Menopause (New York, N.Y.) · 2025
Use of radiofrequency ablation of the vaginal canal for genitourinary syndrome of menopause: a prospective cohort study with 12-month follow-up.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Rothenberger Rodger W, Kopinga Elaine, Dell Jeffrey, Moore Robert D, Miklos John R, Karram Mickey
Аннотация
OBJECTIVES: To determine the 12-month efficacy of radiofrequency ablation of the vaginal canal in reducing the symptoms of genitourinary syndrome of menopause (GSM).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.