Vulvar AtrophyVulvovaginal Signs and SymptomsGenitourinary Syndrome of Menopause (GSM)Quality of LifeMenopause Related ConditionsDyspareuniaUrinary Incontinence, Urgency-frequencySexual FunctionWomen´s HealthVaginal Dryness
Study summary
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.
Eligibility
Sex
FEMALE
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
Patients included in this retrospective data evaluation must have met all of the following criteria:
* 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.
* Patients that had attended at the Department of Obstetrics and Gynecology of Hospital Universitario La Luz between January 2022 and April 2026, regardless of whether they had participated in another study during this period.
Exclusion Criteria:
Patients will be excluded from the study if any of the following conditions were present:
* 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.
* Previous laser and/or radiofrequency treatment in the pelvic region.
* Medical records containing insufficient information for analysis of the primary study variables.
Primary outcome measure(s)
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. — Baseline and at least 8 weeks of use of the tested product. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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