Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors
NCT ID: NCT05713435
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
162 participants
INTERVENTIONAL
2022-12-27
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mona Lisa Touch CO2 laser
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
intravaginal laser
application of intravaginal laser
Fotona Smooth erbium:YAG laser
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.
intravaginal laser
application of intravaginal laser
sham treatment
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.
intravaginal laser
application of intravaginal laser
Interventions
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intravaginal laser
application of intravaginal laser
Eligibility Criteria
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Inclusion 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
* 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
18 Years
100 Years
FEMALE
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Susanne Housmans, MD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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UZ Leuven
Leuven, Flemish Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S66520
Identifier Type: -
Identifier Source: org_study_id
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