also be used to satisfy a requirement from the U.S. Food and Drug Administration (FDA) that manufacturers of transvaginal mesh for POP to conduct postmarketing surveillance of the product and related procedures.
Q: Who participated in the design of the Registry?
A: The PFDR was designed with guidance from the Registry Steering Committee, along with input from a Stakeholder Advisory Board that includes members of industry, the FDA, and CMS as well as patient representatives.
Q: Did patient representatives have input?
A: Patients are represented in the guidance and direction of the Registry through the Stakeholder Advisory Board. The Stakeholder Advisory Board was brought together by the Registry Steering Committee with the intention of being all inclusive in the recommendations that are taken into consideration.
Q: Who is funding the Registry?
A: AUGS received a number of unrestricted educational grants from the medical device industry that were used in the development of the Registry.
Q: What is FDA’s involvement in the Registry?
A: Representatives of the FDA participate on the Stakeholder Advisory Board, whose role is to provide direction and recommendations to the Registry Steering Committee concerning new strategic opportunities and direction for the PFDR.
Q: What is Industry’s involvement in the Registry?
A: Industry representatives participate on the Stakeholder Advisory Board, whose role is to provide direction and recommendations to the Registry Steering Committee concerning new strategic opportunities and direction for the PFDR. Industry will also have the opportunity to access certain parts of the registry (PFDR - Industry Sponsored Research) in order to conduct clinical research to fulfill the FDA’s request for postmarket surveillance for transvaginal mesh for POP.
Q: Who can participate?
A: Healthcare providers of women with PFD, including gynecologists, urologists and Female Pelvic Medicine and Reconstructive Surgery (FPMRS) specialists including urogynecologists and female urologists in both academic and private practice settings, will be eligible to participate in the PFDR. The population for the Registry will include adult female patients who have newly elected to receive surgical or non-surgical treatment for PFD, and will initially focus on patients receiving surgical and non-surgical treatments for POP.
Q: How will the Registry benefit physicians who participate?
A: Physicians who participate in the Registry will help ensure the safety of their clinical practice by participating in benchmarking the safety and efficacy of various POP treatments. Based on information generated from the registry, physicians will achieve a greater understanding of transvaginal mesh and its role in pelvic reconstructive surgery, and be able offer clear, unequivocal evidence about anticipated outcomes.
Q: How will the Registry benefit researchers who participate?
A: Researchers or institutions that participate in the registry may publish or present the results of their own data and will be given priority for the publication of data contributed from their site. All participating sites have access to their individual site's own data, which then a data analysis request can be submitted to use your data for abstract submissions, development of manuscripts and scientific symposia. Sites may publish or present results of their own data after obtaining publication rights from AUGS Publication Subommittee.
Q: How will the Registry benefit patients who participate?
A: One of the main purposes of the Registry is to generate balanced evidence regarding treatments for PFD and to improve patient outcomes. Patients that participate in the Registry may not receive direct benefit, but the knowledge gained regarding comparative treatment outcomes could result in optimization of their future care as well as the care of other patients with PFD.
Data Access and Use
Q: How will the data in the PFDR be used?
A: The Registry will provide a framework for stakeholders in cooperation with AUGS to conduct research to improve knowledge of best medical practices in the treatment of PFDs, in particular for Pelvic Organ Prolapse (POP). Benchmarking reports will allow participating healthcare providers to evaluate treatment outcomes at their specific site. The results of this research will ultimately improve the quality of care for women with these conditions.
Q: Who has access to the data?
A: All participating sites will have access to the data entered regarding the individual site’s own enrolled patients. Beyond that, the Registry Steering Committee will develop written policies for access and utilization of Registry-generated data for abstract submission to scientific meetings, development of manuscripts for peer-review journal submission, or scientific symposia. A Scientific Committee will meet at regular intervals throughout the year to review incoming proposals for consolidated data analyses and will provide recommendations to the Registry Steering Committee that include an assessment of the scientific validity of the proposal as well as its ranked priority for implementation.
The Registry Steering Committee will ensure appropriate dissemination of treatment-related and clinical course related information to health authorities and stakeholders. The main findings of the PFDR will be reported in a Registry Report at least annually and made available to the public via the PFD Registry website.
Q: Will this data be provided to the FDA?
A: The Registry Steering Committee will ensure appropriate dissemination of treatment-related and clinical course related information to health authorities and stakeholders. User facilities are required to report suspected medical device related deaths or serious injuries to the FDA.
Q: How will the data be collected?
A: All data will be collected and entered directly into the Quintiles/Outcome electronic data capture (EDC) system. Some patient-reported data may be collected on paper and entered into the registry by registry or site staff. Sites will be responsible for entering patient data into a secure internet-based EDC registry database via the electronic case report form (eCRF).
Q: How do you ensure quality of the data?
A: The database will be housed by Quintiles/Outcome in a physically and logically secure computer system maintained by Quintiles/Outcome in accordance with a written security policy. The system meets the standards of the International Committee on Harmonization (ICH) guideline E6R1 regarding electronic data handling and is available for audit upon request. The system also meets approved U.S. federal standards for the security of health information and is validated.
Due to the nature of the Registry, it is anticipated that the majority of quality controls will be implemented through edit checks and data queries through the EDC system. Studies conducted as part of Level 3 participation may entail additional quality assurance measures (e.g. monitoring) which will be described in individual study protocols.
In addition, high data quality standards will be maintained and processes and procedures utilized to repeatedly ensure that the data are as clean and accurate as possible when presented for analysis.
Q: When will data from the Registry first be available to the public?
A: The main findings of the PFDR will be reported in a Registry Report at least annually and posted on the PFD Registry website.
Q: How will the registry help manufacturers meet the FDA’s 522 order for postmarket surveillance for transvaginal mesh for the treatment of POP?
A: The PFDR is designed to capture meaningful data that will include those elements required by the FDA’s 522 order for transvaginal mesh for prolapse. The registry will also include a robust platform upon which industry partners will be able to build study-specific research protocols to address individual 522 orders.
Q: How will patients be assured of their confidentiality?
A: In order to maintain patient confidentiality, each patient will be assigned a unique patient identifier upon Registry enrollment. The patient identifier will be used in place of patient name for the purpose of data analysis and reporting. Medical record number or other local reference identifiers are not collected as part of the database. Patients will be informed about data handling procedures and asked for consent at data collection sites as required.
Q: Who is responsible for managing the Registry?
A: The work of the Registry will be guided by a Registry Steering Committee created by AUGS. The committee will be responsible for developing and implementing the strategic goals of the Registry and is the governing body that oversees Registry operations, including the successful implementation, management, and oversight of resources and activities
In addition, a Stakeholder Advisory Board provides a way for key partners to provide input on the Registry and to support and conduct clinical research that will improve the quality of care for women with PFD. In addition to AUGS, key stakeholders include the American Congress of Obstetricians and Gynecologists (ACOG), the Society for Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction (SUFU), American Urologic Association (AUA), Women’s Health Registry Alliance, FDA, Eunice Kennedy Shriver National Institute for Childhood Health and Human Development (CICDH), participating providers, and the medical device industry.