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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jan 26, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating two types of laser treatments—Fractional CO2 laser and Erbium:YAG laser—to see how effective they are in relieving genitourinary symptoms of menopause (GSM) in women who are taking aromatase inhibitors after breast cancer treatment. GSM can cause discomfort and issues like dryness or pain during intercourse, which can significantly impact quality of life. The trial is looking for women aged between 65 and 74 who were diagnosed with breast cancer while premenopausal and are currently experiencing moderate to severe GSM symptoms.

Participants in the trial will receive either one of the laser treatments or a sham (placebo) treatment. They will need to temporarily abstain from vaginal intercourse for one week after the laser therapy. To be eligible, women must not have used any hormonal treatments recently or have ongoing cancer treatments. It’s important for potential participants to know that their safety and comfort are priorities throughout the study, and they will be closely monitored for any potential side effects. If you meet the criteria and are interested, this trial could be a good opportunity to explore effective treatment options for GSM.

Gender

FEMALE

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