Perioperative vaginal estrogen fails to reduce prolapse recurrence

Key takeaways:

• Vaginal estrogen cream after native tissue transvaginal prolapse repair did not improve surgical success rates vs. placebo.
• However, vaginal atrophy scores were improved with estrogen cream.

Application of adjunctive perioperative vaginal estrogen failed to reduce prolapse recurrence after native tissue transvaginal prolapse repair compared with placebo, according to study results published in JAMA.

According to a related press release, 20% of women undergo surgery for either pelvic organ prolapse or urinary incontinence, and about 12% of women aged 65 years and older undergo several prolapse repair surgeries within 5 years. In addition, physicians frequently recommended the application of vaginal cream containing estrogen for several weeks before and after surgery to counteract vaginal atrophy.

“This study would argue against routine prescription of vaginal estrogen to optimize vaginal tissue for prolapse repair — a practice that is recommended by some experts and commonly prescribed anecdotally,” David D. Rahn, MD, professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center, told Healio. “However, in those patients with prolapse and bothersome atrophy-related complaints such as vaginal dryness and pain with intercourse, then vaginal estrogen may still be appropriate. It may also be an important tool postoperatively for patients prone to recurrent urinary tract infections.”

Rahn and colleagues conducted a randomized superiority clinical trial with 199 postmenopausal women with bothersome anterior and apical vaginal prolapse from three tertiary U.S. clinical sites in Texas, Alabama and Rhode Island. All participants were enrolled in urogynecology clinics from December 2016 to February 2020 and were interested in surgical repair.

David D. Rahn

Participants were randomly assigned to 1 g conjugated estrogen cream 0.625 mg/g (n = 102; mean age, 64.9 years) or placebo (n = 97; mean age, 65.2 years) inserted vaginally each night for 2 weeks and then twice weekly to complete 5 weeks of application preoperatively. This routine continued twice weekly for 1 year postoperatively. Overall, 186 participants underwent vaginal hysterectomy and standardized apical fixation.

The primary outcome was time to prolapse repair failure by 12 months postoperatively defined by at least one of the following: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or descension of the apex more than one-third of the vaginal length; subjective vaginal bulge symptoms; or repeated prolapse treatment.

Researchers did not observe significant differences in the primary outcome among women who received vaginal estrogen or those who received placebo through all 12 months. Women who received vaginal estrogen had a 12-month failure incidence of 19%, and women who received the placebo had a 12-month failure incidence of 9% (adjusted HR = 1.97; 95% CI, 0.92-4.22). The most common primary outcome failure was the anatomic recurrence component.

Researchers also noted significantly better masked surgeon assessment of vaginal tissue quality and estrogenization among women who received vaginal estrogen at the time of surgery. Among the 109 women with at least moderately bothersome vaginal atrophy symptoms at baseline, vaginal atrophy scores for most bothersome symptoms were significantly better at 12 months with vaginal estrogen application.

“Further research from this project is still underway. All participants have now been followed to 3 years after surgery, and those clinical results are just now being analyzed,” Rahn said. “In addition, full-thickness vaginal wall biopsies were collected at the time of all 186 surgeries. These are also being analyzed and may yield important information regarding how biomarkers for connective tissue health could point to increased — or decreased — risk for prolapse recurrence.”

Reference:

• Estrogen cream does not improve success rate for prolapse repair. https://www.utsouthwestern.edu/newsroom/articles/year-2023/aug-estrogen-cream-prolapse-repair-surgery.html. Published Aug. 15, 2023. Accessed Aug. 16, 2023.