A recent study found that vaginal mesh hysteropexy may be associated with fewer composite treatment failures over 10 years than vaginal hysterectomy with uterosacral ligament suspension in postmenopausal patients with symptomatic uterovaginal prolapse. Both procedures showed sustained improvements in patient-reported symptoms, sexual function, and quality of life, with similar long-term safety profiles observed.
In the multicenter randomized SUPER trial involving nine US Pelvic Floor Disorders Network sites, researchers randomly assigned 183 postmenopausal patients with symptomatic uterovaginal prolapse to undergo sacrospinous hysteropexy with mesh or vaginal hysterectomy with uterosacral ligament suspension between April 2013 and February 2015. Among the patients, 175 were included in the intention-to-treat analysis, and 112 participated in the extended follow-up through 10 years.
The primary outcome was a composite of prolapse retreatment, prolapse extending beyond the hymen, or bothersome prolapse symptoms. Secondary outcomes included anatomic measures; patient-reported pelvic floor, urinary, bowel, and sexual function; as well as complications and adverse events.
Over 10 years, treatment failure occurred in 40% of patients who underwent hysteropexy compared with 53% of those who underwent hysterectomy. The researchers reported that hysteropexy was associated with a lower likelihood of treatment failure throughout follow-up. Most treatment failures in both groups appeared to be related to anatomic findings rather than symptomatic recurrence, and few new failures were observed during the final 5 years of follow-up.
Despite differences in the primary outcome, both procedures were found to be associated with durable improvements in patient-reported prolapse, urinary, and bowel symptoms. Most patients reported they were "much better" or "very much better" at 10 years, and the researchers found no statistically significant differences between groups in sexual function, dyspareunia, pelvic pain, or overall patient-reported outcomes.
Safety outcomes also appeared comparable between groups. Serious adverse events occurring during years 6 through 10 seemed to be unrelated to either procedure. Mesh exposure was reported in 8% of patients undergoing hysteropexy and was managed conservatively, with 2% having persistent exposure at the final follow-up visit. No patient required surgery for mesh exposure. Patients in the hysteropexy group also had fewer late granulation tissue and suture exposure complications than those who underwent hysterectomy. Approximately 6% of patients who retained their uterus required evaluation for cervical or endometrial pathology during follow-up, and no malignancies were identified.
The researchers noted that although hysteropexy demonstrated a lower composite treatment failure rate, the durability advantage observed at 5 years did not continue to widen during years 6 through 10, suggesting both procedures provided durable long-term outcomes.
The study was limited by lower participation among some nonfailure patients during the extension phase, withdrawal of the vaginal mesh device from the US market during the study period, inclusion of only postmenopausal patients, a predominantly White study population, and reduced in-person assessments during portions of the COVID-19 pandemic.
In an invited commentary, Ali Antoine, MD, and Amy J. Park, MD, both of the Cleveland Clinic, wrote that definitions of prolapse surgery success have evolved to emphasize symptom relief and the need for retreatment over strict anatomic outcomes. They noted that the trial supported counseling patients that uterine preservation and hysterectomy are both reasonable options because each provided durable symptom improvement and comparable patient-reported outcomes over long-term follow-up.
"Both procedures are reasonable options for patients," wrote lead study author Charles W. Nager, MD, of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Diego Health, and colleagues.
Dr. Nager reported receiving royalties from UpToDate outside the submitted work. Additional author disclosures and funding information are available in the published study. For the invited commentary, Dr. Park reported receiving royalties from UpToDate outside the submitted work; no other disclosures were reported.
Source: JAMA Surgery, Editorial