TOPLINE:
Various surgical approaches to treat vaginal vault prolapse may be similarly safe and effective and can produce high rates of patient satisfaction.
METHODOLOGY:
- A randomized clinical trial at nine sites in the United States included 360 women with vaginal vault prolapse after hysterectomy (average age, 66 years).
- The women were randomly assigned to undergo native tissue repair (transvaginal repair using the sacrospinous or uterosacral ligament), sacrocolpopexy (mesh repair placed abdominally via open or minimally invasive surgery), or transvaginal mesh repair.
TAKEAWAY:
- At 36 months, a composite measure of treatment failure — based on the need for retreatment, the presence of symptoms, or prolapse beyond the hymen — had occurred in 28% of the women who received sacrocolpopexy, 29% who received transvaginal mesh, and 43% who underwent native tissue repair.
- Sacrocolpopexy was superior to native tissue repair for treatment success (adjusted hazard ratio, 0.57; P = .01), and transvaginal mesh was noninferior to sacrocolpopexy, the researchers found.
- All of the surgical approaches were associated with high rates of treatment satisfaction and improved quality of life and sexual function.
- Adverse events and mesh complications were uncommon.
IN PRACTICE:
“All approaches were associated with high treatment satisfaction; improved symptoms, quality of life, and sexual function; and low rates of regret,” the authors of the study wrote. “As such, clinicians counseling patients with prolapse can discuss the ramifications of each approach and engage in shared, individualized decision-making.”
SOURCE:
The study was led by Shawn A. Menefee, MD, Kaiser Permanente San Diego in San Diego, California. It was published online in JAMA Surgery.
LIMITATIONS:
The US Food and Drug Administration in April 2019 banned transvaginal mesh for pelvic organ prolapse because of concerns about complications such as exposure and erosion. Five trial participants who had been assigned to receive transvaginal mesh but had not yet received it at that time were rerandomized to one of the other surgical approaches.
DISCLOSURES:
The study was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Researchers disclosed consulting for companies that market medical devices.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.