Microablative and non-ablative laser and radiofrequency treatment of genitourinary syndrome of menopause: A randomised controlled trial with four different energies.
Helena Slongo, Dulce C P Henriques, Alexandra P N Ongaratto, Helymar C Machado, Renata M Triglia, Cássia R T Juliato
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引用次数: 0
Abstract
Objective: This study compared the effects of four different types of energy treatments on women with genitourinary syndrome of menopause.
Material and methods: Four-arm single-blind randomised clinical trial, with 48 postmenopausal women with genitourinary syndrome of menopause. Participants were randomised into four groups: Group 1 received sessions of non-ablative Er:YAG laser; Group 2 received sessions of microablative CO2 laser; Group 3 underwent sessions of non-ablative radiofrequency; and Group 4 received sessions of fractional microablative radiofrequency. The primary outcome was the assessment of symptoms of genitourinary syndrome of menopause correlated with vaginal histological analysis at baseline and 1 month after the end of treatment. Secondary outcomes included sexual function and urinary symptoms, treatment satisfaction and major adverse events.
Results: All treatment modalities demonstrated significant improvement in dryness (p < 0.001) and dyspareunia (p < 0.001) measured by visual analogue scales and in vaginal symptoms assessed with the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (p < 0.001), with no significant differences between groups. All treatment energies resulted in significant increases in tissue thickness (p < 0.001), layer number (p < 0.001), and collagen quantity and depth (p < 0.001), with no significant difference among the groups.
Conclusions: Both microablative and non-ablative energies, whether utilizing laser or radiofrequency, are effective treatments for the symptoms of genitourinary syndrome of menopause, with histological correlations observed and no notable differences in efficacy between modalities.
Clinical trial registration: Registered in REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials). Trial registration number RBR-5vw3vpg. The protocol can be accessed at https://ensaiosclinicos.gov.br/rg/RBR-5vw3vpg.
目的:比较四种能量疗法对绝经期泌尿生殖系统综合征的治疗效果。材料和方法:四臂单盲随机临床试验,48例绝经后泌尿生殖系统综合征妇女。参与者被随机分为四组:第一组接受非烧蚀Er:YAG激光治疗;第二组接受CO2微烧蚀激光治疗;第三组接受非消融射频治疗;第4组接受分次射频微消融治疗。主要结局是评估绝经期泌尿生殖系统综合征的症状与基线和治疗结束后1个月阴道组织学分析的相关性。次要结局包括性功能和泌尿系统症状、治疗满意度和主要不良事件。结论:微烧蚀和非烧蚀能量,无论是激光还是射频,都是治疗绝经期泌尿生殖系统综合征的有效方法,观察到组织学上的相关性,两种治疗方式的疗效无显著差异。临床试验注册:在REBEC (Registro Brasileiro de Ensaios Clínicos;巴西临床试验注册中心)注册。试验注册号RBR-5vw3vpg。该协议可通过https://ensaiosclinicos.gov.br/rg/RBR-5vw3vpg访问。