Genitourinary Syndrome of MenopauseNCT03331328
MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
A study testing MonaLisa Touch in people with Genitourinary Syndrome of Menopause, run by Michigan Institution of Women's Health PC at 1 site in United States.
Trial summary
Aim of the study: To assess the efficacy of MonaLisa Touch procedure for the management of genitourinary syndrome of menopause (GSM) in a randomized double-blind placebo controlled study. 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?
- MonaLisa Touch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 10 Jul 2019
- 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
- Postmenopausal dyspareunia or vaginal dryness rated from moderate to severe
- Desirous of sexual function
- Menopausal women with absence of menstruation for at least 12 months or those who have had bilateral oophorectomy
- Presence of vaginal atrophy symptoms based upon the vaginal health index assessment < 15 and vagina pH >5
- Prolapse stage < III, according to the pelvic organ prolapse quantification (POP-Q) system
- No pelvic reconstructive surgery within 6 months prior to treatment
- Understanding and acceptance of the obligation to return for all scheduled follow-up visits
Who cannot join
- History of vaginal carcinoma or dysplasia, history of vaginal or pelvic radiation
- Acute or recurrent genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida)
- Any serious disease, or chronic condition such as uncontrolled diabetes, that could interfere with the study compliance
- Reconstructive pelvic surgery within the past 6 months
- Have used vaginal estrogen cream, ring or tablet within 3 months prior to entering the study
- Have used vaginal moisturizers, lubricants or homeopathic preparations within 30 14 days of therapy
- Not willing to stop use of any vaginal lubricants or estrogen of any form including phytoestrogens such as Estroven
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Urogynecology of Michigan, P.C.
Dearborn, Michigan, 48124
About this study
Aim of the study: To assess the efficacy of MonaLisa Touch procedure for the management of genitourinary syndrome of menopause (GSM) in a randomized double-blind placebo controlled study.
Read the detailed description
Study design: Randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality.
Background: Genitourinary syndrome of Menopause is a condition of postmenopausal women due to estrogen deprivation which results in progressive worsening of the vaginal and vulvar anatomy with symptoms of vulvar itching or pain during intercourse, vaginal dryness, urinary urgency and frequency and frequent bladder infections. It could ultimately lead to vaginal bleeding, petechial hemorrhages, vaginal narrowing or stenosis and hypertonicity of the pelvic muscles due to anticipation of coital pain. The hypertonicity by itself can cause pelvic pressure or pain.
Thus, GSM is a chronic progressive disease state that if left untreated could have dire vaginal and urogynecological consequences.
MonaLisa Touch is a fractional CO2 laser that has been specially designed with the DEKA pulse to stimulate vaginal tissue. It is delivered in a very precise manner and results in the synthesis of collagen and stratification of the vaginal epithelium with improvement of the vaginal pH and moisturization of the vaginal tissue due to increased blood flow and turgidity of the ground substance from the synthesis of the proteoglycans, hyaluronic acid and collagen.
Initial trials on MonaLisa Touch have shown promising results with significant improvement in vaginal exams and patient satisfaction scores.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- MonaLisa Touch
- Keywords
- MonaLisa, Genitourinary syndrome of menopause (GSM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonaLisa TouchDevice
MonaLisa Touch is a fractional CO2 laser that has been specially designed with the DEKA pulse to stimulate vaginal tissue. It is delivered in a very precise manner and results in the synthesis of collagen and stratification of the vaginal epithelium with improvement of the vaginal pH and moisturization of the vaginal tissue due to increased blood flow and turgidity of the ground substance from the synthesis of the proteoglycans, hyaluronic acid and collagen.
| Study group | Role | What they receive |
|---|---|---|
| Control/sham | Sham comparator | The CO2 laser will not be activated but the same procedure of moving the probe inside the vagina in a systematic manner including depressing the foot pedal at similar frequency will be performed. The smoke evacuator will also be activated, laser eye glasses and masks worn by the laser team and the subject. However, the laser will remain in the standby mode. Receives: Device: MonaLisa Touch |
| Treated | Active comparator | Active arm subjects will be treated intravaginally with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm and the smart stack parameter from 1 to 3. For the vulva, the dot power will be reduced to 26 watts, dwell time 800 μs, dot spacing 800 μm and the smart stack parameter of 1. Receives: Device: MonaLisa Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of dyspareunia as rated by a severity score of dyspareunia
Improvement in the most bothersome symptom (MBS) of vulvovaginal atrophy as defined by improvement in dyspareunia. Patients are required to rate the severity of dyspareunia/dryness as none, mild, moderate or severe. The severity score is given a numerical value (none 0, mild 1, moderate 2 and severe 3).
Measured: 1 year
Secondary outcomes (3)
Assess improvement of vaginal dryness as rated by a severity score
Improvement in the most bothersome symptom (MBS) of vulvovaginal atrophy as defined by improvement in vaginal dryness. Patients are required to rate the severity of dyspareunia/dryness as none, mild, moderate or severe. The severity score is given a numerical value (none 0, mild 1, moderate 2 and severe 3).
Measured: 1 year
Assess improvement in irritative bladder symptoms (urgency, frequency, or urination) as rated by a severity score
Improvement in irritative bladder symptoms. Patients are required to rate the severity irritative bladder symptoms of as none, mild, moderate or severe. The severity score is given a numerical value (none 0, mild 1, moderate 2 and severe 3).
