Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
The treatment is done with a specialized vaginal applicator which allows treatment of vagina, using the Femilift fractional micro ablative CO2 laser system (Alma Lasers, Israel), according to the usual protocol (Laser mode: Pulse, Energy: 40-80 mj/pulse). Before treatment, 5ml of topical anesthetic ointment (10% lidocaine in Vaseline base) will be spread in the vagina and on the vestibule for 30 minutes in both groups to avoid pain from the laser, as well as to allow the comparison between the groups (patients in both groups will not experience pain and therefore will remain blinded to their allocation).
Ahinoam Lev-Sagie
Lapid, Israel
Change in dryness
Change in VAS before and after completion of treatment for dryness
Time frame: Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.
Change in dyspareunia
Change in VAS before and after completion of treatment for dyspareunia
Time frame: Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.