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JAMA. 2019 Sep 17;322(11):1054-1065. doi: 10.1001/jama.2019.12812.

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

Author information

1
Obstetrics, Gynecology, and Reproductive Sciences, UC San Diego Health, San Diego, California.
2
Duke University Medical Center, Durham, North Carolina.
3
Department of OB/GYN, University of Alabama at Birmingham.
4
Alpert Medical School of Brown University, Providence, Rhode Island.
5
University of New Mexico, Albuquerque.
6
Dell Medical School, University of Texas at Austin.
7
University of Pennsylvania, Flourtown.
8
Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee-Womens Research Institute, Pittsburgh, Pennsylvania.
9
Cleveland Clinic Foundation, Cleveland, Ohio.
10
National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
11
Research Triangle International, Research Triangle Park, North Carolina.

Abstract

Importance:

Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.

Objective:

To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.

Design, Setting, Participants:

At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018.

Interventions:

Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension.

Main Outcomes and Measures:

The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate.

Results:

A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; Pā€‰=ā€‰.06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; Pā€‰=ā€‰<.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%).

Conclusions and Relevance:

Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.

Trial Registration:

ClinicalTrials.gov Identifier: NCT01802281.

PMID:
31529008
PMCID:
PMC6749543
[Available on 2020-03-17]
DOI:
10.1001/jama.2019.12812
[Indexed for MEDLINE]

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