Genitourinary Syndrome of MenopauseNCT03288883
RCT of Laser Therapy for GSM
A study testing Photothermal Non-ablative Erbium:YAG-laser and Fractional Microablative CO2-laser in people with Genitourinary Syndrome of Menopause, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with… 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
- What is being tested?
- Photothermal Non-ablative Erbium:YAG-laser and Fractional Microablative CO2-laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2018to 11 Feb 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
- Dryness and dyspareunia with moderate to severe intensity
- Vaginal Health Index <15
- Absence of menstruation for at least 12 months
- Recent Negative Pap-smear test (For women over 65 years old a negative pap smear test up to the age of 65).
Who cannot join
- Not willing to abstain from vaginal intercourse for one week following the laser-therapy
- Use of hormonal therapy within 6 months prior to study inclusion (systemic or local)
- Acute urinary tract infections (UTIs)
- History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
- Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
- Active or history of genital herpes
Show all 9Show fewer
- Prolapse stages > II (according to the POP-Q system)
- History of radiotherapy for cervical or uterine cancer
- Medical condition that may interfere with participants' compliance to the protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Urogynaecology Department, King's College Hospital
London, SE5 9RS
About this study
Official title: Fractional Microablative CO2-laser Versus Photothermal Non-ablative Erbium:YAG-laser for the Management of Genitourinary Syndrome of Menopause: A Non-inferiority, Single-blind Randomised Controlled Trial
The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
Read the detailed description
Genitourinary Syndrome of Menopause (GSM) is the new terminology for "vulvovaginal (VVA)". Although women may present with some or all of the clinical signs and symptoms, the most common symptom of VVA/GSM is vaginal dryness. Vaginal dryness appears early at menopause with a subsequent increase of prevalence as postmenopausal years' progresses and is associated with rising occurrence of lower urinary tract symptoms (LUTS).
The therapeutic management of GSM includes lubricants and moisturizers as a first line therapy and low-dose vaginal estrogens as a second one, especially for women with a history of estrogen dependent cancer. However, lubricants and moisturizers can only be used for symptoms relief during sexual intercourse. They do not restore the local pathophysiology and they are inefficacious when LUTS are present. However, the quality of evidence is low or very-low when estrogens efficacy is compared to placebo, while the risk to the endometrial thickness with sustained vaginal estrogen use is not clear.
Recently, intravaginal laser therapy has been proposed for the management of GSM. There are currently two lasers available. All available studies consistently suggest that both lasers (CO2-laser and Er:YAG-laser) are safe and have a high efficacy on alleviating vaginal dryness and dyspareunia, as well as restoring the local pathophysiology. Additionally, data regarding CO2-laser indicate LUTS improvement, as well as sexual function-satisfaction and quality of women's life. Relevant published data are not available for the Er:YAG-laser. Moreover, there is lack of studies comparing the 2 laser-technologies for the management of postmenopausal women with GSM.
The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Photothermal Non-ablative Erbium:YAG-laser, Fractional Microablative CO2-laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photothermal Non-ablative Erbium:YAG-laserDevice
Laser treatment of the vagina for GSM
Fractional Microablative CO2-laserDevice
Laser treatment of the vagina for GSM
| Study group | Role | What they receive |
|---|---|---|
| Fractional Microablative CO2-laser | Active comparator | Not described Receives: Device: Fractional Microablative CO2-laser |
| Photothermal Non-ablative Erbium:YAG-laser | Active comparator | Not described Receives: Device: Photothermal Non-ablative Erbium:YAG-laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dryness - 10cm visual analogue scale
Measured: 1 year
Dyspareunia- 10cm visual analogue scale
Measured: 1 year
Itching- 10cm visual analogue scale
Measured: 1 year
Burning- 10cm visual analogue scale
Measured: 1 year
Dysuria- 10cm visual analogue scale
Measured: 1 year
Frequency- 10cm visual analogue scale,
Measured: 1 year
Urgency-10cm visual analogue scale
Measured: 1 year
Urinary incontinence- 10cm visual analogue scale
Measured: 1 year
Overall sexual satisfaction- Female sexual function index
Measured: 1 year
Frequency- 3 day voiding diary
Measured: 1 year
Urgency- 3 day voiding diary,
Measured: 1 year
Urinary incontinence- 3 day voiding diary
Measured: 1 year
Overall sexual satisfaction- 10cm visual analogue scale
Measured: 1 year
Overall sexual satisfaction- frequency of sexual intercourse,
Measured: 1 year
Secondary outcomes (8)
Quality of life- patients global impression of improvement questionnaire
Measured: 1 year
Quality of life- day to day impact of vaginal ageing questionnaire
Measured: 1 year
Quality of life- kings health questionnaire
Measured: 1 year
Global impression of improvement- day to day impact of vaginal ageing questionnaire
Measured: 1 year
Global impression of improvement- patients global impression of improvement questionnaire
Measured: 1 year
Global impression of improvement- kings health questionnaire
Measured: 1 year
Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume
Measured: 1 year
Vaginal maturation value- vaginal smear stained with papanicolaou technique and VMI value is evaluated by defining the percentage of superficial, intermediate and paranasal epithelial cells on smear.
