Clinical Review

Energy-based therapies in female genital cosmetic surgery: Hype, hope, and a way forward

OBG Manag. 2019 May;31(5):SS9-SS15

References

Kaplan I, Goldman J, Ger R. The treatment of erosions of the uterine cervix by means of the CO2 laser. Obstet Gynecol. 1973;41:795-796.
Tadir Y, Gaspar A, Lev-Sagie A, et al. Light and energy-based therapeutics for genitourinary syndrome of menopause: consensus and controversies. Lasers Surg Med. 2017;49:137-159.
Gaspar A, Addamo G, Brandi H. Vaginal fractional CO2 laser: a minimally invasive option for vaginal rejuvenation. Am J Cosmetic Surg. 2011;28:156-162.
Salvatore S, Leone Roberti Maggiore U, Athanasiou S, et al. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015;22:845-849.
Benedetto AV. What's new in cosmetic dermatology. Dermatol Clin. 2019;37:117-128.
US Food and Drug Administration. FDA warns against use of energy-based devices to perform vaginal rejuvenation or vaginal cosmetic procedures: FDA safety communication. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm. Accessed April 8, 2019.
Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014;21:1063-1068.
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;25:21-28.
Athanasiou S, Pitsouni E, Grigoradis T, et al. Microablative fractional CO2 laser for the genitourinary syndrome of menopause: up to 12-month results. Menopause. 2019;26:248-255.
Gaspar A, Brandi H, Gomez V, et al. Efficacy of Erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause. Lasers Surg Med. 2017;49:160-168.
Gambacciani M, Levancini M, Russo E, et al. Long-term effects of vaginal erbium laser in the treatment of genitourinary syndrome of menopause. Climacteric. 2018;21:148-152.
Gambacciani M, Levancini M, Cervigni M. Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause. Climacteric. 2015;18:757-763.
Ogrinc UB, Sencar S, Lenasi H. Novel minimally invasive laser treatment of urinary incontinence in women. Lasers Surg Med. 2015;47:689-697.
Okui N. Comparison between erbium-doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence. World J Urol. 2018. doi:10.1007/s00345-018-2445-x.
Blaganje M, Scepanovic D, Zgur L, et al. Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2018;224:153-158.
Haylen BT, Maher CF, Barber MD, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP). Int Urogynecologic J. 2016;27:165-194.
Garcia B, Pardo J. Academic cosmetic gynecology and energy-based therapies: ambiguities, explorations, and the FDA advisories. Int Urogynecol J. 2019;30:1-2.
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;14:215-225.
Shobeiri SA, Kerkhof MH, Minassian VA, et al; IUGA Research and Development Committee. IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J. 2019;30:371-376.
Preti M, Vieira-Baptista P, Digesu GA, et al. The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: an ICS/ISSVD best practice consensus document. Neurourol Urodyn. 2019;38:1009-1023.
Gordon C, Gonzales S, Krychman ML. Rethinking the techno vagina: a case series of patient complications following vaginal laser treatment for atrophy. Menopause. 2019;26:423-427.

Urinary incontinence

The cause of UI is considered to be multifactorial, including disruption in connective tissue supports of the urethrovesical junction leading to urethral hypermobility, pelvic floor muscle weakness, nerve damage to the urethral rhabdosphincter related to pudendal neuropathy or pelvic plexopathy, and atrophic changes of the urethra mucosa and submucosa. Purported mechanisms of action for energy-based therapies designed for treatment of UI relate to direct effects on connective tissue, blood vessels, and possibly nerves.

In 3 clinical trials designed specifically to treat UI with an Er:YAG laser, women showed subjective symptomatic improvement.

Ogrinc and colleagues followed 175 pre- and postmenopausal women with stress UI or mixed UI in a prospective nonrandomized study.¹³ They treated women with an Er:YAG laser for an average of 2.5 (0.5) procedures separated by a 2-month period and performed follow-up assessments at 2, 6, and 12 months after treatment.

After treatment, 77% of women with stress UI had significant improvement in symptoms based on the ICIQ SF and the Incontinence Severity Index (ISI), while only 34% of those with mixed UI had no symptoms at 1-year follow-up. No major adverse effects were noted in either group.

Okui compared the effects of Er:YAG laser treatment with those of tension-free vaginal tape (TVT) or transobturator tape (TOT) sling procedures (n = 50 in each group) in women with stress UI or mixed UI.¹⁴ At 12 months after treatment, all 3 treatments demonstrated comparable improvements in the women with stress UI. Some patients with mixed UI in the TVT and TOT groups showed exacerbation, while all women in the laser-treated group tended to have symptom improvement.

In another recent study, Blaganje and colleagues randomly assigned 114 premenopausal parous women with stress UI to an Er:YAG laser procedure or sham treatment.¹⁵ Three months after treatment, ICIQ-UI SF scores were significantly more improved (P<.001) in the laser-treated group than in the sham group. In addition, 21% of laser-treated patients were dry at follow-up compared with 4% of the sham-treated group.

