Efficacy and Safety of Non-Ablative Dual Wavelength Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Single-Center Prospective Study.
Diode laser
Genitourinary syndrome of menopause
Menopause
Sexual function
Vaginal atrophy
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
29 Oct 2024
29 Oct 2024
Historique:
received:
05
08
2024
accepted:
16
09
2024
medline:
29
10
2024
pubmed:
29
10
2024
entrez:
29
10
2024
Statut:
aheadofprint
Résumé
This study evaluates the efficacy and safety of non-ablative diode laser therapy for genitourinary syndrome of menopause (GSM) in post-menopausal women unable to use hormonal therapies. A pilot prospective study was conducted from September 2023 to April 2024, involving 22 post-menopausal women aged 45-73 years. Participants underwent three sessions of diode laser treatment with the Leonardo Significant improvements were observed in VHIS, increasing from 12 to 19.27 at 6 months (p < 0.001). GSM symptoms improved significantly: vaginal dryness scores decreased from 7.72 ± 2.37 to 3.72 ± 2.53, burning sensation scores dropped from 6.00 ± 3.22 to 1.90 ± 1.81, and dyspareunia scores reduced from 8.09 ± 2.11 to 3.90 ± 2.58 (all p < 0.016). Sexual function improved, indicated by FSFI-6 scores increasing from 12.27 ± 7.29 to 19.30 ± 6.24 (p < 0.016) and SQOL-F scores rising from 63.18 ± 22.93 to 71.45 ± 23.31. No adverse events were reported. Non-ablative diode laser therapy is effective and safe for managing GSM symptoms in post-menopausal women, offering significant symptom relief and enhancing sexual health without serious side effects. Further research with a larger cohort and extended follow-up is needed to confirm these findings. Clinical Trials ID NCT06503003.
Identifiants
pubmed: 39470875
doi: 10.1007/s12325-024-03004-7
pii: 10.1007/s12325-024-03004-7
doi:
Banques de données
ClinicalTrials.gov
['NCT06503003']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.
Références
Portman DJ, Gass MLS. 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(10):1063–8. https://doi.org/10.1097/GME.0000000000000329 .
doi: 10.1097/GME.0000000000000329
pubmed: 25160739
Vitale SG, Laganà AS, Noventa M, et al. Transvaginal bilateral sacrospinous fixation after second recurrence of vaginal vault prolapse: efficacy and impact on quality of life and sexuality. Biomed Res Int. 2018;2018:5727165. https://doi.org/10.1155/2018/5727165 .
doi: 10.1155/2018/5727165
pubmed: 29675427
pmcid: 5851336
Vitale SG, Caruso S, Rapisarda AMC, et al. Biocompatible porcine dermis graft to treat severe cystocele: impact on quality of life and sexuality. Arch Gynecol Obstet. 2016;293(1):125–31. https://doi.org/10.1007/S00404-015-3820-0 .
doi: 10.1007/S00404-015-3820-0
pubmed: 26193956
Palacios S, Nappi RE, Bruyniks N, et al. The European Vulvovaginal Epidemiological Survey (EVES): prevalence, symptoms and impact of vulvovaginal atrophy of menopause. Climacteric. 2018;21(3):286–91. https://doi.org/10.1080/13697137.2018.1446930 .
doi: 10.1080/13697137.2018.1446930
pubmed: 29553288
Kagan R, Kellogg-Spadt S, Parish SJ. Practical treatment considerations in the management of genitourinary syndrome of menopause. Drugs Aging. 2019;36(10):897–908. https://doi.org/10.1007/S40266-019-00700-W .
doi: 10.1007/S40266-019-00700-W
pubmed: 31452067
pmcid: 6764929
Vitale SG, Angioni S, D’Alterio MN, et al. Risk of endometrial malignancy in women treated for breast cancer: the BLUSH prediction model—evidence from a comprehensive multicentric retrospective cohort study. Climacteric. 2024;27(5):482–488. https://doi.org/10.1080/13697137.2024.2376189 .
