Rothenberger Rodger, Kopinga Elaine, Dell Jeffrey, Moore Robert D, Miklos John R, Karram Mickey
Department of OB/GYN & Women's Health, Division of Female Pelvic Medicine and Reconstructive Surgery, The University of Louisville Medical Center, 550 South Jackson Street, Louisville, Kentucky 40202, United States.
California Center for Female Pelvic Health and Sexual Wellness, 2121 East Coast Hwy, Suite #200, Corona Del Mar, CA, United States.
J Sex Med. 2025 Jan 3;22(1):51-56. doi: 10.1093/jsxmed/qdae133.
Genitourinary syndrome of menopause (GSM) is a prevalent condition with a constellation of symptoms including burning, dryness, dyspareunia, and irritative lower urinary tract symptoms that result from vulvovaginal atrophic changes. Though hormonal therapy is a mainstay of treatment in GSM, some patients may pursue nonhormonal therapies.
To determine the efficacy of radiofrequency ablation of the vaginal canal with the MorpheusV applicator in reducing the symptoms of GSM.
We conducted a multicenter prospective case series of women with GSM as confirmed by Vaginal Health Index Score (VHIS). Subjects received 3 treatments of radiofrequency ablation ~4 weeks apart with follow-up to 6-month posttreatment.
The primary endpoint was VHIS at 6-month posttreatment. Secondary endpoints were VHIS at 3 months, Visual analog scale (VAS) pain with each treatment, 3- and 6-month measurements of urogenital distress inventory-6 (UDI-6), and female sexual function index (FSFI) questionnaires.
From 2021 to 2023, 71 women were enrolled in the study with 51 followed to the 6-month follow-up time point. Treatments were found to be low in VAS pain score with mean values of 2.13 ± 2.1, 2.55 ± 2.38, and 2.18 ± 2.14 at treatments 1, 2, and 3 respectively. An improvement in VHIS score was seen from baseline to 3 months after the last treatment (15.00 ± 5.37 vs. 19.62 ± 4.44) and sustained at 6 months (20.23 ± 4.12) (P < .001). Significant improvements in both UDI-6 and FSFI were also noted. Between baseline and 6 months after treatment (FSFI: 18.81 ± 9.57 vs. 22.81 ± 10.34, P < 0.001; UDI-6: 39.58 ± 15.98 vs. 22.42 ± 14.03, P < 0.001). No adverse events were encountered by any subject during this study.
A therapy that is safe and effective in the treatment of both GSM and lower urinary tract symptoms without the use of hormonal methods is clinically impactful for the many patients who cannot receive or do not desire to receive these medications.
Strengths of this study include the utilization of 3 treatment sessions, with follow-up of subjects to 6-month posttreatment with a comprehensive assessment of patient symptoms. Limitations include the unblinded nature of the study and the lack of a comparator group.
The data from this study suggests that radiofrequency ablation of the vaginal canal by the MorpheusV applicator is a safe and effective intervention for GSM. It also shows subjective improvements in stress urinary incontinence, urge urinary incontinence, and sexual function.
更年期泌尿生殖综合征（GSM）是一种常见病症，具有一系列症状，包括灼烧感、干燥、性交困难以及由外阴阴道萎缩性变化引起的刺激性下尿路症状。尽管激素疗法是GSM治疗的主要手段，但一些患者可能会选择非激素疗法。
确定使用MorpheusV治疗仪对阴道管进行射频消融在减轻GSM症状方面的疗效。
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。受试者接受3次射频消融治疗，每次治疗间隔约4周，并在治疗后随访6个月。
主要终点是治疗后6个月的VHIS。次要终点包括治疗后3个月的VHIS、每次治疗时的视觉模拟量表（VAS）疼痛评分、治疗后3个月和6个月的泌尿生殖系统困扰量表-6（UDI-6）测量值以及女性性功能指数（FSFI）问卷。
从2021年到2023年，71名女性参与了该研究，其中51名随访至6个月的时间点。发现治疗的VAS疼痛评分较低，第1、2和3次治疗时的平均值分别为2.13±2.1、2.55±2.38和2.18±2.14。从基线到最后一次治疗后3个月，VHIS评分有所改善（15.00±5.37对19.62±4.44），并在6个月时保持（20.23±4.12）（P＜0.001）。UDI-6和FSFI也有显著改善。治疗后基线和6个月之间（FSFI：18.81±9.57对22.81±10.34，P＜0.001；UDI-6：39.58±15.98对22.42±14.03，P＜0.001）。在本研究期间，没有任何受试者遇到不良事件。
一种在不使用激素方法的情况下对GSM和下尿路症状均安全有效的治疗方法，对许多无法接受或不希望接受这些药物的患者具有临床意义。
本研究的优点包括采用3个治疗疗程，对受试者进行治疗后6个月的随访，并对患者症状进行全面评估。局限性包括研究的非盲法性质以及缺乏对照组。
本研究数据表明，使用MorpheusV治疗仪对阴道管进行射频消融是一种治疗GSM的安全有效干预措施。它还显示出压力性尿失禁、急迫性尿失禁和性功能方面的主观改善。
