Clinical trial · Interventional
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Genitourinary Syndrome of Menopause (GSM) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser CO2 Therapy group | Device | — | UNRESOLVED |
| Multimodal pelviperineal physioterapy group | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Laser CO2 Therapy group
- description
- 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
- interventionNames
- Device: Laser CO2 Therapy group
- type
- EXPERIMENTAL
- label
- Multimodal pelviperineal physioterapy group
- description
- 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.
- interventionNames
- Combination Product: Multimodal pelviperineal physioterapy group
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 38 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDTorres-Lacomba M, Hernandez-Iglesias CM, Del Valle-Rubido C, Navarro-Brazalez B, Rangel-de la Mata P, Lorenzo-Gallego L, Sanchez-Sanchez B, Salvador-Osuna M, Lazaro-Carrasco de la Fuente J. 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). BMJ Open. 2025 Nov 27;15(11):e104711. doi: 10.1136/bmjopen-2025-104711. PMID 41309480