Clinical trial NCT05713435: Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors
Official title: Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of Genitourinary Syndrome of Menopause (GSM) in Patients Using Aromatase Inhibitors: Double Blinded Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Keywords: genitourinary syndrome of menopause
intravaginal laser
breast cancer
aromatase inhibitor
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallel arms of equal size, participants can cross over after 3 initial treatments
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

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

Primary outcomes:
measure: change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment
timeFrame: at 3 months after the end of treatment
Secondary outcomes:
measure: Patient reported effect of laser on other GSM symptoms
timeFrame: at 3 months after the end of treatment
measure: Female Sexual Function Index (FSFI)
timeFrame: at 3 months after the end of treatment
measure: Urinary Distress Index (UDI-6)
timeFrame: at 3 months after the end of treatment
measure: The degree of discomfort of the treatment procedure by the participant
timeFrame: at the end of the each treatment-visit
measure: The longevity of the effect
timeFrame: at 24 months after the end of treatment
measure: Vaginal pH
timeFrame: at 3 months after the end of treatment
measure: Vaginal Health Index Score (VHIS)
timeFrame: at 3 months after the end of treatment
measure: Vaginal Maturation Value (VMV)
timeFrame: at 3 months after the end of treatment
measure: Description of adverse events
timeFrame: until 1 month after the last treatment visit
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Flemish Brabant
Study officials:
affiliation: UZ Leuven
name: Susanne Housmans, MD
role: PRINCIPAL_INVESTIGATOR
References: