In a podium presentation at the Canadian Urologic Association Annual Meeting, Christopher Wallis, MD, and colleagues assessed the effect of these warnings on the use of TVT procedures for SUI.
Utilizing administrative data from a single-payer healthcare system in Ontario, Canada over a 22–year period, the authors characterized trends in the surgical management of SUI. An interrupted time–series analysis using segmented regression was performed to assess rates of each surgical intervention between January 1, 1994, and December 31, 2016: urethropexy, TVT, abdominal/vaginal sling, and transurethral bulking agents. The outcome was the annual population-adjusted rates of SUI surgery for each intervention. Segmented regression was used to assess for changes in these rates over time.
Over the study interval, the authors identified 120 999 women who underwent SUI surgery between 1994 and 2016. The total number of SUI procedures did not significantly change from 1994–2000 (mean 95 per 100 000 population; p=0.89). From 2000–2009, the total number of SUI procedures significantly increased (95 to 147 per 100 000 population; p<0.001; Figure) driven by a significant increase in TVT procedures (19 to 129 per 100 000 population; p<0.001). During this time period, the number of urethropexies, abdominal/vaginal sling, and bulking agent procedures significantly decreased (p<0.001). After 2009, annual rates of any SUI procedure decreased, a trend which continued during the remainder of the study period (147 to 64 per 100 000 population; p<0.001). This trend was associated with a significant decrease in TVT procedures (130 to 60 per 100 000 population; p<0.001) over the same period, as well as significant declines in each of the other SUI treatment modalities (p<0.001).
This large, population-based cohort demonstrates a significant influence of the FDA and Health Canada warnings on patient and physician behavior regarding the management of SUI. Prior to 2009, despite the decreased use of other surgical procedures, the overall number of SUI surgeries performed was significantly increasing, driven by increasing use of TVT procedures. Following the regulatory warnings, the overall rate of SUI procedures significantly declined due to a decrease in the use of both TVT procedures and other operative interventions. These data suggest
that the regulatory warnings had a significant effect on how patients and physicians approach the surgical management of SUI. Further, it suggests that many women may be living with untreated SUI.
Presented by: Christopher J.D. Wallis, MD, Division of Urology, Department of Surgery, University of Toronto Functional Urology Research, University of Toronto, Toronto, ON, Canada
Co-Authors: Joseph LaBossiere1,2,4, Lesley Carr1,4, Refik Saskin2,3,4, Robert Nam1,2,4, Sender Herschorn1,4.
1. Division of Urology, Department of Surgery, University of Toronto, Toronto, ON, Canada
2. Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, ON, Canada
3. Institute of Clinical Evaluative Sciences, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada
4. University of Toronto Functional Urology Research, University of Toronto, Toronto, ON, Canada
Written By: Christopher J.D. Wallis, Urology Resident, the University of Toronto, Twitter: @WallisCJD at the 73rd Canadian Urological Association Annual Meeting - June 23 - 26, 2018 - Halifax, Nova Scotia