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Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03754205
Recruitment Status : Active, not recruiting
First Posted : November 27, 2018
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
IRCCS San Raffaele
Information provided by (Responsible Party):
Themos Grigoriadis, 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.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Device: Microablative Fractional CO2 laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical, Histopathological, Cytological and Microbiological Efficacy of the Micro-ablative Fractional CO2 Laser : A Double-blind Randomized Placebo-controlled Trial
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy




Primary Outcome Measures :
  1. 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness [ Time Frame: 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 :
  1. Day-to Day Impact of vaginal aging questionnaire (DIVA) [ Time Frame: 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

  2. Patients Global Impression of Improvement [ Time Frame: 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. 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria [ Time Frame: 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

  4. 3 days voiding diary [ Time Frame: 24 months ]
    Assesses bladder function (frequency, urgency and incontinence)

  5. Female Sexual Function Index [ Time Frame: 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

  6. International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) [ Time Frame: 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.

  7. King's Health Questionnaire (KHQ) [ Time Frame: 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.

  8. Vaginal Maturation Value [ Time Frame: 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.

  9. Vaginal Health Index Score [ Time Frame: 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.

  10. Epithelial thickness [ Time Frame: 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.

  11. Number of Blood vessels [ Time Frame: 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.

  12. Size of blood vessels [ Time Frame: 24 months ]
    Computerized determination of diameter (in μ), length (in μ) αnd width (in μ) will be performed.

  13. Density of blood vessels [ Time Frame: 24 months ]
    Computerized determination of volume density of blood vessels in percent of total area of subepithelial stroma will be performed

  14. Cultures of vaginal samples [ Time Frame: 24 months ]
    Lactobacilli, aerobic bacteria, anaerobic bacteria, fungi will be evaluated

  15. Polymerase Chain Reaction [ Time Frame: 24 months ]
    Lactobacilli, bacteria and fungi will be evaluated.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754205


Locations
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Greece
Urogynecological Unit of Alexandra Hospital
Athens, Greece, 11528
Sponsors and Collaborators
National and Kapodistrian University of Athens
IRCCS San Raffaele
Investigators
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Principal Investigator: Stavros Athanasiou, Associate Proffesor National and Kapodistrian University of Athens, Greece
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Responsible Party: Themos Grigoriadis, Assistant Professor, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03754205    
Other Study ID Numbers: 674/03-09-2018
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical