Rothenberger Rodger W, Kopinga Elaine, Dell Jeffrey, Moore Robert D, Miklos John R, Karram Mickey
Division of Female Pelvic Medicine and Reconstructive Surgery, University of Louisville Medical Center, Louisville, KY.
California Center for Female Pelvic Health and Sexual Wellness, Corona Del Mar, CA.
Menopause. 2025 Jul 22. doi: 10.1097/GME.0000000000002564.
To determine the 12-month efficacy of radiofrequency ablation of the vaginal canal in reducing the symptoms of genitourinary syndrome of menopause (GSM).
We conducted a multicenter prospective case series of women with GSM as confirmed by Vaginal Health Index Score (VHIS). Participants received three treatments of radiofrequency ablation ~4 weeks apart with follow-up to 12 months posttreatment. The primary endpoint was VHIS at 6 months post-treatment. Secondary endpoints included visual analog scale (VAS) pain score with procedures; provider ease of use; VHIS at 3 and 12 months; Urogenital Distress Inventory-6 (UDI-6); Female Sexual Function Index (FSFI); 12-Item Short Form Health Survey (SF-12); Patient Global Impression of Improvement (PGI-I) scale; and VAS scores associated with overall genitourinary pain, vaginal burning, dysuria, dyspareunia, and pruritis at 3, 6, and 12 months were also collected.
From 2021 to 2024, 25 participants were enrolled, with 21-23 participants included in the various analyses due to missing data. Treatments were found to be high in ease of use and low in VAS pain score. An improvement in VHIS score was seen from baseline to 3 months after the last treatment (11.7±1.7 vs. 17.4±3.5, P<0.001) with continued significant positive association between treatment and improvement with respect to baseline at 6 and 12 months (18.0±3.3, P<0.001 and 18.8±3.1, P<0.001). Significant positive associations between treatment and improvement in UDI-6 to 12 months post-treatment and in FSFI to 6 months post-treatment were seen. FSFI returned to baseline by 12 months. No adverse events were encountered by any participant during this study.
This study suggests that radiofrequency ablation of the vaginal canal by the MorpheusV applicator is a safe and effective intervention for GSM to 12 months post-treatment.
确定阴道射频消融术在减轻绝经后泌尿生殖综合征（GSM）症状方面的12个月疗效。
我们对经阴道健康指数评分（VHIS）确诊为GSM的女性进行了一项多中心前瞻性病例系列研究。参与者接受了三次射频消融治疗，每次治疗间隔约4周，并在治疗后随访12个月。主要终点是治疗后6个月的VHIS。次要终点包括手术时的视觉模拟量表（VAS）疼痛评分；医生操作的难易程度；治疗后3个月和12个月的VHIS；泌尿生殖系统困扰量表-6（UDI-6）；女性性功能指数（FSFI）；12项简短健康调查问卷（SF-12）；患者总体改善印象（PGI-I）量表；还收集了治疗后3个月、6个月和12个月时与总体泌尿生殖系统疼痛、阴道烧灼感、排尿困难、性交困难和瘙痒相关的VAS评分。
2021年至2024年期间，共纳入25名参与者，由于数据缺失，各分析中纳入21至23名参与者。结果发现治疗操作简便，VAS疼痛评分低。从基线到最后一次治疗后3个月，VHIS评分有所改善（11.7±1.7对17.4±3.5，P<0.001），在治疗后6个月和12个月时，治疗与相对于基线的改善之间仍存在显著的正相关（18.0±3.3，P<0.001和18.8±3.1，P<0.001）。在治疗后至12个月的UDI-6以及治疗后至6个月的FSFI方面，治疗与改善之间存在显著的正相关。FSFI在12个月时恢复到基线水平。在本研究中，没有任何参与者出现不良事件。
本研究表明，使用MorpheusV设备进行阴道射频消融术是一种治疗GSM至治疗后12个月的安全有效的干预措施。
