Impact of level three support procedures on enlarged genital hiatus after minimally invasive sacrocolpopexy

Objectives: To evaluate whether posterior colporrhaphy and perineorrhaphy (PR) procedure at time of minimally invasive sacrocolpopexy (MISC) significantly affects the proportion of women with enlarged six-month postoperative GH.

Methods: Females with bothersome prolapse and an enlarged GH (defined as ≥4cm, but < 7.5cm) planning MISC were recruited to a randomized trial (MERIT) of concomitant PR or no PR. Group assignment was revealed to the surgeon intraoperatively at the conclusion of the sacrocolpopexy. The primary outcome was the proportion with enlarged GH 6-months after surgery. Secondary outcomes were composite prolapse recurrence (any vaginal compartment beyond the hymen, feeling a bulge, or retreatment) and dyspareunia at 6 months (“usually” or “always”). Outcomes were collected by masked staff. 96 subjects provided 80% power to detect a 20% difference in the primary outcome using a chi-square statistic with >80% power, assuming 20% attrition. Analyses were conducted as intention-to-treat using all available follow-up data.

Results: Analyses were conducted on 96 of 99 consented participants (49 no PR and 47 PR); mean (SD) age 61.7 years, BMI 27.9kg/m2, and majority were White (n=89, 93.7%) with stage 3 prolapse (n=69, 71.9%). This was the primary prolapse surgery for the majority of subjects (n=83, 86.5%). Demographics for both groups are in Table 1. Three subjects cancelled surgery; 96 were randomized, 7 did not receive their assigned treatment, and 1 MISC was converted to transvaginal native tissue repair due to extensive pelvic adhesions.

For the primary outcome, enlarged GH at 6 months was demonstrated by 2/37 (5.4%) without PR vs 5/32 (15.6%) after PR, p=0.24). Table 1 reports anatomic and subject outcomes at 6-months by group assignments. Notably, there was no group difference on per-protocol analysis or in mean GH: 3.14cm without PR and 3.03cm with PR (p=0.58). Using linear mixed effect regression models, the estimated difference between the PR group and the no PR group for GH at 1 month was -0.46 cm (95 CI -0.77, 0.15) and for GH at 6 months was -0.17 cm (95 CI -0.49, 0.16) adjusting for preoperative GH and perineal body.

Composite Prolapse Recurrence was not statistically different between groups at 6 months (2/43, 4.7% no PR vs 4/38, 10.5% with PR, p=0.41). Half of participants were sexually active at 6 months (n=36, 51.4%) with no group differences in those reporting dyspareunia (6.25% without PR vs 15.8% with PR, p=0.37). Majority of sexually active participants reported no or rare dyspareunia (56.3% without PR, 57.8% with PR, p=0.92).

Conclusions: In women with enlarged genital hiatus, performance of a posterior repair with sacrocolpopexy does not appear to have an adjuvant effect on the observed spontaneous remodeling of the genital hiatus in the short-term. Surgeons may choose to perform PR for other anatomic or physiologic reasons.