Hypothesis / aims of study
The genitourinary syndrome of menopause (GSM) occurs in women that get to the menopausal period in a natural and progressive way or in the ones who need hormone-blocking treatments. In patients with a history of cancer, as they present sudden hormonal suppression, made by chemotherapy or surgery, there is a theoretical potential for these women to develop more severe GSM by inducing an early menopause. The aim of the study was to compare the severity of vaginal atrophy in patients with oncologic and non-oncologic GSM and characterize the urinary, sexual, and genital symptoms found in the studied population.
Study design, materials and methods
This is an analytical cross sectional study involving women who were included in two clinical trials and who signed an informed consent form to participate in the research. One group included women with previous breast cancer diagnoses treated with LED for GSM and the other group included women without cancer diagnoses treated with nonablative radiofrequency for GSM, from January 2017 until September 2020. Self-reported urogynecological symptoms were assessed using a Numeric Visual Scale (NVS); physical and cytological evaluation were assessed by Vaginal Maturation Index (VMI) and Vaginal Health Index (VHI); and four questionnaires were used to assess urinary incontinence, sexual function and genital self-image: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), Female Sexual Function Index (FSFI), Female Sex Quotient (SQ-F) e Female Genital Self-Image Scale-7 (FGSIS-7). Data collection was carried out by reviewing the records of the participants from categorized forms of the service and the data tabulated in SPSS. The sample size was established using a Winpepi calculator (version 11.65): 66 patients, 33 in each group, would be enough to detect a difference of 10 points in the VMI between the oncological and the non-oncological groups (considering a standard deviation of 15 and 8 in each group) . The Kolmogorov-Smirnov normality test was used, determining normality in all variables, and Student's t tests were used to analyze the numerical data, in addition to the Chi-square for the evaluation of qualitative variables with a power of 80% and an alpha of 5%. The study was approved by the Ethical Committee.
Of the 66 patients, 33 were part of the oncological group and 33 of the non-oncological group, with a mean age of 51.88 (±7.71) years and 56.82(±4.93) years, respectively (p=0.003). All urogynecological symptoms reported by patients are shown in Table 1, with the most prevalent being vaginal dryness, sexual dysfunction, dyspareunia and vaginal itching. The physical, cytological, and questionnaire evaluations are shown in table 2. From these only the FGSIS-7 showed statistical differences between the groups (p=0.02). In relation to the VMI, the oncological group had 31.0(±25.4) and the non-oncological had 37.4(±25.2), both classified as “severe atrophic”, without statistical difference (p=0.29).
Interpretation of results
Despite the patients in the oncological group being younger than those in the non-oncological group, the severity of the symptoms of GSM did not differ between the groups. The VMI showed no statistical difference between the groups, which may have occurred due to the loss of data from five patients in the non-oncological group. The VHI showed borderline values for both groups, classifying them as normotrophic. As it is an evaluator dependent index, it is important to see the result with caution. The VMI had shown that both groups had vaginal severe atrophy according to the cytological test. The only difference between the groups was in relation to the FGSIS-7. The oncological group had a less positive genital self-image than the non-oncological group. In a previous study, it was shown that worse body self-image is associated with worse genital self-image , which may explain this result, since the oncological group was consisted of women who underwent treatment for breast cancer, which may include mutilating surgery.