doi: 10.1080/13697137.2024.2376189
pubmed: 39023103
Townsend MK, Curhan GC, Resnick NM, et al. Postmenopausal hormone therapy and incident urinary incontinence in middle-aged women. Am J Obstet Gynecol. 2009;200(1):86.e1. https://doi.org/10.1016/J.AJOG.2008.08.009 .
doi: 10.1016/J.AJOG.2008.08.009
pubmed: 19019333
Vitale SG, Riemma G, Haimovich S, et al. Risk of endometrial cancer in asymptomatic postmenopausal women in relation to ultrasonographic endometrial thickness: systematic review and diagnostic test accuracy meta-analysis. Am J Obstet Gynecol. 2023;228(1):22-35.e2. https://doi.org/10.1016/J.AJOG.2022.07.043 .
doi: 10.1016/J.AJOG.2022.07.043
pubmed: 35932873
Preti M, Vieira-Baptista P, Digesu GA, et al. The clinical role of LASER for vulvar and vaginal treatments in gynaecology and female urology: a best practice document. J Low Genit Tract Dis. 2019;23(2):151. https://doi.org/10.1097/LGT.0000000000000462 .
doi: 10.1097/LGT.0000000000000462
pubmed: 30789385
pmcid: 6462818
Filippini M, Porcari I, Ruffolo AF, et al. CO2-laser therapy and genitourinary syndrome of menopause: a systematic review and meta-analysis. J Sex Med. 2022;19(3):452–70. https://doi.org/10.1016/J.JSXM.2021.12.010 .
doi: 10.1016/J.JSXM.2021.12.010
pubmed: 35101378
Elia D, Gambacciani M, Berreni N, et al. Genitourinary syndrome of menopause (GSM) and laser VEL: a review. Horm Mol Biol Clin Investig. 2019. https://doi.org/10.1515/HMBCI-2019-0024 .
doi: 10.1515/HMBCI-2019-0024
pubmed: 31855563
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” FDA
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(4):423–7. https://doi.org/10.1097/GME.0000000000001293 .
doi: 10.1097/GME.0000000000001293
pubmed: 30640806
Vitale SG, Moore O, Riemma G, et al. Hysteroscopic laser ablation of symptomatic uterine fibroids: insights from a prospective study. Climacteric. 2023;26(5):497–502. https://doi.org/10.1080/13697137.2023.2205581 .
doi: 10.1080/13697137.2023.2205581
pubmed: 37165870
Angioni S, Nappi L, Sorrentino F, et al. Laparoscopic treatment of deep endometriosis with a diode laser: our experience. Arch Gynecol Obstet. 2021;304(5):1221. https://doi.org/10.1007/S00404-021-06154-Z .
doi: 10.1007/S00404-021-06154-Z
pubmed: 34448038
pmcid: 8490256
Nappi L, Pontis A, Sorrentino F, et al. Hysteroscopic metroplasty for the septate uterus with diode laser: a pilot study. Eur J Obstet Gynecol Reprod Biol. 2016;206:32–5. https://doi.org/10.1016/j.ejogrb.2016.08.035 .
doi: 10.1016/j.ejogrb.2016.08.035
pubmed: 27632410
Vitale SG, Saponara S, Sicilia G, et al. Hysteroscopic diode laser myolysis: from a case series to literature review of incisionless myolysis techniques for managing heavy menstrual bleeding in premenopausal women. Arch Gynecol Obstet. 2024;309(3):949–59. https://doi.org/10.1007/S00404-023-07218-Y .
doi: 10.1007/S00404-023-07218-Y
pubmed: 37831177
D’Alterio MN, Scicchitano F, Fanni D, et al. Ex vivo myolysis with dual wavelengths diode laser system: Macroscopic and histopathological examination. Clin Exp Obstet Gynecol. 2021;48(4):875–82. https://doi.org/10.31083/J.CEOG4804138/0390-6663-48-4-875/FIG2.JPG .
doi: 10.31083/J.CEOG4804138/0390-6663-48-4-875/FIG2.JPG
Barba M, Cola A, De Vicari D, et al. Efficacy of a diode vaginal laser in the treatment of the genitourinary syndrome of menopause. Bioeng (Basel, Switzerland). 2023;10(10):1158. https://doi.org/10.3390/BIOENGINEERING10101158 .
