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A Randomized Clinical Trial of the Impact of Local Estrogen on Postoperative Tissue Quality After Vaginal Reconstructive Surgery

Karp, Deborah R. MD*; Jean-Michel, Marjorie MD; Johnston, Yasmin MD; Suciu, Gabriel PhD§; Aguilar, Vivian C. MD; Davila, G. Willy MD

Female Pelvic Medicine & Reconstructive Surgery: July/August 2012 - Volume 18 - Issue 4 - p 211–215
doi: 10.1097/SPV.0b013e31825e6401
Original Articles
Journal Club

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.

A Randomized Clinical Trial of the Impact of Local Estrogen on Postoperative Tissue Quality After Vaginal Reconstructive Surgery.

From the *Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA; †Department of Obstetrics and Gynecology, Bronx-Lebanon Hospital Center, Bronx, NY; ‡Department of Pathology, Cleveland Clinic Florida, Weston; §Section of Biostatistics, Public Health Program, Nova Southeastern University, Davie; and ∥Section of Urogynecology and Pelvic Reconstructive Surgery, Department of Gynecology, Cleveland Clinic Florida, Weston, FL.

Reprints: Deborah R. Karp, MD, 1639 Pierce Dr, Room 4305, Atlanta, GA 30322. E-mail: debby.karp@emory.edu.

Dr Jean-Michel is a consultant for Warner-Chilcott and Boston Scientific. Dr Davila is a consultant for Astellas, American Medical Systems, CL Medical.

The other authors declare that they have nothing to disclose.

Presented as an oral podium at the American Urogynecologic Society’s 31st Annual Scientific Meeting, Long Beach, CA, September 30, 2011.

© 2012 by Wolters Kluwer Health | Lippincott Williams & Wilkins