Genitourinary Syndrome of Menopause Induced by Breast Cancer Treatments: A Randomized Clinical Trial Comparing Multimodal Pelvic Floor Physiotherapy and Fractional CO2 Laser Therapy
Led by University of Alcala · Updated on 2025-04-27
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What this Trial Is About
Researchers are evaluating two non-hormonal treatments to reduce symptoms of genitourinary syndrome of menopause (GSM) in women who have survived breast cancer. GSM is common in this group due to hormonal changes caused by cancer treatments, and effective non-hormonal options are needed. The trial compares multimodal pelvic floor physiotherapy (PPT) and fractional CO2 vaginal laser therapy to see which better improves pelvic pain, sexual function, and quality of life.
Participants will be randomly assigned to one of two groups. One group will receive three monthly sessions of fractional CO2 vaginal laser therapy, each lasting about 15 minutes without anesthesia. The other group will attend eight personalized sessions of multimodal PPT over several weeks, including pelvic floor muscle training, non-ablative radiofrequency therapy, pelvic health education, and use of vaginal moisturizers.
Women will be evaluated at the start, immediately after treatments, and at 3, 6, and 12 months post-intervention. Assessments include sexual function, pelvic pain levels, vaginal health, pelvic floor muscle function, and quality of life. The study will also monitor any adverse effects and analyze the cost-effectiveness of each treatment. This participation timeline allows researchers to understand both short- and longer-term effects of the therapies.
CONDITIONS
Brief Title
Genitourinary Syndrome of Menopause in Breast Cancer
Who Can Participate
Age: 38Years +
FEMALE
Eligibility Criteria
You may qualify if you...
Breast cancer survivors diagnosed with genitourinary syndrome of menopause due to cancer treatment
Vaginal Health Index (VHI) score of 15 or less
Female participants aged 38 years or older
You will not qualify if you...
History of surgery or conservative treatment for pelvic floor dysfunction or genitourinary syndrome of menopause
Currently undergoing chemotherapy or have had breast cancer surgery without chemotherapy or hormonal treatment
Presence of other diseases that may interfere with treatment, such as cancer recurrence, active or untreated urinary tract infections, blood in urine, or cognitive impairments affecting consent or participation
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive one of two non-hormonal treatment options for genitourinary syndrome of menopause: three monthly sessions of fractional CO2 vaginal laser therapy or eight sessions of multimodal pelvic floor physiotherapy involving pelvic floor muscle training, non-ablative radiofrequency therapy, and pelvic health education.
3 monthly visits for laser therapy or 8 sessions over approximately 10 weeks for physiotherapy
Follow-up
Duration - 12 months
Participants are assessed immediately after the intervention and at 3, 6, and 12 months post-intervention to monitor symptom improvement and quality of life.
4 visits (immediately after treatment, and at 3, 6, and 12 months post-treatment)
Genitourinary syndrome of menopause induced by breast cancer treatments: a randomised clinical trial protocol comparing multimodal pelvic floor physiotherapy and fractional CO2 laser therapy (PILME study).
María Torres-Lacomba, Carmen María Hernández-Iglesias, Cristina Del Valle-Rubido...