VMV = ((1x%superficial)+(0.5x%intermediate)+0xparabasal))
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Jul 2018
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
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 King's College Hospital NHS TrustThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandra Hospital, Athens, Greece
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288883
- Sponsor's protocol ID
- RCTGSM
- Status last verified
- Feb 2021
- First submitted
- 7 Sep 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Microablative CO2-laser Versus Photothermal Non-ablative Erbium:YAG-laser for the Management of Genitourinary Syndrome of Menopause: A Non-inferiority, Single-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03288883
- Acronym / sponsor ID
- RCTGSM
- Conditions
- Genitourinary Syndrome of Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Alexandra Hospital, Athens, Greece
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 20 Sep 2017 (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.
The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
Detailed description
Genitourinary Syndrome of Menopause (GSM) is the new terminology for "vulvovaginal (VVA)". Although women may present with some or all of the clinical signs and symptoms, the most common symptom of VVA/GSM is vaginal dryness. Vaginal dryness appears early at menopause with a subsequent increase of prevalence as postmenopausal years' progresses and is associated with rising occurrence of lower urinary tract symptoms (LUTS).
The therapeutic management of GSM includes lubricants and moisturizers as a first line therapy and low-dose vaginal estrogens as a second one, especially for women with a history of estrogen dependent cancer. However, lubricants and moisturizers can only be used for symptoms relief during sexual intercourse. They do not restore the local pathophysiology and they are inefficacious when LUTS are present. However, the quality of evidence is low or very-low when estrogens efficacy is compared to placebo, while the risk to the endometrial thickness with sustained vaginal estrogen use is not clear.
Recently, intravaginal laser therapy has been proposed for the management of GSM. There are currently two lasers available. All available studies consistently suggest that both lasers (CO2-laser and Er:YAG-laser) are safe and have a high efficacy on alleviating vaginal dryness and dyspareunia, as well as restoring the local pathophysiology. Additionally, data regarding CO2-laser indicate LUTS improvement, as well as sexual function-satisfaction and quality of women's life. Relevant published data are not available for the Er:YAG-laser. Moreover, there is lack of studies comparing the 2 laser-technologies for the management of postmenopausal women with GSM.
The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional Microablative CO2-laser | Active comparator | Device: Fractional Microablative CO2-laser |
| Photothermal Non-ablative Erbium:YAG-laser | Active comparator | Device: Photothermal Non-ablative Erbium:YAG-laser |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Dryness and dyspareunia with moderate to severe intensity
- Vaginal Health Index <15
- Absence of menstruation for at least 12 months
- Recent Negative Pap-smear test (For women over 65 years old a negative pap smear test up to the age of 65).
Key exclusion criteria (9 listed)
- Not willing to abstain from vaginal intercourse for one week following the laser-therapy
- Use of hormonal therapy within 6 months prior to study inclusion (systemic or local)
- Acute urinary tract infections (UTIs)
- History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
- Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
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 |
|---|---|---|
| Photothermal Non-ablative Erbium:YAG-laserLaser treatment of the vagina for GSM | Device | Photothermal Non-ablative Erbium:YAG-laser |
| Fractional Microablative CO2-laserLaser treatment of the vagina for GSM | Device | Fractional Microablative CO2-laser |
Primary outcome
Dryness - 10cm visual analogue scale
Time frame: 1 year
Dyspareunia- 10cm visual analogue scale
Time frame: 1 year
Itching- 10cm visual analogue scale
Time frame: 1 year
Burning- 10cm visual analogue scale
Time frame: 1 year
Dysuria- 10cm visual analogue scale
Time frame: 1 year
Frequency- 10cm visual analogue scale,
Time frame: 1 year
Urgency-10cm visual analogue scale
Time frame: 1 year
Urinary incontinence- 10cm visual analogue scale
Time frame: 1 year
Overall sexual satisfaction- Female sexual function index
Time frame: 1 year
Frequency- 3 day voiding diary
Time frame: 1 year
Urgency- 3 day voiding diary,
Time frame: 1 year
Urinary incontinence- 3 day voiding diary
Time frame: 1 year
Overall sexual satisfaction- 10cm visual analogue scale
Time frame: 1 year
Overall sexual satisfaction- frequency of sexual intercourse,
Time frame: 1 year
8 secondary outcomes
Quality of life- patients global impression of improvement questionnaire
Time frame: 1 year
Quality of life- day to day impact of vaginal ageing questionnaire
Time frame: 1 year
Quality of life- kings health questionnaire
Time frame: 1 year
Global impression of improvement- day to day impact of vaginal ageing questionnaire
Time frame: 1 year
Global impression of improvement- patients global impression of improvement questionnaire
Time frame: 1 year
Global impression of improvement- kings health questionnaire
Time frame: 1 year
Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume
Time frame: 1 year
Vaginal maturation value- vaginal smear stained with papanicolaou technique and VMI value is evaluated by defining the percentage of superficial, intermediate and paranasal epithelial cells on smear.
Time frame: 1 year
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 12 Feb 2021.
- Individual participant dataSharing planned: No
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.
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 Photothermal Non-ablative Erbium:YAG-laser and Fractional Microablative CO2-laser in people with Genitourinary Syndrome of Menopause, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 9 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 12 Feb 2021. 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 United Kingdom. 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. 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?
Dryness - 10cm visual analogue scale (time frame: 1 year). The study lists 14 primary outcomes in all. 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 12 Feb 2021.