Clinical Review

The techno vagina: The laser and radiofrequency device boom in gynecology

OBG Manag. 2018 September;30(9):40-46

References

ACOG Committee on Gynecologic Practice. ACOG Committee Opinion No. 378: Vaginal "rejuvenation" and cosmetic vaginal procedures. Obstet Gynecol. 2007;110(3):737-738.
Dunbar SW, Goldberg DJ. Radiofrequency in cosmetic dermatology: an update. J Drugs Dermatol. 2015;14(11):1229-1238.
Leibaschoff G, Izasa PG, Cardona JL, Miklos JR, Moore RD. Transcutaneous temperature-controlled radiofrequency (TTCRF) for the treatment of menopausal vaginal/genitourinary symptoms. Surg Technol Int. 2016;29:149-159.
Alinsod RM. Temperature controlled radiofrequency for vulvovaginal laxity. Prime J. July 23, 2015. https://www.prime-journal.com/temperature-controlled-radiofrequency-for-vulvovaginal-laxity/. Accessed August 15, 2018.
Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: nonsurgical vaginal tightening. J Sex Med. 2010;7(9):3088-3095.
Alinsod RM. Transcutaneous temperature controlled radiofrequency for orgasmic dysfunction. Lasers Surg Med. 2016;48(7):641-645.
Sekiguchi Y, Utsugisawa Y, Azekosi Y, et al. Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy. J Womens Health (Larchmt). 2013;22 (9):775-781 .
Krychman M, Rowan CG, Allan BB, et al. Effect of single-treatment, surface-cooled radiofrequency therapy on vaginal laxity and female sexual function: the VIVEVE I randomized controlled trial. J Sex Med. 2017;14(2):215-225.
Kaptchuk TJ, Goldman P, Stone DA, Statson WB. Do medical devices have enhanced placebo effects? J Clin Epidemiol. 2000;53(8): 786-792.
Gotkin RH, Sarnoff SD, Cannarozzo G, Sadick NS, Alexiades-Armenakas M. Ablative skin resurfacing with a novel microablative CO2 laser. J Drugs Dermatol. 2009;8(2):138-144.
Behnia-Willison F, Sarraf S, Miller J, et al. Safety and long-term efficacy of fractional CO2 laser treatment in women suffering from genitourinary syndrome of menopause. Eur J Obstet Gynecol Reprod Biol. 2017;213:39-44.
Pagano T, De Rosa P, Vallone R, et al. Fractional microablative CO2 laser in breast cancer survivors affected by iatrogenic vulvovaginal atrophy after failure of nonestrogenic local treatments, a retrospective study. Menopause. 2018;25(6):657-662.
Anthanasiou S, Pitsouni E, Antonopoulou S, et al. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climateric. 2016;19(5):512-518.
Cruz VL, Steiner ML, Pompei LM, et al. Randomized, double-blind placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25(1): 21-28.
Vizintin Z, Rivera M, Fistonic I, et al. Novel minimally invasive VSP Er:YAG laser treatments in gynecology. J Laser Health Acad. 2012;2012(1):46-58.
Tien YM, Hsio SM, Lee CN, Lin HH. Effects of laser procedure for female urodynamic stress incontinence on pad weight, urodynamics, and sexual function. Int Urogynecol J. 2017;28(3):469-476.
Oginc UB, Sencar S, Lenasi H. Novel minimally invasive laser treatment of urinary incontinence in women. Laser Surg Med. 2015;47(9):689-697.
US Food and Drug Administration. FDA warns against use of energy based devices to perform vaginal 'rejuvenation' or vaginal cosmetic procedures: FDA safety communication. July 30, 2018. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm. Accessed August 16, 2018.
The American College of Obstetricians and Gynecologists. Fractional laser treatment of vulvovaginal atrophy and US Food and Drug Administration clearance: position statement. May 2016. https://www.acog.org/Clinical-Guidance-and-Publications/Position-Statements/Fractional-Laser-Treatment-of-Vulvovaginal-Atrophy-and-US-Food-and-Drug-Administration-Clearance. Accessed August 16, 2018.
The North American Menopause Society. FDA mandating vaginal laser manufacturers present valid data before marketing. August 1, 2018. https://www.menopause.org/docs/default-source/default-document-library/nams-responds-to-fda-mandate-on-vaginal-laser-manufacturers-08-01-2018.pdf. Accessed August 16, 2018.