doi: 10.3390/BIOENGINEERING10101158
Guerette N. Safety and efficacy of hybrid fractional laser (1470 nm and 2940 nm) for symptoms of genitourinary syndrome of menopause: 12 month prospective multi-center study. J Minim Invasive Gynecol. 2019;26(7):S70. https://doi.org/10.1016/j.jmig.2019.09.676 .
doi: 10.1016/j.jmig.2019.09.676
von Elm E, Altman DG, Egger M, et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007;370(9596):1453–7. https://doi.org/10.1016/S0140-6736(07)61602-X .
doi: 10.1016/S0140-6736(07)61602-X
Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995;22:S1–5. https://doi.org/10.1016/0378-5122(95)00956-6 .
doi: 10.1016/0378-5122(95)00956-6
pubmed: 8775770
Isidori AM, Pozza C, Esposito K, et al. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010;7(3):1139–46. https://doi.org/10.1111/J.1743-6109.2009.01635.X .
doi: 10.1111/J.1743-6109.2009.01635.X
pubmed: 19968774
Volonte S, Barba M, Cola A, et al. Italian validation of the short form of the Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12). Int Urogynecol J. 2022;33(11):3171. https://doi.org/10.1007/S00192-022-05235-0 .
doi: 10.1007/S00192-022-05235-0
pubmed: 35648181
pmcid: 9569287
Symonds T, Boolell M, Quirk F. Development of a questionnaire on sexual quality of life in women. J Sex Marital Ther. 2005;31(5):385–97. https://doi.org/10.1080/00926230591006502 .
doi: 10.1080/00926230591006502
pubmed: 16169822
Milsom I, Arvidsson L, Ekelund P, et al. Factors influencing vaginal cytology, pH and bacterial flora in elderly women. Acta Obstet Gynecol Scand. 1993;72(4):286–91. https://doi.org/10.3109/00016349309068039 .
doi: 10.3109/00016349309068039
pubmed: 8389516
Zerbinati N, Serati M, Origoni M, et al. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. 2015;30(1):429–36. https://doi.org/10.1007/S10103-014-1677-2 .
doi: 10.1007/S10103-014-1677-2
pubmed: 25410301
Salvatore S, Nappi RE, Parma M, et al. Sexual function after fractional microablative CO2 laser in women with vulvovaginal atrophy. Climacteric. 2015;18(2):219–25. https://doi.org/10.3109/13697137.2014.975197 .
doi: 10.3109/13697137.2014.975197
pubmed: 25333211
Nappi RE, Palacios S. Impact of vulvovaginal atrophy on sexual health and quality of life at postmenopause. Climacteric. 2014;17(1):3–9. https://doi.org/10.3109/13697137.2013.871696 .
doi: 10.3109/13697137.2013.871696
pubmed: 24423885
Nappi RE, Palacios S, Panay N, et al. Vulvar and vaginal atrophy in four European countries: evidence from the European REVIVE Survey. Climacteric. 2016;19(2):188–97. https://doi.org/10.3109/13697137.2015.1107039 .
doi: 10.3109/13697137.2015.1107039
pubmed: 26581580
Scavello I, Maseroli E, Di Stasi V, et al. Sexual health in menopause. Medicina (B Aires). 2019;55(9):559. https://doi.org/10.3390/MEDICINA55090559 .
doi: 10.3390/MEDICINA55090559
Vasconcelos P, Ponce G, de Leon R, Serruya SJ, et al. A Systematic review on psychological interventions for sexual health in older age. Int J Sex Heal. 2023;35(3):399. https://doi.org/10.1080/19317611.2023.2215766 .
doi: 10.1080/19317611.2023.2215766
Salvatore S, Ruffolo AF, Phillips C, et al. Vaginal laser therapy for GSM/VVA: where we stand now - a review by the EUGA Working Group on Laser. Climacteric. 2023;26(4):336–52. https://doi.org/10.1080/13697137.2023.2225766 .
doi: 10.1080/13697137.2023.2225766
pubmed: 37395104