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NCT Number: NCT06721936

Genitourinary Syndrome of Menopause in Breast Cancer

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.

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Key information

Age range

38 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location status: Recruiting

Location contact

Jesus Lázaro-Carrasco de la Fuente Dr., PhD

CONTACT

Head of the Department

Jesús Lázaro & María Torres LACOMBA, PhD

CONTACT

[email protected]

678900061

About this study

Background: Genitourinary syndrome of menopause (GSM) induced by breast cancer (BC) treatments is highly prevalent among BC survivors due to the abrupt hor-monal deprivation caused by oncological therapies. Given the contraindication of hor-monal treatments in this population, there is a critical need for effective non-hormonal alternatives to alleviate GSM symptoms.

Objectives: This study aims to compare the effectiveness of multimodal pelvic floor physiotherapy (PPT)-comprising pelvic floor muscle training, vaginal non-ablative radiofrequency, pelvic health education, and vaginal moisturizers-against fractional CO2 vaginal laser therapy in reducing GSM symptoms among BC survivors.

Methods: A randomized, single-blind clinical trial will be conducted with 210 women diagnosed with GSM after undergoing BC treatment. Participants will be ran-domly assigned (1:1) to receive either three sessions of CO2 vaginal laser therapy or eight face-to-face sessions of multimodal PPT. Assessments will be performed at base-line, immediately after the intervention, and at 3-, 6-, and 12- months post-intervention. Primary outcomes will include perineal pain, sexual function, and health-related quality of life (HRQoL). Additionally, a cost-effectiveness analysis will be conducted to evaluate the costs of each intervention relative to the changes in clinical outcomes, and any ad-verse effects will be monitored throughout the study.

Results: It is hypothesized that women undergoing multimodal PPT will show greater reductions in pelvic pain and improvements in pelvic floor muscle strength, endurance, and relaxation compared to those receiving CO2 laser therapy, alongside enhanced sexual function and HRQoL. These improvements are expected to be sus-tained in the short and medium term through continued adherence to home exercises and educational strategies.

Conclusions: This study aims to provide evidence for novel, non-invasive, and non-hormonal treatment strategies to manage GSM in BC survivors, addressing an important gap in the therapeutic landscape for this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Female Sexual Function (FSFI)

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

    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.

  2. Subjective Pelvic Perineal Pain Intensity

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

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

  3. Health-Related Quality of Life (HRQoL)

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

    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.

Secondary outcomes

  1. Vaginal Health Index (VHI)

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

    This index evaluates five key aspects of vaginal health: elasticity, epithelial integrity, pH, hydration, and fluid volume. Each component is scored from 1 to 5, with lower scores in-dicating poorer vaginal health. A VHI score of ≤15 indicates vaginal atrophy.

  2. Impact of Vaginal Symptoms

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

    The Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire assesses the impact of vulvovaginal symptoms in postmenopausal women across four domains: activities of daily living, emotional well-being, sexual functioning, and self-concept/body image. The ques-tionnaire consists of 22 items, each scored on a scale from 0 to 4. The score for each domain is calculated by averaging the scores of its items, with higher scores indicating a greater impact of vaginal symptoms.

  3. Pelvic Floor Dysfunction Symptoms

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

    Assessed using the Spanish version of the Pelvic Floor Distress Inventory-Short Form (PFDI-20), which consists of 20 questions across three subscales: prolapse, anal, and uri-nary symptoms. The total score ranges from 0 to 300, with higher scores indicating greater distress.

  4. Treatment Satisfaction

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

    Satisfaction with the treatment will be assessed using a numerical verbal scale ranging from 0 to 10, where 0 represents no satisfaction and 10 indicates excellent satisfaction. This evaluation will begin with assessment A1.

  5. Pelvic Floor Muscle Tone

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

    Measured using vaginal dynamometry with the Pelvimetre™ (Phenix Vivaltis, Montpel-lier, France). For the assessment, the participant will be in lithotomy position, and the tone of the pelvic floor muscles will be considered when the vaginal device is inserted, and the participant perceives that her muscles are relaxed.

  6. Pelvic Floor Muscle Strength

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

    Measured using vaginal dynamometry with the Pelvimetre™ (Phenix Vivaltis, Montpel-lier, France). The participant, in the lithotomy position, will perform three maximum contractions of the pelvic floor muscles. The average value of the three contractions will be considered.

  7. Pelvic Floor Muscle Contraction

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

    Three maximum pelvic floor muscle contractions will be requested in lithotomy position, and the distance of the urogenital hiatus will be assessed using transperineal ultrasound (Mindray M7, Shenzhen, China).

  8. Pelvic Floor Elasticity

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

    In the lithotomy position, an inspiratory apnea Valsalva maneuver will be requested, and the distance of the urogenital hiatus will be assessed using transperineal ultrasound (Mindray M7, Shenzhen, China).

Study contacts

Contact information is provided by the study sponsor or research team.

María Torres Lacomba, Full Professor

CONTACT

[email protected]

34918854828

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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).

Acronym: PILME

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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