Prolapse phenotypes and 12-month post-operative prolapse recurrence after apical native tissue surgery: a combined analysis using multicenter randomized trials and registry data.

Abstract

<h4>Background</h4>Recurrence after pelvic organ prolapse surgery is not uncommon, and recurrence rates differ based on baseline prolapse characteristics such as genital hiatus size and prolapse stage. Better understanding the relationship between anatomic prolapse subgroups and surgical outcomes may allow surgeons to individualize treatment decisions and improve outcomes. We previously identified clinically relevant prolapse phenotypes (subgroups) defined using the pelvic organ prolapse quantification (POP-Q) system and now seek to study associations between these phenotypes and surgical outcomes in a large, prospectively collected dataset.<h4>Objective</h4>The primary aim was to determine the association between a novel system of phenotyping prolapse and prolapse symptom recurrence 12 months post-operatively in women undergoing vaginal native-tissue apical prolapse surgery. We hypothesized that different prolapse phenotypes would have different risks of prolapse recurrence. Secondary aims included determining associations between the phenotypes and anatomic prolapse recurrence and new onset stress urinary incontinence (SUI).<h4>Study design</h4>This was a secondary analysis of data combined from three multicenter randomized trials and one prospective, multicenter patient registry. Participants from these studies who underwent uterosacral ligament suspension (USLS) or sacrospinous ligament fixation (SSLF) without mesh and had 12 month follow up data were included and categorized into one of 8 phenotypes based on the POP-Q system: (1) no prolapse (n=5, excluded), (2) isolated anterior, (3) isolated posterior, (4) isolated apical, (5) anterior and posterior, (6) anterior-predominant and apical, (7) posterior-predominant and apical, and (8) anterior and posterior and apical. The primary outcome was symptomatic recurrence 12 months after surgery defined as a positive response to the Pelvic Floor Distress Inventory "bulge" question with at least "somewhat" bother. Univariable and multivariable logistic regression analyses (adjusted for prolapse stage (stage II vs. stage III-IV) and prior hysterectomy) were developed for each outcome.<h4>Results</h4>Of 704 participants, most (473 (67.2%)) had anterior-predominant and apical prolapse (used as reference group), followed by the anterior and posterior and apical (101 (14.3%)) and isolated apical (45 (6.4%)) phenotypes. Overall, 184 (26.1%) had sacrospinous ligament fixation, 520 (73.9%) uterosacral ligament suspension and most had midurethral slings (MUS) (454 (64.5%)). Symptomatic prolapse recurrence occurred in 65 (9.2%) overall, ranging from 0% to 29% across phenotype groups, and was particularly uncommon in the isolated posterior (0%) and isolated apical (2.2%: one participant) phenotypes. However, phenotype group was not significantly associated with symptomatic recurrence in univariable or multivariable analysis. Hispanic ethnicity (OR 2.25 [1.17-4.35], p=0.015, private insurance (OR 0.58 [0.35-0.98], p=0.042) and vaginal parity (OR 1.19 [1.02-1.40], p=0.030) were significantly associated with recurrence. Similarly, phenotype was not significantly associated with anatomic recurrence or new or worsening SUI.<h4>Conclusions</h4>Prolapse POP-Q phenotypes were not associated with symptomatic recurrence after native tissue repair surgery. Most women undergoing native tissue apical prolapse surgery have anterior-predominant and apical prolapse. Larger studies may be needed to identify differences in outcomes among less common phenotype groups.