SAN ANTONIO – At 5-year follow-up, outcomes were slightly better on most measures for transvaginal uterosacral ligament suspension versus transvaginal sacrospinous ligament fixation for apical prolapse, but the differences were not statistically significant, according to the first randomized trial to compare the two techniques.
Quality of life improvements were durable, but the overall 5-year success rate – defined as the absence of descent of the vaginal apex more than one-third into the vagina; anterior or posterior vaginal wall descent beyond the hymen; bothersome vaginal bulge symptoms; and further treatment for prolapse – was 39% in the 109 women randomized to bilateral uterosacral ligament suspension (ULS) and 30% in the 109 women randomized to unilateral sacrospinous ligament fixation (SSLF).
Dr. J. Eric Jelovsek
But there was a notable finding in the study. If women failed to meet all the requirements for success at any one visit, they were classified as surgical failures. However, many who missed the mark at one visit met all the requirements for success on other visits, including their last follow-up.
“We don’t think as surgeons that a bulge comes and goes on a yearly basis, but people actually moved in and out of success and failure over time, and that’s new,” Dr. Jelovsek said. “We just don’t understand the dynamic variables of anatomic prolapse, because no one’s looked at it. The assumption of ‘once a failure, always a failure’ may underestimate success rates.”
Nonetheless, using that approach in the study, the investigators found that the anatomic success was 54% in the ULS and 38% in the SSLF groups at 5 years, and 37% of women in the ULS group reported bothersome vaginal bulge symptoms, versus 42% of women with SSLF. A total of 12% of women with ULS and 8% of women with SSLF had undergone POP retreatment at 5 years, either by pessary or secondary surgery but, again, the differences were not statistically significant.
Of the 145 anatomic failures in the study, 41% were stage 3 or 4.
Quality of life improvements, assessed annually by phone, “were maintained over 5 years despite progressive increases in surgical failure rates over time,” with about a 70-point improvement in the Pelvic Organ Prolapse Distress Inventory and similar gains in other measures in both groups, Dr. Jelovsek reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
There were no between-group differences in suture exposure (about 25% in both groups) or sling erosion (about 3%) at 5 years.
There was a difference in granulation tissue: 28.9% with ULS and 18.8% with SSLF (odds ratio with ULS, 1.9; 95% confidence interval 1-3.7). The majority of adverse events occurred within 2 years of surgery.
Early pelvic floor muscle training made no difference in outcomes for the women randomized to it.
The women in the study had stage 2-4 prolapse at baseline. In addition to vaginal suspension surgery, they had vaginal hysterectomies if there was uterine prolapse, and all the women had concomitant retropubic midurethral sling surgery for stress incontinence.
At 2 years, composite success rates were about 60% in both groups (JAMA. 2014 Mar 12;311[10]:1023-34).
The study didn’t identify risk factors for failure, but they would be helpful to know, Dr. Jelovsek said. High-risk women might benefit from a more durable mesh repair. For now at least, “most women say the risk” of pain and other serious mesh complications “completely outweighs the bulge symptoms,” he said.
The trial, an extension of OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss), was conducted at nine U.S. centers in the Pelvic Floor Disorders Network, which is funded by the National Institutes of Health. Dr. Jelovsek reported having no relevant financial disclosures.
* The meeting sponsor information was updated 6/9/2017.