Vaginal AtrophyNCT03754205
Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause
A study testing Microablative Fractional CO2 laser in people with Vaginal Atrophy, run by National and Kapodistrian University of Athens at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Microablative Fractional CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 18 Jan 2018to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
- Menopause
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vaginal Atrophy
- Being tested
- Microablative Fractional CO2 laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microablative Fractional CO2 laserDevice
Also called SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
3 therapies intravaginally administered will be applied at monthly intervals
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Experimental | 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. Receives: Device: Microablative Fractional CO2 laser |
| Placebo Group | Placebo comparator | 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. Receives: Device: Microablative Fractional CO2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-months
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 24 months
3 days voiding diary
Assesses bladder function (frequency, urgency and incontinence)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Size of blood vessels
Computerized determination of diameter (in μ), length (in μ) αnd width (in μ) will be performed.
Measured: 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
Measured: 24 months
Cultures of vaginal samples
Lactobacilli, aerobic bacteria, anaerobic bacteria, fungi will be evaluated
Measured: 24 months
Polymerase Chain Reaction
Lactobacilli, bacteria and fungi will be evaluated.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start18 Jan 2018
- Primary completion15 Apr 2020 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele
- Responsible party
- Principal investigator, Themos Grigoriadis, National and Kapodistrian University of Athens
- Investigators
- Stavros Athanasiou, Associate Proffesor, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754205
- Sponsor's protocol ID
- 674/03-09-2018
- Status last verified
- Jan 2020
- First submitted
- 28 Oct 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical, Histopathological, Cytological and Microbiological Efficacy of the Micro-ablative Fractional CO2 Laser : A Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03754205
- Acronym / sponsor ID
- 674/03-09-2018
- Conditions
- Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 15 Apr 2020 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group | Experimental | Device: Microablative Fractional CO2 laserMicroablative 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. |
| Placebo Group | Placebo comparator | Device: Microablative Fractional CO2 laserPlacebo 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
- Menopause
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microablative Fractional CO2 laserAlso: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy3 therapies intravaginally administered will be applied at monthly intervals | Device | Laser Group, Placebo Group |
Primary outcome
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
15 secondary outcomes
Day-to Day Impact of vaginal aging questionnaire (DIVA)
Time frame: 24 months
Patients Global Impression of Improvement
Time frame: 24 months
10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria
Time frame: 24 months
3 days voiding diary
Time frame: 24 months
Female Sexual Function Index
Time frame: 24 months
International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)
Time frame: 24 months
King's Health Questionnaire (KHQ)
Time frame: 24 months
Vaginal Maturation Value
Time frame: 24 months
Vaginal Health Index Score
Time frame: 24 months
Epithelial thickness
Time frame: 24 months
Number of Blood vessels
Time frame: 24 months
Size of blood vessels
Time frame: 24 months
Density of blood vessels
Time frame: 24 months
Cultures of vaginal samples
Time frame: 24 months
Polymerase Chain Reaction
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
Related trials for Vaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros Athanasiou, Associate Proffesor principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microablative Fractional CO2 laser in people with Vaginal Atrophy, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness (time frame: 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.