By: Dena Moskowitz, MD | Posted on: 01 Feb 2021
The genitourinary syndrome of menopause (GSM) is a common condition affecting more than half of postmenopausal women. Symptoms include vaginal dryness, dysuria, urinary urgency/frequency and recurrent urinary tract infections. The mainstay of treatment for GSM is local hormone replacement, most commonly with estradiol creams or inserts. Vaginal laser therapies (VLTs) provide an additional option for women to treat these bothersome symptoms that can severely affect quality of life and overall health. They are thought to act by inducing microtrauma to encourage collagen formation, angiogenesis and thickening of the vaginal epithelium. Treatments are typically performed in the office, with 3 short procedures separated by 4 to 6 weeks each.
Common types of lasers used for the treatment of GSM are the fractional CO2 (ablative) laser and the Er:YAG (nonablative) laser. Although these technologies have received U.S. Food and Drug Administration (FDA) approval for use in incision, ablation and coagulation of soft tissues, including in the genitourinary system, their initial marketing and use were targeted at consumers as a treatment for “vaginal rejuvenation.” In addition, manufacturers encouraged their use in many genitourinary conditions, including vaginal laxity and stress urinary incontinence, without evidence to show their efficacy. “Vaginal rejuvenation” is an unfortunate term used to describe treatment of GSM, giving VLTs a reputation akin to cosmetic surgery. With their increased use over the last 5 years, and as a result of some reported adverse effects, the FDA subsequently issued a safety communication in 2018 to alert consumers and health care providers that the use of VLTs for the purpose of “vaginal rejuvenation” has not been thoroughly evaluated.1
In response to the 2018 FDA safety communication, several national and international associations have published committee opinions and statements regarding the use of VLTs in genitourinary conditions. A committee opinion from the International Urogynecological Association in 2018 suggested that VLTs have promise in the treatment of GSM but require more robust clinical trials to recommend their routine use.2 A best practice statement by the International Society for the Study of Vulvovaginal Disease and the International Continence Society in 2018 noted a lack of evidence to support the routine use of VLTs in the treatment of GSM.3 More recently, a clinical consensus statement was published by the American Urogynecologic Society in May 2020.4 Perhaps in consideration of studies published in the last several years, this group found that VLTs have promise in the treatment of GSM, with benefits lasting up to 1 year. In regard to safety, it was noted that VLTs have a favorable profile but that the long-term sequelae of treatment are unknown.
Although the intention of the FDA safety communication was to protect consumers from predatory marketing, the actual effect may have been to limit treatment choices for women with GSM by creating an unwarranted fear regarding the safety of VLTs. A review of the literature as well as the Manufacturer and User Facility Device Experience (MAUDE) and Bloomberg Law databases revealed that the safety communication was lacking evidence to demonstrate the danger of these devices.5 More specifically, the authors observed that in many studies the “adverse events” described these were actually found to be a lack of treatment effect, such as dyspareunia. In addition, the information provided in the studies was insufficient to determine if the events were truly representative of device related harm.
As urologists, the treatment of GSM is a standard part of our practice, and clinicians should be knowledgeable regarding the use of VLTs. Although there is a general consensus that more robust clinical data are needed to support the long-term efficacy and safety of VLTs in the treatment of GSM, the 2018 FDA safety communication should not be interpreted to mean that the treatments are highly likely to cause harm. To the contrary, the evidence for their use in GSM shows good short-term safety and efficacy without strong evidence of serious adverse events. The questions regarding which patients represent the best candidates for treatment, the ideal number of treatments and treatment intervals and the long-term safety and efficacy have yet to be answered. Therefore, the routine use of VLTs should not be recommended for GSM, but their use in clinical trials as well as use by qualified and knowledgeable physicians has the potential to help many women experiencing GSM. The technology is currently being used by many different clinicians, ranging from plastic surgeons to aesthetic based nurse practitioners, with little knowledge of the female genitourinary tract. As urologists, we should continue to stay at the forefront of research in the use of VLTs for GSM.