Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.

Официальное название

Retrospective Observational Study in a Cohort of Postmenopausal Women With Genitourinary Syndrome of Menopause (GSM): Characterization of Symptoms and Impact on Quality of Life.

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• 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. [Срок оценки: Baseline and at least 8 weeks of use of the tested product.]

Вторичные конечные точки (3)

• Frequency of GSM symptoms in postmenopausal women who had used the non-hormonal topical gel XCM INTIM for at least 8 weeks. [Срок оценки: Baseline and at least 8 weeks of use of the tested product.]
• Distribution and severity of the symptom associated with the highest level of discomfort (most bothersome/severe GSM symptom) at baseline. [Срок оценки: Baseline]
• Change in the severity of the symptom initially identified as the most bothersome after XCM use for at least 8 weeks. [Срок оценки: Baseline and at least 8 weeks of use of the tested product.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Hospital Universitario La Luz Quirónsalud — Madrid

Публикации

• Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Maturitas. 2014 Nov;79(3):349-54. doi: 10.1016/j.maturitas.2014.07.013. Epub 2014 Aug 19. PMID 25179577
• The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause. 2020 Sep;27(9):976-992. doi: 10.1097/GME.0000000000001609. PMID 32852449
• Moral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto C; as the writing group of the GENISSE study. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018 Apr;21(2):167-173. doi: 10.1080/13697137.2017.1421921. Epub 2018 Feb 7. PMID 29411644
• Huang AJ, Gregorich SE, Kuppermann M, Nakagawa S, Van Den Eeden SK, Brown JS, Richter HE, Walter LC, Thom D, Stewart AL. Day-to-Day Impact of Vaginal Aging questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause. 2015 Feb;22(2):144-54. doi: 10.1097/GME.0000000000000281. PMID 24983271
• Saesen R, Van Hemelrijck M, Bogaerts J, Booth CM, Cornelissen JJ, Dekker A, Eisenhauer EA, Freitas A, Gronchi A, Hernan MA, Hulstaert F, Ost P, Szturz P, Verkooijen HM, Weller M, Wilson R, Lacombe D, van der Graaf WT. Defining the role of real-world data in cancer clinical research: The position of the European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2023 Jun;186:52-61. do PMID 37030077
• Barghout SH, Meti N, Chotai S, Kim CJH, Patel D, Brown MC, Hueniken K, Zhan LJ, Raptis S, Al-Agha F, Deutschman C, Grant B, Pienkowski M, Moriarty P, de Almeida J, Goldstein DP, Bratman SV, Shepherd FA, Tsao MS, Freedman AN, Xu W, Liu G. Adaptive Universal Principles for Real-world Observational Studies (AUPROS): an approach to designing real-world observational studies for clinical, epidemiologic PMID 39572762
• U.S. Food and Drug Administration. Guidance for Industry: Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-Recommendations for Clinical Evaluation. Draft Guidance. Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration; January 2003. Available from: https://www.fda.gov/regulatory-information/search-fda-g

Идентификаторы

NCT: NCT07737782 · RWDGSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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