VAGINAL ATROPHY TREATMENT USINGMICROABLATIVE FRACTIONAL CARBON DIOXIDE LASER: A RANDOMIZED PATIENTAND EVALUATOR-BLINDED SHAM-CONTROLLED TRIAL, AN INTERRIM ANALYSIS
P. RUANPHOO1, S.BUNYAVEJCHEVIN 2;
1Obstetrics andGynecology, Faculty of Med., Chulalongkorn Univ., Bangkok, Thailand,2chulalongkorn Univ., BKK, Thailand.
Introduction: Vulvovaginalatrophy refers to a group of postmenopausal symptoms includingvaginal dryness, irritation, soreness, dyspareunia, dysuria andvaginal discharge. These are associated with decrement of estrogenafter menopause. Management of symptomatic vulvovaginal atrophy mayinclude lubricants, moisturizers and herbal products as dietarysupplement. Vaginal estrogen is classified as the gold standard fortreatment of vaginal atrophy. In recent years, microablativefractional carbon dioxide laser had been introduced for the treatmentof vaginal atrophy. Up to now, there are only descriptive study andcase series reports of the laser use in patients with vaginalatrophy, no report of the randomized controlled trialstudy.
Objective: To evaluate the efficacy of vaginalmicroablative fractional carbon dioxide laser in treatment ofpostmenopausal women with vaginal atrophy symptoms in comparison withthe sham-controlled group.
Methods: Postmenopausal women atfifty year of age or more with moderate to severe intensity of anysymptoms of vaginal atrophy who attended at a gynecologic outpatientclinic of a university hospital in Thailand were invited to thestudy. They were randomized for treatment with vaginal microablativefractional carbon dioxide laser or sham procedure(insertion ofvaginal probe into the vagina without application of laser power)every 4 weeks for 3 sessions. Simple randomization method by computergenerated code was used. Allocation concealment was performed usingopaque sealed envelopes. In each visit, participants were assessed byVHI(vaginal health index) score, vaginal atrophy symptom score andICIQ-VS questionnaire. The participants and evaluators were blindedto the intervention which each participant received. Changes of thesemeasurements between baseline and 12-week follow-up were comparedbetween groups. The sample size of 88 cases was calculated from pilotstudy. The interim analysis were planned to evaluate the efficacy oflaser treatment at 30, 50 70 percent of cases recruitment.
Results:Sixty three postmenopausal women with vaginal atrophy symptoms wererecruited ( laser treatment group (n= 31) , sham procedure( n= 32)).Before and after comparison of the VAS and VHI, the VHI and VASscores were statistically significant differences in lasergroup(p<0.001, p<0.001). But, in sham group, only VHI score wasstatistically significant different(p=0.033). When compared betweengroups, the differences between pre- and 12-week post-treatment ofvaginal health index(VHI) and vaginal atrophy symptom(VAS) score werestatistically significant. The mean + SD of changes of VHI was 3.47 ±3.72 in laser group, compared to 1.33 ± 3.25 in sham group(p=0.039). The mean + SD of change of VAS score was -1.52 ± 1.55 inlaser group, compared to 0.13 ± 2.01 in sham group(p=0.001). Butthere was no statistically significant difference in scores ofICIQ-VS questionnaire in term of vaginal dryness(p=0.316), vaginalsymptom(p=0.208), sexual matter(p=0.286) and quality of life(p=0.089)between groups.
Conclusions: From the interim analysis, wefound that the vaginal microablative fractional carbon dioxide laseris effective in treatment of vaginal atrophy and is in comparison tothe sham controlled procedure. It can be used as an alternativetreatment of vaginal atrophy in postmenopausal women.
References:1.Menopause. 2015; 22: 845-9. 2.Maturitus. 2015; 80: 296-301.3.Lasers Med Sci. 2015; 30: 429-36.
Differencebetween groups in pre- and post- treatment: VAS, VHI and ICIQ-VSquestionnaire
Lasergroup(n=29) Mean ± SD
Shamgroup(n=30) Mean ± SD
ICIQ-VS(Quality of Life)