Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse

Structured Abstract Background The ideal measure of success after surgery for pelvic organ prolapse (POP) has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes are equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of POP surgeries. Objectives To describe the relationships and overlap between participants who met anatomic, subjective, and retreatment definitions of success or failure after POP surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory (POPDI), Short-Form Six-Dimension health index (SF-6D), and quality-adjusted life years (QALYs) between these definitions. Study Design Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥ stage II POP in a cohort of women (N=1,250) from four randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by composite measure requiring: 1) anatomic failure (POPQ Ba, Bp or C > 0); 2) subjective failure (presence of bothersome vaginal bulge symptoms); or 3) pessary or surgical retreatment for POP. POPDI, SF-6D and QALYs were compared between participants who met a variety of definitions of success and failure including novel “intermittent” success/failure over time. Results Among the 433/1,250 (34.6%) women who had surgical failure outcomes at ≥ 1 timepoint, 85.5% (370/433) met only one component of the composite outcome at assessment of initial failure (anatomic failure = 46.7%, 202/433; subjective failure = 36.7%, 159/433; retreatment = 2.1%, 9/433). Only 12.9% (56/433) met criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% (105/433) of these transitioned between success and failure during follow-up, and 83.8% (88/105) of these intermittent success/failures met criteria for success at their last follow-up. There were significant associations between success/failure group and the 1- and 2- year QALYs as well as a time-varying group effect on POPDI and SF-6D scores. Conclusions True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with the majority of intermittent failures being in a state of ‘surgical success’ at their last follow-up. Current composite definitions of success or failure may result in overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after POP surgery.