Vulvovaginal AtrophyCO2VVANCT04021966
Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
A study testing Vaginal laser application in people with Vulvovaginal Atrophy, run by prof. dr. Jan Deprest at 1 site in Belgium.
Trial summary
Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women. Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Vaginal laser application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2019to 31 Dec 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
- Healthy women with menopausal status (>1 year amenorrhea) AND with moderate to severe symptoms of VVA as measured by the MBS score ≥2.
Who cannot join
- Acute or recurrent urogenital infections
- Prolapse ≥ grade 3 according to the Pelvic Organ Prolapse Quantification System
- Hormonal replacement therapy within the last 6 months before study entry
- Use of local estrogens, moisturizers, lubricants or homeopathic preparations within the last 3 months
- Pelvic floor physiotherapy for pelvic floor disorders within the last 3 months
- Any condition that could interfere with study compliance
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women.
Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).
Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Vaginal laser application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal laser applicationProcedure or surgery
One laser treatment cycle consists of 3 vaginal laser applications with a 4-weeks interval. Each application lasts around 5 minutes.
The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.
A vaginal probe will be gently inserted and manually rotated to provide a 360° treatment of the vaginal mucosa.
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | In this arm, participants will have 3 real laser treatments first, followed by 3 consecutive sham treatments. Receives: Procedure: Vaginal laser application |
| Sham | Sham comparator | In this arm, participants will have 3 sham treatments first, followed by 3 consecutive real laser treatments. Receives: Procedure: Vaginal laser application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure is the change in severity of most bothersome symptom (MBS)
The MBS is derived from a selected list of symptoms (consisting of the four most common symptoms of vaginal dryness, vaginal itching/irritation, vaginal soreness and dyspareunia). At baseline, participants are instructed to rate each of these symptoms as not present, mild, moderate or severe and then are asked to select a single symptom among those classified as moderate or severe as the MBS. The MBS is then followed through to the end of treatment, and the change in its severity is used to evaluate symptomatic improvement.
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Secondary outcomes (9)
Assessment of the effect of treatment on the female urogenital health, by means of the globally validated "Vaginal Health Index Score" (VHIS).
The VHIS includes scoring of vaginal moisture, vaginal fluid volume, vaginal elasticity, vaginal pH, and vaginal epithelial integrity on a scale of 1 (poorest) to 5 (best) according to the methods of Robert Wood Johnson Medical School. The lower the score, the greater the atrophy.
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the effect of treatment on the female urogenital health, by means of vaginal pH measurements.
Measurement of the vaginal pH is considered useful, effective, and inexpensive19. Studies have shown that a vaginal pH greater than 5.0 is associated with decreased serum estradiol and menopause. The vaginal pH will be measured with the use of a pH indicator strip and should be sampled from the lateral vaginal wall. This technique is validated. Such strips are available in every clinic.
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the effect of treatment on VVA symptoms (vaginal dryness, vaginal burning, vaginal itching, dyspareunia and dysuria) using the Visual Analog Scale (0-10cm, continuous scale).
For this measurement a continuous Visual Analogue Scale (0-10cm) is used (0 is no pain, 10 is the maximum pain score).
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better).
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the degree of discomfort of the treatment procedure by the patient, by mean of a VAS-score(0-10cm, continuous scale).
For this measurement a continuous Visual Analogue Scale (0-10cm) is used (0 is no pain, 10 is the maximum pain score).
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the degree of difficulty encountered by the physician in performing the treatment, by means of a 5-point Likert scale (1=very difficult, 2=difficult, 3=neutral, 4=easy, 5=very easy).
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the long term satisfaction with, and the longevity of the effect of laser therapy, measured by the need for, and the timing for repeating the same, or initiating an alternative therapy.
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the vaginal wall thickness using in vivo microscopy (vaginal focal depth measurement).
VVA is associated with thinning of the vaginal epithelial layer due to the declining levels of circulating estrogen associated with VVA. Therefore, measurement of the vaginal wall thickness offers an objective measure in the diagnosis and evaluation of VVA and its treatment24. Vaginal focal depth measurements will be performed using the Cytocam-Incident Dark Field device (IDF), a validated technique to quantitatively assess vaginal microcirculation25. As part of the pelvic examination, the handheld device, covered with a sterile disposable cap, will gently be placed into contact with the anterior vaginal wall, 3cm above the hymen, assessing the distance between the subepithelial microcirculation and the epithelial surface in micrometers.
At all clinical visits baseline/study parameters will be assessed before treatment and procedure related outcomes will be assessed after the procedure.
