Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

Vaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03754205
• Other study ID #: 674/03-09-2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: January 15, 2021

Study information

• Verified date: January 2020
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 15, 2021
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Device:
• Microablative Fractional CO2 laser
3 therapies intravaginally administered will be applied at monthly intervals

Locations

Country	Name	City	State
Greece	Urogynecological Unit of Alexandra Hospital	Athens

Sponsors (2)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	IRCCS San Raffaele

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	3 days voiding diary	Assesses bladder function (frequency, urgency and incontinence)	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Size of blood vessels	Computerized determination of diameter (in µ), length (in µ) and width (in µ) will be performed.	24 months
Secondary	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
Secondary	Cultures of vaginal samples	Lactobacilli, aerobic bacteria, anaerobic bacteria, fungi will be evaluated	24 months
Secondary	Polymerase Chain Reaction	Lactobacilli, bacteria and fungi will be evaluated.	24 months