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Background <p>Genitourinary 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.</p> Methods <p>This 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&#xa0;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&#xa0;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.</p> Discussion <p>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.</p> Trial registration <p>Brazilian 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.</p>

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Treatment of genitourinary syndrome of menopause with fractional CO₂ laser versus fractional microablative radiofrequency: study protocol for a double-blind, randomised, non-inferiority trial

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  • 发表日期：

    2026年7月3日

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  • Cássia Caroline Garcia Dalbem Teles,
  • Catarina Maria Mesquita Garcia Dalbem,
  • Matheus Rodrigues de Souza,
  • Nivaldo Antonio Parizotto

摘要

Background

Genitourinary 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.

Methods

This 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 registration

Brazilian 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.