{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T16:40:06Z","timestamp":1774629606374,"version":"3.50.1"},"reference-count":59,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2023,2,13]],"date-time":"2023-02-13T00:00:00Z","timestamp":1676246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,5,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Data are limited regarding fractional CO2 laser as a nonhormonal treatment for vestibular pain.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Aim<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Subjects (n\u2009=\u200970) 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\u00a0weeks apart. At the initial follow-up (week 12), subjects were unblinded and those initially assigned to sham started active treatment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Outcomes<\/jats:title>\n                  <jats:p>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\u2013Revised (FSDS-R), and the O\u2019Leary-Sant voiding and pain indices, the Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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 \u22120.64 [95% CI, \u22120.79 to \u22120.50] and\u2009\u22121.31 [95% CI, \u22121.46 to \u22121.16], 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 \u22125.84 [95% CI, \u22128.80 to \u22122.87] and\u2009\u22129.15 [95% CI, \u221212.11 to \u22126.18], respectively). ICSI scores decreased significantly at weeks 12 and 16 (mean change from baseline \u22120.91 [95% CI, \u22121.65 to \u22120.18] and\u2009\u22120.754 [95% CI, \u22121.49 to \u22120.02], respectively). ICPI scores decreased significantly at week 16 (mean change from baseline \u22120.99 [95% CI, \u22121.63 to \u22120.34]). In contrast, there were no significant changes in outcomes in the sham arm. No serious adverse events occurred.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Implications<\/jats:title>\n                  <jats:p>Fractional CO2 laser treatment in women with vestibular pain resulted in improvement from baseline in multiple key outcome measures of vestibular health.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Strengths and Limitations<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Fractional CO2 laser therapy is a safe and effective nonhormonal treatment for vestibular pain.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jsxmed\/qdac053","type":"journal-article","created":{"date-parts":[[2023,2,13]],"date-time":"2023-02-13T12:32:40Z","timestamp":1676291560000},"page":"800-812","source":"Crossref","is-referenced-by-count":8,"title":["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"],"prefix":"10.1093","volume":"20","author":[{"given":"Sue W","family":"Goldstein","sequence":"first","affiliation":[{"name":"San Diego Sexual Medicine , San Diego, CA United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irwin","family":"Goldstein","sequence":"additional","affiliation":[{"name":"San Diego Sexual Medicine , San Diego, CA United States"},{"name":"Sexual Medicine, Alvarado Hospital , San Diego, CA United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noel N","family":"Kim","sequence":"additional","affiliation":[{"name":"Institute for Sexual Medicine , San Diego, CA United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"Kellogg-Spadt","sequence":"additional","affiliation":[{"name":"Center for Pelvic Pain , Bryn Mawr, PA United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Filippo","family":"Murina","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Vittore Buzzi Children\u2019s Hospital , Milan , Italy"},{"name":"Universit\u00e0 degli Studi , Milan , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2023,2,13]]},"reference":[{"issue":"4","key":"2023053111504493800_ref1","doi-asserted-by":"crossref","first-page":"572","DOI":"10.1016\/j.jsxm.2016.01.020","article-title":"Vulvodynia: assessment and treatment","volume":"13","author":"Goldstein","year":"2016","journal-title":"J Sex Med"},{"issue":"1","key":"2023053111504493800_ref2","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1111\/j.1743-6109.2007.00679.x","article-title":"Vulvodynia","volume":"5","author":"Goldstein","year":"2008","journal-title":"J Sex Med"},{"issue":"4","key":"2023053111504493800_ref3","doi-asserted-by":"crossref","first-page":"549","DOI":"10.1016\/j.sxmr.2019.08.001","article-title":"The sexual pain lesson: if at first you don't succeed\u2026","volume":"7","author":"Goldstein","year":"2019","journal-title":"Sex Med 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