Urogynecology (Philadelphia, Pa.) · 2022
Trends in Performance of Anti-Incontinence Treatment at the Time of Pelvic Organ Prolapse Repair From 2011 to 2019.
СтатьяНазвание и аннотация: Перевод в очереди
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Zemtsov Gregory E, Jelovsek J Eric, O'Shea Michele, Luchristt Doug
Аннотация
IMPORTANCE: There are no publications on national trends in performance of concomitant stress urinary incontinence (SUI) treatment with pelvic organ prolapse surgery over the past decade.
OBJECTIVES: The objective of this study was to describe trends in the performance and type of concomitant SUI treatment from 2011 to 2019.
STUDY DESIGN: Surgical procedures for pelvic organ prolapse and coding for prolapse repair were identified from the American College of Surgeons National Surgical Quality Improvement Program database. An autoregressive interrupted time series model estimated temporal trends in concomitant SUI treatment associated with 3 consequential events: U.S. Food and Drug Administration's (FDA) requirement for postmarketing studies from mesh manufacturers (January 2012), publication of the Outcomes following Vaginal Prolapse Repair and Midurethral Sling (OPUS) trial (June 2012), and the FDA's reclassification of vaginal mesh as a high-risk device (January 2016).
RESULTS: There were 43,370 cases identified. The rate of concomitant SUI treatment decreased from 46.1% to 35.7% across the analysis period. No significant trend before postmarketing studies (-0.2%; 95% confidence interval [CI], -0.8 to 1.1) was observed. After postmarketing studies, there was a downward deflection of -2.0% per quarter (95% CI, -3.6 to -0.4). After OPUS, we observed a flattening of the trend to -0.2% (95% CI, -0.8 to 0.4) that persisted after FDA reclassification. Sling procedures remained predominant (96.2% of SUI procedures) and performance of urethropexy decreased across the analysis period (-0.1%; 95% CI, -0.08 to -0.2).
CONCLUSIONS: After the FDA's order for postmarketing studies, rates of concomitant SUI treatment significantly decreased. Rates stabilized after the OPUS trial at around 35% and did not subsequently change. Rates of nonmesh concomitant SUI treatment decreased during the analysis period.
OBJECTIVES: The objective of this study was to describe trends in the performance and type of concomitant SUI treatment from 2011 to 2019.
STUDY DESIGN: Surgical procedures for pelvic organ prolapse and coding for prolapse repair were identified from the American College of Surgeons National Surgical Quality Improvement Program database. An autoregressive interrupted time series model estimated temporal trends in concomitant SUI treatment associated with 3 consequential events: U.S. Food and Drug Administration's (FDA) requirement for postmarketing studies from mesh manufacturers (January 2012), publication of the Outcomes following Vaginal Prolapse Repair and Midurethral Sling (OPUS) trial (June 2012), and the FDA's reclassification of vaginal mesh as a high-risk device (January 2016).
RESULTS: There were 43,370 cases identified. The rate of concomitant SUI treatment decreased from 46.1% to 35.7% across the analysis period. No significant trend before postmarketing studies (-0.2%; 95% confidence interval [CI], -0.8 to 1.1) was observed. After postmarketing studies, there was a downward deflection of -2.0% per quarter (95% CI, -3.6 to -0.4). After OPUS, we observed a flattening of the trend to -0.2% (95% CI, -0.8 to 0.4) that persisted after FDA reclassification. Sling procedures remained predominant (96.2% of SUI procedures) and performance of urethropexy decreased across the analysis period (-0.1%; 95% CI, -0.08 to -0.2).
CONCLUSIONS: After the FDA's order for postmarketing studies, rates of concomitant SUI treatment significantly decreased. Rates stabilized after the OPUS trial at around 35% and did not subsequently change. Rates of nonmesh concomitant SUI treatment decreased during the analysis period.