Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause
- Conditions
- Vaginal Atrophy
- Interventions
- Device: Microablative Fractional CO2 laser
- Registration Number
- NCT03754205
- Lead Sponsor
- National and Kapodistrian University of Athens
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
- Menopause
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Microablative Fractional CO2 laser 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. Laser Group Microablative Fractional CO2 laser 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.
- Primary Outcome Measures
Name Time Method 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness 24-months 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
Name Time Method Polymerase Chain Reaction 24 months Lactobacilli, bacteria and fungi will be evaluated.
Density of blood vessels 24 months Computerized determination of volume density of blood vessels in percent of total area of subepithelial stroma will be performed
Day-to Day Impact of vaginal aging questionnaire (DIVA) 24 months 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
King's Health Questionnaire (KHQ) 24 months 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.
Patients Global Impression of Improvement 24 months 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
3 days voiding diary 24 months Assesses bladder function (frequency, urgency and incontinence)
Number of Blood vessels 24 months 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 24 months Computerized determination of diameter (in μ), length (in μ) αnd width (in μ) will be performed.
Female Sexual Function Index 24 months 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
Vaginal Health Index Score 24 months 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.
Cultures of vaginal samples 24 months Lactobacilli, aerobic bacteria, anaerobic bacteria, fungi will be evaluated
10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria 24 months 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
International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) 24 months 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.
Vaginal Maturation Value 24 months 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.
Epithelial thickness 24 months 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.
Trial Locations
- Locations (1)
Urogynecological Unit of Alexandra Hospital
🇬🇷Athens, Greece