ArticleTrials2026
Treatment of genitourinary syndrome of menopause with fractional CO₂ laser versus fractional microablative radiofrequency: study protocol for a double-blind, randomised, non-inferiority trial.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGenitourinary syndrome of menopause (GSM) affects a significant proportion of postmenopausal women, leading to symptoms such as vaginal dryness, irritation, dyspareunia, and urinary symptoms. Hormonal therapies are not suitable for all patients, particularly those with contraindications to hormone use. This study aims to compare the efficacy and safety of two non-hormonal therapies-fractional CO₂ laser (CO₂ laser) and fractional microablative radiofrequency (MAFRF)-for the treatment of GSM.
methodsThis protocol describes a randomised, double-blind, non-inferiority clinical trial that will enrol 40 postmenopausal women diagnosed with GSM. Participants will be randomised to receive either fractional CO₂ laser or fractional microablative radiofrequency in three monthly sessions. The primary outcome will be the Vaginal Health Index Score (VHIS), assessed 30 days after the last treatment session (day 90). Secondary outcomes include sexual function, GSM symptom severity, and urinary symptoms. Follow-up assessments will be conducted at 120 and 300 days after the last session (days 180 and 365, respectively). Histological analysis of vaginal biopsies will be performed in a predefined subsample of participants as an exploratory analysis. DISCUSSION: This study is expected to contribute to the comparative understanding of the efficacy and safety of CO₂ laser and MAFRF as non-hormonal therapeutic options for the treatment of GSM, potentially supporting clinical decision-making for women who are not candidates for hormonal therapy.
trial registrationBrazilian Clinical Trials Registry (ReBEC): RBR-2hgwvgy. The trial was registered retrospectively due to administrative delays in the registration process. However, no outcome data were accessed, analysed, or used to inform any decisions prior to registration, and no interim analyses were performed. Additionally, no modifications were made to the study design, outcomes, or planned analyses after the initiation of data collection. Registered on July 2, 2023.
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