Key takeaway. While these studies showed promising short-term results for laser treatment of UI, they need to be replicated in appropriately powered clinical trials that include critical subjective and objective outcomes as well as longer-term follow-up for both effectiveness and safety.

Vaginal laxity/pre-prolapse

Vaginal laxity is defined as the symptom of excessive vaginal looseness.¹⁶ Also referred to as “pre-prolapse,” this subjective symptom generally refers to a widened vaginal opening (genital hiatus) but with pelvic organ prolapse that is within the vagina or hymen.¹⁷ Notably, the definition is ambiguous, and rigorous clinical data based on validated outcomes and prolapse grading are lacking.

Krychman and colleagues conducted the first randomized controlled study comparing monopolar radiofrequency at the vaginal introitus with sham therapy for vaginal laxity in 174 premenopausal women, known as the VIVEVE I trial.¹⁸ The primary outcome, the proportion of women reporting no vaginal laxity at 6 months after treatment, was assessed using a vaginal laxity questionnaire, a 7-point rating scale for laxity or tightness ranging from very loose to very tight. With a single radiofrequency treatment, 43.5% of the active group and 19.6% (P = .002) of the sham group obtained the primary outcome.

There were also statistically significant improvements in overall sexual function and decreased sexual distress. The adjusted odds ratio (OR, 3.39; 95% confidence interval, 1.54–7.45) showed that the likelihood of no vaginal laxity at 6 months was more than 3 times greater for women who received the active treatment compared with those who received sham treatment. Adverse events were mild, resolved spontaneously, and were similar in the 2 groups.

Continue to: Outlook for energy-based...

References

Kaplan I, Goldman J, Ger R. The treatment of erosions of the uterine cervix by means of the CO2 laser. Obstet Gynecol. 1973;41:795-796.
Tadir Y, Gaspar A, Lev-Sagie A, et al. Light and energy-based therapeutics for genitourinary syndrome of menopause: consensus and controversies. Lasers Surg Med. 2017;49:137-159.
Gaspar A, Addamo G, Brandi H. Vaginal fractional CO2 laser: a minimally invasive option for vaginal rejuvenation. Am J Cosmetic Surg. 2011;28:156-162.
Salvatore S, Leone Roberti Maggiore U, Athanasiou S, et al. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015;22:845-849.
Benedetto AV. What's new in cosmetic dermatology. Dermatol Clin. 2019;37:117-128.
US Food and Drug Administration. FDA warns against use of energy-based devices to perform vaginal rejuvenation or vaginal cosmetic procedures: FDA safety communication. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm. Accessed April 8, 2019.
Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014;21:1063-1068.
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;25:21-28.
Athanasiou S, Pitsouni E, Grigoradis T, et al. Microablative fractional CO2 laser for the genitourinary syndrome of menopause: up to 12-month results. Menopause. 2019;26:248-255.
Gaspar A, Brandi H, Gomez V, et al. Efficacy of Erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause. Lasers Surg Med. 2017;49:160-168.
Gambacciani M, Levancini M, Russo E, et al. Long-term effects of vaginal erbium laser in the treatment of genitourinary syndrome of menopause. Climacteric. 2018;21:148-152.
Gambacciani M, Levancini M, Cervigni M. Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause. Climacteric. 2015;18:757-763.
Ogrinc UB, Sencar S, Lenasi H. Novel minimally invasive laser treatment of urinary incontinence in women. Lasers Surg Med. 2015;47:689-697.
Okui N. Comparison between erbium-doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence. World J Urol. 2018. doi:10.1007/s00345-018-2445-x.
Blaganje M, Scepanovic D, Zgur L, et al. Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2018;224:153-158.
Haylen BT, Maher CF, Barber MD, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP). Int Urogynecologic J. 2016;27:165-194.
Garcia B, Pardo J. Academic cosmetic gynecology and energy-based therapies: ambiguities, explorations, and the FDA advisories. Int Urogynecol J. 2019;30:1-2.
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;14:215-225.
Shobeiri SA, Kerkhof MH, Minassian VA, et al; IUGA Research and Development Committee. IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J. 2019;30:371-376.
Preti M, Vieira-Baptista P, Digesu GA, et al. The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: an ICS/ISSVD best practice consensus document. Neurourol Urodyn. 2019;38:1009-1023.
Gordon C, Gonzales S, Krychman ML. Rethinking the techno vagina: a case series of patient complications following vaginal laser treatment for atrophy. Menopause. 2019;26:423-427.

Discuss compounded bioidentical hormones and cancer risk

Energy-based therapies in female genital cosmetic surgery: Hype, hope, and a way forward

References

Urinary incontinence

Vaginal laxity/pre-prolapse

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