Genitourinary Syndrome of Menopause Induced by Breast Cancer Treatments: A Randomized Clinical Trial Protocol Comparing Multimodal Pelvic Floor Physiotherapy and Frac-tional CO2 Laser Therapy (PILME Study).

Status: Recruiting
Location: See location...
Intervention Type: Device, Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 38
Healthy Volunteers: f
View:

• Breast cancer survivors diagnosed with GSM as a result of cancer treatment

• Vaginal Health Index (VHI) score of ≤ 15.

Locations
Other Locations
Spain
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Contact Information
Primary
María Torres Lacomba, Full Professor
maria.torres@uah.es
34918854828
Time Frame
Start Date: 2024-11-29
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 182
Treatments
Active_comparator: Laser CO2 Therapy group
Participants in this group will undergo three treatment sessions using the Monalisa Touch CO2 fractional laser, administered by a senior gynaecologist (MD3) on an outpatient basis, once a month for three consecutive months. Each session will last approximately 15 minutes and will be performed without anaesthesia
Experimental: Multimodal pelviperineal physioterapy group
Participants in this group will attend eight personalized sessions of multimodal PPT, each lasting 50-60 minutes, administered once a week the six first sessions, and the last 2 sessions, one session every two weeks. The multimodal PPT protocol includes: 1) Pelvic Floor Muscle Training (PFMT); 2) Non-Ablative Radiofrequency Therapy (Model: RNG, INDIBA); 3) Therapeutic Pelvic Health Education.
Related Therapeutic Areas
Sponsors
Leads: University of Alcala

This content was sourced from clinicaltrials.gov