Genitourinary Syndrome of MenopauseNCT03738605
Vaginal Laser Therapy in Breast Cancer Survivors
A study testing Microablative Fractional CO2 Laser Therapy in people with Genitourinary Syndrome of Menopause and Vaginal Atrophy, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause, Vaginal Atrophy, Breast Cancer
- What is being tested?
- Microablative Fractional CO2 Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2018to Aug 2020
- 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
- breast cancer history
- dyspareunia
- dryness
Who cannot join
- 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.
Greece1 site, 1 recruiting
- Recruiting
Urogynecological Unit of Alexandra Hospital
Athens, 11528
Stavros Athanasiou, Prof., +306944478555, stavros.athanasiou@gmail.com
Themos Grigoriadis, Assist. Prof., +306948741306, tgregos@yahoo.com
About this study
Official title: Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial
This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.
- Being tested
- Microablative Fractional CO2 Laser Therapy
- Medical subject headings
- Breast Neoplasms, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microablative Fractional CO2 Laser TherapyDevice
Also called SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
5 laser therapies intravaginally administered will be applied at monthly intervals.
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Experimental | Microablative Fractional CO2 Laser Therapy (The 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 Therapy |
| Placebo | Placebo comparator | Placebo therapy (The 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 Therapy |
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: Change from baseline at 1 month post-treatment
Secondary outcomes (15)
3 days voiding diary
Assesses frequency of urination, amount of urine, presence of urgency and/or urinary incontinence and amount of fluid intake
Measured: Change from baseline at 1 month post-treatment
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: Change from baseline at 1 month post-treatment
Patients Global Impression of Improvement
It is a single item questionnaire assessing the impression of participants following the intervention
Measured: At 1-month post-treatment
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 (itching, burning and dysuria) at all" , while 10 "symptom (itching, burning and dysuria) 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 itching, burning and dysuria
Measured: Change from baseline at 1 month post-treatment
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: Change from baseline at 1 month post-treatment
Female Sexual Function Index
It is a questionnaire defining women's sexual function. It includes 6 domains: desire, arousal, orgasm, lubrication, satisfaction and pain. The answer of each Question in each domain are multiplied by a certain factor. Total score is calculated by summing the scores of the all domains with a minimum value of 2 and a maximum of 36. The highest the total score the better is the sexual functioning. Total score above 26.55 defines normal sexual function
Measured: Change from baseline at 1 month post-treatment
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: 6 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: 6 months
International Consultation on Incontinence Questionnaire Short Form
it is a questionnaire with 4 questions assessing the amount of leakage, frequency and type of urinary incontinence. Total score is calculated by summing the 3 out of the 4 questions. Higher scores indicate worst urinary incontinence
Measured: 6 months
Modified Sexual Quality of Life Questionnaire-Male
It includes 12 questions assessing the quality of life and sexual satisfaction of the male partner. Each answer may receive values from 1 to 5. The higher the scores the better subjective evaluation of sexual quality of life
Measured: 6 months
Urogenital Distress Inventory 6
It is a condition specific questionnaire containing 6 questions. The answers of questions assesses the presence of symptoms and the degree of bother on a 4-point scale ("not at all", "a little bit", "moderately" and "greatly" applying to 0, 1, 2 and 3, respectively). Total score is calculated by summing the score of each question. The higher the total score the highest is the symptom bother
Measured: 6 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: 6 months
Number of blood vessels
Biopsies will be obtained from the lateral vaginal wall. Computerized determination of blood vessels number will be performed
Measured: 6 months
Size of blood vessels
Biopsies will be obtained from the lateral vaginal wall. Computerized determination of the blood vessels size will be performed
Measured: 6 months
Collagen
Biopsies will be obtained from the lateral vaginal wall. Determination of collagen types using immunohistochemistry and microscopy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Dec 2018
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Themos Grigoriadis, National and Kapodistrian University of Athens
- Investigators
- Stavros Athanasiou, Associate Proffesor, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738605
- Sponsor's protocol ID
- 767/29-09-2017
- Status last verified
- Jul 2019
- First submitted
- 6 Nov 2018
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03738605
- Acronym / sponsor ID
- 767/29-09-2017
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 13 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 efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo 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 Laser TherapyMicroablative Fractional CO2 Laser Therapy (The 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 | Placebo comparator | Device: Microablative Fractional CO2 Laser TherapyPlacebo therapy (The 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 (3 listed)
- breast cancer history
- dyspareunia
- dryness
Key exclusion criteria (3 listed)
- 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 Laser TherapyAlso: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy5 laser therapies intravaginally administered will be applied at monthly intervals. | Device | Laser Group, Placebo |
Primary outcome
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
Time frame: Change from baseline at 1 month post-treatment
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
3 days voiding diary
Time frame: Change from baseline at 1 month post-treatment
Day-to Day Impact of vaginal aging questionnaire (DIVA)
Time frame: Change from baseline at 1 month post-treatment
Patients Global Impression of Improvement
Time frame: At 1-month post-treatment
10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria
Time frame: Change from baseline at 1 month post-treatment
King's Health Questionnaire (KHQ)
Time frame: Change from baseline at 1 month post-treatment
Female Sexual Function Index
Time frame: Change from baseline at 1 month post-treatment
Vaginal Maturation Value
Time frame: 6 months
Vaginal Health Index Score
Time frame: 6 months
International Consultation on Incontinence Questionnaire Short Form
Time frame: 6 months
Modified Sexual Quality of Life Questionnaire-Male
Time frame: 6 months
Urogenital Distress Inventory 6
Time frame: 6 months
Epithelial thickness
Time frame: 6 months
Number of blood vessels
Time frame: 6 months
Size of blood vessels
Time frame: 6 months
Collagen
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Related trials for Genitourinary Syndrome of Menopause
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases
RecruitingObservational study
Predictors of Religious Orientation Attitudes in Menopausal Women
Menopause, Menopausal Syndrome
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
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
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 study director
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 Therapy in people with Genitourinary Syndrome of Menopause and 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 3 inclusion and 3 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 30 Jul 2019. 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?
Contact Stavros Athanasiou, Associate Professor (+306944478555, stavros.athanasiou@gmail.com), or a site near the patient. 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: Change from baseline at 1 month post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2019.