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

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

Inclusion Criteria:Recruited participants will meet all of these criteria:a history of breast cancerpremenopausal at diagnosis of breast cancerusing AI as an adjuvant treatmentmoderate 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 therapyUse of non-hormonal vaginal preparations within the last 6 weeks before inclusionUse of hormonal therapy within 6 months prior to inclusion (systemic or local)Acute urinary or genital tract infectionsA history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree lacerationProlapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification SystemPrevious vaginal mesh implantationAbnormal 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 probeAny condition that could interfere with study compliance