Genitourinary Syndrome of Menopause in Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age38+
SponsorUniversity of Alcala
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer survivors diagnosed with GSM as a result of cancer treatment
Vaginal Health Index (VHI) score of ≤ 15.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Multimodal pelviperineal physioterapy group
Combination productThe 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
DeviceThe 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.
Treatment groups
182 Participants
are divided into 2 treatment groupsGroup A: Laser CO2 Therapy groupActive comparator 1 intervention
Group B: Multimodal pelviperineal physioterapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 A1.2
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.
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 A1.3
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.
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.Secondary outcomes
1
Vaginal Health Index (VHI)
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.
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 A1.2
Impact of Vaginal Symptoms
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.
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 A1.3
Pelvic Floor Dysfunction Symptoms
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.
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 A1.4
Treatment Satisfaction
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov