AUA 2019: Vaginal Laser Therapy in Today's Urologists' Practice: What Evidence Tells Us? What FDA Warns Patients About?
Vaginal laser treatment is given in three sessions, each of which lasts less than 5 minutes. The three treatments are given at 4-6 week intervals. The procedure is done in the office, with no anesthesia needed. Treatment can be given both internally to the vulva, and externally, to the vestibule.
The most common use of vaginal lasers is for the treatment of genitourinary syndrome of menopause (GSM). Post-menopausal changes of the vagina include epithelial thinning, loss of blood supply, loss of glycogen, decreased elasticity, increased pH and changes in the microbiome. Decreased estrogen affects all domains of female sexual dysfunction, including desire, arousal, lubrication, and pain. After the release of the Women’s Health Initiative study showing an association between hormone replacement therapy and cancer, the use of estrogen for GSM went down significantly. As a result, many women have suffered with GSM and had no treatment options.
In 2010 Co2 lasers were approved by the FDA for several indications but no specific mention of GSM was included in these studies. Therefore, the use of vaginal laser treatment for GSM was considered to be off-label. The first study of laser treatment for GSM was published by Salvatore et al in 2014, and it showed significant improvement in all domains of the Female Sexual Function Index as well as improved sexual satisfaction and general quality of life after treatment. Very few adverse events were reported. These findings were replicated in similar studies, however the studies are heterogeneous in outcome measures, lack control groups, have short follow up, and are generally supported by industry. Therefore, there continues to be a lack of strong evidence to support the use of vaginal laser therapy for GSM. Other reported treatment indications include stress urinary incontinence, vaginal laxity, and vulvodynia, however the studies are lacking in number of subjects and long-term follow up.
Overall vaginal laser therapy appears to be safe with few adverse events. Adverse events that have been reported include vaginal laceration after resumption of intercourse, persistent dyspareunia, and a fibrous band in the vagina. On July 30, 2018 the Food and Drug Administration (FDA) issued a safety communication to patients and health care providers regarding the use of lasers for treatment of genitourinary symptoms of menopause, urinary incontinence, or sexual function. This warning states that the safety and effectiveness of treatment with these lasers has not been established and may be associated with serious adverse events. This was done because laser manufacturers were marketing these treatments to women for a variety of indications that were not supported by data. Dr. Ackerman notes that in the FDA warning the use of vaginal lasers for GSM was equated to its use for “vaginal rejuvenation,” which is considered a cosmetic procedure. However, she notes that GSM is a medical condition which has negative impact on quality of life and therefore the two are not equal. Although more evidence is needed, vaginal lasers show promise as a treatment for GSM, a vitally important health issue for women.
Presented by: A. Lenore Ackerman, MD, Cedars-Sinai Medical Center
Written by: Dena Moskowitz, MD; Assistant Professor of Clinical Urology, University of California Irvine; @demoskowitz at American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois