Study on Perioperative Vaginal Estrogen in Postmenopausal Women

Researchers have found in a new study that perioperative application of intravaginal estrogen cream in postmenopausal women undergoing a standardized native tissue apical vaginal prolapse repair may not reduce prolapse recurrence.

The clinical trial published in JAMA by David D. Rahn and colleagues, conducted across three tertiary medical centers in the US, has examined the effects of perioperative vaginal estrogen on the success of surgical repair for apical and uterovaginal prolapse in postmenopausal women. The study aimed to compare the efficacy of vaginal estrogen with a placebo cream in reducing the recurrence of prolapse following native tissue surgical repair.

Study Details

The trial enrolled 206 postmenopausal women who were experiencing bothersome anterior and apical vaginal prolapse and were interested in surgical repair. Out of these, 186 women underwent surgery and were randomized to receive either 1g of conjugated estrogen cream (0.625 mg/g) or a placebo. The intervention involved applying the cream vaginally nightly for 2 weeks and then twice weekly for at least 5 weeks before surgery. The application continued twice weekly for 12 months postoperatively. The surgical procedure included vaginal hysterectomy (if uterus present) and standardized apical fixation using uterosacral or sacrospinous ligament fixation.

Primary Outcome

The primary outcome of the study was the time to failure of prolapse repair within 12 months after surgery. Failure was defined by at least one of three criteria:

• Anatomical/objective prolapse of the anterior or posterior walls beyond the hymen
• Apex descending more than one-third of the vaginal length
• Subjective vaginal bulge symptoms or repeated prolapse treatment

The study found that perioperative vaginal estrogen did not significantly improve surgical success rates. The 12-month failure incidence was 19% for the vaginal estrogen group and 9% for the placebo group. The adjusted hazard ratio was 1.97 (95% CI, 0.92-4.22), indicating no significant difference in outcomes between the two groups. The most common component of failure was anatomic recurrence, rather than vaginal bulge symptoms or repeated prolapse treatment.

Additional Findings

The assessment of vaginal tissue quality and estrogenization by masked surgeons at the time of the operation was significantly better in the vaginal estrogen group. In participants with bothersome vaginal atrophy symptoms at baseline, the vaginal atrophy score for the most bothersome symptom was significantly better at 12 months with vaginal estrogen.

Conclusion

In conclusion, the study found that perioperative vaginal estrogen application did not lead to improved surgical success rates after native tissue transvaginal prolapse repair. This research contributes valuable insights into the potential effects of estrogen in surgical prolapse management and highlights the complexities of such interventions in postmenopausal women. Further studies may be needed to explore alternative strategies for enhancing surgical outcomes in prolapse repair.

Reference

Rahn, D. D., Richter, H. E., Sung, V. W., Pruszynski, J. E., & Hynan, L. S. (2023). Perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair: A randomized clinical trial. JAMA: The Journal of the American Medical Association, 330(7), 615. https://doi.org/10.1001/jama.2023.12317