Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors

Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of Genitourinary Syndrome of Menopause (GSM) in Patients Using Aromatase Inhibitors: Double Blinded Randomized Controlled Clinical Trial.

To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer

The objective is to compare microablative fractional CO2 laser (CO2 laser) (SmartXide2 V2 LR, Monalisa Touch; DEKA, Florence, Italy) and non-ablative photothermal Erbium:YAG laser (Er:YAG laser) (Fotona Smooth™ XS; Fotona, Ljubljana, Slovenia) - with sham vaginal applications for treatment of vaginal dryness as the leading symptom in breast cancer patients with iatrogenic menopause and treated with an AI.

Inclusion Criteria:

Recruited participants will meet all of these criteria:

• a history of breast cancer
• premenopausal at diagnosis of breast cancer
• using AI as an adjuvant treatment
• moderate to severe symptoms of GSM (VAS ≥ 4/10)
• currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)

Exclusion Criteria:

• Not willing to abstain from vaginal intercourse for 1 week following laser therapy
• Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion
• Use of hormonal therapy within 6 months prior to inclusion (systemic or local)
• Acute urinary or genital tract infections
• A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration
• Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System
• Previous vaginal mesh implantation
• Abnormal result in the last cervical smear (maximum 36 month before enrollment)
• Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser)
• Vaginal stenosis that does not allow the placement of the laser probe
• Any condition that could interfere with study compliance