Genitourinary Syndrome of Menopause in Breast Cancer

NCT06721936 | Recruiting DMC

• 1 other identifier: 2024/1/012
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Genitourinary Syndrome of Menopause (GSM); Breast Cancer Female

Keywords

Breas cancer; Cost-effectiveness; Dyspareunia; Genitourinary syndrome of menopause; Laser therapy; Menopause; Physiotherapy; Quality of life

Outcome Measures

Primary Outcomes (3)

• Female Sexual Function (FSFI)

  The FSFI is a 19-item questionnaire that evaluates sexual function across six domains: de-sire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored from 0 to 5, with higher scores indicating better sexual function. The total FSFI score ranges from 2 to 36, with higher scores reflecting improved sexual function.

  Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

• Subjective Pelvic Perineal Pain Intensity

  Measured using a 100-mm horizontal Visual Analog Scale (VAS), with "no pain" on the left and "worst imaginable pain" on the right.

  Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

• Health-Related Quality of Life (HRQoL)

  This 40-item questionnaire evaluates HRQoL across four general domains (physical, emo-tional, social, and functional well-being), along with two specific subscales: breast cancer (9 items) and arm symptoms (4 items). The scores for the BC subscale (BCS) and arm subscale range from 0 to 56. The Trial Outcome Index (TOI), a key measure, is the sum of the BCS and the physical and functional well-being subscales, with scores ranging from 0 to 92. The total FACT-B score ranges from 0 to 144, where higher scores indicate better HRQoL.

  Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

Secondary Outcomes (8)

• Vaginal Health Index (VHI)

  Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

• Impact of Vaginal Symptoms

  Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

• Pelvic Floor Dysfunction Symptoms

  Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

• Treatment Satisfaction

  Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

• Pelvic Floor Muscle Tone

  Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.

Study Arms (2)

Laser CO2 Therapy group

ACTIVE COMPARATOR

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

Device: Laser CO2 Therapy group

Multimodal pelviperineal physioterapy group

EXPERIMENTAL

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.

Combination Product: Multimodal pelviperineal physioterapy group

Interventions

Multimodal pelviperineal physioterapy group COMBINATION_PRODUCT

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

Multimodal pelviperineal physioterapy group

Laser CO2 Therapy group DEVICE

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.

Laser CO2 Therapy group

Eligibility Criteria

• Age: 38 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer survivors diagnosed with GSM as a result of cancer treatment
• Vaginal Health Index (VHI) score of ≤ 15.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Related Publications (1)

• Torres-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 DERIVED

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

María Torres Lacomba, Full Professor

CONTACT

34918854828; maria.torres@uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 6, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

ES (1)