Pather Kaveshan, Dilgir Sapna, Rane Ajay
Department of Obstetrics and Gynecology, Townsville University Hospital, Douglas, Queensland, Australia.
Department of Obstetrics and Gynecology, Townsville University Hospital, Douglas, Queensland, Australia; Department of Obstetrics and Gynecology, Mater Private Hospital Townsville, Pimlico, Queensland, Australia.
Sex Med. 2021 Dec;9(6):100427. doi: 10.1016/j.esxm.2021.100427. Epub 2021 Oct 23.
Vaginal laxity or the sensation of vaginal looseness affects anywhere from 24% to 50% of postpartum women.
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.
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.
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.
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;9:100427.
阴道松弛或阴道松弛感影响着24%至50%的产后女性。
评估ThermiVa（美国德克萨斯州ThermiAesthetics公司）单极射频设备治疗外阴阴道松弛和性功能障碍的有效性和安全性。
TIGHT研究是一项在澳大利亚和印度的3个地点进行的前瞻性单盲随机假对照试验。该研究纳入了18岁以上主诉阴道松弛的经产妇。参与者被随机分为治疗组和假手术组。治疗组患者使用有源探头进行治疗，而安慰剂组的女性使用仅达到亚治疗温度的假探头进行治疗。
主观成功率通过女性性功能指数（FSFI）、阴道松弛问卷（VLQ）、阴道排气评分（VFS）和阴道松弛困扰评分（VLBS）的改善来确定。客观成功率通过改良牛津评分（MOS）和生殖裂孔（GH）长度来衡量。
招募了63名参与者（假手术组n = 29，治疗组n = 34）。在治疗组中，FSFI评分在3个月时改善（平均差异8分，P值0.02），在6个月时改善（平均差异5分，P值0.07）。在基线时，假手术组和治疗组分别有89.7%和87.2%的患者在VLQ上将自己归类为“松弛”。在6个月时，假手术组73.1%的患者仍认为自己“松弛”，而治疗组为32.4%（P值0.01）。VLBS也显示主观成功率（P值0.02）。与VFS、MOS和GH相关的结果未显示出统计学显著差异。
ThermiVa治疗与阴道松弛和性功能障碍的适度主观改善相关，并且在6个月的试验期内被证明是安全的。帕瑟·K、迪尔吉尔·S、拉内·A。ThermiVa治疗生殖裂孔（TIGHT）研究。性医学2021；9：100427。
