Seeking Clinical Sites for SUI Surgery Registry Network – Apply by June 22
The American Urogynecologic Society is pleased to announce the development of a registry module collecting data about stress urinary incontinence surgery (SUI). This SUI registry module is housed within the AUGS AUGS Urogynecology Quality Registry (AQUIRE) registry, which currently has an active Merit-Based Incentive Payment System module focused on pelvic organ prolapse (POP) surgery patients. The SUI registry module includes not only information about the medical history of the patient and the procedure performed, but unique device identifier (UDI) data about implanted devices as well as a patient-reported outcomes section and will be a valuable benchmarking tool for surgeons. As part of this effort, we are looking for sites who can rapidly recruit high volumes of patients undergoing surgery for SUI to participate.
Apply today using the form below!
What is the SUI Surgery Module?
The SUI Surgery Module is a multi-center registry to follow patients at 6 weeks, 1, 2, and 3 years post-surgery. This registry module reflects not a specific hypothesis to be tested, but a commitment to acquire robust data regarding the objective and subjective outcomes of patients receiving surgery for SUI. The registry module itself utilizes a minimum data set developed by key opinion leaders in AUGS and SUFU to collect information about SUI surgery. Data entry is designed to be quick and easy, and will eventually be integrated with EHR. The registry module is specifically designed by surgeons to be efficient and streamlined and maximize efficiency and usability on the part of providers and patients themselves, while sophisticated enough to be able to distinguish between dependent and independent variables. The module allows the patients to communicate directly with the registry, reducing the follow-up compliance requirements on the centers.
We are anticipating that the data entry burden for the surgeon or site will be 3-5 minutes per patient at enrollment, and 2-3 minutes for each of the postop timepoints. We will provide updates to these estimates as the beta testing process continues.
What is the aim of the SUI Surgery Module?
Based on rapid enrollment of 2000 SUI surgery patients, the end goal of the registry module is to evolve into a national network with possible collaborative regional networks established, similar to the structure of the successful Vascular Quality Initiative. In addition to provider benchmarking, the registry module has the potential to address a number of outstanding research questions in the field including but not limited to:
- A real-world estimation of the rates of pain, dyspareunia, and mesh or material exposure/erosion among patients undergoing SUI surgery,
- The ability to evaluate rates of pain, dyspareunia and mesh or material exposure/erosion for different procedures and devices
- A comparison of long-term subjective and objective success rates between devices and techniques
- An estimation of whether women experiencing adverse outcomes are more, or less, likely to follow up with their original provider
The registry module will also support future opportunities including potential collaboration on post-market surveillance studies, development and implementation of patient-reported outcome quality measures, and support of an Advanced Payment Model based around SUI.
Clinical Sites Description
We are seeking up to 10 clinical sites (community-based and academic) to recruit patients.
Clinical sites will be responsible for recruiting approximately 200 subjects over 12 months undergoing any surgical procedure for SUI including sling implantation, peri-urethral bulking and the Burch procedure. Sites will enter data through the AQUIRE platform. Clinical sites are not required to be current AQUIRE users to be eligible for this opportunity but current AQUIRE users are encouraged to apply. It is not necessary to have ongoing/previous registry or data input experience.
Sites where SUI surgery is regularly performed are highly desired and encouraged to apply. SUI surgery performed concomitant with other surgery is acceptable. Sites must commit to efficient completion of the participation and data warehousing agreements (see links below) given the rapid timeline for enrollment. Please note that IRB approval is NOT required to participate in the SUI Surgery Module.
View the sample Participation Agreement and Data Warehousing Agreement
Benefit to the Clinical Site
- Your site will be part of AUGS’ ongoing commitment to a full array of treatment options for women with SUI
- Your site will receive local and regional benchmarking information to for Quality Reporting and Quality Improvement efforts
- Your site will receive $50 per patient enrolled (until registry recruitment hits 50%, then $35 per patient)
- Site participants will be invited to participate in the SUI Surgery Module User Group meeting to be held during the PFD Week meeting to discuss opportunities for improvement and for research opportunities using registry data
- Site participants will receive earlier access to the data for hypothesis-driven research once recruitment is complete
Clinical Site Application Process
Your application will serve as your site’s intent to participate as a clinical site in this registry network.
Clinical site applications are due to AUGS by June 22 via the Clinical Site Interest Form below. The online form/application requires the following items:
- PI's biosketch –first page of NIH biosketch
- One-page description of resources at your institution, and clinical infrastructure including which EHR your site uses, number of providers and surgical volume as well as other information that supports your application
Questions about the application process or the SUI Surgery Module? Please contact Colleen Skau at email@example.com.
Clinical Site Interest Form
Please upload the first page of the PI’s NIH biosketch or equivalent biographical document.
Please upload a one-page description of clinical infrastructure at your site including which EHR your site uses, number of providers, and surgical volume as well as other information that supports your application.