"The world of laser vaginal rejuvenation is fast paced, with new companies adding a laser platform nearly each month," write Jessica DeLong, MD, and Jennifer Miles-Thomas, MD.
Jessica DeLong, MD
Jennifer Miles-Thomas, MD
Dr. DeLong and Dr. Miles-Thomas are assistant professors of urology at Eastern Virginia Medical School in Norfolk, VA. They are partners in the Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, a division of Urology of Virginia, PLLC.
Women’s health, and in particular vaginal health, has quickly become a hot topic in urology. The world of laser vaginal rejuvenation is fast paced, with new companies adding a laser platform nearly each month. For urologists, these latest treatments bring many potential opportunities as well as challenges. This article aims to clearly introduce the treatment modalities as well as their indications.
First, let us point out that patients with vaginal symptoms are urology patients. We see them in our practices every day. We will explain how to navigate this market and understand your options.
We as urologists are very comfortable discussing erectile dysfunction and sexual dysfunction in males. We have had years of training, and patients seek us out for our expertise. Vaginal laser therapy is not a treatment for female sexual dysfunction (FSD), per se. The International Society for the Study of Women’s Sexual Health (ISSWSH) has many courses available if you wish to learn more about the pathophysiology and treatment options for FSD. Laser vaginal therapy is a treatment option for a finite number of female vaginal symptoms, the majority of which are treatable in the office.
After menopause, many women suffer from the genitourinary syndrome of menopause (GSM). This constellation of symptoms may include vaginal dryness, vaginal itching, urinary symptoms, pain, and decreased laxity of the vagina, which can cause dyspareunia. These changes may also result in an increased risk of urinary tract infections (Aust N Z J Obstet Gynaecol Oct. 25, 2017 [Epub ahead of print]; JAMA 2017; 317:1388). Therapies for vaginal atrophy include vaginal estrogens, vaginal moisturizers or lubricants, and selective estrogen receptor modulators (SERMs).
Women who have a prior history of hormone-sensitive malignancies are unable or at times unwilling to use vaginal estrogen preparations. Vaginal laser therapy has become a viable alternative treatment option.
The active medium in the laser determines its amplitude and wavelength. In urology, the use of a laser was first described in 1986 but became more frequently utilized in 1990 for removal of benign prostatic tissue (Ther Adv Urol 2011; 3:81-9). We currently use Nd:YAG (neodymium-doped yttrium aluminum garnet), Ho:YAG (holmium:YAG), Thu:YAG (thulium:YAG), CO2 (carbon dioxide) and KTP (potassium titanyl phosphate) lasers commonly in our surgical practices. Laser therapy is not new to urologists, which makes us well suited to expand its use to other indications (figure) (Ther Adv Urol 2011; 3:81-9). In the 1990s and 2000s, research focused on using laser therapy to decrease thermal damage to the epithelium and minimize bleeding (American Journal of Cosmetic Surgery 2012; 29:89-96) as it was applied to vaginal tissue.
Three primary platforms
When assessing the laser vaginal rejuvenation market, we suggest forming your research around both treatment indications and proposed laser mechanism of action. There are currently three basic categories of energy used for this purpose: radio frequency (RF), CO2, and erbium:YAG (Er:YAG) (table).
These three platforms have been utilized to create both ablative and coagulative effects. The proposed mechanism of action of fractionated therapy allows for small areas of tissue ablation and adjacent tissue coagulation. The resultant tissue changes induce an increase in cytokines, which in turn stimulate re-epithelialization, angiogenesis, and stimulation of fibrocytes to become fibroblasts. The remodeling of the vaginal tissues results in the desired changes, including thicker epithelium, increase in lubrication, an increase in collagen, and firmer tissue (Aust N Z J Obstet Gynaecol Oct. 25, 2017 [Epub ahead of print]).
Radiofrequency. RF generally penetrates tissue more deeply and therefore is indicated for vaginal laxity. The frequency is lower with a relatively longer wavelength allowing for deep tissue heating. Several RF platforms are also available that treat GSM, and some advertise for treatment of stress urinary incontinence (SUI) also with a combination of internal and external applicators.
CO2. The CO2 laser is a fractionated laser operating at a wavelength of 10,600 nm. This relatively short wavelength allows for more superficial tissue penetration. The most common indication for laser vaginal therapy is GSM, although companies are also touting efficacy in treating SUI. It can also be used on the vulva and to treat lichen sclerosis (LS).
