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IMS Menopause Live

Vaginal laser therapy in gynecology practice: a real new option but keep an eye on the scientific data

11 September 2017

The word 'LASER' is an acronym for 'Light Amplification by Stimulated Emission of Radiation'. Laser light energy has been widely used for different medical and surgical indications. Different light sources are available for the laser practitioner. In the last years, a number of publications have appeared and vaginal laser has gained interest as a treatment for genitourinary syndrome of menopause (GSM) and as an option for stress urinary incontinence (SUI) [1-10].

The carbon dioxide (CO2) laser is the first-generation laser for GSM treatment. In 2011, Gaspar and colleagues [1] first demonstrated that vaginal fractional CO2 laser treatment induced a significant improvement in clinical and histological signs of vaginal atrophy. Subsequently, in a pivotal paper, Salvatore and colleagues [2] reported a 12-week study where symptoms were analyzed before and after three sessions (one per month) of fractionated CO2 laser, using a specific, registered technology. This paper opened a new era for non-hormonal treatment of GSM. Other studies confirmed these data, showing morphological changes in vaginal tissues, and the alleviation of the symptoms of dryness and dyspareunia [3], with an improvement in sexual gratification.

In the same years, there were studies of the thermal effects of a non-ablative 2940 nm Erbium:YAG laser, using precisely controlled, sequentially packaged bursts of long pulses (SMOOTH® mode vaginal erbium laser, VEL). The SMOOTH mode is registered and allows the use of full beam and patterned handpieces to deliver Er:YAG laser energy with different fluences to the vaginal tissue. VEL increases the tissue temperature up to the optimal range, but does not exceed the threshold for ablation or tissue damage, leading to significant improvement in GSM [4-7].

Both the microablative fractional CO2 laser and the non-ablative VEL have been repeatedly reported in observational studies to be effective for GSM treatment: vaginal dryness improves in 80–90% of women and dyspareunia in all (100.0%) sexually active women, with clinical changes similar to those induced by local estrogen administration. In addition, VEL treatment induces a deep collagen remodelling and synthesis [3], leading to a reinforcement to correct mild to moderate SUI [8-10]. VEL was reported to improve SUI as well as vaginal prolapse, by assessing the impact on the Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), the PAD test, the post-void residual urine volume and Q-tip angulation [8-10]. After VEL treatment, a reduction of four to six points in the ICIQ-UI score has been reported, with a success in 70–80% of patients [8-10].

Comment

Although data from large randomized trials are not available, the results from observational studies are encouraging, and ablative-pulsed CO2 laser and VEL are now being widely used in clinical practice. Vaginal laser treatment may be appropriate for women who cannot or do not want to be treated with hormones, as well as for women who do not accept long-term use of moisturizers/lubricants because of interference with sexuality. Cohort prospective studies show that both microablative fractional CO2 laser and VEL procedures are effective and safe, if applied with the appropriate parameters, and no serious adverse effects have ever been reported.

For both the first-generation microablative CO2 laser and for the VEL, we have to underline that the majority of the published data were obtained using only two systems [1-10]. There are now some other CO2 and erbium laser systems marketed for the treatment of GSM or SUI using different machines and technologies, without solid efficacy and safety data. Physicians must be aware that specific technologies and different machines may have different effects on tissues, even using the same laser wave lengths. We must require preclinical and clinical studies, demonstrating that any given machine is safe and effective, before claims can be made by the laser producers.

Marco Gambacciani

Department of Obstetrics and Gynaecology, Pisa University Hospital, Pisa, Italy

and

Mauro Cervigni

Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy

References

  1. Gaspar A, Addamo G, Brandi H. Vaginal fractional CO2 laser: a minimally invasive option for vaginal rejuvenation. Am J Cosmetic Surg 2011;28:156-62
    https://doi.org/10.1177/074880681102800309
  2. Salvatore S, Nappi RE, Zerbinati N, et al. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric 2014;17:363-9
    http://www.ncbi.nlm.nih.gov/pubmed/24605832
  3. Sokol ER, Karram MM. An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy. Menopause 2016;23:1102-7
    http://www.ncbi.nlm.nih.gov/pubmed/27404032
  4. Vizintin Z, Lukac M, Kazic M, Tettamanti M. Erbium laser in gynecology, Climacteric 2015;18(Suppl 1):4-8
    http://www.ncbi.nlm.nih.gov/pubmed/26366793
  5. Gambacciani M, Levancini M, Cervigni M. Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause. Climacteric 2015;18:757–63
    http://www.ncbi.nlm.nih.gov/pubmed/26029987
  6. Gaspar A, Brandi H, Gomez V, Luque D. Efficacy of Erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause. Lasers Surg Med 2016;49:160–8
    http://www.ncbi.nlm.nih.gov/pubmed/27546524
  7. Gambacciani M, Levancini M. Vaginal erbium laser as second-generation thermotherapy for the genitourinary syndrome of menopause: a pilot study in breast cancer survivors. Menopause 2017;24:316-19
    http://www.ncbi.nlm.nih.gov/pubmed/28231079
  8. Ogrinc UB, Sencar S, Lenasi H. Novel minimally invasive laser treatment of urinary incontinence in women. Lasers Surg Med 2015;47:689-97
    http://www.ncbi.nlm.nih.gov/pubmed/26388213
  9. Fistonic N, Fistonic I, Gustek SF, et al. Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women--a pilot study. Lasers Med Sci 2016;31:635-43
    http://www.ncbi.nlm.nih.gov/pubmed/26861984
  10. Tien YW, Hsiao SM, Lee CN, Lin HH. Effects of laser procedure for female urodynamic stress incontinence on pad weight, urodynamics, and sexual function. Int Urogynecol J 2016;28:469-76
    http://www.ncbi.nlm.nih.gov/pubmed/27631824