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Women having surgery for pelvic organ prolapse are often prescribed vaginal estrogen to boost the odds of a successful procedure. Now a clinical trial shows it doesn't actually work.
Pelvic organ prolapse is a disorder where weakened muscles and other tissues in the pelvis allow one or more organs -- including the uterus, bladder or rectum -- to protrude into the vagina.
Often, women with the condition do not have symptoms and don't need treatment. In other cases, prolapse causes problems like pelvic pressure, urine leakage and discomfort during exercise or sex. More-severe cases may require surgery to restore support to the pelvic organs.
While that often brings relief, about 12% of women over 65 need a repeat surgery within five years.
"Unfortunately, recurrent prolapse and re-operation is not rare," said Dr. David Rahn, lead researcher on the new trial and a professor of obstetrics and gynecology at UT Southwestern Medical Center in Dallas.
After menopause, tissue in the vagina often atrophies, or thins. So it's become common practice for doctors to prescribe vaginal estrogen cream to postmenopausal women who are scheduled to undergo prolapse surgery.
The thinking has been that estrogen, used before and after surgery, will help fortify thinning vaginal tissue and lower the odds of a repeat prolapse.
But there has never been a clinical trial to test the tactic -- until now. And the new findings, recently published in the Journal of the American Medical Association, suggest it doesn't work after all.
Rahn's team found that among nearly 200 postmenopausal women who underwent prolapse surgery, those who used a vaginal estrogen cream before and after the procedure were no less likely to have a prolapse recurrence.
Of women randomly assigned to use estrogen, 19% had a recurrence in the year after surgery. That compared with 9% of women randomly assigned to use a placebo (inactive) cream. Statistically, the difference between the two groups was not significant.
"Vaginal estrogen had no benefit when it came to 'optimizing' tissues before surgery, or in the healing process after surgery," Rahn said. "So it should not be used to try to reduce prolapse recurrence."
That does not, however, mean that women having prolapse surgery should never use vaginal estrogen.
Some women in the trial benefited in other ways: Those who had been bothered by symptoms of vaginal atrophy before surgery -- reporting problems like dryness and pain during sex -- saw a greater improvement in those issues compared to the placebo group.
So when women with prolapse have those types of symptoms and want to try vaginal estrogen, it "should not be withheld," Rahn said. That, he noted, is presuming they have no contraindications to using the hormone (such as a history of breast cancer or blood clots).
Dr. Dara Shalom, associate chief of urogynecology at Northwell Health in New York, had similar observations.
"In our practice, we believe there is a role for treating severe atrophy with vaginal estrogen prior to surgery, in order to improve tissue quality and, potentially, the healing process," said Shalom, who was not involved in the trial.
"However," she added, "it has not been shown to have an effect on surgical success rates or prolapse recurrence."
The trial included 186 women who underwent prolapse surgery at one of three U.S. medical centers. About half were randomly assigned to use vaginal estrogen cream for at least five weeks before surgery, then continue for a year afterward; the rest were given a placebo cream.
At the outset, 55% of patients said they had bothersome symptoms of vaginal atrophy. And those who used estrogen cream reported a bigger improvement over the next year: On average, they moved from "moderate bother" to "no bother."
But estrogen made no difference when it came to its primary purpose of preventing prolapse recurrence.
Rahn said he expects the findings will change some minds about the role of estrogen in prolapse surgery.
"Doctors who may have delayed prolapse repair surgery to allow time for preoperative vaginal estrogen to have its effect probably would reconsider this rationale," he said.
The U.S. Office on Women's Health has more on pelvic organ prolapse.
SOURCES: David Rahn, MD, professor, obstetrics and gynecology, University of Texas Southwestern Medical Center, Dallas; Dara Shalom, MD, associate chief, urogynecology, Northwell Health, associate professor, obstetrics and gynecology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y.; Journal of the American Medical Association, Aug. 15, 2023
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