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

Genitourinary Syndrome of Menopause Clinical Trial

— LASI  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713435
• Other study ID #: S66520
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2022
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Susanne Housmans, MD
• Phone: +3216332211
• Email: susanne.housmans[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Syndrome

Intervention

Device:
• intravaginal laser
application of intravaginal laser

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Flemish Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment	scored on a 10 cm VAS	at 3 months after the end of treatment
Secondary	Patient reported effect of laser on other GSM symptoms	scored on a 10 cm VAS	at 3 months after the end of treatment
Secondary	Female Sexual Function Index (FSFI)	measured with FSFI questionnaire. The cut-off score of >26,55 will be used to discriminate between women with impaired and unimpaired sexual functioning	at 3 months after the end of treatment
Secondary	Urinary Distress Index (UDI-6)	Measured with UDI-6 questionnaire	at 3 months after the end of treatment
Secondary	The degree of discomfort of the treatment procedure by the participant	scored on a 10 cm VAS	at the end of the each treatment-visit
Secondary	The longevity of the effect	Determined by questioning the need the participant feels for repeat treatment, and its nature (repeat laser or alternatives) until two years after the end of treatment.	at 24 months after the end of treatment
Secondary	Vaginal pH	Measured with a pH indicator strip (range 3.6-6.1) and is sampled from the lateral vaginal wall in the lower third of the vagina	at 3 months after the end of treatment
Secondary	Vaginal Health Index Score (VHIS)	Scoring of vaginal moisture, vaginal fluid volume, vaginal elasticity, vaginal pH, and vaginal epithelial integrity on a scale of 1 (poorest) to 5 (best) according to the methods of Robert Wood Johnson Medical School. The lower the score, the greater the atrophy. Vaginal moisture is an assessment of the appearance and spread or consistency of the secretions which coat the vagina. Vaginal elasticity is a measure of the ability of the vaginal tissue to stretch from the examiner's finger. Vaginal epithelial integrity takes into account color, thickness, and ability of the tissue to resist breaking secondary to touch.	at 3 months after the end of treatment
Secondary	Vaginal Maturation Value (VMV)	A vaginal smear will be obtained from the lateral vaginal wall using a spatula and will be stained according to the Papanicolaou technique. The Vaginal Maturation Index (VMI) is evaluated by defining the proportion of superficial, intermediate, and parabasal epithelial cells on the smear. To combine this information into a single score for quantifying estrogenization, the VMV was calculated. It is based on weighted proportions of cell types from the VMI and calculated using Meisels' formula: the percentage of superficial cells (S) plus 0.5 times the percentage of intermediate cells (I) coded from the cytology sample [MV= %S + (0.5 × % I)	at 3 months after the end of treatment
Secondary	Description of adverse events	Adverse events are questioned at each visit following an intravaginal treatment.	until 1 month after the last treatment visit