A Double-Blind Randomized Sham-Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause.

Document Type

Article

Publication Date

4-2021

Publication Title

The journal of sexual medicine

Abstract

BACKGROUND: 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.

AIM: To assess the effect of fractional carbon dioxide (CO

METHODS: We conducted a parallel, randomized, double-blind, sham-controlled trial to compare menopausal women treated with fractional CO

OUTCOMES: 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.

RESULTS: 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.

CLINICAL IMPLICATIONS: Further well-powered research is needed to determine efficacy of fractional CO

STRENGTHS & LIMITATIONS: We present a sham-controlled double-blinded randomized trial using validated tools; the main limitation included an underpowered proportion of sexually active participants for the primary outcome.

CONCLUSION: This study was underpowered to draw conclusions regarding the efficacy of fractional CO

Volume

18

Issue

4

First Page

761

Last Page

769

DOI

10.1016/j.jsxm.2021.01.188

ISSN

1743-6109

PubMed ID

33757774

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