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An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy

Sokol, Eric R. MD; Karram, Mickey M. MD

doi: 10.1097/GME.0000000000000700
Original Articles
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Objectives: The aim of the study was to assess the safety and efficacy of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause (GSM).

Methods: Women presenting with GSM and meeting study criteria were enrolled. Examinations at baseline and follow-up (3 mo after final treatment) evaluated dilator tolerance and vaginal pH. Visual analog scales were used to assess pain, vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria; Vaginal Health Index scores were completed before each treatment and at follow-up; Female Sexual Function Index and Short Form 12 questionnaires were also completed. Participant satisfaction was measured on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Women received three laser treatments, 6 weeks apart.

Results: Thirty women participated (mean age 58.6 ± 8.8 y). None withdrew or were discontinued due to an adverse event; three were lost to follow-up. Average improvement in visual analog scale scoring was 1.7 ± 3.2 for pain, 1.4 ± 2.9 for burning, 1.4 ± 1.9 for itching, 6.1 ± 2.7 for dryness, 5.1 ± 3.0 for dyspareunia, and 1.0 ± 2.4 for dysuria; improvement in average Vaginal Health Index and Female Sexual Function Index scores were statistically significant (P < 0.001). Twenty-five of 30 participants (83%) showed increase in comfortable dilator size at 3-month follow up. Before the second and third treatments, 86.6% (26 of 30) of women reported they were better or much better than at the previous treatment; 26 of 27 women (96%) were reportedly satisfied or extremely satisfied at follow-up.

Conclusions: In this sample, the data suggest that the fractional CO2 laser is effective and safe for treatment of the symptoms associated with GSM.

1Division of Urogynecology and Pelvic Reconstructive Surgery, Stanford University, Stanford, CA

2Advanced Urogynecology and Pelvic Surgery, The Christ Hospital, Cincinnati, OH.

Address correspondence to: Eric R. Sokol, MD, Stanford University School of Medicine, 300 Pasteur Drive, Room G332, Stanford, CA 94305. E-mail: esokol@stanford.edu

Received 2 December, 2015

Revised 19 April, 2016

Accepted 19 April, 2016

Funding/support: This trial was supported by Deka Medical Electronics Laser Associated Società a Responsabilità Limitata (DEKA M.E.L.A. Srl) using the investigators’ protocol with oversight by the Stanford University IRB as well as The Christ Hospital IRB; participants did not pay for treatment.

Financial disclosure/conflicts of interest: M.M.K. is a paid consultant of Cynosure, Inc.

© 2016 by The North American Menopause Society.