In a recent study report, researchers have suggested no improvement in Genitourinary Syndrome of Menopause with CO2 Laser Therapy. The results have been published in The Journal of Sexual Medicine.
Despite some prospective case series showing effectiveness of vaginal laser to treat genitourinary syndrome of menopause (GSM), there is a paucity of placebo-controlled level one evidence.
With this background, researchers undertook the current study to assess the effect of fractional carbon dioxide (CO2) laser therapy to treat GSM against a sham comparator.
As for the study design, the research team conducted a parallel, randomized, double-blind, sham-controlled trial to compare menopausal women treated with fractional CO2 laser against sham treatment for improvement in GSM-related dyspareunia. Three treatments were given 6 weeks apart, and participants attended a 6-month visit from study start for primary (proportion improved) and secondary (vaginal health index, VHI; visual analogue scale, VAS; modified global assessment, PGI-I; Female Sexual Function Index, FSFI; Day-to-Day Impact of Vaginal Aging, DIVA; Urinary Distress Inventory short-form, UDI-6) assessments.
The primary endpoint was a 2-stage improvement in GSM-related dyspareunia from baseline to 6 months determined by a severity scale, and the proportion of subjects who achieved this were compared between groups.
Data analysis revealed the following facts.
Thirty participants were randomized to laser (n = 14) or sham (n = 16). In the treatment arm, 13 attended all treatments, and 1 attended at least 2 while in the sham arm, 14 attended all treatments, and 2 attended at least 2 treatments.
Twelve (86%) in the treatment arm and 16 (100%) in the sham arm attended the 6-month visit.
There were no differences in the proportion improved between treatments and controls (64% vs. 67%, respectively, P = 1.000).
Both arms showed significant within-group improvements based on VHI and VAS, but not between groups.
Similar findings were observed on sexual impact questionnaires with improvements within both groups from baseline to 6 months but not by median differences between the groups at 6 months.
There were no adverse events in either of the arms.
For the full article follow the link: 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 Mar 20;[EPub Ahead of Print], J Cruff, S Khandwala
Primary source: The Journal of Sexual Medicine