Cruz et al. (2018)(3030 Cruz VL, Steiner ML, Pompei LM, Strufaldi R, Fonseca FL, Santiago LH, 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. doi: 10.1097/GME.0000000000000955 https://doi.org/10.1097/GME.000000000000...
) |
Brazil |
RCT |
CO2-laser |
Vaginal estriol |
Randomized 45 Allocated 15 Analyzed 13 |
Randomized 45 Allocated 15 Analyzed 14 |
2 |
1 |
55.9 ± 5.2
|
56.9 ± 6.0
|
Aged 45–70 years who presented with amenorrhea for 24 months or longer and at least one moderate symptom of VVA. |
2 laser therapies every 4 weeks |
20 weeks |
Primary outcomes include improvement of VHI and VVA symptoms (VAS). Secondary outcomes include improvement of sexual function (FSFI). |
Girardelli et al. (2017)(2828 Girardelli S, Pitsouni E, Athanasiou S, Marotta E, Candiani M, Salvatore S. A double-blind randomised controlled trial of microablative fractional CO2 laser vs sham therapy on sexual function of women with vulvovagina atrophy (VVA): an interim analysis. Neurourol Urodyn. 2017;36 Suppl 2:S12-3. doi: 10.1002/nau.23302 https://doi.org/10.1002/nau.23302...
) |
Greece |
RCT |
CO2-laser |
Sham-laser |
Randomized 55 Allocated 27 Analyzed 27 |
Randomized 55 Allocated 28 Analyzed 28 |
0 |
0 |
- |
- |
Women with postmenopausal VVA. |
3 laser therapy every 1 month |
4 months |
FSFI, UDI-6, VAS for various genital symptoms (more specifically dyspareunia, dysuria, vaginal dryness, vaginal itching and vaginal burning sensation). |
Ruanphoo and Bunyavejchevin (2020)(2727 Ruanphoo P, Bunyavejchevin S. Treatment for vaginal atrophy using microablative fractional CO2 laser: a randomized double-blinded sham-controlled trial. Menopause. 2020;27(8):858-63. doi: 10.1097/GME.0000000000001542 https://doi.org/10.1097/GME.000000000000...
) |
Thailand |
RCT |
CO2-laser |
Sham-laser |
Randomized 63 Allocated 31 Analyzed 29 |
Randomized 63 Allocated 32 Analyzed 30 |
2 |
2 |
- |
- |
Postmenopausal women at fifty years of age or more with moderate to severe intensity of any symptoms of vaginal atrophy. |
3 laser therapies every 4 weeks |
12 weeks |
VHI, VAS, and scores of ICIQ-VS questionnaire in terms of vaginal dryness, vaginal symptom, sexual matter and quality of life. |
Politano et al. (2019)(3131 Politano CA, Costa-Paiva L, Aguiar LB, Machado HC, Baccaro LF. Fractional CO2 laser versus promestriene and lubricant in genitourinary syndrome of menopause: a randomized clinical trial. Menopause. 2019;26(8):833-40. doi: 10.1097/GME.0000000000001333 https://doi.org/10.1097/GME.000000000000...
) |
Brazil |
RCT |
CO2-laser |
Promestriene IV 10mg Vaginal gel lubrificant |
Randomized 72 Allocated 24 Analyzed 24 |
Promestriene group Randomized 72 Allocated 24 Analyzed 24 Lubrificant group Randomized 72 Allocated 24 Analyzed 24 |
2 |
Promestriene group 5 Lubrificant group 9 |
57.8 ± 5.0
|
Promestriene group 57.2 ± 5.7 Lubricant group 56.8 ± 5.3
|
Aged 50 to 70 years; physiological amenorrhea for at least 12 months; symptoms of vaginal dryness with or without dyspareunia, vaginal burning, or pruritus; and no use of hormonal medications to treat vaginal symptoms in the prior 6 months. |
3 laser therapies every 30 days |
14 weeks |
Vaginal maturation, VHI score, and sexual function (FSFI) |
Singwongsa and Vallibhakara (2019)(2525 Singwongsa A, Vallibhakara O. The effect of vaginal Erbium-YAG laser treatment for the genitourinary syndrome of menopause: a randomized controlled study. Maturitas. 2019;124:153-4. doi: 10.1016/j.maturitas.2019.04.124 https://doi.org/10.1016/j.maturitas.2019...
