An interventional study of Microablative Fractional CO2 laser in Vaginal Atrophy, sponsored by National and Kapodistrian University of Athens. Status unknown at 1 site in Greece. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Treatment
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.
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's enrollment of 60 is above the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →National and Kapodistrian University of Athens is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Also known as: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
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
Time frame: 24-months
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
Time frame: 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
Time frame: 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
Time frame: 24 months
3 days voiding diary
Assesses bladder function (frequency, urgency and incontinence)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Size of blood vessels
Computerized determination of diameter (in μ), length (in μ) αnd width (in μ) will be performed.
Time frame: 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
Time frame: 24 months
Cultures of vaginal samples
Lactobacilli, aerobic bacteria, anaerobic bacteria, fungi will be evaluated
Time frame: 24 months
Polymerase Chain Reaction
Lactobacilli, bacteria and fungi will be evaluated.
Time frame: 24 months
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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National and Kapodistrian University of Athens