Abstract and Introduction
Objective: The aim of this study was to evaluate the efficacy of vaginal CO2 laser for the treatment of vaginal atrophy compared to the sham procedure.
Methods: Between June 2016 and May 2017, postmenopausal women with moderate to severe intensity of any vaginal atrophy symptoms (VAS) were invited to participate in the study. A total of 88 women were randomized to receive treatment with either vaginal CO2 laser or sham procedures every 4 weeks for three sessions. Both the participants and the evaluators were blinded to the treatment. Vaginal Health Index (VHI) score (primary outcome), VAS score, and the item for vaginal dryness from the International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms questionnaire were compared between the two groups by intention-to-treat analysis at 12 weeks after treatment.
Results: Eighty-eight women were enrolled into the study and nine women were lost to follow-up. After 12 weeks of laser treatment, the VHI, VAS, and International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms (item for vaginal dryness) scores were significantly improved. For VHI and VAS scores the mean difference between the laser group versus the sham group was 1.37 (95% CI: 0.12–2.63), P < 0.001 and −1.52 (95% CI: −2.21 to −0.82), P = 0.03, respectively.
Conclusions: This study demonstrated that the application of microablative fractional CO2 laser was effective in treating vaginal atrophy. It could be a promising alternative treatment for postmenopausal women with vaginal atrophy.
Vulvovaginal atrophy or atrophic vaginitis refers to a group of postmenopausal symptoms related to an alteration of the vulva, vagina, and lower urinary tract. The International Society for the Study of Women's Sexual Health and The North American Menopause Society proposed the nomenclature, "genitourinary syndrome of menopause" as a new terminology. These symptoms are associated with the decrement of estrogen after menopause. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge. On examination, thinning, dryness, and pallor of the vaginal mucosa and flatten labia majora owing to loss of labial fat pad are common findings. As atrophy progresses, petechial hemorrhage may be found in the mucosa causing the vagina to become short and narrow.[1–3] Almost half of the postmenopausal women were reported to have vaginal atrophy.[1,4,5] This percentage may, however, actually be underestimated due to underreporting by the patients or underrecognized by the healthcare providers. Evidence suggested that vaginal atrophy has profound negative effects on sexual health and quality of life.[4,5] Hence, it is important to treat postmenopausal women with vaginal atrophy.
The treatment regimens, according to the 2013 position statement of The North American Menopause Society on management of symptomatic vulvovaginal atrophy, are nonprescription therapies; lubricants, moisturizers, herbal dietary supplements (eg, black cohosh, soy, or other herbs), and prescription therapies; vaginal estrogen, which is the criterion standard for treating vaginal atrophy. Selecting the treatment for vaginal atrophy depends on several factors such as severity of the condition, patient preference, effectiveness, and safety of the treatment. Ospemifene, which is a Selective Estrogen Receptor Modulator, is the other treatment option for moderate to severe dyspareunia associated with vaginal atrophy.[5–9] In recent years, microablative fractional CO2 laser has become available for treating pelvic floor dysfunction including vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components.[10,11] Several prospective studies reported significant improvement of signs and symptoms of vaginal atrophy including health-related quality of life after being treated with vaginal CO2 laser. There were three case series that reported on the long-term positive effect of vaginal laser on vaginal atrophy symptoms (VAS; burning, dryness, and dyspareunia), Vaginal Health Index (VHI), and Female Sexual Function Index score for at least 1 year after three sessions of fractional CO2 laser.[12–14] Up to now, there are only a few studies reporting on the efficacy and safety of microablative fractional CO2 laser by comparing it to the criterion standard therapy such as vaginal estrogen. But there is no report comparing vaginal laser with placebo or sham procedure. As a result, we conducted a randomized controlled trial to evaluate the efficacy of microablative fractional CO2 laser by comparing it to a placebo (sham) procedure for the treatment of vaginal atrophy in postmenopausal women.
Menopause. 2020;27(8):858-863. © 2020 The North American Menopause Society