Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

The Clinical, Histopathological, Cytological and Microbiological Efficacy of the Micro-ablative Fractional CO2 Laser : A Double-blind Randomized Placebo-controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Atrophy
• Intervention / Treatment: Device: Microablative Fractional CO2 laser

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11528
    • Urogynecological Unit of Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Group; 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.	Device: Microablative Fractional CO2 laser; 3 therapies intravaginally administered will be applied at monthly intervals; Other Names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Placebo Comparator: Placebo Group; 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.	Device: Microablative Fractional CO2 laser; 3 therapies intravaginally administered will be applied at monthly intervals; Other Names: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months
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	24 months
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	24 months
3 days voiding diary	Assesses bladder function (frequency, urgency and incontinence)	24 months
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	24 months
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.	24 months
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.	24 months
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.	24 months
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.	24 months
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.	24 months
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.	24 months
Size of blood vessels	Computerized determination of diameter (in μ), length (in μ) αnd width (in μ) will be performed.	24 months
Density of blood vessels	Computerized determination of volume density of blood vessels in percent of total area of subepithelial stroma will be performed	24 months
Cultures of vaginal samples	Lactobacilli, aerobic bacteria, anaerobic bacteria, fungi will be evaluated	24 months
Polymerase Chain Reaction	Lactobacilli, bacteria and fungi will be evaluated.	24 months

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Collaborators: IRCCS San Raffaele
• Investigators: Principal Investigator: Stavros Athanasiou, Associate Proffesor, National and Kapodistrian University of Athens, Greece

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Anticipated): April 15, 2020
• Study Completion (Anticipated): January 15, 2021

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 674/03-09-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No