There are many treatments available for genitourinary syndrome of menopause (GSM), however, there is no standard method for assessing response. The assessment of epithelial stratification by means of cytology can be an objective measurement mechanism. [1] The aim of the study was to perform the analysis of vaginal cytology and the vaginal maturation index as an objective evaluation method in the treatment of GSM.

Retrospective cross-sectional observational study with archived laboratory samples collected from patients treated at a pelvic rehabilitation center and paired epidemiological information. All provided free and informed consent for collection and analysis of material. Vaginal cytology samples from women aged 18-65 years, with at least one sign and symptom of GSM. Women with vaginal infection, impaired understanding, impossibility of gynecological position and pregnant were excluded. The Vaginal Maturation Index (VMI) was calculated and reports were compared by 2 examiners, paired with clinical data, Vaginal Health Index (VHI), pH and Visual Analogue Scale (VAS) of the most bothersome symptoms. The processing of the material with staining and the first report was carried out by the laboratory designated as a tertiary service and later a second report issued on the same material by a second cytologist from a laboratory called central. Both cytologies were blind to each other's reports and to treatments performed by patients in the service. The interpretation of the magnitude of the intraclass correlation coefficients (ICC) concordance estimator was agreed as: 0 (absence), 0-0.19 (poor), 0.20-0.39 (weak), 0.30-0.59 (moderate), 0.60-0.79 (substantial), and ≥ 0.80 (almost complete). [2] Bland-Altman analysis was performed to determine consistency of laboratory report agreements. The necessary number of 79 slides was estimated to determine the reliability of the ICC of 0.75 with 2 observations per subject, generating a total number of observations of 158 for a confidence interval of 0.20. The t test was used to compare symptoms by VAS (greater or less than 5) with the intensity of atrophy by VMI.

88 slides were reviewed with a total of 176 observations. The mean age of the participants was 53.5±6.2 years, 40.9% had a history of 0 or 1 childbirth and 83.9% were sexually active. Mean vaginal pH was 6.0±1, VHI was 15.7±3.5 and VMI was 30.5±27.5. 33.5% of the evaluated slides had an VMI of 0 due to the lack of identification of cells in the superficial layer. There was no identification of an association between greater complaints in VAS and lower VMI by t test. The VMI showed an intraclass agreement index of 0.94 for mean measurements and 0.89 for individual measurements. Bland-Altman analysis demonstrated consistency of agreement between examiners (Figure 1).

The VMI is a method for objectively quantifying the severity of vaginal atrophy and a potential proof-of-concept tool for assessing response to treatments for GSM. However, the reliability assessment is necessary in view of the possibility of intra- or inter-examiner interpretation variation. The analysis of a continuous quantitative data can help to promote greater reliability of this variable that is transformed into a categorical variable (this one with greater potential for divergence). [3] In the present study, a high number of patients were observed without any identification of superficial cells, therefore with zero VMI and severe atrophy. Despite not having demonstrated an association between greater atrophy and a higher degree of symptoms by VAS, the VMI can potentially be used to monitor response to treatments more objectively than symptom questionnaires, to unify response assessment in different methods of GSM treatments - for comparison of effectiveness - and as a potential tool for individualized treatment proposals, proportional to the severity of each patient's condition.

The vaginal maturation index proved to be a consistent parameter for evaluation among examiners and may be an additional objective tool for evaluating the response to treatments for GSM.

Mercier J, Morin M, Reichetzer B, Lemieux MC, Khalifé S, Dumoulin C. Genitourinary syndrome of menopause symptom severity and impact outcome measures: are they reliable and correlated? Menopause. 2018; 26(6):659-664. DOI: 10.1097/GME.0000000000001287
Zou, G. Y. Sample size formulas for estimating intraclass correlation coefficients with precision and assurance. Statistics in Medicine. 2012;31(29):3972–3981. DOI:10.1002/sim.5466.
Lumbanraja IL, Siregar MFG, Lumbanraja SN, Adenin I, Lintang LS, Halim B. Association of Vaginal Maturation Index and Vaginal pH with the Most Bothersome Symptoms of Genitourinary Syndrome of Menopause. J South Asian Feder Obst Gynae. 2021;13(5):288–291.

Continence 7S1 (2023) 100960
DOI: 10.1016/j.cont.2023.100960