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A randomized clinical trial of the impact of local estrogen on postoperative tissue quality after vaginal
Deborah R Karp1, Marjorie Jean-Michel, Yasmin Johnston
1Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA 30322, USA. debby.karp@emory.edu
Objective:
To evaluate the use and effect of early administration of vaginal estrogen via a continuous low-dose estradiol vaginal ring placed immediately after pelvic reconstructive surgery.
Methods:
This was a randomized controlled trial of 65 postmenopausal women undergoing vaginal reconstructive surgery. The subjects were randomly assigned to receive an estradiol-releasing vaginal ring, placebo vaginal ring, or control without vaginal ring for 12 weeks immediately after vaginal reconstructive surgery. The primary outcome was tissue quality based on vaginal maturation 3 months postoperatively. Secondary outcome measures were subjective and objective signs of atrophy; vaginal pH; the presence of granulation tissue, microscopic inflammation, and major healing abnormalities; and the ability to tolerate an intravaginal ring.
Results:
At 12 weeks, the estradiol ring group had a significantly improved maturation value (P<0.01) and objective atrophy assessment (P<0.01) compared with the placebo ring and control arms. Granulation tissue was increased in the placebo ring arm (P<0.01). Subjective atrophy scores did not differ among the groups (P=0.39).
Conclusions:
Early administration of vaginal estrogen after vaginal surgery via an estradiol-releasing ring is feasible and results in improved markers of tissue quality postoperatively compared to placebo and controls.
