Genitourinary Syndrome of Menopause in Breast Cancer
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).
University of Alcala
182 participants
Nov 29, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Breast cancer survivors diagnosed with GSM as a result of cancer treatment
- Vaginal Health Index (VHI) score of ≤ 15.
Exclusion Criteria3
- 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.
Interventions
The multimodal PPT protocol includes: Pelvic Floor Muscle Training (PFMT): This component includes techniques to raise awareness of the pelvic floor, incorporating both manual and instrumental intravaginal techniques. Non-Ablative Radiofrequency Therapy (Model: RNG, INDIBA): Applied during all eight sessions, with each session lasting 25 minutes. Therapeutic Pelvic Health Education: Designed to empower participants with knowledge about their condition and the pelvic-perineal area. This educational intervention aims to enhance understanding, promote self-care, and encourage behaviours that alleviate symptoms associated with GSM
The fractional laser application will be delivery with the following probes: 90° Probe for Incontinence: Maximum power of 40W; 360° Probe for Vaginal Atrophy: Maximum power of 40W and Right-Angle Probe for Vulvar Atrophy: Maximum power of 24W.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06721936