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

NCT07737782 | Not Yet Recruiting

• 1 other identifier: RWDGSM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Atrophy; Vulvovaginal Signs and Symptoms; Genitourinary Syndrome of Menopause (GSM); Quality of Life; Menopause Related Conditions; Dyspareunia; Urinary Incontinence, Urgency-frequency; Sexual Function; Women´s Health; Vaginal Dryness

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at least 8 weeks of use of the tested product.

Secondary Outcomes (3)

• 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.

• Distribution and severity of the symptom associated with the highest level of discomfort (most bothersome/severe GSM symptom) at baseline.

  Baseline

• 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.

Other Outcomes (2)

• Adverse effects/events related to the use of the topical measure.

  From the beginning of XCM INTIM use through 30 days after completion of the 8-10-week use period.

• Adherence to the use of the vulvovaginal gel

  From completion of at least 8 weeks of XCM INTIM use onward.

Study Arms (1)

Postmenopausal women with at least one symptom of GSM documented in their medical records.

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 retrospectively documented symptom of GSM in their medical records and retrospectively documented use of the hormone-free vulvovaginal gel XCM INTIM for a minimum of 8 weeks.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mucosa Innovations, S.L.: lead
• Hospital Universitario La Luz Quirónsalud: collaborator
• Clínica Vilaboa: collaborator

Study Sites (1)

Hospital Universitario La Luz Quirónsalud

Madrid, Madrid, 28003, Spain

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1016/j.ejca.2023.03.013. Epub 2023 Mar 21.

  PMID: 37030077 BACKGROUND

• 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, and precision oncology research. Br J Cancer. 2025 Feb;132(2):139-153. doi: 10.1038/s41416-024-02899-x. Epub 2024 Nov 21.

  PMID: 39572762 BACKGROUND

• 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-guidance-documents/estrogen-and-estrogenprogestin-drug-products-treat-vasomotor-symptoms-and-vulvar-and-vaginal-atrophy

  BACKGROUND

MeSH Terms

Conditions

Dyspareunia; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Albi-González, MD

  Hospital Universitario La Luz Quirónsalud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Manuel Rodríguez-Vilaboa

CONTACT

+34629288597; jorge.vilaboa@mucosainnovations.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

ES (1)