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Trial registered on ANZCTR


Registration number
ACTRN12616001403426
Ethics application status
Approved
Date submitted
19/09/2016
Date registered
10/10/2016
Date last updated
18/06/2019
Date data sharing statement initially provided
18/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the MonaLisa Touch procedure in the treatment of postmenopausal vulvovavaginal symptoms
Scientific title
A double-blinded, randomised, placebo-controlled trial of the efficacy of the MonaLisa Touch procedure for the treatment of postmenopausal vulvovaginal symptoms
Secondary ID [1] 289431 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postmenopausal vulvovaginal symptoms 299111 0
Vulvovaginal symptoms 299112 0
Postmenopausal symptoms 299113 0
Genitourinary syndrome of menopause 299114 0
Condition category
Condition code
Reproductive Health and Childbirth 299137 299137 0 0
Menstruation and menopause
Renal and Urogenital 300193 300193 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MonaLisa Touch (MLT) procedure involves the superficial application of fractionated CO2 laser, to the vaginal mucosa by a specifically designed vaginal probe. The 5 minute treatment claims to 'rejuvenate' the mucosa and reverse postmenopausal vulvovaginal symptoms. Patients will receive the typical treatment course, which will consist of 3 treatments, each at least 4 weeks apart. These treatments will be performed by a suitably qualified gynaecologist.

Topical anaesthetic (2.5g of 4% lignocaine cream) will be applied the vulva for a minimum for 30 minutes. The treatment involves slow insertion of the vaginal probe into the vagina until it reaches the cervix or vaginal vault. The laser is set at dot power 40 watt, dwell time 1000 microseconds, dot spacing 1000 micrometres, smart stack parameter 2 and emission mode DP. The laser will then be activated as it is withdrawn to provide complete treatment of the vaginal walls. Energy is applied to vaginal walls in a pattern pre-determined by perforations in the probe matrix which covers the laser probe, allowing for even-spacing of energy and preventing treatment of confluent areas. Furthermore, a mirror at the end of the probe angled at 45 degrees protects the cervix from treatment. The duration of the procedure is anticipated to be approximately 5 minutes.

Adherence will be monitored by in-person attendance.
Intervention code [1] 295022 0
Treatment: Devices
Comparator / control treatment
The control group will undergo the same treatment setup as in the intervention group, including application of topical anaesthetic, insertion and incremental withdrawal of the probe down the vagina. For the placebo treatment, laser will be set at lowest energy settings of 0.5W, dwell time of 100 microseconds, spacing of 2000 micrometres, smart stack of 1 and emission mode smart pulse.
Control group
Placebo

Outcomes
Primary outcome [1] 298612 0
Visual analogue scale (VAS) score of the most severe postmenopausal vulvovaginal symptom- intensity of symptoms including vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria
Timepoint [1] 298612 0
At screening consultation, first treatment, second treatment (4 weeks after first), third treatment (8 weeks after first), follow-up consultation 3-months after last-treatment, and follow-up consultation 12-months after first-treatment.
Secondary outcome [1] 324762 0
Level of procedural pain/discomfort, assessed using a visual analogue scale.
Timepoint [1] 324762 0
After first treatment, second treatment (4 weeks after first treatment) and third treatment (8 weeks after first treatment).
Secondary outcome [2] 324763 0
Overall satisfaction with the procedure, assessed using a 5-point Likert scale.
Timepoint [2] 324763 0
At follow-up consultation, 3-months after final treatment.
Secondary outcome [3] 324764 0
Procedural complication rates, such as vaginal bleeding, infection, pain, and vaginal discharge.
These are reported by the patient to the practitioner, or the practitioner's observations.
Timepoint [3] 324764 0
After first treatment, second treatment (4 weeks after first treatment) and third treatment (8 weeks after first treatment).
Secondary outcome [4] 327814 0
Assessment of Quality of Life - 6D (AQoL-6D) Scores - 6 dimensions
Timepoint [4] 327814 0
Before and after treatment course
Secondary outcome [5] 327815 0
Vaginal Health Index Scores (VHIS) - based on vaginal elasticity, fluid volume, pH, epithelial integrity and moisture
Timepoint [5] 327815 0
At screening consultation, first treatment, second treatment, third treatment, follow-up consultation 3-months after last-treatment, and follow-up consultation 12-months after first-treatment.
Secondary outcome [6] 327816 0
Occurrence of adverse events since previous visit, assessed by symptom and scored on severity (mild, moderate, severe), noting treatment required (none, concomitant medication required, other), outcome (resolved, ongoing, other), duration (hours, days, weeks) and relationship to study (no relation to definite relation, or unknown).
Timepoint [6] 327816 0
At first treatment, second treatment, third treatment, follow-up consultation 3-months after last-treatment, and follow-up consultation 12-months after first-treatment.
Secondary outcome [7] 371670 0
Histological assessment of vaginal skin at baseline (taken on the right side of the vagina 3cm above the hymenal remnant) and repeated at the 6 monthly assessment on the left side of the vagina (3cm above the hymenal remnant) following the completion of the intervention by laser or placebo. Histological assessment will be completed in a blinded fashion by a suitably qualified histopathologist unaware of the group the woman is randomised to, or the order of the assessments (baseline or 6 months).
Timepoint [7] 371670 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Symptomatic women with any of 1-5:
1. Post-menopausal women who have not had a menstrual period for at least 12 months (with an intact uterus) and/or have vulvovaginal symptoms substantial enough for them to present to their health care provider due to symptoms
2. Women who have previously trialled topical intra-vaginal oestrogen preparations without alleviation of symptoms or with side effects to the treatment
3. Women who have contraindications to topical intra-vaginal oestrogen preparations.
4. Women who have previously had a hysterectomy and have vaginal atrophy symptoms and have an elevation of FSH (>30) consistent with a post-menopausal state.
5. Women who have symptoms of vaginal atrophy and do not wish to use topical oestrogen.

