Dyspareunia, Genitourinary Syndrome of Menopause (GSM), Menopause Related Conditions, Quality of Life, Sexual Function, Urinary Incontinence, Urgency-frequency, Vaginal Dryness, Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Women´s Health
Conditions
Keywords
Genitourinary Syndrome of Menopause, Vulvovaginal Signs and Symptoms, Patient Reported Outcome Measures, Quality of Life, Day-to-Day Impact of Vaginal Ageing, Women´s Health, Real World Data
Brief 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.
Detailed description
Genitourinary Syndrome of Menopause (GSM) encompasses a constellation of vulvovaginal and urinary signs and symptoms associated with estrogen deficiency and the resulting thinning of the urogenital mucosa. These symptoms include vaginal dryness, dyspareunia, itching/burning, irritation, dysuria, urinary frequency and urgency, among others. GSM symptoms are typically chronic and, unlike vasomotor symptoms of menopause, tend to worsen over time. GSM affects between 27% and 84% of postmenopausal women and remains a frequently underdiagnosed and consequently undertreated condition. This underdiagnosis is primarily related to insufficient physician-patient communication regarding the condition. Patients may not report symptoms because they consider them a normal consequence of aging or feel embarrassed, while healthcare professionals do not always actively inquire about them. Furthermore, GSM symptoms have a variable impact on the quality of life of menopausal women and may significantly affect multiple aspects of patients' lives, including daily activities, self-esteem, intimate relationships, and psychological well-being. In routine clinical practice, there is often limited information regarding which symptoms patients perceive as most bothersome and which dimensions of quality of life are most affected. For this reason, and in line with the principles of Value-Based Healthcare, questionnaires assessing the impact of GSM on women's quality of life have increasingly been incorporated into clinical practice in recent years, with the aim of focusing healthcare activities on those that generate the most meaningful patient outcomes. One example is the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire, extensively used in the Women´s Health Unit of the Hospital Universitario La Luz Quirónsalud. The usual management of women with GSM includes the use of topical agents aimed at improving symptoms, with or without local estrogen therapy. When estrogen use is contraindicated, or when patients prefer non-hormonal alternatives, hormone-free creams and gels are commonly recommended. XCM INTIM (a non-hormonal topical gel containing olive oil, betaine, and xylitol; Mucosa Innovations S.L.) is among these products. This study aims to retrospectively describe the pattern of GSM symptoms and their impact on quality of life among postmenopausal women who used XCM INTIM gel. Additionally, when available data from medical records, healthcare professional notes, and/or patient-completed questionnaires collected as part of routine clinical practice permit, the study will explore symptom evolution and functional impact in women with sufficient follow-up (defined as documentation of at least 8 weeks of product use). Real-world data (RWD) studies provide valuable complementary evidence to clinical trials by capturing the effectiveness and safety of treatments in routine clinical practice settings. In this context, the present protocol describes a retrospective observational study in a cohort of menopausal women with GSM who attended the Women's Health Unit of Hospital Universitario La Luz Quirónsalud between January 2022 and April 2026. The study aims to characterize the most prevalent genitourinary symptoms, their severity, and their impact on quality of life, as well as evaluate their evolution following the use of XCM INTIM topical gel.
Interventions
None listed
Sponsors
Mucosa Innovations, S.L.
Hospital Universitario La Luz Quirónsalud
Clínica Vilaboa
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of GSM symptoms 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. | 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. | 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. | Baseline and at least 8 weeks of use of the tested product. | 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. |
Countries
Spain
Contacts
CONTACTJorge Manuel Rodríguez-Vilaboa
PRINCIPAL_INVESTIGATORManuel Albi-González, MD
Hospital Universitario La Luz Quirónsalud
Outcome results
None listed