Treatment for Vaginal Atrophy Using Microablative Fractional CO2 Laser

A Randomized Double-Blinded Sham-Controlled Trial

Purim Ruanphoo, MD; Suvit Bunyavejchevin, MD, MHS

Disclosures

Menopause. 2020;27(8):858-863. 

In This Article

Discussion

Vaginal microablative fractional CO2 laser for treatment of vaginal atrophy is the activation of vaginal tissue to regenerate. The supraphysiologic level of the heat from the laser induces production of a variety of growth factors, which induce cell proliferation and subsequent tissue repair.[23] Microscopic evaluation of the vaginal tissue after laser treatment showed thickening of the epithelial layer and increase papillae projecting from the connective tissue into the epithelium, which represent the regenerative characteristic of the vaginal mucosa that is similar to the premenopausal vaginal mucosa.[10,11]

Our randomized trial showed that after 12 weeks of treatment with vaginal CO2 laser, there were significant improvements in the VHI score and VAS score among women with vaginal atrophy, whereas in the sham group, there were no significant improvements for all measurements. These results were consistent with other previous uncontrolled prospective studies that showed vaginal CO2 laser treatment did improve symptoms and signs of vaginal atrophy.[12–14,24–26] In a previous randomized-controlled trial conducted by Cruz et al,[15] they evaluated the efficacy of fractional CO2 laser and compared it to local estrogen and the combination of both treatments. Participants were randomly assigned to three treatment arms: laser with estriol treatment, laser with placebo treatment, and sham procedure with estriol treatment. After 20 weeks, the participants who received laser with estriol treatment and laser with placebo treatment showed significant improvement in VHI and VAS compared to the participants that were only treated with estriol. In another randomized trial, the effects of fractional CO2 laser therapy were compared to vaginal promestriene and vaginal lubricants among women with genitourinary syndrome of menopause.[27] The women from the CO2 laser group had a significantly higher VHI score after 14 weeks of treatment compared to women in the promestriene and lubricant groups. Vaginal maturation significantly improved in the CO2 laser group compared to the other treatment groups, but it should be noted that they did not compare the results of the laser group to a sham group to confirm the efficacy of CO2 laser versus placebo. Our study is the first trial that compared the effect of vaginal CO2 laser with the placebo (sham procedure) to see whether the placebo effect can improve VAS. Our results confirmed that the CO2 laser could improve VHI and VAS when compared to the sham group. After completion of the study, all participants were treated according to The North American Menopause Society guideline for vaginal atrophy among postmenopausal women.[5] We detected minor adverse effects of the vaginal laser which were similar to previous reports.[12,14,15,27] These side effects lasted only for a few days. No serious adverse event was noted in this study.

The strength of this study was its randomized trial design that compared the effects of vaginal CO2 laser to the sham procedure. Also, the dropout rate in the study was small. In addition, this study was double blinded so bias was minimized. Moreover, we used the standardized outcome measurements (VHI and VAS scores) and validated questionnaire (ICIQ-VS, item for vaginal dryness) to assess vaginal atrophy. Furthermore, the vaginal laser and the sham procedures were performed by a single operator to avoid interpersonal clinical skill variation.

This study had some limitations. First, we did not study the effect of vaginal laser on sexual function[28] because sexual activity among Thai menopausal women was low (38%). Second, the follow-up period in this study was only 12 weeks. Thus, additional study with a longer follow-up period and larger sample size should be conducted to assess the long-term effects of vaginal CO2 laser in terms of efficacy and side effects. Third, the sham procedure was performed in the same manner as the laser treatment but without laser power application. Participants might, however, perceive that there was no noise and vibration during the procedure. This might cause unblinding to those participants and result in bias to participants' reported outcomes. Fourth, we assessed adverse events at the last visit. This could be a source of recall bias because participants might not recall the discomfort which occurred in the previous visits.

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