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Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device

Vanaman Wilson, Monique, J., MD*; Bolton, Joanna, MD; Jones, Isabela, T., MD; Wu, Douglas, C., MD, PhD§; Calame, Antoanella, MD‖,¶; Goldman, Mitchel, P., MD§,¶

doi: 10.1097/DSS.0000000000001453
Original Article

BACKGROUND Although transcutaneous temperature-controlled radiofrequency (TTCRF) may effectively treat vulvovaginal laxity (VVL), atrophic vaginitis (AV), orgasmic dysfunction (OD), and stress urinary incontinence (SUI), there is a lack of histopathologic evidence to validate its use.

OBJECTIVE Evaluate clinical and histological changes induced by vulvovaginal TTCRF.

MATERIALS AND METHODS This was a prospective, nonrandomized trial. Ten female subjects with mild-to-moderate VVL, with or without AV, OD, and/or SUI underwent 3 TTCRFs at 4-week intervals. Five subjects underwent pre- and post-treatment biopsies of the labia majora and vaginal canal for histology. Assessments were performed at baseline and Days 10, 30, 60, and 120.

RESULTS Investigator-rated VVL improved significantly from baseline to Day 10, with improvement maintained through Day 120 (p = .001 and .001, respectively). Sexual satisfaction improved significantly by Day 60 (p = .001). Improvement in AV reached significance at Day 120 (p = .048). Although OD and SUI improved steadily, the difference in improvement did not reach statistical significance. Histology revealed that post-treatment increases in collagen, elastin, vascularity, and small nerve fibers.

CONCLUSION Transcutaneous temperature-controlled RF resulted in significant improvements in AV, VVL, and sexual satisfaction with milder improvements in OD and SUI. Post-treatment histology demonstrated neocollagenesis, neoelastogenesis, neoangiogenesis, and the first reported finding of TTCRF-related neurogenesis.

*California Skin Institute, Sunnyvale, California;

Alliant Dermatology, The Villages, Florida;

McLean Dermatology and Skincare Center, McLean, Virginia;

§Goldman, Butterwick, Groff, Fabi and Wu, Cosmetic Laser Dermatology, San Diego, California;

Compass Dermatopathology, San Diego, California;

Department of Dermatology, University of California, San Diego, San Diego, California

Address correspondence and reprint requests to: Monique J. Vanaman Wilson, MD, California Skin Institute, 603 S. Knickerbocker Dr. Sunnyvale, Sunnyvale, CA 94087, or e-mail:

Supported by ThermiGen LLC.

© 2018 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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