New Australian MonaLisa TouchTM clinical trial

Marianne_BCNAMarianne_BCNA Administrator Posts: 70

MonaLisa TouchTM (MLT) is a new, non-hormonal treatment for women with vaginal atrophy (VA).

Vaginal atrophy most commonly occurs after menopause, when oestrogen levels fall and the walls of the vagina become thinner, drier and may become inflamed. VA also affectS women who have had breast cancer, where medications affect oestrogen levels and bring on menopausal symptoms. This often distressing condition can cause painful burning, itching, dryness, painful intercourse and pain during urination.

MLT is a type of fractional CO2 laser technology treatment which involves pin-point laser applications to the vaginal lining. At present, there is not enough evidence about the effectiveness of MonaLisa TouchTM for it to be recommended as a medical treatment. It is currently expensive to access and there is no Medicare rebate available. This article provides an interesting overview of fractional CO2 therapy for vaginal atrophy.

University of NSW Associate Professor Jason Abbott (a gynaecologist and obstetrician) is currently running a clinical trial in Australia which will evaluate how effective MonaLisa TouchTM is in treating postmenopausal VA symptoms in women with a history of breast cancer.

The study is being conducted in Sydney.

You can read more about the trial on our Clinical trials for women who have completed active treatment webpage. 

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Comments

  • ZoffielZoffiel Regional VictoriaMember Posts: 1,167
    Thanks Marianne. I'd register for that but, of course, being out in the sticks in another state I can't. 

    It takes a certain degree of confidence, or desperation, to agree to have ones vagina lasered, but it would be excellent if they had a big enough sample to establish if this treatment works. VA is one of the less recognised side effects of cancer treatment. I'd go to considerable trouble and expense to restore some semblance of my previous sex life if I thought the treatment would work.
  • mum2jjmum2jj Member Posts: 3,124
    Shame I live so far away, otherwise would be very interested.
  • MKitty68MKitty68 Member Posts: 260
    edited February 6
    I would also be very interested in being a part of this, however I am in Brisbane, a shame someone here couldn't do the same. 
    In Brisbane these treatments are in the vicinity of $2,000 for the three treatments
  • DeanneDeanne Sunshine Coast QldMember Posts: 1,938
    edited February 6
    Yes, I agree @MKitty68. I had to drive to Kedron for treatment from the Sunshine Coast as otherwise there was a waiting list for nearly 6 months locally. It cost $1800 for 3 treatments and gynaecologist reduced her fee to $450 for a further 2 treatments. I am on Femara which caused atrophy within the first 6 months. 
  • AfraserAfraser MelbourneMember Posts: 1,273
    Interesting. Like @zoffiel I am wary about lasering my vagina, but would also like to see some more research done. I too have little doubt that Femara has been instrumental in the problem, which like @Deanne manifested itself within 6 months of starting hormonal treatment. 
  • mum2jjmum2jj Member Posts: 3,124
    @Deanne, how well did it work for you? @Afraser I don’t know if Fe area is solely to blame. I am triple neg and can’t take any of those drugs but did do chemo twice in 18mths and have vaginal atrophy. I think the chemopause has a lot to do with it too. 
    Hugs ladies. 
    Paula x
  • DeanneDeanne Sunshine Coast QldMember Posts: 1,938
    edited February 7
    It improved things Paula, @mum2jj, but not back to completely normal. I was fine after chemo and for 2 years on Tamoxifen but having ovaries out at 49 and then 6 months on Femara seemed to be the problem for me. It was very sudden.
    Deanne xxx
  • Jane221Jane221 Central Coast, NSWMember Posts: 902
    Thanks for this Marianne, I'm definitely going to see if I can be involved as this is an issue that plagues me. Jane xx
  • AfraserAfraser MelbourneMember Posts: 1,273
    I was way past the menopause before cancer and before starting Femara - yes, it could be age related, but it's too much of a coincidence that I had no issue whatsoever, including during chemo, before starting Femara and non functional 6 months later!  I accept it as part of the treatment, and have simply worked around it, but It's still one of the side effects that isn't spoken too much about by oncologists and clearly can cause a lot of angst at an already difficult time for many women.
  • mum2jjmum2jj Member Posts: 3,124
    edited February 7
    @Afraser maybe mine was just too much chemo in a short span of time. Who knows, mine was certainly a slower onset than you femera ladies. The only plus side is that being triple neg I can use (reluctantly) vagifem pessaries which have helped with the UTI’s I was plagues with and the dryness. @Deanne are you going to have more treatments ?  I agree it is something never mentioned by my oncologist as a side effect. @Jane221it will be great if you can get involved. Keep us posted as to what’s involved. Maybe I should plan a few more trips to Sydney. 
    Hugs all. 
    Paula x
  • DeanneDeanne Sunshine Coast QldMember Posts: 1,938
    I hope to keep up with the maintenance treatments @mum2jj. I think it has helped to avoid issues like UTI’s etc. I think that without being on Femara the results would be much better and last longer between treatments. While many women do suffer from these issues who are not on hormonal treatment for bc, the incidence is much higher if you are. I think I read something like 40% compared to 60%. 

     I did discuss my issues with my oncologist but she said pessaries are not something she would want me to try unless the situation was much worse. Then she has had women who use them for short periods of time. I definitely don’t want to compromise my recurrence chances! It seems that the laser treatment is my best option. I think it has helped.
    Deanne xxx
  • AfraserAfraser MelbourneMember Posts: 1,273
    I too was interested (temporarily) in the vagifem pessaries and my oncologist was guardedly OK about trying them, but then I read the list of potential side effects on the product website! As with chemo, I am accustomed to a scary list and recognising this is just a list of possibilities and may never happen, but given existing conditions I went off the idea of using the product fairly quickly. 
  • mum2jjmum2jj Member Posts: 3,124
    I hear you both. If my cancer was not triple neg I would not go near them, ha unfortunately said that I don’t know what I would have done as I was getting a UTI every two to three weeks it was an awful time. I wish Mona Lisa was more affordable. Paula x
  • Jane221Jane221 Central Coast, NSWMember Posts: 902
    Hi, just a quick update: I have applied to participate in the trial and got a lovely email back from Prof Abbott. Looks like I might be eligible (yay!) but still need to go through the screening process etc. It is a 12 month study which uses a randomised trial method to determine the effectiveness of the Mona Lisa treatment (MLT) compared to a placebo. Participants will be randomly placed into groups and then either being put into the MLT group or a placebo group. Participants won't know which group they're in during the study as the procedures (biopsies / vaginal examinations / use of the MLT device etc) will all look the same - they just don't switch on the laser for the placebo group :) 

    A total of 3 treatments will be performed with a 4 week break in between. Participants will be assessed 4 weeks after each treatment and then 6 months after the final one to find out what changes may / may not have happened. If the MLT procedure is found to be successful then women in the placebo group will have the opportunity to have a 3 treatment course for free, following the completion of the study.

    Hopefully the results of the study will show MLT to be successful and a possible therapy for those of us that can't use oestrogen hormone creams etc. If the trial shows the therapy to be helpful then there will be good evidence to lobby to have the procedure available through Medicare, to make it more affordable, as those of us that have looked into this before have baulked at the expense, especially on top of so many other financial hits because of treatment.

    Will let you know if I'm accepted and how things go. Jane xx
  • SoldierCrabSoldierCrab Bathurst NSW Member Posts: 1,636
    @Jane221 can you please post this into the Lets talk about Vaginas group ....
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