Welcome to Nashville and welcome to the second joint AUGS-IUGA scientific meeting. Join us in celebrating the 40th annual scientific meeting of the American Urogynecologic Society and the 44th annual meeting of the International Urogynecological Society. This year's joint meeting has brought together nearly 2,300 physicians, scientists, trainees, physical therapists and trainees from 65 different countries. The program committee led by Roy Yang of IUGA and Mimi Lukits of AUGS has put together an outstanding program for us this week focused on the theme of advancing physician and patient well-being and wellness. We'd like to take a moment to recognize Drs. Yang and Lukits for their commitment to organizing this meeting. Thank you. Excellent job. Let's get it together. The program committee led by Roy from IUGA and Miki Lukits from AUGS have put together an outstanding program for us this week focusing on the theme of advancing patient and physician well-being and wellness. Throughout this meeting, you will find that sessions touch on this theme. Emotional burnout is increasingly being noticed as a concern for many professions, but it has a special resonance in medicine where the term was coined. Key components include emotional exhaustion, depersonalization and reduced personal accomplishment. And this can have an effect on clinical outcome and also on the workforce. Not surprisingly, burnout has an impact on the clinical care we provide and also on academic productivity. As we recognize the consequences of physical burnout, the need to prevent it has become important. Research has shown that interventions to enhance control on work environment and improve satisfaction at work actually reduce physician burnout. This year's meeting was designed with the individual experience and physician wellness in mind. The program committee has provided a combination of workshops and specialized education in addition to the scientific program that will allow meeting participants to make the meeting suit their needs. There are more than 800 workshops and 58 attended yesterday's basic science programming. For the rest of the week, you'll have the chance to take in some of the nearly 400 long oral, short oral, scientific salons and video presentations and view more than 300 non-discussed posters or follow the allied health track. There are moderated panel sessions with evidence-based presentations from multinational and diverse group of experts. These sessions have been paired with surgical tutorials. Please sign up for these deep dive presentations to enhance your clinical approaches. Our meeting app will assist you in building your own schedule and if you haven't downloaded it already, go to the app store and search for Augs iUGA 2019. And for those of you that are using social media, please use hashtag Augs iUGA 2019. We'd like to thank all exhibitors and sponsors whose support makes this meeting possible. You will have your first chance to connect with our supporters this evening at the welcome reception at 6 p.m. It is now our pleasure to present the Lifetime Achievement Award and I'll start off with the iUGA Lifetime Achievement Award. The iUGA Lifetime Achievement Award was established in 2001 to recognize an iUGA member for the exceptional contributions both to iUGA and to the field of urogynecology. This year's recipient has certainly made his mark on both. After training in obstetrics and gynecology, he spent time in the United Kingdom to further gain surgical experience. He has since conducted extensive research and published over 200 peer-reviewed publications, book chapters, and co-authored three books. He has lectured around the world and trained subspecialists in his country and abroad. He was instrumental in establishing the subspecialty of urogynecology for the Royal College of Australian and New Zealand obstetricians and gynecologists. He served as iUGA's president from 2002 to 2004 and was co-editor-in-chief of the International Urogynecology Journal from 2011 to 2016. This is just a snapshot of all this year's iUGA Achievement Award recipient has accomplished. Perhaps one of his colleagues said it best when she said, he's an awe-inspiring figure to begin with, but when you get to know him, he's a fatherly mentor who provides reassurance, advice, support, and plenty of pearls of wisdom. He's certainly our go-to professor for anything urogynecology. It is my great honor and privilege to announce this year's iUGA Lifetime Achievement Award winner, Professor Peter Dwyer. Do you want to say a few words? Do you want to say a few words? Yeah, just a few words. He wants to say a few words. Congratulations. Thank you. Yeah, it's very important to say a few words without being cut off, but my wife Pam just said to me that she deserves the Lifetime Achievement Award. She's the mother of my six children. As Winston Churchill once said, behind every great man there's a woman shaking her head, and that's very true with my wife. I've been coming to these meetings now for the last 30 years, since I was a fellow with Stuart Stanton in London. My co-fellow was Bob Freeman, who's here today, and I must say it's been a marvelous journey over the time. It's allowed us to make friends all over the world. It's allowed us to present our research and hopefully in a small way advance urogynecology on an international basis. My fellows do most of the work over the last 30 years, and I shine in their sunshine. So I thank them for their work and for their friendship, and I thank Rani and the RUJ Executive for this very great honour you've just given me. Thank you very much. It's much appreciated. Thank you, Jeffrey. Thank you, Rani. Thank you, Jeffrey. Thank you, Rani. So AUGS also has a Lifetime Achievement Award, named after Jack Robertson, who was not only one of the key founders of the American Urogynecologic Society, but also served as its first president. He had a surprising ability to cross disciplines in the interest of what was best for women, and he was also an amazingly