Laser technology devices

Laser (Light Amplification by Stimulated Emission of Radiation) therapy, which uses a carbon dioxide (CO2), argon, YAG, or erbium energy source, also is currently marketed as a method to improve various gynecologic conditions, including genital pelvic relaxation syndrome, vaginal laxity, GSM, lichen sclerosus, and sexual problems such as dyspareunia and arousal or orgasmic disorders.

The CO2 laser therapy device, such as the MonaLisa Touch (DEKA Laser), appears to be very popular and widely available. It delivers fractional CO2 laser energy to the vaginal wall, creating sequential micro traumas that subsequently undergo a healing reaction; the newly healed area has an improved underlying tissue architecture (but at a superficial level). The laser’s proposed mechanism of action is that it ablates only a minute fraction of the superficial lamina propria; it acts primarily to stimulate rapid healing of the tissue, creating new collagen and elastic fibers. There is no evidence of scarring.¹⁰

Treatment outcomes with laser device therapy

Authors of a 2017 study series of CO2 laser treatments in women with moderate to severe GSM found that 84% of participants experienced significant improvement in sexual function, dyspareunia, and otherwise unspecified sexual issues from pretreatment to 12 to 24 months posttreatment.¹¹ These findings are consistent with several other case series and provide supportive evidence for the efficacy and safety of CO2 laser therapy. This technology may be appropriate for the treatment of GSM.

Laser technology shows excellent promise for the treatment of GSM symptoms by virtue of its superficial mechanism of action. In addition, several trials have demonstrated efficacy and safety in breast cancer patient populations.¹² This is particularly interesting since breast cancer treatments, such as aromatase inhibitors (considered a mainstay of cancer treatment), can cause severe atrophic vaginitis. Breast cancer survivors often avoid minimally absorbed local vaginal hormonal products, and over-the-counter products (moisturizers and lubricants) are not widely accepted. Hence, a nonhormonal treatment for distressing GSM symptoms is welcomed in this population.

Pagano and colleagues recently studied 82 breast cancer survivors in whom treatment with vaginal moisturizers and lubricants failed.¹² Participants underwent 3 laser treatment cycles approximately 30 to 40 days apart; they demonstrated improvements in vaginal dryness, vaginal itchiness, stinging, dyspareunia, and reduced sensitivity.

Microablative fractional CO2 laser may help reestablish a normative vaginal microbiome by altering the prevalence of lactobacillus species and reestablishing a normative postmenopausal vaginal flora.¹³

The tracking and reporting of adverse events associated with laser procedures has been less than optimal. In my personal clinical experience, consequences from both short- and long-term laser treatments have included vaginal canal agglutination, worsening dyspareunia, and constricture causing vaginal hemorrhage.

Cruz and colleagues recently conducted a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of fractional CO2 laser compared with topical estriol and laser plus estriol for the treatment of vaginal atrophy in 45 postmenopausal women.¹⁴ They found statistically significant differences in dyspareunia, dryness, and burning compared with baseline levels in all 3 treatment groups. Results with the fractional CO2 laser treatment were deemed to be similar to those of the topical estriol and the combined therapy.¹⁴

By contrast, an erbium (Er):YAG laser, such as the IntimaLase (Fotona, LLC) laser, functions by heating the pelvic tissue and collagen within the introitus and vaginal canal.^15,16 When the underlying collagen is heated, the fibers are thought to thicken and shorten, which may result in immediate contracture of the treated tissue. Additionally, this process stimulates the existing collagen to undergo remodeling and it also may cause neocollagen deposition.¹⁵ In a general review of gynecologic procedures, after 1 to 4 treatment sessions (depending on the study), most patients reported improved sexual satisfaction or vaginal tightness.¹⁵

Although trials have included small numbers of patients, early evidence suggests some lasers with reportedly deeper penetration may be useful for treatment of vaginal laxity, but further studies are needed. In smaller studies, the Er:YAG laser has shown efficacy and safety in the treatment of stress urinary incontinence and improved lower urinary tract symptoms, quality of life, and sexual function.^16,17

Insurance does not cover energy-based treatment costs

Currently, both laser and radiofrequency device treatments are considered fee-for-service interventions. Radiofrequency and laser treatments for gynecologic conditions are not covered by health insurance, and treatment costs can be prohibitive for many patients. In addition, the long-term safety of these treatments remains to be studied further, and the optimal time for a repeat procedure has yet to be elucidated.

