Materials and methods
cancers, genital organ prolapse stage II, abnormal vaginal bleeding, vaginal atrophy symptoms, TCTR20191030001, dyspareunia, pain, vaginal lubricants, genitourinary tract infection, vaginal atrophy, dryness
CANCERS, SURGICAL MENOPAUSE, DYSPAREUNIA, GENITOURINARY TRACT INFECTION, MAY, SECONDARY, VAGINAL ATROPHY, PRIMARY OVARIAN INSUFFICIENCY
This randomized sham-controlled study was conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand, between May 2019 and September 2020. The target population was postmenopausal women attending gynecology clinic or gender health clinic with vaginal atrophy symptoms (dryness, dyspareunia, irritation, and pain). The inclusion criteria were as follows: postmenopausal women with at least one symptom of moderate-to-severe vaginal atrophy and age more than 40 years. (Moderate-to-severe vaginal atrophy was defined by the most bothersome symptom score at least “2” in at least one vaginal atrophy symptom [0 = no symptom, 1 = mild, 2 = moderate, 3 = severe]). As the inclusion criteria of our study were women older than 40 years, the postmenopausal women in this study included natural menopause, surgical menopause, primary ovarian insufficiency, and participants with history of chemoradiation therapy for cancers. Both sexually active and sexually inactive women were included in this study. The exclusion criteria were as follows: history of hormonal therapy, vaginal lubricants, vaginal moisturizers, or spermicide in previous three months; active or recent genitourinary tract infection in previous one month; abnormal vaginal bleeding; genital organ prolapse stage II; history of vaginal surgery in previous three months; and previous vaginal laser treatment.This study was conducted at King Chulalongkorn Memorial Hospital (KCMH), Bangkok, Thailand, between May 2019 and September 2020. The study was not advertised. The primary outcome of this study was to evaluate the effect of erbium YAG laser on the number of vaginal lactobacilli. The secondary outcomes were to evaluate the effect of erbium YAG laser on vaginal atrophy symptoms and vaginal pH.After obtaining written informed consent, all participants were interviewed to collect demographic data and randomized into the laser group and sham group using block-of-four randomization with a sealed envelope. Participants in the laser group were treated with erbium in yttrium aluminum–garnet crystal (Er:YAG) laser (Fotona Smooth™ XS, Fotona, Ljubljana, Slovenia) at a wavelength of 2940 nm, with a spot size of 7 mm, frequency of 1.6 Hz, and laser energy of 6.0 J/cm [
Assessment of vaginal atrophy scoreFor sample size calculation, two independent proportion formulas were used. The sample size was calculated using data obtained from our pilot study. The proportion in the study group and control group was 0.4 and 0.9, respectively. (The result of sample size calculation was the proportion of participants with grade 1 vaginal lactobacilli after vaginal erbium laser treatment and after sham operation). Using 5% type I error and 20% type II error, the calculated sample size was 17 per group. Adding 20% drop out, a total of 42 participants were needed.The randomization sequence was generated by computer generated block of 4 randomization and the allocation concealment was done by sequentially numbered sealed envelopes. The first author (N.P.) kept the randomization schedule. All participants were blinded during the study period. All vaginal swab slides were sent to a microbiologist with identification numbers that did not mention about the study group. Therefore, a microbiologist who evaluated vaginal lactobacilli grading was also blinded. However, all the vaginal laser and sham applications were performed by the first author (N.P.) and those procedures cannot be blinded to the provider.This study was funded by Ratchadapisek Sompot and approved by the Institutional Review Board of Faculty of Medicine, Chulalongkorn University. This study was registered in Thai Clinical Trial Registry on 30/10/2019 (TCTR20191030001; Statistical analysis was performed by SPSS version 22.0. For descriptive statistics, the number, percentage, and mean ± standard deviation (SD) were used for continuous data, while the number and percentage were used for categorical data. For analytical statistics, repeated measures ANOVA and Friedman test were used for continuous and categorial data, respectively. A 