Who can use the registry?
The SUI Surgery Module can be used by any surgeon who does procedures for stress urinary incontinence. This includes urologists, gynecologists, and urogynecologists in private practice, at community hospitals and academic centers. You can join if you do 5 SUI surgeries a year or 500. You can also enroll as an individual, there is no requirement for your whole practice or department to use the module.
Why should I participate?
The goal of the SUI Surgery Module is to collect real-world data to share with healthcare providers, patients, and the public that will offset the public confusion fostered by misinformation and muddling of prolapse associated adverse outcomes with SUI procedures. Your investment in generating this evidence is essential to increasing the quality of care urogynecologists provide and preserving choices for women having SUI surgery. The SUI Surgery Module is not a randomized controlled trial or a research project; there is no start date or end date, we intend to continually enroll new patients and incorporate new devices and surgeries into the Module. Just like your practice, the SUI Module is always evolving, and we need your help to collect data on the newest additions to the field.
What procedures are included in the SUI Module?
Any surgery for SUI can be input into the registry. This includes synthetic and biologic slings, Burch procedures and peri-urethral bulking agents. The SUI module is designed for patients with a diagnosis of SUI and while the module is not intended for entirely prophylactic sling placement, entry of concomitant procedures is permitted. Note, data about conservative therapy (physical therapy or pessaries) are not collected in the SUI Module.
What is the SUI Surgery Module Patient Population?
All women over 18 years of age undergoing surgery for urinary incontinence are eligible for inclusion in this quality improvement initiative.
Specifically, the population of patients included in the ACQUIRE SUI Surgery Module are all women undergoing the following urinary incontinence surgeries:
- Midurethral slings (retropubic, transobturator, single incision)
- Pubovaginal slings (any material, characterized by placement and fixation at the urethrovesical junction, fixation to abdominal wall or pubis)
- Burch or Marshall-Marchetti-Krantz procedure (open or laparoscopic)
- Periurethral bulking agent injection.
As the SUI Surgery Module is focused on large-scale, real-world data acquisition, patients undergoing concomitant surgeries for other gynecologic or urologic conditions, are eligible for inclusion.
Patients that do not wish to participate will not be included in the SUI quality improvement program. Patients who do not have internet access should be offered access to computers to complete their Patient Reported Outcomes (PRO) survey when they present to the office for their post-operative check-up and annual follow-up/mesh surveillance visits (if applicable).
Note: As the etiology of stress urinary incontinence in adult women is believed to be distinct from that of men and children, men of any age and women under the age of 18 are not included in the program. Patients with a history of suspected or known pelvic malignancy, exposure to pelvic radiation therapy are also not included.
How long does it take to enter data?
Data entry is designed to be quick and easy and the necessary information is generally readily available in most EHRs. To help you get started, a detailed manual and quick start guide to data entry are available as well as video tutorials of the data entry process.
What data is collected?
The SUI Surgery Module collects basic information about a patient’s medical history and examination/diagnosis as well as baseline assessment of her own symptoms. In addition to some information about the index procedure and whether concomitant procedures were performed, the SUI Surgery Module collects unique device identifier information where applicable. Providers and patients also complete follow-up forms six weeks after surgery and one, two, and three years after surgery. Specific types of data collected in the ACQUIRE SUI Surgery Module include:
Demographic Information at the time of Index Surgery: Age, Body Mass Index, topical estrogen use, current smoking, current or previous overactive bladder medication use are recorded by the surgeon
Procedure Information: SUI Surgery type, including trade name for sling devices, as well as any concomitant surgery gynecologic or prolapse repair procedure (by compartment) are recorded by the surgeon
Quality/Process Measures: Data regarding the preoperative evaluation and documentation, and preoperative counseling, as well as performance of intraoperative cystoscopy, are recorded.
Perioperative Outcomes: Urologic injury (related or unrelated to SUI procedure), perioperative transfusion, 30-day readmission or reoperation, and voiding dysfunction beyond 30 days are recorded by the surgeon and by the patient in separate events
Efficacy and QoL Outcome Measures: Surgeons record cough stress test results, patient report of SUI, any SUI retreatment, and de novo overactive bladder at the 1-year point. Patients report SUI symptoms, SUI retreatment, or new overactive bladder symptoms, as well as complete the ICIQ-SF and PGI-I questionnaires, and a satisfaction Likert scale, at the 1-year, 2-year, and 3-year time points. In addition, an open-field dialogue box is provided at each time point to allow patients to express their thoughts, satisfactions and dissatisfactions regarding their SUI surgery experience.
A complete list of data elements is available in our SUI Surgery Case Report Form (CRF). Email firstname.lastname@example.org for a copy.
What are the benefits of the SUI Module?
The Module allows you to track your outcomes in real time and collect feedback directly from the patients. AUGS also provides benchmarking reports so you can see how you compare to your peers across the country. Data from the SUI Surgery Module can be used to support the quality of care you provide during department or institution evaluation.
Users of the SUI Surgery Module are invited to the User Group meeting at AUGS’ annual meeting to discuss improvements or suggestions for the module as well as connect with other users. Users will also have the opportunity to participate in future quality improvement projects and help develop toolkits for providers looking to improve their outcomes.
How much does the SUI Surgery Module cost to use?
The SUI Surgery Module is free for all AUGS members to use. Not an AUGS member? Get signed up for membership today!