Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial

Abstract

Background: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market.

Objective: Our objective was to compare the efficacy and adverse events of these 2 procedures.

Study design: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes.

Results: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively.

Conclusion: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

Trial registration: ClinicalTrials.gov NCT01802281.

Keywords: hysterectomy; hysteropexy; masking; prolapse; randomized clinical trial; surgery; uterine prolapse; uterovaginal prolapse; vaginal hysterectomy; vaginal mesh.

Conflict of interest statement

The authors report no conflict of interest

Copyright © 2021 Elsevier Inc. All rights reserved.

Figures

Figure 1-

Consort Diagram of Participants. Colonic Diverticular perforation and leukemia are the causes of death for the 2 participants in the hysterectomy group who died during 0–60 months and lung cancer is the cause of death for the 1 participant in the hysteropexy group who died during 0–60 months. POP-Q indicated Pelvic Organ Prolapse Quantification; PFDI, Pelvic Floor Distress Inventory.

Figure 2-

Failure Probability for the Composite Primary Outcome Comparing Hysteropexy to Hysterectomy in the Intent-to-Treat Population by Randomized Intervention. Failure probability from survival analysis excluding the 8 ineligible participants was conducted using an interval-censored proportional hazard model with an assumed baseline piecewise exponential hazard with 5 constant hazard periods: (0–12 months, 12–24 months, 24–36 months, 36–48 months, and 48–60 months) and controlled for site consistent with study randomization as well as prior prolapse surgery per clinical standards. Available follow-up data were included for all participants through 60 months of follow-up. At the time of analysis, 11 participants were censored prior to 36 months (7 in the hysteropexy group and 4 in the hysterectomy group), 7 participants were censored between 36 and 60 months (2 in the hysteropexy group and 5 in the hysterectomy group), and 86 were censored at 60 months (50 in the hysteropexy group and 36 in the hysterectomy group). The median (IQR) follow-up time was 60.0 (21.0, 60.0) months for the hysteropexy group and 45.0 (9.0, 60.0) for the hysterectomy group. The hazard rate in the hysteropexy group (incidence density per person-year) in year 1 was 0.15; year 2, 0.07; year 3, 0.06; year 4, 0.05; and year 5, 0.05. In the hysterectomy group, the hazard rate in year 1 was 0.26; year 2, 0.13; year 3, 0.11; year 4, 0.09; and year 5, 0.09. The solid lines represent the piecewise exponential model and the 95% CI for the piecewise exponential model is shown by the red shaded area for the hysteropexy group and the blue shaded area for the hysterectomy group. The failure probability from the sensitivity nonparametric interval-censored Kaplan-Meier analysis is represented by the dotted lines.

Figure 3-

Distribution of the Composite Surgical Failure Outcome in the Intent-to-Treat Population by Randomized Intervention. The intent to treat population in the hysteropexy group consists of 88 participants; however, 1 participant discontinued without attending any visits after 6 weeks and is not included in this figure. The intent to treat population in the hysterectomy group consists of 87 participants; however, 1 participant discontinued without attending any visits after 6 weeks and is not included in this figure.