Effect of Fractional CO2 Laser vs Sham Treatment on Symptom Severity of Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial

Abstract

<h3>Study Objective</h3> To determine the efficacy of fractional CO₂ laser for treatment of vaginal symptoms associated with menopause. <h3>Design</h3> This study is a double-blind, randomized, sham-controlled trial with 12-month follow-up. Enrollment commenced September 19, 2016, with final follow-up June 30, 2020. <h3>Setting</h3> Outpatient clinic in a single, tertiary referral hospital. <h3>Patients or Participants</h3> Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 90 were recruited. <h3>Interventions</h3> Three treatments using a fractional micro-ablative CO₂ laser system performed 4-8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group. <h3>Measurements and Main Results</h3> The coprimary outcomes were symptom severity assessed by Visual Analog Scale (VAS and Vulvovaginal Symptom Questionnaire (VSQ) at 12 months. Secondary outcomes including quality of life, Vaginal Health Index (VHI) and vaginal histology were assessed. From 85 participants randomized (mean age 57 (SD 8) years), 78 (91.7%) completed 12-month follow-up. From baseline to 12 months between CO₂ laser and sham groups, there was no significant difference in symptom severity (VAS score for overall vaginal symptoms: laser -17.2 vs sham -26.6 (difference 9.4 [95%CI -28.6, 47.5]); VAS score for single most severe symptom: laser -24.5 vs sham -20.4 (difference -4.1 [95%CI -32.5, 24.3]); or VSQ score: laser -3.1 vs sham -1.6 (difference -1.5 [95%CI -5.9, 3.0]). There were no significant differences in quality of life, VHI or histological comparisons between laser and sham treatment. There were 16 adverse events in the laser group and 17 in the sham group including vaginal pain/discomfort (44% vs. 68%), spotting, discharge or lower urinary symptoms. No severe adverse events were reported in either group. <h3>Conclusion</h3> Among women with postmenopausal vaginal symptoms, treatment with fractional CO₂ laser vs sham treatment did not significantly improve vaginal symptoms after 12 months.