Laser-Based Devices for Female Genitourinary Indications: Position Statements From the European Society for Sexual Medicine (ESSM)

Abstract

Background Laser-based technologies have been commercially marketed as “wonder treatments” without a sufficient and adequate body of evidence. In addition, on July 30, 2018, the U.S. Food and Drug Administration issued a warning regarding the safety of the use of laser-based devices for the following indications: vaginal “rejuvenation” or cosmetic vaginal procedures, vaginal conditions and symptoms related to menopause, urinary incontinence, and sexual function. Aim To perform a thorough review of the available literature regarding laser-based vaginal devices for the treatment of female genitourinary indications and summarize the results in several short statements according to the level of evidence. Methods A comprehensive review of the literature regarding laser treatments for gynecological indications was performed based on several databases. Eligible were studies that included at least 15 patients. Outcomes Several aspects, including preclinical data, have been investigated. For each topic covered, data on laser-based devices were analyzed. Results Despite the high heterogeneity of studies and its limitations, the committee released several statements regarding the use of laser-based devices for genitourinary indications. Clinical Implications Available data in the clinical setting are still poor, and the impact of these technologies on vaginal symptoms and signs has not been clearly established. Strengths & Limitations All studies have been evaluated by a panel of experts providing recommendations for clinical practice. Conclusion It is too early in the evolution and research of laser-based devices to make decisive recommendations regarding vaginal treatments. There is grave need to carry out randomized controlled trials with proper design for safety reasons, possible harm, and short-/long-term benefits for the different indications studied.

5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)

“…[128][129][130][131][132] The value of local testosterone application and of invasive measures like vaginal laser or hyaluronic acid injections is still unclear. [133][134][135] In summary, gynaecological and sexual symptoms are important challenges for most ABC patients. In particular, even in an anonymous setting, patients are often too shy to report their problems regarding impaired sexual life.…”

Pixel-CO2 laser for the treatment of stress urinary incontinence

“…Professional bodies such as the North American Menopause Society (NAMS) and the International Society for the study of Women’s Sexual Health (ISSWSH) in a consensus recommendation have stated that when treating GSM in women that are high risk for breast cancer, the microablative fractional CO2 laser, or other non-ablative energy-based treatments, can offer a potential advantage over pharmacologic therapies [ 6 ]. Other professional organizations such as the European Society for Sexual Medicine (ESSM) and the International Urogynecological Association (IUGA) issued committee opinions stating that therapeutic advantages of nonsurgical laser-based treatments can only be recommended after robust clinical trials that will demonstrate their short-/long-term benefits and complication profile [ 7 , 8 ].…”

Results of a Phase I-II Study on Laser Therapy for Vaginal Side Effects after Radiotherapy for Cancer of Uterine Cervix or Endometrium

“…Although the exact mechanism of how this type of treatment works is still unknown [27], several studies showed the benefit of laser treatment in menopausal genitourinary syndromes and breast cancer survivors [20]. Unfortunately, these studies included only a small number of patients, did not report on side effects and long-term results and were performed with different types of lasers (CO 2 , erbium) [24]. However, a systematic review described a rapid and statistically significant benefit on vaginal tissues with improved self-reported outcomes and clinical parameters [20].…”

“…Intravaginal laser therapy is a new non-pharmacological treatment successfully proposed especially for the management of symptoms produced by menopausal genital atrophy. Due to the satisfactory efficacy of this treatment, the term "vaginal rejuvenation" has been proposed by some authors [24][25][26][27][28].…”