Evaluation of the MonaLisa Touch procedure in the treatment of postmenopausal vulvovavaginal symptoms
A double-blinded, randomised, placebo-controlled trial of the efficacy of the MonaLisa Touch procedure for the treatment of postmenopausal vulvovaginal symptoms
GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia
78 participants
Sep 19, 2016
Interventional
Conditions
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.
Eligibility
Inclusion Criteria7
- Symptomatic women with any of 1-5:
- 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
- Women who have previously trialled topical intra-vaginal oestrogen preparations without alleviation of symptoms or with side effects to the treatment
- Women who have contraindications to topical intra-vaginal oestrogen preparations.
- 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.
- 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.
Exclusion Criteria8
- Use of systemic or local hormone replacement therapy in the six months prior to study intervention
- Use of vaginal moisturisers or other preparations in the 30 days prior to study intervention.
- Current urinary tract infection.
- Active genital infections.
- Current genital herpes infection.
- Pelvic organ prolapse (most substantial prolapse) POPQ system stage 2.
- Previous vaginal prolapse surgery where there is mesh repair in the pelvis.
- Chronic disease states which will interfere with compliance to study
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Interventions
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.
Locations(1)
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ACTRN12616001403426