Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial. (15th November 2022)

• Record Type: Journal Article
• Authors: Page, Ann‐Sophie; Verbakel, Jan Y.; Verhaeghe, Johan; Latul, Yani P.; Housmans, Susanne; Deprest, Jan
• Is Part Of: BJOG. Volume 130:Number 3(2023)
• Page Start: 312
• Page End: 319
• Publication Date: 2022-11-15
• Subjects: atrophy -- menopause -- placebo -- randomised controlled trial -- vaginal laser therapy; Obstetrics -- Periodicals; Gynecology -- Periodicals; 618
• DOI: 10.1111/1471-0528.17335
• Languages: English
• ISSNs: 1470-0328

Abstract

Abstract: 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. Abstract : Linked article : This article is commented on by Dudley Robinson, pp. 320 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471‐0528.17334 This article includes Author Insights, a video abstract available at: https://vimeo.com/745297201 .