amicable guy and really a charming person to be around. So this year's recipient is Dr. Mark Walters, who is Professor and Vice Chair of Gynecology and Obstetrics at the Gynecology and Women's Health Institute of the Cleveland Clinic. You all know him as a renowned educator and prolific author, with more than 200 publications, 60 book chapters, and three heavily used books. And his commitment to education is obvious through his service to AUGS. He served as the Course Director for the Comprehensive Review Course in FPRMS, which helped many of us get our boards. And he also has started the Fundamentals in Urogynecology course, which we held at this meeting and had a very large subscription. So his depth of knowledge in the field and his commitment to sharing his knowledge with the next generation is a huge part of his reputation. And in fact, he has nurtured and cultivated many of the leaders, not just in urogynecology, but in gynecology as well. I think he truly exemplifies the model that Jack Robertson left and is the perfect recipient of this award. And more than that, I'm personally proud to be able to present it to him. Dr. Walters. I'll be back. Stand over here. Great. Yep. And I think our slide says he's at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, California State University, and he's a professor at the University of California, I think our slide says he's at the University of Michigan, but we all know he's not. He's at the Cleveland Clinic. So my apologies. There you go. Many of our colleagues presently share the collective perception that innovation has taken a hit, and the sense of loss of control introduces the topic that we'd like to address in the opening session, which is what is the state of innovation in urogynecology? We sometimes forget that the specialty of urogynecology is really quite young, and I see this youth in our collective consciousness, by which I mean the pooled mood of our specialty, and at this moment, that collective consciousness is a bit glum. For the first time in our short history, we have been restricted by regulatory agencies from Australasia to the United Kingdom to North America. Most recently, on April 16th of this year, the FDA published their latest safety action, ordering the remaining manufacturers of transvaginal mesh for prolapse to immediately stop selling and distributing surgical mesh products in the U.S. This followed the TGA ban on transvaginal mesh in 2017, and the surgical pause on transvaginal mesh in the U.K., which included midurethral slings, issued in 2018. Many companies in this space have simply stopped making and marketing their products. So the media coverage of the dissension has been particularly polarizing and demoralizing, but more than that, the resulting limits on practice and available products has directly impacted our clinical work and what we can offer our patients, and under these conditions, we've heard increasing laments that innovation in urogynecology is dead. But is it? We think this is an important question. Innovation is often regarded as uniformly positive. The paradox is that there are some innovations that diffuse rapidly, yet are of unproven or limited value, or actually pose risk, while there are other innovations that could potentially deliver benefits to patients and yet are slow to achieve uptake or make it to the patient's bedside. Still, there is no doubt that innovation is necessary for us clinicians and for the health care that we provide to patients. The aim of innovation is to produce something new or improve on something that is more efficient, more effective, of better quality, safer, sustainable, and affordable. Innovation enables our patients to make a choice based on efficacy and complications. The difficulty is what the patient is told, and even more difficult is what the patient understands when they sign their consent form. Innovation is often perceived as improved, but do our patients really understand the potential unknown risks and benefits? So we can accept the notion that innovation is good for our patients, and you might think that until very recently it's always been an integral part of urogynecology, right? Well, perhaps in the last 20 years, but before that, during the majority of the 20th century, surgeons' creativity was the main driver of innovation in urogynecology. And when we think of innovators like Dr. Marshall, Dr. Birch, and Tanago, when we think of people like Dr. McCall, Dr. Nichols, and Dr. Addison, their innovations were really related to making changes to the surgery that they were performing and building those into techniques. And their revelations reached us through the surgical literature, but really they were usually case series with short-term follow-up, and the reports dutifully documented complications, but weren't real safety assessments. In fact, valid investigations of efficacy with controls or even observational methodologies were surprisingly rare, and usually published decades after the acceptance of the new procedures. The standards of scientific evaluation and reporting began to change in the 90s, and this was largely due to Wolframston and his introduction of the TBT mediretor surgical sling. While this innovation was initially surgeon-driven, the recruitment of an industry partner to create a product was a departure from just reporting a surgical technique, and this brought about new standards to the process. Corporate responsibility to investors demanded a rigorous assessment to any new product, and TBT was carefully evaluated for efficacy and safety. In an ideal world, this approach would have been compulsory for all new surgical devices. Unfortunately, the FDA's 510 process essentially eliminated the need for new products to demonstrate safety and efficacy. Subsequent manufacturers saw Johnson & Johnson having fabulous success with the TBT, so fiduciary responsibility to investors was also seen as redundant. And in this laissez-faire environment, the new corporate-backed innovation exploded. While