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

Primary Purpose

Genitourinary Syndrome of Menopause

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
intravaginal laser
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genitourinary Syndrome of Menopause focused on measuring genitourinary syndrome of menopause, intravaginal laser, breast cancer, aromatase inhibitor

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Mona Lisa Touch CO2 laser

Fotona Smooth erbium:YAG laser

sham treatment

Arm Description

Power: 30 W. Dwell time: 1000 μs. Spacing: 1000 μm. Depth: SmartStack parameter from 1 to 3 depending on the treatment status. D-pulse mode. At the introitus the power will be reduced to 24 W

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. 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.

The blocking device is inserted over the laser outlet before attaching the application speculum. With this device the laser beam is blocked entirely. 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. 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient reported effect of laser on other GSM symptoms
scored on a 10 cm VAS
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
Urinary Distress Index (UDI-6)
Measured with UDI-6 questionnaire
The degree of discomfort of the treatment procedure by the participant
scored on a 10 cm VAS
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.
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
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.
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)
Description of adverse events
Adverse events are questioned at each visit following an intravaginal treatment.

Full Information

First Posted
January 9, 2023
Last Updated
January 26, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05713435
Brief Title
Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genitourinary Syndrome of Menopause
Keywords
genitourinary syndrome of menopause, intravaginal laser, breast cancer, aromatase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 parallel arms of equal size, participants can cross over after 3 initial treatments
Masking
ParticipantOutcomes Assessor
Masking Description
participant and outcome assessor are blinded
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mona Lisa Touch CO2 laser
Arm Type
Active Comparator
Arm Description
Power: 30 W. Dwell time: 1000 μs. Spacing: 1000 μm. Depth: SmartStack parameter from 1 to 3 depending on the treatment status. D-pulse mode. At the introitus the power will be reduced to 24 W
Arm Title
Fotona Smooth erbium:YAG laser
Arm Type
Active Comparator
Arm Description
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. 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.
Arm Title
sham treatment
Arm Type
Sham Comparator
Arm Description
The blocking device is inserted over the laser outlet before attaching the application speculum. With this device the laser beam is blocked entirely. 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. 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.
Intervention Type
Device
Intervention Name(s)
intravaginal laser
Intervention Description
application of intravaginal laser
Primary Outcome Measure Information:
Title
change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment
Description
scored on a 10 cm VAS
Time Frame
at 3 months after the end of treatment
Secondary Outcome Measure Information:
Title
Patient reported effect of laser on other GSM symptoms
Description
scored on a 10 cm VAS
Time Frame
at 3 months after the end of treatment
Title
Female Sexual Function Index (FSFI)
Description
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
Title
Urinary Distress Index (UDI-6)
Description
Measured with UDI-6 questionnaire
Time Frame
at 3 months after the end of treatment
Title
The degree of discomfort of the treatment procedure by the participant
Description
scored on a 10 cm VAS
Time Frame
at the end of the each treatment-visit
Title
The longevity of the effect
Description
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.
Time Frame
at 24 months after the end of treatment
Title
Vaginal pH
Description
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
Time Frame
at 3 months after the end of treatment
Title
Vaginal Health Index Score (VHIS)
Description
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.
Time Frame
at 3 months after the end of treatment
Title
Vaginal Maturation Value (VMV)
Description
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)
Time Frame
at 3 months after the end of treatment
Title
Description of adverse events
Description
Adverse events are questioned at each visit following an intravaginal treatment.
Time Frame
until 1 month after the last treatment visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Housmans, MD
Phone
+3216332211
Email
susanne.housmans@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Deprest, PhD
Phone
+3216332211
Email
jan.deprest@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Housmans, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Housmans, MD
Phone
+3216332211
Email
susanne.housmans@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Jan Deprest, PhD
Phone
+3216332211
Email
jan.deprest@uzleuven.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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