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Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

Primary Purpose

Vaginal Atrophy

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Microablative Fractional CO2 laser
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Atrophy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
  • Menopause

Exclusion Criteria:

  • Systemic or local hormonal therapy the last 6 months
  • Use of moisturizers or lubricants the last month
  • Active genital infection (i.e herpes, vaginitis)
  • Prolapse stage >=2
  • Underlying pathologies that could interfere with the protocol compliance

Sites / Locations

  • Urogynecological Unit of Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser Group

Placebo Group

Arm Description

Microablative Fractional CO2 laser therapy at monthly intervals. The laser parameters that will be used are the following: (1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.

Placebo CO2 laser therapies at monthly intervals. The laser parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.

Outcomes

Primary Outcome Measures

10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness

Secondary Outcome Measures

Day-to Day Impact of vaginal aging questionnaire (DIVA)
It includes 4 domains: activities of daily living (5 items), sexual functioning (5 items), emotional well-being (4 items), self-concept and body image (5-items). Each item of each domain could receive values from 0 to 4. Mean scores are calculated on each of the domain scales. Higher scores indicate greater symptom impact
Patients Global Impression of Improvement
It is a single question with 7 possible answers. Patients will chose the answer that applies at their impression of improvement after the laser therapy
10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria
It is a straight line with 2 endpoints "0" and "10". Zero defines "no symptom at all", while 10 "symptom as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of symptom
3 days voiding diary
Assesses bladder function (frequency, urgency and incontinence)
Female Sexual Function Index
It includes 6 domains assessing sexual functioning (desire, arousal, orgasm, lubrication, satisfaction and pain). Total score is calculated by summing scores of the 5 domains multiplied by certain factors with a minimum value of 2 and maximum 36
International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)
It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively.
King's Health Questionnaire (KHQ)
It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.
Vaginal Maturation Value
It is calculated by defining the percentage of superficial, intermediate and parabasal epithelial cells on the vaginal pap smear, following the formula (1x%superficial)+(0.5x%intermediate)+(0x%parabasal). It may receive values from 0 to 100%.It is considered to be an indicator of the estrogenic stimulation, whereas values of 0-49%, 50-64% and 65-100% indicate absent/low, moderate and high estrogenic effect on the vaginal epithelium, respectively.
Vaginal Health Index Score
It evaluates vaginal elasticity, fluid volume, ph of vaginal fluid, epithelial integrity and moisture. Each one of these may receive scores from 1 to 5. Total score is calculated by summing the 5 scores ranging from 5 to 25. Higher scores indicate better vaginal status.
Epithelial thickness
Biopsies will be obtained from the lateral vaginal wall. Epithelial thickness (in μ) will be measured by a vertical line between basal layer cells and superficial layers.
Number of Blood vessels
Computerized determination of number of capillary profiles in the test area will be performed percent of total area of subepithelial stroma), will be performed.
Size of blood vessels
Computerized determination of diameter (in μ), length (in μ) αnd width (in μ) will be performed.
Density of blood vessels
Computerized determination of volume density of blood vessels in percent of total area of subepithelial stroma will be performed
Cultures of vaginal samples
Lactobacilli, aerobic bacteria, anaerobic bacteria, fungi will be evaluated
Polymerase Chain Reaction
Lactobacilli, bacteria and fungi will be evaluated.

Full Information

First Posted
October 28, 2018
Last Updated
January 13, 2020
Sponsor
National and Kapodistrian University of Athens
Collaborators
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT03754205
Brief Title
Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause
Official Title
The Clinical, Histopathological, Cytological and Microbiological Efficacy of the Micro-ablative Fractional CO2 Laser : A Double-blind Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Anticipated)
Study Completion Date
January 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
Collaborators
IRCCS San Raffaele

