Fait Tomas, Baltazár Tivadar, Bubenickova Leona, Kestranek Jan, Stepan Martin, Muller Miroslav, Turcan Pavel
Department of Obsterics and Gynaecology, 2nd Faculty of Medicine, Charles University, 150 00 Prague, Czech Republic.
Department of Health Care Studies, College of Polytechnics Jihlava, 586 01 Jihlava, Czech Republic.
J Clin Med. 2023 Sep 27;12(19):6234. doi: 10.3390/jcm12196234.
Vaginal laxity is a widespread and undertreated medical condition associated especially with vaginal parity.
To evaluate the efficacy and safety of electroporation therapy treatment of vulvovaginal laxity by the Jett Plasma for Her II device.
The Jett Plasma for Her II Study is a multicentric, prospective, randomized, single-blinded, and controlled study. Women presenting with vaginal laxity were randomized to receive electroporation therapy delivered to the vaginal tissue (active-82 patients) vs. therapy with zero intensity (placebo-9 patients).
A total of 91 subjects whose average age was 48.69 ± 10.89 were included. Due to the results of a one-way analysis of variance, it may be concluded that in the case of the vaginal laxity questionnaire (VLQ), there is a statistically significant difference between actively treated patients and the placebo group (F = 46.91; < 0.001). In the case of the female sexual function index (FSFI), a one-way ANOVA test also showed a statistically significant difference between the actively treated patients and the placebo group (F = 7.97; = 0.005). In the case of the incontinence impact questionnaire-7 (IIQ-7), a one-way ANOVA test showed a statistically significant difference between the actively treated patients and the placebo group (F = 15.51; < 0.001). It confirms that improvement of vaginal laxity is conjoined with benefits in symptoms of urinary incontinence. Biopsy performed after the end of the treatment shows an increase in the vaginal mucosa thickness by an average of 100.04% in the active group. The treatment was well tolerated with no adverse events. No topical anesthetics were required.
Treatments of vulvovaginal laxity by electroporation therapy achieved significant and sustainable 12-month effectiveness. Responses to the questionnaires also suggest subjective improvement in self-reported sexual function, incontinence, sexual satisfaction, and urogenital distress.
阴道松弛是一种普遍存在且治疗不足的医学状况，尤其与经阴道分娩有关。
评估Jett Plasma for Her II设备的电穿孔疗法治疗外阴阴道松弛的疗效和安全性。
Jett Plasma for Her II研究是一项多中心、前瞻性、随机、单盲和对照研究。出现阴道松弛的女性被随机分配接受阴道组织电穿孔治疗（82例）与零强度治疗（9例安慰剂）。
共纳入91名平均年龄为48.69±10.89岁的受试者。根据单因素方差分析结果，可以得出结论，在阴道松弛问卷（VLQ）方面，积极治疗的患者与安慰剂组之间存在统计学显著差异（F = 46.91；P < 0.001）。在女性性功能指数（FSFI）方面，单因素方差分析也显示积极治疗的患者与安慰剂组之间存在统计学显著差异（F = 7.97；P = 0.005）。在尿失禁影响问卷-7（IIQ-7）方面，单因素方差分析显示积极治疗的患者与安慰剂组之间存在统计学显著差异（F = 15.51；P < 0.001）。这证实了阴道松弛的改善与尿失禁症状的改善相关。治疗结束后进行的活检显示，积极治疗组的阴道黏膜厚度平均增加了100.04%。该治疗耐受性良好，无不良事件。无需局部麻醉。
电穿孔疗法治疗外阴阴道松弛在12个月内取得了显著且持续的效果。问卷回复也表明，自我报告的性功能、尿失禁、性满意度和泌尿生殖系统困扰在主观上有所改善。
