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 FDA removed this mesh product from the U.S. market.

Objective

Our objective was to compare the efficacy and adverse events of these two procedures.

Study Design

At 9 clinical sites in the U.S. NIH/NICHD Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multi-site randomized superiority clinical trial; comparing a sacrospinous hysteropexy with graft (hysteropexy) to 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 POP-Q examination, and presence, severity and impact/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=0.06). This study reports the 5 year outcomes.

Results

One hundred and eighty three 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 hysterectomy. One hundred seventy-five (175) were included in the trial, and 156 (89%) completed the 5 year follow-up. The primary outcome showed fewer failures for hysteropexy compared to hysterectomy through 5 years (adjusted hazard ratio, 0.58 [95% CI: 0.36 to 0.94], p=0.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% CI: -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% (129/183) of participants 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 compared to 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.