Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors (LASI)
Genitourinary Syndrome of Menopause
About this trial
This is an interventional treatment trial for Genitourinary Syndrome of Menopause focused on measuring genitourinary syndrome of menopause, intravaginal laser, breast cancer, aromatase inhibitor
Eligibility Criteria
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
Sites / Locations
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Sham Comparator
Mona Lisa Touch CO2 laser
Fotona Smooth erbium:YAG laser
sham treatment
Power: 30 W. Dwell time: 1000 μs. Spacing: 1000 μm. Depth: SmartStack parameter from 1 to 3 depending on the treatment status. D-pulse mode. At the introitus the power will be reduced to 24 W
Phase I (vaginal) Renovalase™ mode with (a) fluence of 5,5J/cm2, (b) SMOOTHTM mode frequency 1.6 Hz, and (c) spot size 7 mm. Phase II (vestibulum and introitus) Renovalase™ mode with (a) fluence 10 J/cm2, (b) SMOOTHTM mode frequency 1.6Hz, and (c) spot size 7 mm.
The blocking device is inserted over the laser outlet before attaching the application speculum. With this device the laser beam is blocked entirely. Phase I (vaginal) Renovalase™ mode with (a) fluence of 5,5J/cm2, (b) SMOOTHTM mode frequency 1.6 Hz, and (c) spot size 7 mm. Phase II (vestibulum and introitus) Renovalase™ mode with (a) fluence 1,5 J/cm2, (b) SMOOTHTM mode frequency 1.6Hz, and (c) spot size 7 mm.