Genitourinary Syndrome of Menopause in Breast Cancer

Launched by UNIVERSITY OF ALCALA · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find the best way to help women who are breast cancer survivors deal with a condition called Genitourinary Syndrome of Menopause (GSM). This condition can cause issues like pelvic pain and difficulties with sexual health, often because of the hormonal changes that happen after cancer treatments. In the study, 210 women diagnosed with GSM will be randomly assigned to receive either a special type of laser treatment for the vagina or a series of physical therapy sessions focused on the pelvic floor. The goal is to see which treatment works better in improving symptoms and overall quality of life over time.

To participate, women need to be breast cancer survivors who have been diagnosed with GSM and have a specific score indicating their vaginal health. However, those who have had certain other pelvic treatments or are currently undergoing chemotherapy won’t be eligible. Throughout the trial, participants will complete assessments at various times to check on their progress, helping researchers understand how effective these non-invasive treatments are for managing GSM in breast cancer survivors. This study aims to provide valuable information on alternative options for women facing these challenges.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Breast cancer survivors diagnosed with GSM as a result of cancer treatment
• • Vaginal Health Index (VHI) score of ≤ 15.
• Exclusion Criteria:
• • History of conservative treatment or surgery for pelvic floor dysfunction or GSM
• • Currently undergoing chemotherapy, or have undergone BC surgery but have not received chemotherapy or hormonal treatment.
• • Presence of concomitant or systemic diseases that could interfere with the proposed treatments, such as a recurrence of the oncological process, active or recurrent untreated urinary tract infections, hematuria, or cognitive impairments that hinder the participant's ability to comprehend study information, respond to questionnaires, provide informed consent, or fully participate in the study.