Hypothesis / aims of study
Since 1999 transvaginal sling (TVS) procedures have been an effective treatment for Canadian women with stress urinary incontinence (SUI). However, complications associated with transvaginal mesh led to warnings from the U.S. Food and Drug Administration (FDA) and Health Canada in 2008 and 2010, respectively. We hypothesized that these warnings would significantly decrease the utilization of TVS procedures for SUI. Therefore, we sought to characterize trends in the surgical management of SUI in a single-payer healthcare system in Ontario, Canada over a 22-year period.
Study design, materials and methods
We performed an interrupted time-series analysis using segmented regression among women aged 18 years and older undergoing surgical treatment for SUI between January 1, 1994 and December 31, 2016 in Ontario, Canada. The passage of time was considered the primary exposure. The outcome was the annual population-adjusted rates of SUI surgery over time stratified by modality: urethropexy, TVS, abdominal/vaginal sling and transurethral bulking agents.
We identified 120 999 women who underwent SUI surgery between 1994 and 2016. The total number of SUI procedures did not significantly change between 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) driven by a significant increase in TVS procedures (19 to 129 per 100 000 population, p<0.001). During this time period, the number of urethropexy, 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 TVS 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).
Interpretation of results
This large, population-based cohort demonstrates a significant influence of the FDA and Health Canada warnings on patient and physician behaviour regarding the management of SUI. Prior to 2009, despite decreased utilization of other surgical procedures, the overall number of SUI surgeries performed was significantly increasing driven by increasing utilization of TVS procedures. Following the regulatory warnings, the overall rate of SUI procedures significantly declined due to a decrease in the utilization of both TVS procedures and other operative interventions.