Science Update: NIH-supported study finds no difference between two surgeries commonly done to treat vaginal prolapse

A five-year comparison of two surgeries for vaginal prolapse—uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF)—found no significant differences in failure rates between the two. The study, funded by NICHD’s Pelvic Floor Disorders Network, also showed that most women who underwent either surgery reported improvements in their symptoms. Furthermore, researchers found no differences in failure rates or symptoms among women who received physical therapy to improve muscle control, compared to those who did not receive extra therapy. The findings appear in the Journal of the American Medical Association.

Background

Vaginal prolapse occurs when pelvic organs bulge into the vagina or stick out beyond the opening of the vagina. Women with this condition may complain of feeling pressure in the vagina, having a sense that something is falling out of the vagina, or having difficulty emptying their bladder or bowels.

Vaginal prolapse is one of several conditions involving the pelvic floor, a group of muscles and tissues that help support the pelvic organs, such as the bladder, bowel, and uterus. A pelvic floor disorder is a condition in which muscles or connective tissues of the pelvic floor weaken or are injured, resulting in discomfort and other problems.

The OPTIMAL  study compared two surgeries commonly done to correct vaginal prolapse. In each, the vagina is pulled back into position by attaching it to internal ligaments in the pelvic area. The researchers wanted to know if one method worked better than the other. They also were interested in whether physical therapy, called behavioral and pelvic floor muscle therapy, could improve outcomes after surgery. The original OPTIMAL study initially followed women for two years, but it was extended for three years in the current (E-OPTIMAL) study, which looked at outcomes five years after the initial surgery.

Results

Of 244 women, ranging from 35 to 79 years old, researchers found that five years after surgery, 61.5 percent of those who had ULS and 70.3 percent who had SSLF had surgical failure. These differences were not statistically significant, and therefore both types of surgery had similar outcomes.

However, the authors note that surgical failure was predefined and not necessarily reflective of a patient's perspective on comfort or symptom relief. The authors defined surgical failure as one of the following: descent of the top of the vagina to greater than one-third of total vaginal length or descent of any portion of the vaginal wall beyond the hymen, which are determined by physical exam; retreatment for prolapse (such as placement of a pessary  or surgery); or bothersome symptoms as reported by the patients (such as a bulge or pressure).

Women receiving physical therapy were taught special exercises. The researchers found that 48 percent had anatomic failure (similar definition to surgical failure), compared to 49.5 percent of women who did not undergo physical therapy. Again, these differences were not statistically significant, suggesting that the exercises did not offer an additional benefit based on the study's definition of success.

Despite these findings, most of the women in the study reported improved prolapse symptoms. Furthermore, the proportion of women who needed retreatment for prolapse was low—11.9 percent for ULS patients and 8.1 percent for SLLF patients.

Significance

"While the surgical failure rates were higher than anticipated, most women still had meaningful improvements in their symptoms and quality of life and did not seek further treatment," said Donna Mazloomdoost, M.D., program director of the NICHD Pelvic Floor Disorders Network. "The findings reinforce the need for more long-term studies on treatments for pelvic floor disorders and a better understanding of what women consider to be successful outcomes."

Reference

Jelovsek JE, et al. Effect of uterosacral ligament suspension vs sacrospinous ligament fixation with or without perioperative behavioral therapy for pelvic organ vaginal prolapse on surgical outcomes and prolapse symptoms at 5 years in the OPTIMAL randomized clinical trial. JAMA DOI: 10.1001/jama.2018.2827.