References

ACOG Committee on Gynecologic Practice. ACOG Committee Opinion No. 378: Vaginal "rejuvenation" and cosmetic vaginal procedures. Obstet Gynecol. 2007;110(3):737-738.
Dunbar SW, Goldberg DJ. Radiofrequency in cosmetic dermatology: an update. J Drugs Dermatol. 2015;14(11):1229-1238.
Leibaschoff G, Izasa PG, Cardona JL, Miklos JR, Moore RD. Transcutaneous temperature-controlled radiofrequency (TTCRF) for the treatment of menopausal vaginal/genitourinary symptoms. Surg Technol Int. 2016;29:149-159.
Alinsod RM. Temperature controlled radiofrequency for vulvovaginal laxity. Prime J. July 23, 2015. https://www.prime-journal.com/temperature-controlled-radiofrequency-for-vulvovaginal-laxity/. Accessed August 15, 2018.
Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: nonsurgical vaginal tightening. J Sex Med. 2010;7(9):3088-3095.
Alinsod RM. Transcutaneous temperature controlled radiofrequency for orgasmic dysfunction. Lasers Surg Med. 2016;48(7):641-645.
Sekiguchi Y, Utsugisawa Y, Azekosi Y, et al. Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy. J Womens Health (Larchmt). 2013;22 (9):775-781 .
Krychman M, Rowan CG, Allan BB, et al. Effect of single-treatment, surface-cooled radiofrequency therapy on vaginal laxity and female sexual function: the VIVEVE I randomized controlled trial. J Sex Med. 2017;14(2):215-225.
Kaptchuk TJ, Goldman P, Stone DA, Statson WB. Do medical devices have enhanced placebo effects? J Clin Epidemiol. 2000;53(8): 786-792.
Gotkin RH, Sarnoff SD, Cannarozzo G, Sadick NS, Alexiades-Armenakas M. Ablative skin resurfacing with a novel microablative CO2 laser. J Drugs Dermatol. 2009;8(2):138-144.
Behnia-Willison F, Sarraf S, Miller J, et al. Safety and long-term efficacy of fractional CO2 laser treatment in women suffering from genitourinary syndrome of menopause. Eur J Obstet Gynecol Reprod Biol. 2017;213:39-44.
Pagano T, De Rosa P, Vallone R, et al. Fractional microablative CO2 laser in breast cancer survivors affected by iatrogenic vulvovaginal atrophy after failure of nonestrogenic local treatments, a retrospective study. Menopause. 2018;25(6):657-662.
Anthanasiou S, Pitsouni E, Antonopoulou S, et al. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climateric. 2016;19(5):512-518.
Cruz VL, Steiner ML, Pompei LM, et al. Randomized, double-blind placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25(1): 21-28.
Vizintin Z, Rivera M, Fistonic I, et al. Novel minimally invasive VSP Er:YAG laser treatments in gynecology. J Laser Health Acad. 2012;2012(1):46-58.
Tien YM, Hsio SM, Lee CN, Lin HH. Effects of laser procedure for female urodynamic stress incontinence on pad weight, urodynamics, and sexual function. Int Urogynecol J. 2017;28(3):469-476.
Oginc UB, Sencar S, Lenasi H. Novel minimally invasive laser treatment of urinary incontinence in women. Laser Surg Med. 2015;47(9):689-697.
US Food and Drug Administration. FDA warns against use of energy based devices to perform vaginal 'rejuvenation' or vaginal cosmetic procedures: FDA safety communication. July 30, 2018. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm. Accessed August 16, 2018.
The American College of Obstetricians and Gynecologists. Fractional laser treatment of vulvovaginal atrophy and US Food and Drug Administration clearance: position statement. May 2016. https://www.acog.org/Clinical-Guidance-and-Publications/Position-Statements/Fractional-Laser-Treatment-of-Vulvovaginal-Atrophy-and-US-Food-and-Drug-Administration-Clearance. Accessed August 16, 2018.
The North American Menopause Society. FDA mandating vaginal laser manufacturers present valid data before marketing. August 1, 2018. https://www.menopause.org/docs/default-source/default-document-library/nams-responds-to-fda-mandate-on-vaginal-laser-manufacturers-08-01-2018.pdf. Accessed August 16, 2018.

The techno vagina: The laser and radiofrequency device boom in gynecology

References

Laser technology devices

Treatment outcomes with laser device therapy

Insurance does not cover energy-based treatment costs

Pages

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