The ThermiVa In Genital Hiatus Treatment (TIGHT) Study.

Introduction Vaginal laxity or the sensation of vaginal looseness affects anywhere from 24% to 50% of postpartum women. Aim To evaluate the efficacy and safety of the ThermiVa (ThermiAesthetics, TX, USA) monopolar radiofrequency device in the treatment of vulvovaginal laxity and sexual dysfunction METHODS: The TIGHT study was a prospective single blinded randomized sham-control trial conducted over 3 sites in Australia and India. The study included parous woman over the age of 18 who complained of vaginal laxity/looseness. Participants were randomized into a treatment group and a sham group. Patients in the treatment group were treated with an active probe, whereas, women in the placebo group were treated with sham probes that only reached subtherapeutic temperatures. Main outcome measures Subjective success was determined by improvement in the Female Sexual Function Index (FSFI), Vaginal Laxity Questionnaire (VLQ), Vaginal Flatus Score (VFS), and the Vaginal laxity Bother Score (VLBS). Objective success was measured via the Modified Oxford Score (MOS) and Genital Hiatus (GH) length. Results Sixty-three participants were recruited (sham n = 29, treatment n = 34). In the treatment group, FSFI scores improved at 3 months (mean difference 8-points, P value .02), and at 6 months (mean difference 5-points, P value .07). At baseline 89.7% and 87.2% of patients in the sham and treatment groups, respectively, classified themselves as "loose" on the VLQ. At 6 months 73.1% of patients in the sham group still identified as "loose" compared to 32.4% of patients in the active group (P value .01). Subjective success was also noted in the VLBS (P value .02). Results pertaining to VLFS, MOS, and GH did not reveal statistically significant results. Conclusion Treatment with ThermiVa was associated with a modest subjective improvement in vaginal laxity and sexual dysfunction and proved to be safe over the 6-month trial period. Pather K, Dilgir S, Rane A. The ThermiVa In Genital Hiatus Treatment (TIGHT) Study. Sex Med 2021;XX:XXXXXX.