The goal of this clinical trial is to retrospectively identify the most prevalent symptoms of genitourinary syndrome of menopause (GSM) among postmenopausal women and to evaluate their impact on quality of life. Moreover, based on data collected from medical records and/or patient-reported questionnaires, if available data enable it, it will be assessed whether treatment with the topical vulvovaginal gel XCM INTIM for a minimum of 8 weeks results in changes in symptom severity and in the impact of these symptoms across different quality-of-life domains.
Postmenopausal women (defined as at least 12 consecutive months of amenorrhea)
Present at least one symptom of GSM documented in the medical record
Evidence in the medical record that the patient had perceived the GSM symptom(s) as having an impact on her quality of life.
Documentation in the medical record that the patient had initiated treatment with XCM INTIM, together with follow-up clinical data including an assessment performed at least 8 weeks after treatment initiation.
Use of topical vulvovaginal hormonal products within 4 weeks prior to initiation of XCM INTIM treatment.
Use of systemic estrogen therapy within 8 weeks prior to initiation of XCM INTIM treatment.
Presence of relevant gynecological and/or urinary conditions that could have interfered with the assessment of symptoms attributed to GSM, including but not limited to active vulvovaginal and/or urinary tract infections, significant vulvar lesions, active gynecological malignancies, severe stress urinary incontinence (Sandvik score ≥ 8), pelvic organ prolapse stage III or higher (POP-Q), or any other condition considered by the investigator to be a significant confounding factor.
Previous radiotherapy involving the pelvic and/or genital region.
Postmenopausal women attended at the Department of Obstetrics and Gynecology of Hospital Universitario La Luz between January 2022 and April 2026, with at least one symptom of GSM documented in their medical records.
Cohort
Retrospective
Not listed
Change in the impact of GSM symptoms on quality-of-life domains, assessed via PROMs, in postmenopausal women who had used the non-hormonal topical gel XCM INTIM for at least 8 weeks.
Change in the magnitude of quality of life-domain scores between baseline and at least week 8 after initiation of use of XCM INTIM will be assessed using a widely used PROM questionnaire. The PROM questionnaire will be the 23-item Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire comprising 4 domains: Activities of Daily Living, Emotional Well-being, Sexual Functioning, and Self-Concept and Body Image. Each item will be scored from 0 (lowest impact/best quality of life) to 4 (highest impact/worst quality of life). Domain scores will be calculated as the means of the corresponding item scores, with higher scores indicating greater impairment in quality of life.
Frequency of GSM symptoms in postmenopausal women who had used the non-hormonal topical gel XCM INTIM for at least 8 weeks.
The frequency of GSM symptoms reported by postmenopausal women and documented in medical records, clinician notes, and/or patient questionnaires will be assessed when existing recorded data. Symptoms of interest will include dyspareunia, non-coital vulvovaginal discomfort or pain, vulvovaginal dryness, vulvovaginal itching and/or burning, urinary symptoms (frequency, urgency, dysuria, or burning during urination). For each symptom, frequency will be summarized as the number and percentage of participants reporting the symptom. Symptom prevalence will be evaluated at baseline and after at least 8 weeks of XCM INTIM use.
Distribution and severity of the symptom associated with the highest level of discomfort (most bothersome/severe GSM symptom) at baseline.
The most bothersome symptom (MBS), if reported by the participant and/or if documented in the medical record, clinician notes, or patient questionnaires, will be identified and categorized (e.g., dyspareunia, non-coital vulvovaginal discomfort or pain, vulvovaginal dryness, vulvovaginal itching and/or burning, urinary symptoms). Symptom severity will be scored in a 1-3 scale (1: mild, 2: moderate, or 3: severe), according to the available clinical documentation. Results will be summarized as the number and percentage of participants for each symptom category and severity level.
Change in the severity of the symptom initially identified as the most bothersome after XCM use for at least 8 weeks.
Change in the magnitude of severity of the most bothersome symptom, if documented, between baseline and at least week 8 after initiation of use of XCM INTIM will be assessed. Symptom severity will be scored in a 1-3 scale (1: mild, 2: moderate, or 3: severe), according to the existing available clinical documentation.
Adverse effects/events related to the use of the topical measure.
Number (percentage) of patients with grade 1-4 NCI-CTCAE adverse effects/events related to the topical measure will be collected from medical records, when available.
Adherence to the use of the vulvovaginal gel
Adherence to XCM INTIM use will be assessed based on information documented in medical records, clinician notes, and/or patient-reported information. Participants will be classified as having either good adherence or poor adherence according to the available clinical documentation. Adherence will be rated as good or poor based on whether the participant had continued using the topical gel after completing the 8-week use period or not. Results will be summarized as the number and percentage of participants in each adherence category.
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Mucosa Innovations, S.L.
Lead sponsor
Hospital Universitario La Luz Quirónsalud
Collaborator
Clínica Vilaboa
Collaborator
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