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Effect of treatment, in sexually active patients, on female sexual function, by means of the validated "Female Sexual Function Index" (FSFI) specific questionnaire
The FSFI is a brief, 19-item self-report measure of female sexual function that provides scores on six domains of sexual function as well as a total score. The six domains include: desire (2 items; score range 1-5; factor 0.6; minimum score 1.2; maximum score 6.0), arousal (4 items; score range 0-5; factor 0.3; minimum score 0; maximum score 6.0), lubrication (4 items; score range 0-5; factor 0.3; minimum score 0; maximum score 6.0), orgasm (3 items; score range 0-5; factor 0.4; minimum score 0; maximum score 6.0), satisfaction (3 items; score range 0-5; factor 0.4; minimum score 0; maximum score 6.0), and pain (3 items; score range 0-5; factor 0.4; minimum score 0; maximum score 6.0).
Full Scale Score Range: minimum score 2.0, maximum score 36.0. Higher values represent a better outcome.
Measured: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Aug 2019
- Primary completion27 Sep 2021
- Study completion31 Dec 2021
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 Vulvovaginal AtrophyStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- prof. dr. Jan Deprest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, prof. dr. Jan Deprest, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021966
- Sponsor's protocol ID
- S61680
- Acronym
- CO2VVA
- Status last verified
- Jan 2022
- First submitted
- 9 Jul 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Page AS, Verbakel JY, Verhaeghe J, Latul YP, Housmans S, Deprest J. Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial. BJOG. 2023 Feb;130(3):312-319. doi: 10.1111/1471-0528.17335. Epub 2022 Nov 15.
PubMed 36349391
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04021966
- Acronym / sponsor ID
- CO2VVA / S61680
- Conditions
- Vulvovaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- prof. dr. Jan DeprestUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Jul 2019 (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.
Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women.
Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).
Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Procedure: Vaginal laser applicationIn this arm, participants will have 3 real laser treatments first, followed by 3 consecutive sham treatments. |
| Sham | Sham comparator | Procedure: Vaginal laser applicationIn this arm, participants will have 3 sham treatments first, followed by 3 consecutive real laser treatments. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy women with menopausal status (>1 year amenorrhea) AND with moderate to severe symptoms of VVA as measured by the MBS score ≥2.
Key exclusion criteria (6 listed)
- Acute or recurrent urogenital infections
- Prolapse ≥ grade 3 according to the Pelvic Organ Prolapse Quantification System
- Hormonal replacement therapy within the last 6 months before study entry
- Use of local estrogens, moisturizers, lubricants or homeopathic preparations within the last 3 months
- Pelvic floor physiotherapy for pelvic floor disorders within the last 3 months
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 |
|---|---|---|
| Vaginal laser applicationOne laser treatment cycle consists of 3 vaginal laser applications with a 4-weeks interval. Each application lasts around 5 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. A vaginal probe will be gently inserted and manually rotated to provide a 360° treatment of the vaginal mucosa. | Procedure or surgery | Laser, Sham |
Primary outcome
Primary outcome measure is the change in severity of most bothersome symptom (MBS)
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
The MBS is derived from a selected list of symptoms (consisting of the four most common symptoms of vaginal dryness, vaginal itching/irritation, vaginal soreness and dyspareunia). At baseline, participants are instructed to rate each of these symptoms as not present, mild, moderate or severe and then are asked to select a single symptom among those classified as moderate or severe as the MBS. The MBS is then followed through to the end of treatment, and the change in its severity is used to evaluate symptomatic improvement.
9 secondary outcomes
Assessment of the effect of treatment on the female urogenital health, by means of the globally validated "Vaginal Health Index Score" (VHIS).
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the effect of treatment on the female urogenital health, by means of vaginal pH measurements.
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the effect of treatment on VVA symptoms (vaginal dryness, vaginal burning, vaginal itching, dyspareunia and dysuria) using the Visual Analog Scale (0-10cm, continuous scale).
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better).
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the degree of discomfort of the treatment procedure by the patient, by mean of a VAS-score(0-10cm, continuous scale).
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the degree of difficulty encountered by the physician in performing the treatment, by means of a 5-point Likert scale (1=very difficult, 2=difficult, 3=neutral, 4=easy, 5=very easy).
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the long term satisfaction with, and the longevity of the effect of laser therapy, measured by the need for, and the timing for repeating the same, or initiating an alternative therapy.
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Assessment of the vaginal wall thickness using in vivo microscopy (vaginal focal depth measurement).
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Effect of treatment, in sexually active patients, on female sexual function, by means of the validated "Female Sexual Function Index" (FSFI) specific questionnaire
Time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 36349391Page AS, Verbakel JY, Verhaeghe J, Latul YP, Housmans S, Deprest J. Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial. BJOG. 2023 Feb;130(3):312-319. doi: 10.1111/1471-0528.17335. Epub 2022 Nov 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal laser application in people with Vulvovaginal Atrophy, run by prof. dr. Jan Deprest at 1 site in Belgium.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 10 Jan 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome measure is the change in severity of most bothersome symptom (MBS) (time frame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment). 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 NCT04021966, 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 10 Jan 2022.