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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Genitourinary Syndrome of Menopause

Treatments: Device: intravaginal laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05713435

S66520

Details and patient eligibility

About

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

Full description

The objective is to compare microablative fractional CO2 laser (CO2 laser) (SmartXide2 V2 LR, Monalisa Touch; DEKA, Florence, Italy) and non-ablative photothermal Erbium:YAG laser (Er:YAG laser) (Fotona Smooth™ XS; Fotona, Ljubljana, Slovenia) - with sham vaginal applications for treatment of vaginal dryness as the leading symptom in breast cancer patients with iatrogenic menopause and treated with an AI.

Enrollment: 162 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 3 patient groups

Mona Lisa Touch CO2 laser

Active Comparator group

Description:

1. Power: 30 W. 2. Dwell time: 1000 μs. 3. Spacing: 1000 μm. 4. Depth: SmartStack parameter from 1 to 3 depending on the treatment status. 5. D-pulse mode. 6. At the introitus the power will be reduced to 24 W

Treatment:

Device: intravaginal laser

Fotona Smooth erbium:YAG laser

Active Comparator group

Description:

1. 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. 2. 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.

Treatment:

Device: intravaginal laser

sham treatment

Sham Comparator group

Description:

1. The blocking device is inserted over the laser outlet before attaching the application speculum. With this device the laser beam is blocked entirely. 2. 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. 3. 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.

Treatment:

Device: intravaginal laser