BEST OVERALL PAPER: Characteristics Associated with Surgical Failure after Native Tissue Apical Prolapse Repair

Objectives: In a multicenter randomized trial of postmenopausal patients with symptomatic anterior/apical vaginal prolapse undergoing native tissue vault suspensions, there were no significant differences in failure for those randomized to perioperative intravaginal estrogen vs. placebo cream. The objective of this secondary analysis was to identify clinical and demographic characteristics associated with surgical failure among these subjects.

Methods: This was a planned ancillary analysis of a randomized, double-blind trial including participants with ≥stage 2 apical and/or anterior vaginal wall prolapse undergoing transvaginal native tissue apical repair at 3 sites. Participants underwent vaginal hysterectomy (if uterus present) and standardized uterosacral or sacrospinous ligament suspension (USLS or SSLS) at the surgeon’s discretion. The intervention was 1g conjugated estrogen (CE) vaginal cream (0.625mg/g) or identical placebo (1:1), inserted nightly for 2wk, then 2x/wk for ≥5 weeks preoperatively and continued 2x/wk for 1yr postoperatively. The primary outcome was time-to-failure by 12mo after surgery defined by ≥1 of 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending >1/3 vaginal length, subjective vaginal bulge, or retreatment. For this analysis, participants were grouped according to failure vs. success, and these predictor factors were compared: age, time since menopause, race/ethnicity, BMI, baseline GH, POP-Q stage, and surgery type (USLS or SSLF). Individual factors were assessed for association with the hazard of surgical failure using Cox proportional hazards models, adjusting for site and treatment group (i.e., CE vs. placebo). All factors with a p< 0.50 from this analysis were included in the final multivariable model; site and treatment group were kept in this model. The proportional hazards assumption was tested using the Grambsch-Therneau test, and the fit of the model was assessed using residual plots.

Results: One hundred eighty-six participants underwent surgery; 183 provided complete data. There were 30(16.4%) failures and 153(83.6%) successes. On initial descriptive analysis, failure was associated with decreasing age and shorter duration since menopause, Hispanic ethnicity, and greater baseline GH (Table 1); there was no association with increasing BMI, race, baseline POP-Q stage, or USLS vs. SSLS. In the final model, which included age (per 10 years), time since menopause, race, BMI >30 kg/m², GH >4.5, POP-Q stage, surgery type, and treatment, only age (per 10 years) remained significant (Table 2): adjusted HR 0.38 (95%CI 0.16-0.89), p=0.027.

Conclusions: In this cohort of postmenopausal women, increasing age had a protective effect from surgical failure over 12mo after transvaginal native-tissue prolapse repair. This unexpected finding may point to selection of comparatively healthier older participants (e.g., with better connective tissue) when opting to proceed with elective surgery in a person of increasingly advanced age. Observation continues in this trial to 36mo post-surgery; as additional failures accumulate, likely other predictors will be identified.