Genitourinary Syndrome of MenopauseLASINCT05713435
Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors
A study testing intravaginal laser in people with Genitourinary Syndrome of Menopause, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- intravaginal laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Dec 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Flemish Brabant, 3000
Susanne Housmans, MD, +3216332211, susanne.housmans@uzleuven.be
Jan Deprest, PhD, +3216332211, jan.deprest@uzleuven.be
About this study
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.
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
Read the 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.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- intravaginal laser
- Keywords
- genitourinary syndrome of menopause, intravaginal laser, breast cancer, aromatase inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravaginal laserDevice
application of intravaginal laser
| Study group | Role | What they receive |
|---|---|---|
| Mona Lisa Touch CO2 laser | Active comparator | 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 Receives: Device: intravaginal laser |
| Fotona Smooth erbium:YAG laser | Active comparator | 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. Receives: Device: intravaginal laser |
| sham treatment | Sham comparator | 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. Receives: Device: intravaginal laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 3 months after the end of treatment
Secondary outcomes (9)
Patient reported effect of laser on other GSM symptoms
scored on a 10 cm VAS
Measured: at 3 months after the end of treatment
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
Measured: at 3 months after the end of treatment
Urinary Distress Index (UDI-6)
Measured with UDI-6 questionnaire
Measured: at 3 months after the end of treatment
The degree of discomfort of the treatment procedure by the participant
scored on a 10 cm VAS
Measured: at the end of the each treatment-visit
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.
Measured: at 24 months after the end of treatment
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
Measured: at 3 months after the end of treatment
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.
Measured: at 3 months after the end of treatment
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)
Measured: at 3 months after the end of treatment
Description of adverse events
Adverse events are questioned at each visit following an intravaginal treatment.
Measured: until 1 month after the last treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start27 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel arms of equal size, participants can cross over after 3 initial treatments
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Housmans, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713435
- Sponsor's protocol ID
- S66520
- Acronym
- LASI
- Status last verified
- Jun 2024
- First submitted
- 9 Jan 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05713435
- Acronym / sponsor ID
- LASI / S66520
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- genitourinary syndrome of menopause, intravaginal laser, breast cancer, aromatase inhibitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 parallel arms of equal size, participants can cross over after 3 initial treatments
| Arm | Type | Receives |
|---|---|---|
| Mona Lisa Touch CO2 laser | Active comparator | Device: intravaginal laser1. 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 |
| Fotona Smooth erbium:YAG laser | Active comparator | Device: intravaginal laser1. 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. |
| sham treatment | Sham comparator | Device: intravaginal laser1. 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravaginal laserapplication of intravaginal laser | Device | Fotona Smooth erbium:YAG laser, Mona Lisa Touch CO2 laser, sham treatment |
Primary outcome
change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment
Time frame: at 3 months after the end of treatment
scored on a 10 cm VAS
9 secondary outcomes
Patient reported effect of laser on other GSM symptoms
Time frame: at 3 months after the end of treatment
Female Sexual Function Index (FSFI)
Time frame: at 3 months after the end of treatment
Urinary Distress Index (UDI-6)
Time frame: at 3 months after the end of treatment
The degree of discomfort of the treatment procedure by the participant
Time frame: at the end of the each treatment-visit
The longevity of the effect
Time frame: at 24 months after the end of treatment
Vaginal pH
Time frame: at 3 months after the end of treatment
Vaginal Health Index Score (VHIS)
Time frame: at 3 months after the end of treatment
Vaginal Maturation Value (VMV)
Time frame: at 3 months after the end of treatment
Description of adverse events
Time frame: until 1 month after the last treatment visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Housmans, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravaginal laser in people with Genitourinary Syndrome of Menopause, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Housmans, MD (+3216332211, susanne.housmans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment (time frame: at 3 months after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.