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

ConditionGenitourinary Syndrome of Menopause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • intravaginal laser

    Device

    application of intravaginal laser

Treatment groups

162 Participants
are divided into 3 treatment groups
Group A: Mona Lisa Touch CO2 laserActive comparator 1 intervention
Group B: Fotona Smooth erbium:YAG laserActive comparator 1 intervention
Group C: sham treatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
at 3 months after the end of treatment

Secondary outcomes

1

Patient reported effect of laser on other GSM symptoms

scored on a 10 cm VAS

Time frame
at 3 months after the end of treatment
2

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

Time frame
at 3 months after the end of treatment
3

Urinary Distress Index (UDI-6)

Measured with UDI-6 questionnaire

Time frame
at 3 months after the end of treatment
4

The degree of discomfort of the treatment procedure by the participant

scored on a 10 cm VAS

Time frame
at the end of the each treatment-visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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