Prolapse Repair: Sacrocolpopexy and Mesh Offer Comparable Success, Study Reveals
USA: In a randomized clinical trial, researchers have unveiled promising results for a novel surgical technique addressing vaginal vault prolapse. The study, which meticulously examined the efficacy of apical suspension repair, offers new hope for patients grappling with this challenging condition.
The study, published in JAMA Surgery, revealed that sacrocolpopexy outperformed native tissue repair regarding composite primary efficacy outcome. Meanwhile, transvaginal mesh was found to be comparable to sacrocolpopexy, showing no inferiority. All treatment approaches demonstrated lasting improvements in patient-reported outcomes, and there were no significant differences in decision regret or overall satisfaction among the treatment groups.
Vaginal vault prolapse is a condition where the top of the vagina sags or drops and often results from weakened pelvic support structures. It can cause significant discomfort and negatively impact quality of life, leading many to seek surgical intervention. Traditional treatments have included various forms of pelvic reconstructive surgery, but recent advances are pushing the boundaries of these techniques.
The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Considering this, Shawn A. Menefee, Kaiser Permanente San Diego, San Diego, California, and colleagues aimed to compare the safety and efficacy of 3 surgical approaches for vaginal vault prolapse after hysterectomy.
For this purpose, the researchers conducted a multisite, 3-arm randomized clinical trial between February 2016 and April 2019, aimed to evaluate different surgical interventions for symptomatic vaginal vault prolapse after hysterectomy. Participants were women seeking surgical correction and were randomly assigned to receive either mesh-augmented repair (sacrocolpopexy or transvaginal mesh) or transvaginal native tissue repair.
The study involved nine clinical sites within the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Outcomes were assessed biannually for up to 60 months until the last participant reached 36 months of follow-up. Data analysis occurred from November 2022 to January 2023.
The primary outcome measured was the time to composite treatment failure, which included retreatment for prolapse, prolapse beyond the hymen, or ongoing prolapse symptoms, analyzed using survival models. Secondary outcomes encompassed patient-reported symptom-specific results, objective measures, and adverse events.
The study led to the following findings:
- Of 376 randomized participants (mean age, 66.1 years), 96% had surgery, and 82% completed follow-up.
- Adjusted 36-month failure incidence was 28% for sacrocolpopexy, 29% for transvaginal mesh, and 43% for native tissue repair. Sacrocolpopexy was superior to native tissue repair (adjusted hazard ratio [aHR], 0.57).
- Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60) but was noninferior to sacrocolpopexy (aHR, 1.05).
- All three surgeries resulted in sustained benefits in subjective outcomes.
- Mesh exposure rates were low (3% for sacrocolpopexy and 5% for transvaginal mesh) as were the rates of dyspareunia.
In the study, participants who underwent apical repair for vaginal vault prolapse showed similar composite failure rates for sacrocolpopexy and transvaginal mesh at the study's end. Both techniques had lower failure rates than native tissue repair, but only sacrocolpopexy demonstrated a statistically significant improvement.
"Additionally, the low incidence of mesh-related complications and adverse events supported the overall safety of both sacrocolpopexy and transvaginal mesh," the researchers wrote.
Reference:
Menefee SA, Richter HE, Myers D, et al. Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial. JAMA Surg. 2024;159(8):845–855. doi:10.1001/jamasurg.2024.1206
