Safety and efficacy of fractional CO2 laser treatment to the vestibule: a randomized, double-blind, sham-controlled, prospective 3-site clinical study in women with vestibular pain

Abstract

Abstract Background Data are limited regarding fractional CO2 laser as a nonhormonal treatment for vestibular pain. Aim We sought to perform what is, to our knowledge, the first multisite prospective randomized, double-blind, sham-controlled clinical trial to assess the safety and efficacy of fractional CO2 laser treatment to the vestibule in women with vestibular pain. Methods Subjects (n = 70) meeting inclusion/exclusion criteria at each of 3 sites were randomized 2:1 to active or sham (zero energy) fractional CO2 laser treatment using the vestibular probe (SmartXide2 V2LR - MonaLisa Touch, DEKA, Florence, Italy). Subjects in each treatment arm received 3 treatments 4 weeks apart. At the initial follow-up (week 12), subjects were unblinded and those initially assigned to sham started active treatment. Outcomes Outcome measures included changes from baseline in sexual activity diaries and scores for the Vulvoscopic Genital Tissue Appearance Scale (VGTA), vestibular cotton-tipped swab testing, McGill Pain Questionnaire, Female Sexual Function Index (FSFI), Female Sexual Distress Scale–Revised (FSDS-R), and the O’Leary-Sant voiding and pain indices, the Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI). Results After active treatment, VGTA scores significantly improved in 5 parameters. Pain associated with cotton-tipped swab testing was significantly reduced at weeks 4 through 16 (mean change from baseline −0.64 [95% CI, −0.79 to −0.50] and −1.31 [95% CI, −1.46 to −1.16], respectively). FSFI pain domain scores improved significantly at weeks 12 and 16 (mean change from baseline 0.925 [95% CI, 0.10-1.75] and 1.22 [95% CI, 0.40-2.05], respectively). FSFI total scores increased significantly at weeks 12 and 16 (mean change from baseline 6.24 [95% CI, 2.64-9.85] and 4.96 [95% CI, 1.36-8.57], respectively). FSDS-R scores decreased significantly at weeks 12 and 16 (mean change from baseline −5.84 [95% CI, −8.80 to −2.87] and −9.15 [95% CI, −12.11 to −6.18], respectively). ICSI scores decreased significantly at weeks 12 and 16 (mean change from baseline −0.91 [95% CI, −1.65 to −0.18] and −0.754 [95% CI, −1.49 to −0.02], respectively). ICPI scores decreased significantly at week 16 (mean change from baseline −0.99 [95% CI, −1.63 to −0.34]). In contrast, there were no significant changes in outcomes in the sham arm. No serious adverse events occurred. Clinical Implications Fractional CO2 laser treatment in women with vestibular pain resulted in improvement from baseline in multiple key outcome measures of vestibular health. Strengths and Limitations Strengths of the study were that it was a multisite prospective randomized double-blind, sham-controlled clinical trial that included multiple measures related to vestibular pain and sexual function. Limitations were the nonvalidated primary outcome measure and limited study cohort. Conclusion Fractional CO2 laser therapy is a safe and effective nonhormonal treatment for vestibular pain.