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.
Mucosa Innovations, S.L.
Lead sponsor
Hospital Universitario La Luz Quirónsalud
Collaborator
Clínica Vilaboa
Collaborator