Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
Genitourinary Syndrome of Menopause
About this trial
This is an interventional treatment trial for Genitourinary Syndrome of Menopause focused on measuring laser, mamma cancer
Eligibility Criteria
Inclusion Criteria: Breast cancer survivor in endocrine therapy Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia Able to read and understand Danish Able to give written informed consent Exclusion Criteria: Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively) Use of Chemotherapy (6 months prior to the baseline visit) Acute urinary tract infection or active genital infection History of vaginal reconstructive surgery
Sites / Locations
- Department of Obstetrics and Gynaecology, Randers Regional Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active laser group
Sham laser group
In the active laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting; dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2 to 3. At the level of the vaginal introitus, the dot power decreases to 20 Watt.
In the sham laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy), using the following setting; dot power 0,5 watt, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1