CO₂ laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial

Abstract

Purpose

This study aimed to clarify the efficacy of intravaginal CO₂-laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM).

Materials and methods

This double-blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO₂-laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline.

Results

Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] –5.6 [2.8], −6 [2.6], 12.3 [8.9], −2.9 [2.8], −2.3 [2.8], −0.9 [2.1], and −8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (–1.9 [2], −1.4 [1.9], and −1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all p < 0.005).

Conclusions

CO₂ laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments.

摘要

目的：本研究旨在阐明阴道内CO₂激光治疗绝经后妇女绝经期泌尿生殖系统综合征（GSM）的疗效。

材料和方法：这项双盲、随机、安慰剂对照试验纳入了诊断为GSM, 并伴随恼人症状——阴道干涩和性交困难的绝经后妇女。治疗包括三个疗程。采用10cm视觉模拟量表对CO₂激光治疗（治疗组）与假治疗组（对照组）进行比较, 主要终点为阴道干涩和性交困难程度的变化。次要终点如下：女性性功能指数（FSFI；总分和所有领域）、瘙痒、烧灼、排尿困难和泌尿生殖障碍量表（UDI-6）分值的变化；泌尿生殖道症状发生率；是否存在不良事件。所有结果均在研究伊始和治疗4个月后进行评估。

结果：58名妇女（28名为治疗组, 30名为假治疗组）符合入选条件。在实验组中, 阴道干涩、性交困难、FSFI（总分）、瘙痒、烧灼、排尿困难和UDI-6评分等均显著改善（平均值[标准差]–5.6[2.8]、-6[2.6]、-2.3[8.9]、-2.9[2.8]、-2.3[2.8]、-0.9[2.1]和-8.0[15.3]）。在对照组中, 阴道干燥、瘙痒和烧灼感明显改善（分别为-1.9[2]、-1.4[1.9]和-1[1.9]）治疗组中的改变均有利。方案完成后, 与对照组相比, 治疗组中出现阴道干燥、性交困难和性功能障碍的患者比例显著降低（均p<0.005）。

结论：CO₂激光治疗GSM优于对照手术治疗, 可作为一种有效的治疗方法。

Keywords:

• Vulvovaginal atrophy
• atrophy
• lower urinary tract symptoms
• menopause
• sexual function
• genitourinary syndrome of menopause

Potential conflict of interest

No potential conflict of interest was reported by the author(s).

Source of funding

Nil.