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Genitourinary Syndrome of Menopause in Breast Cancer

RecruitingNAAges 38 Years - anyFemaleUniversity of Alcala
NCT06721936 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized, single-blind clinical trial will compare the effectiveness of multimodal pelvic floor physiotherapy (PPT) and fractional CO2 vaginal laser therapy in reducing genitourinary syndrome of menopause (GSM) symptoms among breast cancer (BC) survivors. GSM, induced by cancer treatments, is common in BC survivors due to hormonal deprivation, and effective non-hormonal treatments are needed. The study will enroll 210 women diagnosed with GSM following BC treatment, who will be randomly assigned to either three sessions of CO2 vaginal laser therapy or eight sessions of multimodal PPT, which includes pelvic floor muscle training, vaginal non-ablative radiofrequency, education, and moisturizers. Primary outcomes will include perineal pain, sexual function, and health-related quality of life (HRQoL), with assessments at baseline, post-intervention, and at 3, 6, and 12 months. The hyp

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📋 Eligibility rules (as published)
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.
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What it tests

  • Multimodal pelviperineal physioterapy group
  • Laser CO2 Therapy group
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Where

1 site
Hospital Universitario Ramón y Cajal
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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