this brought tremendous investment and resources to surgical innovation within urogynecology, the process was not balanced. The missing element was the patient. And when safety concerns did surface, and they limited further innovation, as we have now learned, defining safety and efficacy of new products is in the patient's best interest, and as physicians, it is our duty to protect those interests. You might think of this as patient-centered innovation. So what is patient-centered innovation? Patient-centered innovation is similar to patient-centered healthcare. It is a new way of thinking and doing things, wherein doctors and patients can work collaboratively to improve the way healthcare is designed and delivered, so that it better meets the needs and priorities of patients. Patient-centered care ensures that doctors and patients and healthcare systems are equal partners in planning, developing and monitoring innovations to make sure that their needs are balanced for efficacy and safety. So how can we involve patients in the whole process? We need to review the role of our patients and carers, starting right from when an idea is conceived, through the stages of regulatory control, right to the end. Not just at the end, as is done now. The patient needs to be in the center right from the beginning. The patient is now the expert. So if we have to pursue the ideal of patient-centered innovation, we need to consider what are the forces that are involved in its optimization, and these include industry, regulation, regulatory bodies, physicians and academics. So let's consider these individually. When considering the impact of industry on patient-centered innovation, it is important to remember that their fiduciary responsibility is to shareholders. They create value for shareholders through the development of an effective and safe product, which underlines the imperative of research proving efficacy and safety. However, discovery often focuses on the outcomes achieved by the innovator, neglecting the importance of spread and scalability of the innovation. We recognize for years that adopters frequently don't realize the same results with a new intervention, and this could be for a number of reasons, from innovator bias to learning curve to a system or cultural obstacles that vary by environment. The importance of adopters is especially important to the successful implementation of a new product, as the variability and complications and effectiveness is usually what leads to product liability and litigation. Clearly, successful implementation of new products should be a priority for industry, as their duty to shareholders requires companies to avoid litigation. Consequently, it is in the best interest of industry to apply resources not only to discovery, but also to the successful implementation of innovation, and this translates to ensuring that there's adequate professional development for physicians adopting a new technology, and also resources devoted to following and reporting results in the real world, such as surgical registries. Let's consider regulatory bodies who are responsible to the government and are the gatekeepers. Their role is to regulate the sale of medical products, including devices, and monitor their safety. The problems with measures and tapes is probably due to the fact that to be legally marketed across the world, the main prerequisite was previously simply to demonstrate equivalence to an existing device that had been shown to be biocompatible. Changes are needed and are currently happening. Regulators need to ensure that a product is adequately assessed using phase one studies right at the beginning before it comes to clinical practice. These results need to be generalizable. Long-term monitoring is needed, and this could perhaps be done through unbiased registries. Consideration needs to be given to training. The problem is that there are different regulatory bodies in different countries. To globalize this, a voluntary body called the International Medical Device Regulators Forum has been developed. Physicians are the third group that are necessary to accomplish patient-centered innovation. Our fiduciary responsibility is to the individual patient. Of course, no two patients are the same, which is why they benefit from treatment choices. However, for them to compare different treatment options, patients need to understand the benefits and the risk of available treatments. While the context of shared decision-making within that context, it is a surgeon's responsibility to ensure that patients comprehend the benefits and risk of alternative treatments. However, this framework is compromised by innovative products for which the long-term or even the short-term outcomes are unknown. Moreover, a surgeon innovator who is enamored by a new procedure also potentially compromises the informed consent process through the loss of objectivity. In fact, patients tend to lose objectivity themselves, especially towards innovation, as our society imbues innovation as not just new but also improved. This can be particularly misleading when innovations are being marketed or part of marketing campaigns for hospitals or physicians. Also, if a surgeon providing an informed consent is not the innovator but is an adopter, then the patient could suffer from poor generalizability of the purported outcomes. What is the learning curve for the new procedure, and where is the adopter on that curve? This highlights the challenge of lifelong learning for surgeons and the importance of effective professional development that utilizes simulation and preceptors to ensure that patient safety is not compromised by the introduction of innovative procedures. Recognizing the challenges of innovation brings to effective informed consent and shared decision-making highlights the potential harm to patients from imprudent surgical innovation, and yet limiting surgical innovation through excessive regulation also harms patients in the long run. The answer is not