Rationale and design for fractional microablative CO₂ laser versus photothermal non-ablative erbium:YAG laser for the management of genitourinary syndrome of menopause: a non-inferiority, single-blind randomized controlled trial

Abstract

Genitourinary syndrome of menopause (GSM) is a common condition affecting up to 50% of postmenopausal women and up to 70% of postmenopausal breast cancer survivors. GSM is a chronic condition with a significant impact on sexual health and quality of life. The mainstay of treatment has been with symptomatic relief using topical emollients or lubricants. Second-line treatment is with topical vaginal estrogens to restore the physiology of the vaginal epithelium. For some, the latter is not suitable or acceptable. Newer treatments with ospemifene and vaginal lasers have now been introduced. The two main types of laser currently used for the treatment of GSM are the fractional microablative CO₂ laser and the non-ablative photothermal erbium:YAG laser.

We present a study protocol for a multicenter, prospective, non-inferiority, single-blinded, randomized controlled trial comparing the fractional microablative CO₂ laser versus the photothermal non-ablative erbium:YAG laser for the management of GSM.

We will recruit 88 postmenopausal women across two sites who will be randomized to one of the two laser groups. Participants will all have GSM symptoms and a Vaginal Health Index Score < 15. All participants will receive an active treatment. Each participant will receive three applications of vaginal laser 1 month apart and will be followed up at 1 month, 6 months, and 12 months. Our primary outcomes will look at all changes of GSM symptoms (dryness, dyspareunia, itching, burning, dysuria, frequency, urgency), urinary incontinence (if present), and overall sexual satisfaction. Both subjective and objective means will be used to assess participants.

The findings of this trial have the potential to allow clinicians and women suffering from GSM to make an informed decision when opting for a specific laser type. The trial will add to the current growing body of evidence for the safe use of vaginal lasers in GSM as an alternative treatment. We hope this trial will provide robust and long-term data for the safe use of both lasers.

Trial registration: ClinicalTrials.gov identifier: NCT03288883.

摘要

更年期泌尿生殖系统综合征(GSM)是一个常见的情况, 影响了高达50%的绝经后妇女和高达70%的绝经后乳腺癌的幸存者。GSM是一种慢性疾病, 对性健康和生活质量有明显的影响。治疗的主要方法是用局部润肤剂或润滑剂来缓解症状。二线治疗是用局部用阴道雌激素来恢复阴道上皮细胞的生理功能。对于某些人来说, 第二种方法是不合适的或不能接受的。用奥培米芬和阴道激光治疗的新方法现在已经被引进。目前用于GSM处理的激光主要有两种类型:点阵CO₂激光和非剥脱性铒激光。

我们设计了一项多中心、前瞻性、非劣效、单盲、随机对照试验的研究方案, 对点阵CO₂激光和非剥脱性铒激光用于GSM的治疗进行比较。

我们将在两个地点招募88名绝经后妇女, 她们将被随机分到两个激光组之一。参与者都有GSM症状, 阴道健康指数得分< 15。所有参与者将接受积极治疗。每位参与者将接受阴道激光治疗, 一个月一次, 共3次, 并分别在1个月、6个月和12个月接受随访。我们的主要结果将着眼于GSM症状的所有变化(干涩、性交困难、瘙痒、灼烧、排尿困难、尿频、尿急)、尿失禁(如果存在)和总体性满意度。将采用主观和客观两种方法对参与者进行评估。

这项试验的结果有可能使临床医生和患有GSM的妇女当选择一种特定的激光类型时, 做出明智的决定。这次试验进一步增加了阴道激光治疗GSM是安全的证据, 并可以作为治疗GSM的方法之一。我们希望这项试验能为两种激光的安全使用提供可靠和长期的数据。

Keywords:

• Laser
• genitourinary syndrome of menopause
• vulvovaginal atrophy
• erbium:YAG laser
• CO₂ laser

Conflict of interest

The authors report no conflict of interest.

Source of funding

Nil.