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

Last updated: June 28, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Atrophy

Treatment

intravaginal laser

Clinical Study ID

NCT05713435
S66520
  • Ages 18-100
  • Female

Study 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

Eligibility Criteria

Inclusion

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 afterchemotherapy, surgical or medicinally induced (GnRH analogues for the duration ofthe trial)

Exclusion

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 theinvestigator, 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 tothe measurement of the primary outcome (6 months after inclusion, 3 months afterlast laser)

  • Vaginal stenosis that does not allow the placement of the laser probe

  • Any condition that could interfere with study compliance

Study Design

Total Participants: 162
Treatment Group(s): 1
Primary Treatment: intravaginal laser
Phase:
Study Start date:
December 27, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • UZ Leuven

    Leuven, Flemish Brabant 3000
    Belgium

    Active - Recruiting

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