Actively Recruiting

Phase Not Applicable
Age: 38Years +
FEMALE
ID06721936

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

182

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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)

Trial Site Locations

Total: 1 location

1

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Actively Recruiting

Loading map...

Research Team

M

María Torres Lacomba, Full Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging ...

Breast Cancer Female

Actively Recruiting

1 location

A Prospective Evaluation of the Peri-operative Hypoxia in Br...

Breast Cancer Female

Actively Recruiting

1 location

Assessment of Oncological Safety, Quality of Life, and Envir...

Breast Cancer Female

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/41309480