AND have symptoms including one or more of: vaginal dryness; vaginal burning; vaginal itching; dyspareunia or dysuria.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of systemic or local hormone replacement therapy in the six months prior to study intervention
2. Use of vaginal moisturisers or other preparations in the 30 days prior to study intervention.
3. Current urinary tract infection.
4. Active genital infections.
5. Current genital herpes infection.
6. Pelvic organ prolapse (most substantial prolapse) POPQ system stage 2.
7. Previous vaginal prolapse surgery where there is mesh repair in the pelvis.
8. Chronic disease states which will interfere with compliance to study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Third-party telephone randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation block
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5966 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 13388 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 293806 0
Charities/Societies/Foundations
Name [1] 293806 0
Australasian Gynaecological Endoscopy & Surgery Society Limited
Address [1] 293806 0
YRD Event Management
PO Box 717 Indooroopilly
QLD 4068 AUSTRALIA
Country [1] 293806 0
Australia
Primary sponsor type
University
Name
GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia
Address
Locked bag 2000
Barker St
Randwick, 2031 NSW
Country
Australia
Secondary sponsor category [1] 292638 0
None
Name [1] 292638 0
None
Address [1] 292638 0
n/a
Country [1] 292638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295239 0
South Eastern Sydney Local Health District EC00134
Ethics committee address [1] 295239 0
Room G71 East Wing
Edmund Blackett Building
Prince of Wales Hospital
High St
RANDWICK NSW 2031
Ethics committee country [1] 295239 0
Australia
Date submitted for ethics approval [1] 295239 0
27/11/2015
Approval date [1] 295239 0
30/05/2016
Ethics approval number [1] 295239 0
15/330

Summary
Brief summary
Vulvovaginal symptoms affect up to 50% of post-menopausal women. Thinning of the vaginal lining following the sudden drop of oestrogen post-menopause potentiates symptoms such as vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria, which cause significant discomfort and impact the livelihoods of many women and their partners.
First line treatments include topical vaginal moisturisers, lubricants and hormonal therapies; oestrogen hormone replacement therapy is indicated for systemic symptoms. However, patient compliance and efficacy are varied and limited, and some groups, namely women with a history of breast cancer or blood clots, are contraindicated to use of hormonal therapies.

MonaLisa Touch (MLT) is a non-hormonal treatment of the vaginal lining, applying pin-point laser energy aiming to restore the skin to pre-menopausal state. The treatment is 5 minutes and claims to provide relief for vulvovaginal symptoms. Rapid uptake and FDA approval of the MLT procedure have proceeded on the basis of limited scientific evidence - only 2 prospective cohort studies, of a 12 week study period, exist to date.
Therefore, it is necessary to produce high-quality scientific evidence, with a long-term follow-up of patients, to effectively determine the safety and efficacy of the MLT procedure in relieving vulvovaginal symptoms in post-menopausal women. This study is a randomised, double-blinded trial with a 12 month follow-up period, to evaluate the efficacy of intra-vaginal fractional carbon dioxide treatment for the treatment of post-menopausal vulvovaginal symptoms.

The study will enrol a minimum of 78 patients, who will undergo three treatments, at least 4 weeks apart. Clinical follow-up will continue for a minimum of 12 months after the initial treatment with assessors blinded to the initial treatment type. Treatment outcomes will include: symptom intensity, Vaginal Health Index scores, Quality of Life scores, vaginal skin histology, treatment discomfort, treatment acceptability and treatment complications.
Data from this study will allow patients and practitioners to make a more informed decision regarding treatment of these symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66342 0
A/Prof Jason Abbott
Address 66342 0
School of Women's and Children's Health
Level 1, Royal Hospital for Women
Barker Street
Randwick NSW 2031
Country 66342 0
Australia
Phone 66342 0
(+61) 491231771
Fax 66342 0
Email 66342 0
j.abbott@unsw.edu.au
Contact person for public queries
Name 66343 0
A/Prof Jason Abbott
Address 66343 0
School of Women's and Children's Health
Level 1, Royal Hospital for Women
Barker Street
Randwick NSW 2031
Country 66343 0
Australia
Phone 66343 0
(+61) 491231771
Fax 66343 0
Email 66343 0
j.abbott@unsw.edu.au
Contact person for scientific queries
Name 66344 0
A/Prof Jason Abbott
Address 66344 0
School of Women's and Children's Health
Level 1, Royal Hospital for Women
Barker Street
Randwick NSW 2031
Country 66344 0
Australia
Phone 66344 0
(+61) 491231771
Fax 66344 0
Email 66344 0
j.abbott@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Summary results
No Results