Do Vaginas Need Rejuvenating?

Laser therapy for vaginal rejuvenation is a hot (and profitable) intervention.  

Lasers themselves are alluring.  They hold a promise of more power than anything we can do for ourselves. In health care, they have many uses – some with good evidence, others not.  The use of lasers for improving circulation and tissue health in the vagina is a growing trend.  Is it more than an expensive, flashy, placebo?

A British morning show did an expose with a live demonstration1.  What is the attraction and what bring women to pay roughly $1200/visit for vaginal laser treatments?  

Women are seeking help for:
Vaginal dryness
Painful intercourse
Vaginal skin irritation
Appearance

Some women experience uncomfortable symptoms from the hormonal changes that occur with peri-menopause and menopause. The lasers are promoted to women as a non-hormonal treatment to restore vaginal tissue hydration and mobility.  They are also promoted as a way to change the appearance of the labia and make the tissues “more firm” as a “Laser of Youth” for lady bits. 

I am left with many questions:
Is it beneficial for women to seek an eternal youthful appears to their labia for a self-esteem perspective?

What are the long-term effects for the tissues?

Does laser therapy live up to the claims? 

Is the effect the same or better as the hormonal therapy and/or topical ointments currently used to relieve these problems?

We don’t know the answers to these questions because there is no evidence supporting the claims, and there is evidence showing little change in the tissues following treatment.

Laser therapy as a treatment modality for genitourinary syndrome of menopause: A critical appraisal was published in January of 2017 on the current evidence on the treatment of vulvovaginal atrophy. 2 Neither the Mona Lisa (CO2 laser) or the Yr:YEG near infrared laser have undergone testing compared to a placebo and none of the studies found by the authors in their literature review used any control group.   The 220 women included in the review completed symptoms questionnaires as the measure of effectiveness.  There were no negative effects and the treatments are considered safe.  What we don’t know is if the laser treatment is the reason for the improvement.


I applaud the authors for recommending a placebo-controlled trial. 

They found no studies have been done on the lasers and that the term Genitourinary Syndrome of menopause (GSM) includes a variety of symptoms that have different causes and treatment options.  This paper addresses the older term “vulvovaginal atrophy” which included vaginal dryness and irritation – subjective symptoms most commonly treated with hormonal therapy and/or topical ointments.

Treatment typically is three 5-10 min sessions, administered 4 – 6 weeks apart.

The authors report that “some participants <in the literature> show improvement after one treatment procedure while some show improvement after 2 – 3 treatment procedures.” 2 It is important to note that what is improved, by how much, and how that is determined is not defined.

220 women are included in the review. There are no RCTs and the review included 3 case series without control groups.  The paper refers to “subjective cure rates” based on participant self-report on questionnaires.  The studies followed up for only three months, and no long-term data is available.  The authors concluded, “Lasers have become a very expensive option for the treatment of symptomatic GSM, without a single trial comparing active laser treatment to placebo”2

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The two types of laser included in this review are Mona Lisa (CO2) and ER:YEG (near infra-red).  The Mona Lisa laser is ablative, and the ER:YEG is non-ablative. There are no other substatantive differences. This treatment is not covered by insurance (remember, there are no RCTs showing effectiveness and there is no long-term data) and costs between $1000 - $1500/visit.2 The Mona Lisa is a CO2 laser designed to stimulate and promote the regeneration of collagen fibers and to restore hydration and elasticity within the vaginal mucosa. The Er: YAG  is a laser with a wavelength of 2,940 nm, which emits laser energy in the mid-infrared region. This laser has 10 to 15 times the affinity for water absorption than the CO2 laser at a wavelength of 10,600 nm. This treatment approach enables a deeper secondary thermal effect and controlled heating of the target mucous membrane of the vaginal wall.

These lasers have been cleared for clinical use by the FDA and are being marketed both to healthcare practitioners and to consumers.  The women seeking this treatment for pain are desperate for help.  This puts the burden of proof of effectiveness and efficacy firmly on the providers. It is also important to point out that we do not know if it is effective long-term, or if it is more than an expensive placebo.  It MAY be effective!

What is the harm?  At this point, the harm is two-fold:

1)   The cost is a burden for the person in need.

2)   The person in need is IN Need.  This is not vanity treatment; this is to fill a need for comfort (in order to move without pain, rubbing, dryness) and self-confidence.

My hesitancy as a health care provider in promoting this option is that we do not have a placebo-controlled study, and we do not know the long-term effects.  It may be that this is a much-needed relief and a viable treatment.  Without a large, long-term, randomized, placebo-controlled study to assess safety and efficacy we do not know.  Is this better than low-dose local hormones for tissue health?  Is this better than a combination of hormones and moisturizers for dryness?  We don’t know. 
What role with the new selective estrogen receptor modulator play (SERM)?  We don’t know.

How many times can I say “We do not know”? One more!

An additional problem is with definitions and that leads to a challenge in determining effectiveness.

What is normal in the aging vagina? 

Is aging a pathology or something to be adapted to?

Define “improved” in these studies – would that carry over as a predictive value for another person?

 

My hope is that these authors continue to study and continue to push for the independent placebo-controlled randomized trial (a straightforward study design).  For women considering the procedure, I urge caution and clear discussions with your healthcare team for all your choices.  The jury is still out on this one.

 

Sandy Hilton, PT, DPT, MS

 

 

1. http://metro.co.uk/2017/09/20/woman-undergoes-designer-vagina-surgery-on-live-tv-its-visibly-different-6942159/ Accessed 15 January 2018.

2. Arunkalaivanan, A, Kaur, H Onuma, O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: A critical appraisal.Int Urogynelcol J January 19, 2017.