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

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.

Vestibular tissue changes following administration of intravaginal prasterone: a vulvoscopic open-label pilot study in menopausal women with dyspareunia

“…In addition, none of the outcome measures have yet been validated, although they have been used in multiple studies. 21 , 25 , 26 , 28 To the best of our knowledge, there are no established and validated outcome measures to assess vestibular tissue health.…”

“…The sexual event diary has not been validated but has been previously reported. 26 , 28 Adverse events were collected at every visit.…”

Physical Modalities for the Treatment of Localized Provoked Vulvodynia: A Scoping Review of the Literature from 2010 to 2023

“…One randomized controlled trial (RCT) 20,21 and two case series 18,19 of patients undergoing fractional CO2 laser therapy for LPV reported positive outcomes.…”

“…Ninomiya and Sekiguchi 19 administered three treatments at one-month intervals to twenty premenopausal participants using fractional CO2 laser at "basic settings" that could be adjusted at the physician's discretion. The randomized trials reported by Goldstein et al 20,21 examined the effectiveness of CO2 fractional laser therapy (30W) among 70 LPV participants, followed by an open-label treatment of those in the control group. Participants were randomized 2:1 for active treatment and sham, respectively.…”

“…The RCT and both case series consistently demonstrated success in alleviating dyspareunia. Goldstein et al 20,21 reported improvements in subjective pain measures, FSFI pain scores, and O'Leary/Sant scores. Similarly, Murina et al 18 documented statistically significant improvements in dyspareunia and NRS vulvar pain scores, which decreased from 8.5 prior to treatment to 5.1 at an unspecified post-treatment time.…”