TY - JOUR
T1 - Laser versus sham for genitourinary syndrome of menopause
T2 - A randomised controlled trial
AU - Page, Ann-Sophie
AU - Verbakel, Jan Y.
AU - Verhaeghe, Johan
AU - Latul, Yani P.
AU - Housmans, Susanne
AU - Deprest, Jan
N1 - Publisher Copyright: © 2022 John Wiley & Sons Ltd.
PY - 2023/2
Y1 - 2023/2
N2 - Objective: To assess whether CO2 laser treatment is more effective than sham application in relieving the most bothersome symptom (MBS) in women with genitourinary syndrome of menopause (GSM). Design: Single-centre, sham-controlled, double-blind, randomised trial. Setting: A tertiary centre in Belgium. Population: Sixty women with moderate to severe GSM symptoms. Methods: All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely. Main outcome measures: The primary outcome was the participant-reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short-term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit. Results: The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (−23.60%; 95% CI −36.10% to −11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (−13.20%; 95% CI −22.70% to −3.73%) in those receiving sham applications (p = 0.13). There were no serious adverse events reported up to 18 months. Conclusions: In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported.
AB - Objective: To assess whether CO2 laser treatment is more effective than sham application in relieving the most bothersome symptom (MBS) in women with genitourinary syndrome of menopause (GSM). Design: Single-centre, sham-controlled, double-blind, randomised trial. Setting: A tertiary centre in Belgium. Population: Sixty women with moderate to severe GSM symptoms. Methods: All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely. Main outcome measures: The primary outcome was the participant-reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short-term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit. Results: The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (−23.60%; 95% CI −36.10% to −11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (−13.20%; 95% CI −22.70% to −3.73%) in those receiving sham applications (p = 0.13). There were no serious adverse events reported up to 18 months. Conclusions: In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported.
KW - atrophy
KW - menopause
KW - placebo
KW - randomised controlled trial
KW - vaginal laser therapy
UR - http://www.scopus.com/inward/record.url?scp=85143226841&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/1471-0528.17335
DO - https://doi.org/10.1111/1471-0528.17335
M3 - Article
C2 - 36349391
SN - 1470-0328
VL - 130
SP - 312
EP - 319
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 3
ER -