IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity
- 36 Downloads
This committee opinion reviews the laser-based vaginal devices for treatment of genitourinary syndrome of menopause, vaginal laxity, and stress urinary incontinence. The United States Food and Drug Administration has issued a warning for unsubstantiated advertising and use of energy-based devices. Well-designed case–control studies are required to further investigate the potential benefits, harm, and efficacy of laser therapy in the treatment of genitourinary syndrome of menopause, vaginal laxity, and stress urinary incontinence. The therapeutic advantages of nonsurgical laser-based devices in urogynecology can only be recommended after robust clinical trials have demonstrated their long-term complication profile, safety, and efficacy.
KeywordsLaser Energy-based devices Genitourinary syndrome of menopause Vaginal laxity Stress urinary incontinence FDA
The authors would like to thank Dr. Veronica Mallet (2017 committee member) and Dr. Pallavi Latthe (2018-2019 committee chair) for their invaluable contributions to this manuscript.
Compliance with ethical standards
Conflicts of interest
- 2.FDA. FDA warns against use of energy-based devices to perform vaginal 'rejuvenation' or vaginal cosmetic procedures: FDA Safety Communication. 2018. [2018 August 1].Google Scholar
- 4.American-College-of-Plastic-Surgeons. Nonsurgical vaginal rejuvenation. 2018. [29 October 2018]. Available from: https://www.plasticsurgery.org/cosmetic-procedures/nonsurgical-vaginal-rejuvenation.
- 6.Portman DJ, ML G. 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;21:1063–8.CrossRefPubMedGoogle Scholar
- 8.Moore RD, Miklos JR, O C. Evaluation of sexual function outcomes in women undergoing vaginal rejuvenation/vaginoplasty procedures for symptoms of vaginal laxity/decreased vaginal sensation utilizing validated sexual function questionnaire (PISQ-12). Surg Technol Int. 2014;24:253–60.PubMedGoogle Scholar
- 11.Millheiser L, Kingsberg S, Pauls R. A cross-sectional survey to assess the prevalence and symptoms associated with laxity of the vaginal introitus [abstract 206]. In: ICS Annual Meeting. Toronto, Ontario, Canada; 2010.Google Scholar
- 18.Isaza PG, Jaguszewska K, Cardona JL, Lukaszuk M. Long-term effect of thermoablative fractional CO2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopause. Int Urogynecol J. 2018;29(2):211–5.Google Scholar
- 28.Cruz VL, Steiner ML, Pompei LM, Strufaldi R, Fonseca FLA, Santiago LHS, 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):21–8.Google Scholar
- 31.Cardozo L. Fractional microablative CO2-laser versus photothermal non-ablative erbium:YAG-laser for the management of genitourinary syndrome of menopause: a non-inferiority, single-blind randomised controlled trial https://clinicaltrials.gov/ct2/show/NCT03288883?cond=gsm&rank=32018. Available from: https://clinicaltrials.gov/ct2/show/NCT03288883?cond=gsm&rank=3. Accessed 26 Nov 2018.
- 37.Fistonic I, et al. Laser treatment of early stages of stress urinary incontinence significantly improves sexual life. In: Annual Conference of European Society for Sexual Medicine. 2012.Google Scholar
- 40.Pergialiotis V, et al. A systematic review on vaginal laser therapy for treating stress urinary incontinence: do we have enough evidence? Int Urogynecol J. 2017.Google Scholar
- 41.FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for vaginal rejuvenation. 2018. (cited 2018 August 1).Google Scholar