Laser devices for vaginal rejuvenation: efficacy, regulation and marketing

• Genitourinary syndrome of menopause (GSM) is common and can be treated with over-the-counter vaginal lubricants or vaginal estrogen supplements.

• Atrial energy devices (such as CO₂ laser) are licensed in Canada to treat symptoms of GSM; however, these devices are often marketed for “vaginal rejuvenation,” with claims that they will tighten the vagina, improve sexual function, and treat urinary incontinence .

• Unlike drugs, controlled studies are not required for the approval of many new medical devices, and although several case series have suggested that vaginal energy devices may be effective for GSM or incontinence, recent randomized controlled trials have not shown a benefit .

• The marketing of these devices for vaginal resuscitation and urinary incontinence may not serve the best interests of patients.

In the mid-2010s, atrial energy devices (such as fractional CO₂ laser, erbium doped yttrium aluminum garnet laser [Er:YAG], diode lasers or radiofrequency ablation) have emerged as a new potential treatment for genitourinary syndrome of menopause (GSM). Clinical diagnosis of GSM requires the presence of vaginal symptoms (irritation, reduced lubrication, burning, dyspareunia or discharge) and signs (labial or clitoral atrophy, vaginal dryness, intravaginal stenosis or friable vaginal tissue).1 It is associated with health complications (eg, urinary tract infections, vaginal bleeding, lower urinary tract symptoms), can impair sexual function, and can negatively affect quality of life. About 40%-80% of postmenopausal people have GSM, and only about half discuss their symptoms with a doctor.2 About a third of postmenopausal women with GSM use over-the-counter vaginal lubricants,1 and about one-tenth use vaginal prescription treatments (most often estrogen-based treatments).2 Where do evolving laser resurfacing treatments fit into the spectrum of treatments available to treat GSM?

The North American Menopause Society guideline makes a strong recommendation for over-the-counter products as first-line treatment of GSM and for vaginal estrogen as second-line treatment for patients with moderate to severe GSM.1 In randomized controlled trials of GSM patients, vaginal estrogen treatments (such as vaginal rings, tablets, or creams) are 4-12 times more likely to improve symptoms than placebo, and no differences in efficacy have been observed between these formulations estrogen.3

Vaginal lasers heat the vaginal epithelium and induce thermal necrosis, which induces collagen remodeling and synthesis, neovascularization, and elastin formation. This may lead to improved vaginal elasticity and restoration of premenopausal epithelial function.4 The first atrial energy device was granted a medical device license by Health Canada in 2015 for the treatment of GSM, meaning it was deemed to meet key safety, efficacy and device quality metrics. Unlike drugs, controlled studies are not required for regulatory approval of many new medical devices. After licensing, marketing of the devices discussed the regulators’ “signature” in their direct-to-consumer advertising,5 and the indication of the device was renamed by some providers from the GSM medical condition to providing “vaginal resuscitation”. Vaginal reanimation procedures with energy devices are supposed to tighten the vagina and treat stress urinary incontinence — indications separate from GSM treatment.1^,5

Few high-quality studies support the use of vaginal energy devices for GSM, the most common indication, or for incontinence. For GSM, a systematic review published in 2021 identified 26 studies with 2678 participants who had GSM and were treated with a vaginal laser or energy device.6 Most studies (23 of 26) were prospective or retrospective case series that reported positive outcomes—most commonly an improvement in the Female Sexual Function Index score—with the use of vaginal CO₂ laser; However, the quality of the evidence was low, with a high risk of bias. Three randomized controlled trials with 179 patients showed no significant difference between vaginal laser therapy and vaginal hormone therapy.6 However, a high-quality, sham-controlled randomized trial of 85 patients found that CO₂ Laser treatment did not significantly improve GSM symptoms, quality of life, or sexual function at 12 months, compared with sham treatment. Both groups showed no significant difference in beneficial histological changes on vaginal biopsy.7 The systematic review and randomized trial found no risk of serious adverse events with laser therapy, compared with sham or standard care.6^,7 However, the United States Food and Drug Administration has reported that “vaginal burns, scarring, pain during intercourse, and recurrent/chronic pain” may occur with energy-based vaginal resuscitation.5

A systematic review on the treatment of urinary incontinence with vaginal energy devices (most commonly Er:YAG lasers) identified mostly case series with a high or very high risk of bias.8 Selected studies have shown a small reduction in stress incontinence. However, outcome measures were generally subjective and follow-up periods were short. A randomized, multicenter, sham-controlled clinical trial (n = 101) of a CO₂ The laser device for treating stress incontinence showed no subjective or objective improvement in stress incontinence or difference in adverse events.9 In contrast, numerous randomized controlled trials of pelvic floor therapy or surgery have shown benefits for women with stress incontinence.10

Vaginal laser treatments are offered across Canada, and the 10 most populous cities all have at least 1 provider offering energy-based vaginal rejuvenation procedures. The number of patients paying for these procedures cannot be identified, nor the exact number of vaginal laser systems active in Canada. Direct-to-patient marketing of vaginal lasers is easily found online, and the various benefits of vaginal rejuvenation are listed on provider websites. Patients can self-refer for this service, and the publicly reported cost to providers is thousands of dollars for treatment and maintenance sessions.

Vaginal resuscitation procedures are used to treat urinary incontinence and GSM, as well as for less clear indications (eg, vaginal tightening for better sexual satisfaction), without good evidence that it helps in either of these conditions. For many vagal energy devices, this represents a difference between the licensing of a medical device by Health Canada and how those devices are used and marketed. A procedure with limited high-quality evidence to support its effectiveness and a potential financial conflict of interest for providers may not serve the best interests of people in Canada, even if the risk of adverse events is low.

Health Canada has identified a need to better address medical device regulation. Mandatory reporting of serious incidents with the use of medical devices and the ability to require information on the safety and effectiveness of medical devices from manufacturers represent significant progress in this regard.11 However, there are still limitations to the approval process, such as the lack of a requirement for peer-controlled studies.12 The College of Physicians and Surgeons of Ontario has policies on advertising so that it is accurate and supported by evidence. However, it is unclear whether or how advertising by medical providers is actively monitored by regulators. Better clinical evidence standards are needed for new devices, and regulators should monitor how new medical devices are portrayed to the public.

Patients undergoing energy-based vaginal resuscitation therapy may seek treatment for GSM or urinary incontinence. Their symptoms may not have been properly assessed and they may not have been offered standard evidence-based treatments. Although vaginal energy devices may be a reasonable low-risk intervention in some cases (eg, patients for whom estrogen therapy has been ineffective or contraindicated), they should be evidence-based first-line treatments for most patients with GSM or incontinence before substantial out-of-pocket for interventions with limited high-quality evidence. Providers offering laser energy therapy should carefully consider how the procedure is portrayed in advertisements, and consensus discussions for atrial energy devices should reflect the limitations of the evidence, standard care alternatives, and the limited efficacy of treatment with these devices. devices compared to standard therapies.