Pilot study of radiofrequency thermal therapy performed twice on the entire vaginal wall for vaginal laxity.

OBJECTIVE Radiofrequency thermal (RFT) therapy is commonly performed to treat vaginal laxity (VL), but the optimal technique of RFT therapy is unclear. We aimed to evaluate the efficacy and safety of RFT therapy performed twice on the whole vaginal wall in women with VL. METHODS This was a single-arm, open-label clinical trial conducted in a tertiary hospital in the Republic of Korea from July 2018 to January 2019. Non-pregnant, adult women with VL, defined as a score ≤3 on a vaginal laxity questionnaire (VLQ), were recruited. RFT therapy consisted of 2 office procedures performed 3 weeks apart. Starting from the upper vaginal wall at the 12 o'clock position, the whole vaginal wall was slowly rubbed with a heated vaginal probe for 20 minutes. After the 2nd RFT therapy session, patients had follow-up visits at 4 and 12 weeks, and changes in the VLQ score, Female Sexual Function Index (FSFI) score, Female Sexual Distress Scale (FSDS) score, and vaginal pressure at rest and during the Valsalva maneuver and treatment-emergent adverse events (TEAEs) were examined. RESULTS Thirty subjects were enrolled, but 28 were evaluated for efficacy measurements. RFT therapy improved the VLQ score (means at baseline, 4 weeks, and 12 weeks were 2.5, 4.9, and 4.8, respectively; p < 0.0001), FSFI score (means at baseline, 4 weeks, and 12 weeks were 21.9, 27.0, and 27.2, respectively; p < 0.0001), and FSDS score (means at baseline, 4 weeks, and 12 weeks were 33.8, 21.1, and 18.6, respectively; p < 0.0001); however, vaginal pressure did not increase. The effect of RFT therapy peaked at the 4-week follow-up and plateaued at week 12. No TEAE was observed, except transient grade 1 vaginal pain. CONCLUSION RFT therapy performed twice on the whole vaginal wall showed promising efficacy and safety profiles and has merit for further investigation.