Measured: 1 year
Assess improvement in vaginal burning as rated by a severity score
Improvement in the vulvovaginal atrophy symptom of burning as defined by improvement in dyspareunia. Patients are required to rate the severity of dyspareunia/dryness as none, mild, moderate or severe. The severity score is given a numerical value (none 0, mild 1, moderate 2 and severe 3).
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 posted6 Nov 2017
- Study start13 Sep 2017
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
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.
- 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
- Model description
- All subjects will be consented for the study prior to the procedure. They will be made aware of the meaning of case control study. Subjects will be randomized to a treatment or a non-treatment group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan Institution of Women's Health PC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salil Khandwala, Michigan Institution of Women's Health PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331328
- Sponsor's protocol ID
- 1176303
- Status last verified
- Aug 2019
- First submitted
- 31 Aug 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03331328
- Acronym / sponsor ID
- 1176303
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- MonaLisa, Genitourinary syndrome of menopause (GSM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Michigan Institution of Women's Health PCUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 6 Nov 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.
Aim of the study: To assess the efficacy of MonaLisa Touch procedure for the management of genitourinary syndrome of menopause (GSM) in a randomized double-blind placebo controlled study.
Detailed description
Study design: Randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality.
Background: Genitourinary syndrome of Menopause is a condition of postmenopausal women due to estrogen deprivation which results in progressive worsening of the vaginal and vulvar anatomy with symptoms of vulvar itching or pain during intercourse, vaginal dryness, urinary urgency and frequency and frequent bladder infections. It could ultimately lead to vaginal bleeding, petechial hemorrhages, vaginal narrowing or stenosis and hypertonicity of the pelvic muscles due to anticipation of coital pain. The hypertonicity by itself can cause pelvic pressure or pain.
Thus, GSM is a chronic progressive disease state that if left untreated could have dire vaginal and urogynecological consequences.
MonaLisa Touch is a fractional CO2 laser that has been specially designed with the DEKA pulse to stimulate vaginal tissue. It is delivered in a very precise manner and results in the synthesis of collagen and stratification of the vaginal epithelium with improvement of the vaginal pH and moisturization of the vaginal tissue due to increased blood flow and turgidity of the ground substance from the synthesis of the proteoglycans, hyaluronic acid and collagen.
Initial trials on MonaLisa Touch have shown promising results with significant improvement in vaginal exams and patient satisfaction scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All subjects will be consented for the study prior to the procedure. They will be made aware of the meaning of case control study. Subjects will be randomized to a treatment or a non-treatment group.
| Arm | Type | Receives |
|---|---|---|
| Control/sham | Sham comparator | Device: MonaLisa TouchThe CO2 laser will not be activated but the same procedure of moving the probe inside the vagina in a systematic manner including depressing the foot pedal at similar frequency will be performed. The smoke evacuator will also be activated, laser eye glasses and masks worn by the laser team and the subject. However, the laser will remain in the standby mode. |
| Treated | Active comparator | Device: MonaLisa TouchActive arm subjects will be treated intravaginally with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm and the smart stack parameter from 1 to 3. For the vulva, the dot power will be reduced to 26 watts, dwell time 800 μs, dot spacing 800 μm and the smart stack parameter of 1. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal dyspareunia or vaginal dryness rated from moderate to severe
- Desirous of sexual function
- Menopausal women with absence of menstruation for at least 12 months or those who have had bilateral oophorectomy
- Presence of vaginal atrophy symptoms based upon the vaginal health index assessment < 15 and vagina pH >5
- Prolapse stage < III, according to the pelvic organ prolapse quantification (POP-Q) system
Key exclusion criteria (7 listed)
- History of vaginal carcinoma or dysplasia, history of vaginal or pelvic radiation
- Acute or recurrent genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida)
- Any serious disease, or chronic condition such as uncontrolled diabetes, that could interfere with the study compliance
- Reconstructive pelvic surgery within the past 6 months
- Have used vaginal estrogen cream, ring or tablet within 3 months prior to entering the study
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 |
|---|---|---|
| MonaLisa TouchMonaLisa Touch is a fractional CO2 laser that has been specially designed with the DEKA pulse to stimulate vaginal tissue. It is delivered in a very precise manner and results in the synthesis of collagen and stratification of the vaginal epithelium with improvement of the vaginal pH and moisturization of the vaginal tissue due to increased blood flow and turgidity of the ground substance from the synthesis of the proteoglycans, hyaluronic acid and collagen. | Device | Control/sham, Treated |
Primary outcome
Improvement of dyspareunia as rated by a severity score of dyspareunia
Time frame: 1 year
Improvement in the most bothersome symptom (MBS) of vulvovaginal atrophy as defined by improvement in dyspareunia. Patients are required to rate the severity of dyspareunia/dryness as none, mild, moderate or severe. The severity score is given a numerical value (none 0, mild 1, moderate 2 and severe 3).
3 secondary outcomes
Assess improvement of vaginal dryness as rated by a severity score
Time frame: 1 year
Assess improvement in irritative bladder symptoms (urgency, frequency, or urination) as rated by a severity score
Time frame: 1 year
Assess improvement in vaginal burning as rated by a severity score
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 14 Aug 2019.
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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 MonaLisa Touch in people with Genitourinary Syndrome of Menopause, run by Michigan Institution of Women's Health PC at 1 site in United States.
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 7 inclusion and 7 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 14 Aug 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 United States. 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?
Improvement of dyspareunia as rated by a severity score of dyspareunia (time frame: 1 year). 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 14 Aug 2019.