) |
Thailand |
RCT |
Erbium: YAG laser |
Sham-laser |
Randomized 34 Allocated 17 Analyzed 17 |
Randomized 34 Allocated 17 Analyzed 17 |
- |
- |
- |
- |
- |
3 laser therapies every 4 weeks |
12 weeks |
VAS, VHI, vaginal pH, VMI |
Aguiar et al. (2020)(2929 Aguiar LB, Politano CA, Costa-Paiva L, Juliato CR. Efficacy of fractional CO2 laser, promestriene, and vaginal lubricant in the treatment of urinary symptoms in postmenopausal women: a randomized clinical trial. Lasers Surg Med. 2020;52(8):713-20. doi: 10.1002/lsm.23220 https://doi.org/10.1002/lsm.23220...
) |
Brazil |
RCT |
CO2-laser |
Promestriene IV 10mg Vaginal lubrificant |
Randomized 72 Allocated 24 Analyzed 24 |
Promestriene group Randomized 72 Allocated 24 Analyzed 24 Lubrificant group Randomized 72 Allocated 24 Analyzed 24 |
2 |
Promestriene group 5 Lubrificant group 7 |
57.8 ± 5.0
|
Promestriene group 57.2 ± 5.3 Lubrificant group 56.8 ± 5.3
|
Women aged ≥ 50 years, who were amenorrhoeic for at least 1 year, with symptoms related to GSM, and who did not use hormonal therapy for at least last 6 months previously and any kind of medication for OAB (oral anti-muscarinics or oral β3-adrenoceptor agonists). |
3 laser therapies every 30 days |
14 weeks |
Urinary symptoms (ICIQ-UI SF, and the ICIQ-OAB). |
Li et al. (2021)(2626 Li FG, Maheux-Lacroix S, Deans R, Nesbitt-Hawes E, Budden A, Nguyen K, et al. Effect of fractional carbon dioxide laser vs sham treatment on symptom severity in women with postmenopausal vaginal symptoms: a randomized clinical trial. JAMA. 2021;326(14):1381-9. doi: 10.1001/jama.2021.14892 https://doi.org/10.1001/jama.2021.14892...
) |
Australia |
RCT |
CO2-laser |
Sham-laser |
Randomized 85 Allocated 43 Analyzed 38 |
Randomized 85 Allocated 42 Analyzed 40 |
5 |
2 |
55 ± 7
|
58 ± 8
|
Women aged 18 years and older who were fluent in English and had not previously received vaginal energy-based treatment for menopausal symptoms. Participants must have been amenorrheic for at least 12 months, either naturally or iatrogenically, and experiencing 1 or more of the following vaginal symptoms: dyspareunia, burning, itching, or dryness severe enough to prompt presentation to seek further treatment. |
3 laser therapies every 1 month (minimum, 4 weeks; maximum, 8 weeks) |
12 months |
Severity of overall vaginal symptoms and individual symptoms of dyspareunia, dysuria, vaginal dryness, burning, and itching were assessed on a VAS; The VSQ is a 21-item validated instrument to measure vulvovaginal symptoms in postmenopausal women. This questionnaire assesses 4 domains (symptoms, emotions, life impact, and sexual-impact); Assessment of Quality of Life–6D scale13 and sexual satisfaction (Monash University Women's Health Program Female Sexuality Satisfaction Questionnaire; Vaginal Health Index Score (VHI- vaginal elasticity, vaginal fluid amount, pH, epithelial integrity, and hydration); vaginal skin biopsy (changes to collagen (reduced type I to type III fibril ratio, loss of trabecular disposition, absent fibrillogenesis), lamina propria (absence of activated fibroblasts, loss of mucopolysaccharides), epithelium (thinning of superficial layer; superficial keratinization; loss of rugae, elastic fibers, and subepithelial papillae; increase in subepithelial connective tissue), and decreased vascularization). |
Paraiso et al. (2020)(88 Paraiso MF, Ferrando CA, Sokol ER, Rardin CR, Matthews CA, Karram MM, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET trial. Menopause. 2020;27(1):50-6. doi: 10.1097/GME.0000000000001416 https://doi.org/10.1097/GME.000000000000...
) |
USA |
RCT |
CO2-laser |
Vaginal estrogen cream |
Randomized 69 Allocated 34 Analyzed 30 |
Randomized 69 Allocated 35 Analyzed 32 |
2 |
1 |
61 ± 8
|
60 ± 7
|
Menopausal women with absence of menstruation for at least 12 months and reported bothersome vaginal dryness of ≥7 cm on VAS. |
3 laser therapies every 1 month |
6 months |
The primary outcome includes improvement of vaginal dryness (VAS). Secondary outcomes included VHI, VMI scores, quality of life (DIVA), sexual function (FSFI) and the urinary symptoms (UDI−6). |
Salvatore et al. (2021)(2323 Salvatore S, Pitsouni E, Grigoriadis T, Zacharakis D, Pantaleo G, Candiani M, et al. CO2 laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial. Climacteric. 2021;24(2):187-93. doi: 10.1080/13697137.2020.1829584 https://doi.org/10.1080/13697137.2020.18...
