BACKGROUND AND PURPOSE:

• Vaginal hysterectomy with suture apical suspension and sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) have both been used for the treatment of uterovaginal prolapse
  • The mesh product has been removed from the US market by the FDA pending further research
• 3-year follow-up study suggested better primary outcomes with hysteropexy, but the results were nonsignificant (P=0.06)
• Nager et al. (AJOG, 2021) compared the 5-year efficacy and adverse events of hysterectomy and hysteropexy for treating uterovaginal prolapse

METHODS:

• Multisite randomized superiority clinical trial
• Participants
  • Postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse
• Interventions
  • Hysteropexy: sacrospinous hysteropexy with graft
  • Hysterectomy: vaginal hysterectomy with uterosacral ligament suspension
• Study design
  • Participants were masked to their intervention group
  • 6-month study intervals through 60 months
• Primary outcome
  • A failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms)
• Secondary outcomes
  • Complications or adverse events
  • Individual anatomic measures of the pelvic organ prolapse quantification examination
  • Presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms (measured by validated questionnaires)

RESULTS:

• Hysteropexy: 93 women | Hysterectomy: 90 women
  • Mean age 66 years; 89% completed 5-year follow-up
• There were fewer failures with hysteropexy, compared with hysterectomy
  • Hysteropexy: 37% failure rate
  • Hysterectomy: 54% failure rate
  • Difference −18% (95% CI, −33% to −3%)
  • Adjusted hazard ratio 0.58 (95% CI, 0.36 to 0.94); P=0.03
• No group differences were demonstrated in patient-reported
  • Pelvic floor symptoms
  • Prolapse symptoms
  • Bowel function symptoms
  • General quality of life
  • Body image
  • Pelvic pain
• Adverse events for hysteropexy vs hysterectomy
  • Mesh exposure: 8% vs 0% | No surgeries required for any mesh exposures | 6 treated with estrogen cream
  • Granulation tissue after 12 weeks: 1% vs 12%
  • Suture exposure after 12 weeks: 3% vs 21%

CONCLUSION:

• At 5-year follow-up, failure rates for the treatment of uterovaginal prolapse with sacrospinous hysteropexy with mesh was 18% lower than vaginal hysterectomy uterosacral ligament suspension
• Vaginal hysterectomy was associated with more frequent foreign body reactions such as apical granulation tissue 
• There were no differences in patient-reported pain or quality of life
• The authors state

In designing the current trial, investigators sought to address the safety and efficacy issues raised in the 2011 FDA Safety Communication

The FDA order does not prevent surgeons from using mesh for transvaginal repair, and this study suggests there may be benefit

Learn More – Primary Sources:

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

Related ObG Topics:

Results From the OPTIMAL Trial Five Years Out: Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation for Prolapse?

Comparing the Use of Mesh Against Standard Repair for Prolapse

SUPeR Trial Results: Hysterectomy vs Mesh for Uterovaginal Prolapse