stricter oversight but better training of surgeons to strengthen their understanding of the ethical issues associated with innovation and the primacy of the patient in that ethical framework. The relationship between academics and industry is a partnership which is a double-edged sword for it carries with it a potential for an exciting future as much as a prospect of misappropriation. Academics produce research to define efficacy and safety, and the motivation is usually not monetary. As you all know, most clinical research, especially RCTs on new products are undoubtedly expensive and are funded by industry, but the investigations are often led by very well-qualified scientists. The ties between researchers and industry include not only grant support but also consultancies on new products, being present on advisory boards, speakers' bureaus, royalties, equalities, and shares. Universities are increasingly using the conflict of interest declarations to try and manage faculty members with these complex links. But how can academic institutions impose a conflict of industry policy when some of them actually enter into partnership with drug companies to set up research centers and teaching programs? Both sides see a benefit to this arrangement. For financially struggling medical centers, it means cash. For the companies that make drugs and devices, it means access to research talent, affiliation, and technical transfer. So what needs to be done? Considering that there are mutual benefits, a paradigm reshift in the way academia and industry interacts needs to be considered. The cooperation needs to be at arm's length. Both parties need to maintain ethical standards, have strong conflict of interest policies, and reconsider financial arrangements. One has to be mindful that the ultimate aim of the two is completely different. It is well to remember that the cost of industry-sponsored trips, meals, gifts, conferences, symposiums, and onreniums, consulting fees, and research grants are simply added to the prices of drugs and devices. We've already identified a number of threats to successful patient-centered innovation that arise from the interactions of industry, academics, physicians, and regulatory bodies. And our recent history as a specialty provides clear examples as well. In fact, the introduction of transvaginal mesh kits for prolapse is a tangible example of innovation that was not patient-centered. The evidence that was used to market these products was largely based on the experience of the innovators, who were usually physicians within our field. These innovators became strong advocates based on their own experience, and when the products were used in different settings by less experienced surgeons, the results were less beneficial with significant complications. This was a failure of implementation of innovation as well as a failure of continuing education of practicing surgeons. As already noted, the absence of meaning regulatory system allowed the marketing of products for which there was inadequate evidence of safety and efficacy. While this was an omission on the part of the regulatory bodies, there is adequate blame to go around, as manufacturers marketed products that they knew were inadequately tested, and physicians used them. And in the absence of adequate evidence of safety and efficacy, how could they provide patients with reasonable benefits and risk? So all of these entities failed to meet their responsibilities, but how do we fix this? Ethical surgeons are the key to balancing the risk of unregulated surgical innovation with the risk of no innovation due to overregulation. This highlights why new innovation should be restricted to research settings until adequate evidence is accumulated. Increasingly we see that the ongoing development and evaluation of innovation necessitates continuous information, education, and training of healthcare professionals. Who is better place to assume this role than professional organizations? Professional organizations are run as non-profit associations governed by peers. We also have access to diverse expertise both national front and internationally. We have strong governance structures in place. We are transparent in our goals, and more importantly, we have a network of members. The annual meetings are not just formal meetings where academics share data on efficacy and safety on new products. They offer a venue for physicians, academics, industry, and regulatory bodies to interact. They provide a unique opportunity to network at a personal level and exchange ideas and learn from each other. As you can see during this meeting, we have a large number of industry sponsors. These meetings provide industry a chance to meet physicians and familiarize them with new products. More importantly, the younger generation get an opportunity to listen and interact with experienced colleagues who can model ethical innovation, thereby empowering them to become future leaders in our field. The importance of physician education to successful implementation of innovation keeps coming up. And for the last few decades, manufacturers of surgical devices have seen training of surgeons on their devices as their responsibility. And in fact, they've spent millions of dollars on that responsibility. And yet education is not within the skill set of industry, who generally hire the innovators to provide training in short formats that are not tied to the development of competence or credentialing. In contrast, our societies are experienced purveyors of professional development. They can provide impartial perspectives on new technology with simulation-enhanced workshops, competence-focused curricula, and patient-centric approaches that highlights benefits, risks, and alternative treatments. In fact, this expertise and equipose is why education provided by professional organizations can seek CME accreditation. The arm's-length equipoise that professional organizations have for education also applies to research. Research funds to evaluate