Genitourinary Syndrome of Menopause in Breast Cancer

Recruiting · NCT06721936 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

Laser CO2 Therapy groupMultimodal pelviperineal physioterapy group

What this trial is about

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 hypothesis is that multimodal PPT will lead to greater improvements in pelvic pain, muscle function, and sexual health, with sustained benefits over time. This trial aims to provide evidence for non-invasive, non-hormonal treatments to manage GSM in BC survivors, filling a significant therapeutic gap.

Who can take part

Age range

38 Years and older

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

Hospital Universitario Ramón y Cajal - Madrid, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →