Characteristics associated with composite surgical failure over 5 years of women in a randomized trial of sacrospinous hysteropexy with graft versus vaginal hysterectomy with uterosacral ligament suspension

Background: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures-Randomized Trial (SUPeR) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate compared to vaginal hysterectomy with uterosacral suspension (USLS) through 5 years.

Objectives: To identify factors associated with rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft versus vaginal hysterectomy with USLS for uterovaginal prolapse.

Study design: This planned secondary analysis of a comparative effectiveness trial of two transvaginal apical suspensions (NCT01802281) defined surgical failure as either re-treatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤ 1 year, >1 year, no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate p<0.2, additional clinically important variables, apical repair and clinical site. Backward selection determined final retained risk factors (p<0.1) with statistical significance evaluated by Bonferroni correction (p<0.005). Final factors were assessed for interaction with type of apical repair at p<0.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors.

Results: In the final multivariable model, body mass index (BMI) (increase of 5 kg/m2: adjusted hazard ration (aHR) 1.7, 95% Confidence Interval (CI), 1.3, 2.2, p<0.001) and duration of prolapse symptoms, (increase of 1 year: aHR 1.1, 95% CI 1.0, 1.1, p<0.005) were associated with composite surgical failure, where rate of failure was 2.9 and 1.8 times higher in obese and overweight than normal/underweight women (95% CI 1.5, 5.8 and 0.9, 3.5) and 3.0 times higher in women experiencing >5 years prolapse symptoms compared to ≤5 years (95% CI 1.8, 5.0). Sacrospinous hysteropexy with graft had a lower rate of failure than hysterectomy with USLS (aHR 0.6, 95% CI 0.4, 1.0, p=0.05). Interaction between symptom duration and apical repair (p=0.07) indicated failure was less likely after hysteropexy compared to hysterectomy for those with ≤5 years symptom duration, (aHR 0.5 (95% CI 0.2, 0.9) but not for those with >5 years symptoms (aHR1.0, 95% 0.5, 2.1).

Conclusions: Risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach, include obesity and duration of prolapse symptoms. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse.