Clinical trial shows commonly prescribed treatment no better than placebo in protecting against recurrence of pelvic organ prolapse
Vaginal estrogen cream, which is commonly prescribed to help women after surgery for pelvic organ prolapse (POP), did not prevent a recurrence of the condition, according to results of a multicenter clinical trial led by UT Southwestern Medical Center. However, the medication did reduce symptoms of vaginal atrophy. The findings, reported in JAMA, could lead to new ways to improve outcomes of prolapse repairs, the study authors said.
David Rahn, M.D., is Professor of Obstetrics and Gynecology at UT Southwestern.
“Our results would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair, a practice that is recommended by some experts,” said study leader David Rahn, M.D., Professor of Obstetrics and Gynecology at UT Southwestern.
By the age of 80, about 1 in 5 women will undergo surgery for either POP – a condition in which pelvic muscles and tissues can no longer support organs such as the uterus, bowel, or bladder, causing them to bulge into the vagina – or urinary incontinence. The lifetime risk of undergoing surgery specifically for POP is about 13%.
The most common surgical techniques for repairing prolapse use native tissues in the pelvis. Unfortunately, about 12% of women 65 years and older will undergo another prolapse repair surgery within five years.
Doctors frequently recommend using vaginal cream containing estrogen for several weeks before and after surgery to counteract the vaginal atrophy that accompanies menopause, a risk factor for POP. However, no studies have examined whether this cream improves the surgical success rate.
To answer this question, Dr. Rahn and his colleagues conducted a clinical trial involving 186 postmenopausal women with POP who were treated at one of three sites: UT Southwestern and medical centers in Alabama and Rhode Island. Half used an estrogen cream for five weeks before surgery and for 12 months afterward. The other half used an identically appearing placebo.
A year after surgery, about 19% of the women in the vaginal estrogen group had a POP recurrence compared with 9% of those in the placebo group, which was not statistically significant.
Using the estrogen cream wasn’t completely without merit, Dr. Rahn said. Women in the vaginal estrogen group were less likely to have symptoms associated with the vaginal atrophy that typically accompanies menopause, such as vaginal dryness and pain with intercourse.
Dr. Rahn added that vaginal wall biopsies collected during the study may provide biomarkers that could predict which women are most at risk for POP recurrence after surgery.
Other UTSW researchers who contributed to this study include Jessica Pruszynski, Ph.D., Assistant Professor of Obstetrics and Gynecology, and Linda Hynan, Ph.D., Professor in the Peter O’Donnell Jr. School of Public Health at UT Southwestern.
The study was funded by the National Institute on Aging (R01 AG047290) and a Bridge Award from the American Board of Obstetrics & Gynecology and the American Association of Obstetricians and Gynecologists Foundation. Database access was made possible through the National Center for Advancing Translational Sciences (UL1 TR003163). Pfizer Inc. provided the study drug through an investigator-initiated award (WI195371).