Erbium. Er:YAG operates at 2,940 nm and is ablative. Different platforms utilize this technology alone or in combination with a diode operating at 1,470 nm (called a hybrid fractional laser). The proposed mechanism of action is similar to CO2 in that neocollagenesis is stimulated; the controlled thermal injury also results in angiogenesis. The erbium platform carries the same indications as CO2, currently being marketed for GSM, LS, and SUI.
Using vaginal laser therapy
All of the laser platforms can be utilized in the office. Typically, a topical anesthetic is applied to the treatment area for 10 to 20 minutes. The laser energy can be applied internally to the epithelium of the vagina through a probe or externally with adaptors. Each treatment takes between 5 and 10 minutes, for a total office visit time of 30 to 45 minutes. Most platforms suggest between three and five treatment sessions for optimal results spaced 4 to 6 weeks apart. There is no downtime following the procedure.
Contraindications for the procedures include active vaginal or urinary tract infection, undiagnosed vaginal or cervical lesions, active genitourinary cancer, and pregnancy (including 3 months following pregnancy). Pelvic organ prolapse greater than stage 2 is considered a relative contraindication. The therapy is not recommended for women with prior mesh prolapse surgery.
Cost to the patient is set by the clinician, as the procedure is not covered by insurance. Some studies have begun to compare the cost of using local hormone creams (as well as pad usage) with the laser treatment. Typical cost to the patient ranges from $800 to $1,250 per treatment depending on the procedure performed and local market; disposables cost to the clinician range from $0 to $250 per session.
Outcomes data and patient counseling
Histologic data exist for all platforms, showing restoration of epithelial and subepithelial structures on biopsy. The majority of data in this field is subjective and questionnaire based. The Female Sexual Function Index (FSFI), International Consultation on Incontinence Modular Questionnaire UI Short Form (ICIQ-UI-SF), Vaginal Health Index Score (VHI-S), and visual analog scale (VAS) for vulvar pain are utilized (Aust N Z J Obstet Gynaecol Oct. 25, 2017 [Epub ahead of print]).
Overall, these energy platforms appear to be safe with intermediate follow-up. The selection of procedure is at this point largely clinician dependent, with all three platforms receiving FDA approval for GSM. For those patients with concomitant SUI, this may offer some improvement over no treatment, although there is a paucity of randomized controlled trials (RCTs). A single double-blind RCT exists for CO2 lasers (n=45) that showed results similar to other available studies for GSM, with no significant adverse events at 20 weeks of follow-up (Menopause 2018; 25:21-8). There are no RCTs looking at SUI.
The majority of data is from small trials (generally 50 patients or fewer), without controls and with follow-up limited to under 1 year. Across multiple studies, the improvement in VHI-S is >80%. Complications are few and generally self-limited, with a minority of patients reporting pain with probe insertion, burning, itching, minor bleeding, and sensation change (Aust N Z J Obstet Gynaecol Oct. 25, 2017 [Epub ahead of print]).
Trials are ongoing to determine longer-term follow-up for GSM and to examine treatment efficacy for SUI. VELAS (Vaginal Erbium Laser Academy Study), an international multicenter study, will hopefully provide the most robust study population yet, looking at 1,500 postmenopausal women with up to 1 year of follow-up.
Cost of acquisition
The cost of a cosmetic laser platform is variable. Depending on the current promotion and the exact laser platform, one should consider an expense of $110,000 to $200,000. Many laser companies have seasonal promotions that may include additional discounts for disposables as well as marketing support.
Words of caution
While vaginal laser therapy represents a very attractive, minimally invasive option for women presenting with GSM and potentially SUI, use caution when counseling your patients. There is a scarcity of RCTs evaluating this therapy for either condition across all three platforms. Histologic exam does seem to confirm positive changes for GSM, and only minor if any adverse events have been reported. Duration of response is unknown. Patient satisfaction with the procedures is high across the board, with early and intermediate follow-up (Int Urogynecol J 2017; 28:681-5), but more study is urgently needed in this quickly expanding field.
Section Editor Christopher M. Gonzalez, MD, MBA, is professor and chairman of urology at University Hospitals Case Medical Center and Case Western Reserve University School of Medicine, Cleveland.