new evaluations are directed to our organization foundations, eliminates the perceived risk of bias associated with direct industry funding. Surgical registries, which both our associations have, provide an excellent receptacle for ongoing knowledge on safety and complications, and how well a new innovation will be implemented in the real world. Professional societies can advocate for funding for research projects strictly following the code of conduct. Our societies have all the key to our wider membership through our journals and presentations at annual meetings. As we become more aware of the important role that professional organizations have to play in cultivating patient-centered innovation, it is worthwhile to consider what are the greatest obstacles to realizing it. We've already noted that the importance of responsible regulatory process and the need for separation between industry and the academy that provides research to determine safety and efficacy for new technologies. What we have neglected is the inclusion of the patient voice. Now, let's be clear. Professional organizations are formed to serve the needs of their members, but a better understanding and inclusion of the needs of patients is part of that equation. We need to be advocates for our patients. So for those of you who have feared that innovation in urogynecology is dead, be reassured that it is far from dead. Instead, it is reconstituting itself in a new format that will allow patient-centered innovation to flourish. And your professional organization, IUGA and AUGS, are already cultivating that ground. For example, both IUGA and AUGS are maintaining a balanced approach to assessing new technology. On Monday, you saw the expanded basic science session and the Prolapse and Matched Consensus Conference, which was sponsored by AUGS. On Thursday, we have the International Urogynecological Consultation on Prolapse sponsored by IUGA. And when you can't attend meetings, you have webcasts and webinars and podcasts to disseminate new information on new innovation. We are also ensuring that investigation maintains an appropriate focus on patient safety. And this is reflected in the global statement on midurethral slings signed by 50 sister societies and by the Innovation and Surgery Roundtable at this meeting. AUGS is an active member in the ACOG Patient Safety Council. And the focus on patient safety is also seen in AUGS' work with the FDA to develop a framework for a longitudinal collection of real-world data. And both societies work with industry to facilitate 522 studies. In fact, we have added a session this afternoon to present late-breaking results from the 522 studies along with discussion. And I hope you can make that. We also have dedicated resources towards the management of patient complications, including workshops here at PFD Week and research support for new studies focused on surgical complications as well as a jointly written position statement on mesh complications and their management by FPRMS specialists, which we'll be publishing shortly. But perhaps the most important step towards patient-centered innovation are recent efforts to engage patients and advocate for their needs. Both organizations have developed websites which are dedicated to patients with pelvic floor disorders. And IUGA's website includes resources available in 19 different languages. AUGS has created a new patient advisory group comprised of patients with pelvic floor disorders. The goal of the group is to inform AUGS board and committees on issues that are important to women with pelvic floor disorders. And these include providing a patient's perspective on new clinical guidance documents, patient information sheets, as well as quality improvement activities. IUGA is developing a new patient focus group. That's okay. Our organizations have both sought to cultivate strong industry support of innovation through collegial relationships with industry while ensuring that funding is at arm's length. And examples include the development of the IUGA Surgical Registry and AUGS Acquire Registry. These registries help the companies to meet their regulatory requirements while ensuring that implementation of new technology is optimized. Similarly, the AUGS Foundation and FIUGA facilitate interactions between academic members and industry through the provision of third-party research grants. And increasingly, our organizations are providing third-party education to clinician members around new technologies. For example, here at PFD Week and through the fellows course. This allows industry to ensure that adopters of new technology are optimally trained without a conflict of interest. Lastly, both societies are cultivating a culture of transparency that is necessary to create patient-centered innovation. For example, AUGS will provide an addendum to our annual report this year that will provide public transparency on industry support. We also want to celebrate innovators in our specialty, and so AUGS has created a new lectureship, the AUGS Innovator Lectureship, which will begin next year. IUGA has a strong conflict of interest policy, and AUGS are developing a new conflict of interest policy this year. And towards celebrating our innovators, IUGA have the Ulf Umstein Lecture. So as I noted in a recent editorial in FPRMS, mature surgical specialties are not defined by procedures, as the management of all conditions evolves over time. Our patients benefit from this progression as it provides choices of alternative treatments that will fit their specific conditions and personal priorities. Viewed from this perspective, the patient becomes the center of ethical innovation that defines the framework of how innovation will proceed. So we have not lost the opportunity to innovate. We've only lost our naivete. Thank you for listening. Thank you very much. Thank you.

joint AUGS-IUGA scientific meeting

physicians

well-being

emotional burnout

patient-centered innovation

professional organizations

safety

efficacy