“May you live in interesting times,” goes the somewhat mischievous blessing. These are indeed interesting times, when many of us face the daily paradox of taking care of women with stress incontinence, seeing the benefits most women enjoy from midurethral sling procedures, and then witnessing the public assault leveled at them nationally and internationally. How can we reconcile the puzzling fact that the midurethral sling is one of the most intensely scrutinized procedures in gynecologic surgery, and yet still there is the perception that we don’t have enough information about them to determine their safety?
Although peer-reviewed research, with Randomized Controlled Trials at the pinnacle of that structure, is a vitally important part of our assessment of intervention, it may be that we now require a supplemental kind of evidence. Many of the international bodies that have come to their various conclusions about the safety of mesh in gynecologic use lay out a compelling argument for the development of registry data. Unlike traditional academic research projects, which often have a significant time delay due to data collection and analysis, registries offer the promise of real-life performance assessment on a large scale with the opportunity for real-time feedback and continuous improvement. With more quality improvement focus physicians can easily track their outcomes and identify gaps in care. Registries can also allow patients to provide their evaluation of their treatment, and to have their perspectives included in the medical community Furthermore, based on the breadth of data collected, registries provide the opportunity to address a variety of questions and adapt to fit the ever-changing demands of the field.
For over a year now, AUGS has been developing the SUI Surgery Registry Module that is embedded into the AUGS Quality Improvement Registry (AQUIRE). For this project, AUGS has partnered with the FDA and SUFU representatives in developing the core minimum dataset. This module has been built from the ground up with the following priorities:
- It has both objective and patient-reported outcomes (PROs) about the critical outcomes of efficacy and safety over 3 years
- It tracks specific device information (when devices are used) using barcode scanning technology
- It allows for local and regional benchmarking of Quality and of outcomes, so that individuals and practices can understand their outcomes relative to their communities
- Above all, unlike many research-based registries, it is designed to be usable; it uses a minimum core data set of no more than 15 fields for entry, designed to take no more than 3-5 minutes of data entry
The SUI Surgery Registry Module in AQUIRE is not a “sling registry” – it is specific to a disease condition and its surgical treatments, not to a particular device. We will include robust cohorts of women receiving autologous slings, Burch procedures, periurethral bulking, and biologic slings.
It is my belief that women with pelvic floor disorders deserve choices. All women should have a variety of non-mesh options for treatment of SUI; however, I believe that they should also have the option of midurethral mesh slings as well. We can decide to throw our hands up in despair that the message of the benefits of midurethral slings has been lost in the noise. Or, we can be part of the solution. The SUI Registry is AUGS’ commitment to preserving choices for women who suffer from SUI.
If you share my opinion that the midurethral sling should remain among the choices available to women with SUI, you can be part of this effort! AUGS is releasing a Request for Applications (RFA) to be part of our SUI Registry module. Physicians who are willing to take a few minutes to register their patients receiving SUI treatments can receive payment from AUGS for each patient. More importantly, though, those physicians can be part of the effort to get this message out. The more quickly that we can achieve our goal of registering 2,000 women undergoing SUI treatments, the sooner we can make this new kind of data available to the public, and support all choices for our patients.
See the RFA for details.