Among one in three women in the U.S. has pelvic floor disorder, a condition that often develops after bearing children and getting older. These disorders could lead to incontinence, painful intercourse or prolapse of pelvic organs into the vaginal canal.

Surgeons have been performing procedures to improve these symptoms for decades, but few studies have tracked how patients fared beyond the first couple of years after surgery.

A Duke-led study published in the Journal of the American Medical Association followed women for five years after two common prolapse surgeries and found failure rates for both procedures were equally high, at over 60%.

However, surveys of the nearly 300 women in the study found that even for patients whose surgical adjustments regressed or caused new or worsening symptoms. "This was surprising to us," said lead author J. Eric Jelovsek, M.D., director of Data Science for Women's Health in Obstetrics and Gynecology at Duke.

"That failure rate was higher than we expected. But that does not necessarily align with how patients feel, and we don't know why that is. It is possible the definitions we set for failure, in this case, were too stringent," said Jelovsek.

The randomized clinical trial, known by the acronym OPTIMAL, began in 2010 as an initiative of the National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network.

The mission was to compare two common treatments for prolapse sacrospinous ligament fixation (SSLF), resulting in a 70.3% failure at 5 years, and ligament vaginal vault suspension (ULS), resulting in a 61.5% failure at 5 years. Participants' median age was 57 years.

For both operations, surgeons access the affected area through the vagina, bringing points of the tissue upward to connect with ligaments in the pelvis. The goal was to reattach the woman's tissue to support pelvic organs and reduce incontinence. No synthetic mesh was used in either procedure.

If after five years, the repaired tissue descended past the upper third of the vaginal canal, researchers considered the surgery a failure. The procedure was also considered failed if the patient felt a bothersome bulge or sensation of prolapse, or were treated again with surgery or a removable pessary to relieve their symptoms.

"The results suggest that neither procedure might work as well in the long-term as surgeons once thought," Jelovsek said. "We may be at the point where we need to think of treating prolapse as treating a chronic disease that's likely to return over time."

"It's like getting a hip or knee replaced. It will definitely improve quality of life. And it is absolutely worth it, but down the road, this will likely be something we'll have to revisit," Jelovsek said.