4. Oversight

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

5. Study Description

Brief Summary
This study evaluates the clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Group
Arm Type
Experimental
Arm Description
Microablative Fractional CO2 laser therapy at monthly intervals. The laser parameters that will be used are the following: (1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo CO2 laser therapies at monthly intervals. The laser parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.
Intervention Type
Device
Intervention Name(s)
Microablative Fractional CO2 laser
Other Intervention Name(s)
SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Intervention Description
3 therapies intravaginally administered will be applied at monthly intervals
Primary Outcome Measure Information:
Title
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
Description
It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness
Time Frame
24-months
Secondary Outcome Measure Information:
Title
Day-to Day Impact of vaginal aging questionnaire (DIVA)
Description
It includes 4 domains: activities of daily living (5 items), sexual functioning (5 items), emotional well-being (4 items), self-concept and body image (5-items). Each item of each domain could receive values from 0 to 4. Mean scores are calculated on each of the domain scales. Higher scores indicate greater symptom impact
Time Frame
24 months
Title
Patients Global Impression of Improvement
Description
It is a single question with 7 possible answers. Patients will chose the answer that applies at their impression of improvement after the laser therapy
Time Frame
24 months
Title
10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria
Description
It is a straight line with 2 endpoints "0" and "10". Zero defines "no symptom at all", while 10 "symptom as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of symptom
Time Frame
24 months
Title
3 days voiding diary
Description
Assesses bladder function (frequency, urgency and incontinence)
Time Frame
24 months
Title
Female Sexual Function Index
Description
It includes 6 domains assessing sexual functioning (desire, arousal, orgasm, lubrication, satisfaction and pain). Total score is calculated by summing scores of the 5 domains multiplied by certain factors with a minimum value of 2 and maximum 36
Time Frame
24 months
Title
International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)
Description
It is a 12-items questionnaire evaluating nocturia, urgency, bladder pain, frequency, hesitancy, straining, intermittency, urinary incontinence (urge, stress and unexplained), frequency of urinary incontinence and nocturnal enuresis. Filling, voiding and incontinence symptoms subscales range from 0 to 15, 0 to 12 and 0 to 20, respectively.
Time Frame
24 months
Title
King's Health Questionnaire (KHQ)
Description
It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.
Time Frame
24 months
Title
Vaginal Maturation Value
Description
It is calculated by defining the percentage of superficial, intermediate and parabasal epithelial cells on the vaginal pap smear, following the formula (1x%superficial)+(0.5x%intermediate)+(0x%parabasal). It may receive values from 0 to 100%.It is considered to be an indicator of the estrogenic stimulation, whereas values of 0-49%, 50-64% and 65-100% indicate absent/low, moderate and high estrogenic effect on the vaginal epithelium, respectively.
Time Frame
24 months
Title
Vaginal Health Index Score
Description
It evaluates vaginal elasticity, fluid volume, ph of vaginal fluid, epithelial integrity and moisture. Each one of these may receive scores from 1 to 5. Total score is calculated by summing the 5 scores ranging from 5 to 25. Higher scores indicate better vaginal status.
Time Frame
24 months
Title
Epithelial thickness
Description
Biopsies will be obtained from the lateral vaginal wall. Epithelial thickness (in μ) will be measured by a vertical line between basal layer cells and superficial layers.
Time Frame
24 months
Title
Number of Blood vessels
Description
Computerized determination of number of capillary profiles in the test area will be performed percent of total area of subepithelial stroma), will be performed.
Time Frame
24 months
Title
Size of blood vessels
Description
Computerized determination of diameter (in μ), length (in μ) αnd width (in μ) will be performed.
Time Frame
24 months
Title
Density of blood vessels
Description
Computerized determination of volume density of blood vessels in percent of total area of subepithelial stroma will be performed
Time Frame
24 months
Title
Cultures of vaginal samples
Description
Lactobacilli, aerobic bacteria, anaerobic bacteria, fungi will be evaluated
Time Frame
24 months
Title
Polymerase Chain Reaction
Description
Lactobacilli, bacteria and fungi will be evaluated.
Time Frame
24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness) Menopause Exclusion Criteria: Systemic or local hormonal therapy the last 6 months Use of moisturizers or lubricants the last month Active genital infection (i.e herpes, vaginitis) Prolapse stage >=2 Underlying pathologies that could interfere with the protocol compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Athanasiou, Associate Proffesor
Organizational Affiliation
National and Kapodistrian University of Athens, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urogynecological Unit of Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece

12. IPD Sharing Statement

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Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

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