The heat is on

Three years ago, we wrote an editorial calling for more research on the use of vaginal lasers in gynecology before widespread adoption took hold¹. Since then, there has been a varied response. On the one hand, there has been a rapid escalation in the global marketing and uptake of lasers for a variety of purposes, often with little control. There has been an increasing range of conditions for which vaginal lasers are claimed to be effective, often with little or no evidence base. Some laser companies appear to be encouraging those purchasing their devices to use them for as wide a range of conditions as possible to maximize laser time and revenue, even if the treatment area is well out of that person’s normal field of practice. On the other hand, we have seen a concerted effort by some sections of the scientific community, supported by some of the laser companies, most notably DEKA (MonaLisa CO2) and Fotona (Erbium:YAG Smooth), to conduct ongoing research to try and establish whether the promising early results and apparent safety of these devices are substantiated. The Vaginal Erbium Laser Academy (VELA) was established to bring together those who use the Er:YAG Smooth laser technology (Fotona) to share their research and experience. This Supplement contains a selection of some of the presentations at their last meeting in October 2019.

Whilst there is an increasing body of evidence to suggest that various forms of thermomodulation can improve various aspects of women’s health, most notably genitourinary syndrome of the menopause (GSM) and stress urinary incontinence, there are many who remain cautious and sceptical about the benefits, safety and appropriateness of this treatment modality. This will only be resolved by the publication of appropriate quality data and suitable governance and guidelines around its application. In our view, there are three specific areas that need addressing: efficacy and cost-effectiveness, long-term safety, and governance around its use including appropriate standards and training.

A number of recent reviews^2–7 have highlighted that, whilst the published results largely show efficacy of laser for either GSM or stress urinary incontinence, the quality of the supporting evidence is still fairly low and, as highlighted in this Supplement, there remain many unanswered questions about the place of vaginal laser in clinical practice. More robust clinical trials and randomized, controlled trials are underway and these results will help to clarify many of these issues. However, even if the efficacy is established, there still needs to be a rational clinical debate about the role of laser. Vaginal estrogens are the gold-standard treatment for vulvovaginal atrophy, which is the principal underlying condition of GSM, and there are now other options such as dehydroepiandrosterone or ospemifene. All of these are well-established, regulated, patient-controlled interventions that are readily available with minimal side-effects and are relatively cheap. Where the standard treatments are contra-indicated, e.g. previous breast cancer, the role of a more invasive and expensive treatment such as laser may be evident. For those with no such contraindications, appropriate guidelines and clinical pathways need to be established. It is necessary to emphasize here that women with vulvovaginal atrophy are not a homogeneous group, and the presentation and severity of the various symptoms within this symptom set can be very diverse with different phenotypes of women.

As clinicians, patient safety is our first priority. Results from the trials to date have shown that the procedure is generally well tolerated with minimal serious adverse effects, but, as already highlighted, the quality of the evidence is low and the studies are almost all short-term. There remains a genuine concern that repeated thermal injury could cause vaginal scarring and long-term pain. The vagina is not the dermis and long-term experience from dermatology cannot be extrapolated to the vagina. The studies to date have been conducted by experienced operators in a controlled manner. Multiple treatment courses and more widespread adoption by less trained individuals may not have comparable results. A few case reports have emerged of more serious complications, and the medical community should remain wary of adopting this technique outside of clinical trials⁸. Recent experience with vaginal mesh tells us that vaginal pain is a very debilitating condition and may not be evident for many years, so high vigilance is required. That does not mean that laser therapy should not be adopted for certain conditions if the evidence supports its use, but it does mean there should be robust processes in place around training those undertaking it, regulating the procedures and maintaining a register of all patients treated.

There is a requirement for international standardization of methodology. Different laser modalities have their own manufacturer’s instructions, but it should be up to clinicians, independently of industry and ideally in conjunction with the relevant professional bodies or specialist societies, to draw up operating standards and guidelines. These should include patient selection, consent, treatment guidelines and protocols, the mandatory collection of outcome data and a registry of patients treated. There also needs to be a focus on training, both in terms of competence and who carries out the procedure. In our opinion, these procedures should only be done by gynecologists or other health professionals who are suitably trained in women’s health. Both vulvovaginal atrophy and stress urinary incontinence are debilitating symptoms that can be part of a wider set of problems and anyone offering laser therapy should have a full understanding of these conditions, the management options available, their potential complications and how to deal with them. Whist the vaginal laser technique itself may seem straightforward, women being offered treatment have the right to be confident that those doing the procedure fully understand the condition they are treating and are suitably trained. In our opinion, there is no place for these vaginal treatments in cosmetic practices or in other professional practices such as dermatology or primary care unless under the direct supervision and responsibility of a gynecologist.

Over the last 6 years since the original publication⁹, vaginal laser treatment has shown promise as a potential treatment of both GSM and mild stress urinary incontinence. Organizations like VELA are setting the right example by trying to pull together the available data and experience of one particular device, but, as shown in this Supplement, there is still a long way to go. Only 35% of registered users of the FotonaSmooth^® responded to a request for information on adverse events. As the data accumulate, it is critical that those advocating laser therapy remain cautious about its potential benefits until robust data are available to support those claims. There is an urgent need for international operating standards, guidelines and training to ensure those using these devices are appropriately trained and collect all their outcome data.

Potential conflict of interest

TCH has done paid consultancy work for Shionogi and has received lecture fees from Theramex and Shionogi. Rossella E. Nappi has had past financial relationships (lecturer, member of advisory boards and/or consultant) with Boehringer Ingelheim, Ely Lilly, Endoceutics, Gedeon Richter, HRA Pharma, Procter & Gamble Co, TEVA Women's Health Inc and Zambon SpA. At present, she has ongoing relationships with Astellas, Bayer HealthCare AG, Exceltis, Fidia, Merck Sharpe & Dohme, Novo Nordisk, Palatin Technologies, Pfizer Inc, Shionogi Limited and Theramex.

Source of funding

TCH's travel and subsistence to attend the VELA meeting were reimbursed by Fotona.