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Critical analysis of methods for assessing genitourinary syndrome of menopause used in clinical trials

Lima, Sônia M.R.R. PhD; Honorato, Juliana V. MD

 

Menopause: December 2019 – Volume 26 – Issue 12 – p 1436–1442

doi: 10.1097/GME.0000000000001406

 

Abstract

 

Objective: The aim of the study was to determine the most used methods for assessing genitourinary syndrome of menopause by the latest studies on the subject, and to critically assess their differences and comparability.

 

Methods: A narrative review of the literature was conducted, employing the terms genitourinary syndrome, vaginal atrophy, urogenital atrophy, and atrophic vaginitis, to analyze methods used to assess treatment efficacy. Only controlled randomized clinical trials assessing improvement of genitourinary syndrome of menopause, conducted in the last 5 years, and considering all types of treatment, were selected.

 

Results: Of the 37 studies included, 24 combined both objective and subjective methods thereby ensuring reproducibility and efficacy of symptom relief of the treatment analyzed. The vaginal maturation index was the most used objective method, followed by vaginal pH. One study used histological and immunohistochemistry tests. Regarding subjective methods, the “Most bothering Symptom” and other questionnaires as the Female Sexual Function Index for sex life, the Verbal Rating Scale, among others, were used.

 

Conclusions: Despite the heterogeneity observed, particularly for subjective assessment of symptoms, there was a tendency to standardize methods and to use an objective method together with a subjective, which seems to be fundamental to guarantee reproducibility and comparability of results of each treatment analyzed. Histological and immunohistochemistry tests may be an option as an objective method in further studies, to better assess thickness, vascularization, among other parameters.