BACKGROUND AND PURPOSE:

• Nager et al. (JAMA, 2019) compared vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy for efficacy and adverse events

METHODS:

• Randomized superiority clinical trial (RCT)
  • Study of Uterine Prolapse Procedures Randomized Trial (SUPeR trial)
  • 3 years of follow-up from the last woman to enroll  
• Participants
  • Postmenopausal
  •  Symptomatic uterovaginal prolapse
• Interventions
  • Vaginal mesh hysteropexy
  • Vaginal hysterectomy with uterosacral ligament suspension
• Primary outcome
  • A composite outcome representing a failed procedure
    • Re-treatment of prolapse | Prolapse beyond the hymen | Prolapse symptoms
• Secondary outcomes
  • Operative outcomes and adverse events

RESULTS:

• 175 participants | 97% completed 3-year follow-up
  • Vaginal mesh hysteropexy: 93 women | vaginal hysterectomy with uterosacral ligament suspension: 90 women  
  • Mean age: 66 years

Primary outcome: Composite failure measures

• There was no significant difference between groups (p=0.6)
  • Adjusted hazard ratio: 0.62 (95% CI, 0.38 to 1.02)
• 36-month follow-up failure incidence
  • Hysteropexy group: 26% (95% CI, 15% to 35%)
  • Hysterectomy group: 38% (95% CI, 25% to 49%)
• Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (p<0.001)
  • Hysteropexy group: 111.5 (39.7) min
  • Hysterectomy group: 156.7 (43.9) min
  • Difference, −45.2 (95% CI, −57.7 to −32.7)

Adverse Events

• Overall adverse events
  • Hysteropexy group: 10%
  • Hysterectomy group: 2%
  • Risk difference: 0.07 (95% CI, 0.01-0.14; P = .03)
• Mesh exposure occurred in 8% of women in the mesh group
• Most common adverse events included
  • UTIs, SUI, urgency incontinence |Constipation
  • No difference found between groups

CONCLUSION:

• No significant differences were found in the composite surgical failure outcomes after 3 years
• However, the authors note the very wide confidence intervals and imprecision of the results
• FDA halted the sale and distribution of mesh kits for vaginal prolapse repair after the current study was completed
• Researchers will continue follow-up for 5 years 

Learn More – Primary Sources:

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial

Mesh implants have similar outcomes to hysterectomy for vaginal prolapse repair

Related ObG Topics:

Mesh and Pelvic Organ Prolapse: ACOG Practice Advisory & ACOG/AUGS Recommendations 

Robotic vs Vaginal vs Open Surgery for Vaginal Prolapse – How Do They Compare?

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