RecruitingNot ApplicableNCT06721936

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).

Sponsor

University of Alcala

Enrollment

182 participants

Start Date

Nov 29, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Female Genitourinary Syndrome of Menopause (GSM)

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

Sex: FEMALEMin Age: 38 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at treatments for genitourinary syndrome of menopause (GSM) — a condition that causes vaginal dryness, discomfort, and urinary symptoms — in breast cancer survivors whose symptoms were caused or worsened by cancer treatment. The goal is to find safe and effective ways to manage these symptoms in women who cannot use hormone therapy. **You may be eligible if...** - You are a breast cancer survivor who developed GSM as a result of cancer treatment - You have a low vaginal health score (VHI score of 15 or less), indicating significant vaginal changes **You may NOT be eligible if...** - You have previously had treatment or surgery for pelvic floor problems or GSM - You are currently undergoing chemotherapy, or you have had breast cancer surgery but have not yet received chemotherapy or hormonal treatment - You have cancer that has returned, an active urinary tract infection, blood in your urine, or cognitive difficulties that prevent you from giving informed consent or answering questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTMultimodal pelviperineal physioterapy group

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

DEVICELaser CO2 Therapy group

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.