Long-term clinical and histological safety and efficacy of the CO2 laser for treatment of genitourinary syndrome of menopause: an original study.

IF 2.9 4区 医学 Q1 OBSTETRICS & GYNECOLOGY Climacteric Pub Date : 2023-12-01 Epub Date: 2023-08-31 DOI:10.1080/13697137.2023.2246886
A Casiraghi, A Calligaro, N Zerbinati, M Doglioli, A F Ruffolo, M Candiani, S Salvatore
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Abstract

Objective: This study aimed to evaluate histological modifications of the vaginal mucosa after repeated microablative fractional CO2 laser treatments. As secondary objectives we evaluated the clinical effects associated with repeated microablative fractional CO2 laser treatments using validated questionnaires.

Methods: A prospective intervention study was performed in the Division of Gynecology and Obstetrics, Urogynecology Unit, IRCCS San Raffaele Scientific Institute with 15 postmenopausal women complaining of genitourinary syndrome of menopause symptoms. The cohort of patients was submitted to at least two previous laser treatment cycles in the past years. The Vaginal Health Index (VHI), visual analog scale (VAS), Female Sexual Function Index (FSFI), Urinary Distress Inventory-6 (UDI-6), International Consultation on Incontinence Questionnaire - Urinary Incontinence (ICIQ-UI) and 5-point Likert scale were used. Moreover, histological examinations were carried out on all samples.

Results: At 4 weeks after the last treatment, the VHI score and all FSFI items were significantly increased compared with baseline. We observed a statistically significant decrease in both frequency and severity for all urinary symptoms after the follow-up. We observed a statistically significant increase in the number of epithelial cell layers with a consequent increase in epithelial thickness, in the number of glycogen-filled cells and in the number of papillae after the laser treatment. No signs of fibrosis were observed as neovascularization was observed in each woman.

Conclusions: This is the first study demonstrating the histological persistency of efficacy in repeated annually laser treatment cycles, with tissue changes always leading to regenerative results without any sign of fibrosis.

Clinical trial registration: ClinicalTrials.gov ID: NCT04868812 (release date: 27 April 2021).

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CO2激光治疗绝经期泌尿生殖系统综合征的长期临床和组织学安全性和有效性:一项原始研究。
目的:探讨经多次CO2激光微消融治疗后阴道黏膜的组织学改变。作为次要目的,我们使用有效的问卷来评估重复微烧蚀分数CO2激光治疗的临床效果。方法:在圣拉斐尔科学研究所泌尿妇科妇科妇科进行前瞻性干预研究,纳入15名绝经后妇女,主诉绝经症状为泌尿生殖系统综合征。该队列患者在过去几年中至少接受过两次激光治疗周期。采用阴道健康指数(VHI)、视觉模拟量表(VAS)、女性性功能指数(FSFI)、尿窘迫量表-6 (UDI-6)、国际尿失禁咨询问卷-尿失禁(ICIQ-UI)和李克特5点量表。此外,对所有样本进行组织学检查。结果:末次治疗后4周,VHI评分和FSFI各项指标均较基线显著升高。我们观察到,随访后,所有泌尿系统症状的发生频率和严重程度均有统计学上的显著下降。我们观察到,在激光治疗后,上皮细胞层数、上皮厚度、糖原填充细胞数量和乳头数量均有统计学意义的增加。在每个妇女中都观察到新生血管,没有观察到纤维化的迹象。结论:这是第一个证明在每年重复的激光治疗周期中疗效的组织学持久性的研究,组织变化总是导致再生结果,没有任何纤维化迹象。临床试验注册:ClinicalTrials.gov ID: NCT04868812(发布日期:2021年4月27日)。
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来源期刊
Climacteric
Climacteric 医学-妇产科学
CiteScore
1.70
自引率
7.10%
发文量
53
审稿时长
1 months
期刊介绍: Climacteric is the official journal of the International Menopause Society (IMS). As an international peer-reviewed journal it publishes original research and reviews of all aspects of aging in women. Climacteric was founded by the IMS in 1998 and today has become a leading journal in the publication of peer-reviewed papers on the menopause, climacteric and mid-life health. Topics covered include endocrine changes, symptoms attributed to the menopause and their treatment, hormone replacement and alternative therapies, lifestyles, and the counselling and education of peri- and postmenopausal women. Climacteric, published bimonthly, also features regular invited reviews, editorials and commentaries on recent developments. The editorial review board of Climacteric includes leading scientific and clinical experts in the field of midlife medicine and research and is headed by its Editor-in-Chief, Professor Rod Baber of Australia. He and his team of Associate Editors act independently to set a clear editorial policy, co-ordinate peer review, and ensure a rapid response to submitted papers.
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