IUGA weighs in on laser vaginal devices

July 8, 2019

The safety and efficacy of targeting vulvovaginal tissues are the topic of this committee opinion.

The potential benefits, liabilities and efficacy of laser therapy for treating genitourinary syndrome of menopause, vaginal laxity and stress urinary incontinence require further investigation through well-designed, case–control studies.

At least that’s the opinion of the International Urogynecological Association (IUGA) in its International Urogynecology Journal, due to the fact that most of the literature about laser-based devices for these three disorders is observational.

Therefore, “The therapeutic advantages of nonsurgical laser-based devices in urogynecology can only be recommended after robust clinical trials have demonstrated their long-term complication profile, safety, and efficacy,” wrote the IUGA Research and Development Committee.

The two major vaginal lasers are ablative COand nonablative Erbium YAG.

The committee noted that in July 2018 the FDA issued a warning for unsubstantiated advertising and use of energy-based devices. Further, the FDA has yet to clear or approve for marketing any energy-based device to treat these urogynecology symptoms or conditions, or any symptoms related to menopause, urinary incontinence or sexual function, as they may cause serious adverse events like vaginal burns, scarring, pain during sexual intercourse and recurring/chronic pain. 

Unlike lasers being used in plastic surgery on skin and facial tissues, targeting vulvovaginal tissues may cause long-term complications, according to the committee, which proposes perhaps a registry for further study and elucidation.

There was only one published randomized, double-blind, placebo-controlled clinical trial of laser treatment for treating genitourinary syndrome of menopause (GSM) by searching PubMed and EMBASE in May 2018. That trial, along with seven observational studies, found no adverse events and no case needed to be stopped because of patient pain or intolerance.

In all the observational studies, GSM symptoms decreased through the end of follow-up, and the reduction in dyspareunia and dryness were significant up to 18 months in two of the studies. One of the other studies found that after 2 years, 84% of patients achieved improvement in their GSM symptoms.

There was also a significant increase in sexual function in the five observational studies that assessed sexual function.

On the other hand, no evidence-based papers evaluating the safety or efficacy of laser therapy to treat stress urinary incontinence (SUI) were identified.

But observational cohort studies or case series indicate an improvement in the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) scores 1 month after CO2laser for SUI.

In addition, a recent systematic review of 13 studies with 818 patients who underwent laser therapy for SUI, with a follow-up period of up to 6 months for most studies, surmised that such therapy may be a useful, minimally invasive strategy for treating SUI.

“However, our analysis does not allow firm conclusions or recommendations” for SUI, wrote the IUGA committee.

Because there is no literature available about outcomes for energy-based devices predicated on physician specialty or level of training, the committee is unable to make recommendations about provider training or expertise needed to perform laser-based procedures for a given indication. 

Nonetheless, from a medicolegally standpoint, any physician in the United States with a medical license, or their nurse practitioners, can conceivably perform these laser-based procedures. 

The committee also pointed out that in some countries, patients are charged more for energy-based treatments, but that providers should not use these devices for indications lacking scientific evidence. 

Moreover, in July, the American College of Obstetricians and Gynecologists (ACOG) reaffirmed its position statement from 2016 about fractional laser treatment of vulvovaginal atrophy, noting that the FDA has cleared both a fractional CO2 laser and a Q-switched Nd:YAG laser system for several indications, but that “the specific indication for the treatment of vulvovaginal atrophy is not listed.”

Despite initial data indicating potential use of the technology, “additional data clearly are needed to further assess the efficacy and safety of this procedure in treating vulvovaginal atrophy, particularly for long-term benefit,” the statement points out.