) |
Greece and Italy |
RCT |
CO2-laser |
Sham-laser |
Randomized 60 Allocated 30 Analyzed 28 |
Randomized 60 Allocated 30 Analyzed 30 |
0 |
0 |
57.0 ± 6.9
|
58.4 ± 6.0
|
Postmenopausal women with GSM diagnosis according to the definition by the International Society for the Study of Women's Sexual Health and The North American Menopause Society, with no age limit. Dryness and dyspareunia related to GSM had to be the two most bothersome symptoms in all women. |
3 laser therapies every 1 month |
4 months |
Changes in dryness and dyspareunia intensity; Changes in aspects of sexual functioning; Changes in itching; Burning, and dysuria intensity; Changes in UDI-6; Changes in dryness and dyspareunia incidence; Changes in sexual dysfunction incidence; Urinary incontinence; and Adverse Events. |
Cruff and Khandwala (2021)(2424 Cruff J, Khandwala S. A double-blind randomized sham-controlled trial to evaluate the efficacy of fractional carbon dioxide laser therapy on genitourinary syndrome of menopause. J Sex Med. 2021;18(4):761-9. doi: 10.1016/j.jsxm.2021.01.188 https://doi.org/10.1016/j.jsxm.2021.01.1...
) |
USA |
RCT |
CO2-laser |
Sham-laser |
Randomized 30 Allocated 14 Analyzed 11 |
Randomized 30 Allocated 16 Analyzed 12 |
2 |
0 |
61 (54−66)
|
59 (56−65)
|
Menopausal women (or status-post bilateral oophorectomy) with dyspareunia or vaginal dryness rated as moderate-severe and who were desirous of sexual function, had vaginal atrophy based on a Gloria Bachmann VHI 28 score <15 and a vaginal pH > 5, prolapse less than Pelvic Organ Prolapse Quantification System (POP-Q)29 stage III, no pelvic reconstructive surgery within 6 months of treatment, ability to provide consent, and willing and able to attend all treatments and follow-up. |
3 laser therapies every 6 weeks |
6 months |
Primary endpoint was improvement in GSM-related dyspareunia. Secondary objectives were to determine the impact of treatment on vaginal health, GSM symptoms, bothersome LUTS, sexual function, safety, and impact on quality-of-life. |
Eftekhar et al. (2020)(2020 Eftekhar T, Forooghifar T, Khalili T, Shariat M, Haghollahi F. The effect of the CO2 fractional laser or premarin vaginal cream on improving sexual function in menopausal women: a randomized controlled trial. J Lasers Med Sci. 2020;11(3):292-8. doi: 10.34172/jlms.2020.49 https://doi.org/10.34172/jlms.2020.49...
) |
Iran |
RCT |
CO2-laser X RF |
Sham-laser |
CO2-laser group Randomized 246 Allocated 82 Analyzed 78 RF group Randomized 246 Allocated 82 Analyzed 80 |
Randomized 246 Allocated 82 Analyzed 79 |
CO2-laser 4 RF group 2 |
3 |
CO2-laser group 56.3 ± 7.2 and RF group 57.7 ± 7.3
|
54.8 ± 11.5
|
Women with history of UI symptoms, sexual intercourse, sexual problems due to VVA, at least one year after the termination of menstruation, the presence of VVA symptoms, and sexual dysfunction. |
CO2-laser group 3 laser therapies every 4 weeks RF group 3 RF sessions every 4 weeks |
6 weeks |
Urinary incontinence was evaluated using the ICIQ. In addition, pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12), VHI and VAS were used to determine sexual satisfaction. |
Page et al. (2023)(3232 Page AS, Verbakel JY, Verhaeghe J, Latul YP, Housmans S, Deprest J. Laser versus sham for genitourinary syndrome of menopause: a randomised controlled trial. BJOG. 2023;130(3):312-9. doi: 10.1111/1471-0528.17335 https://doi.org/10.1111/1471-0528.17335...
) |
Belgium |
RCT |
CO2-laser |
Sham-laser |
Randomized 60 Allocated 30 Analyzed 28 |
Randomized 60 Allocated 30 Analyzed 29 |
2 |
1 |
57.40 ± 7.07
|
56.20 ± 6.30
|
Women with moderate to severe symptoms of GSM (i.e. vaginal dryness, vaginal itching, vaginal burning, dyspareunia and dysuria) shown by an Most Bothersome Symptom score of 2 or more |
3 laser therapies every 4 weeks |
3 months |
Dyspareunia; Vaginal dryness; Dysuria; Vaginal burning; VAS score; Vaginal burning; Vaginal itching; FSFI score; ICIQ-OAB score; VHI score; Vaginal pH |