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#Grand Rounds

SUPeR Trial Results: Hysterectomy vs Mesh for Uterovaginal Prolapse

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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

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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

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