Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)

Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no dryness" and 10 indicates "maximum dryness". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.

Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "maximum pain during sexual activity". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.

Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no itching" and 10 indicates "maximum itching". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.

The Vaginal Health Index Score assesses five parameters (elasticity, secretions, epithelial integrity, moisture, and pH), each rated from 1 to 5. The total score ranges from 5 (worst condition) to 25 (optimal vaginal health).

The FSFI is a 19-item self-reported questionnaire evaluating six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36. A score below 26.55 is considered indicative of sexual dysfunction based on established clinical cutoffs.

The pH will be quantified using MColorpHast™ pH indicator strips (0-14 range, Merck®). The strip will be placed directly on the right lateral vaginal wall for a few seconds, and the result will be determined by comparing the colour to the manufacturer's reference scale. Higher pH values are typically associated with hypoestrogenic states and genitourinary symptoms of menopause

Pelvic anatomy will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system, with the patient in gynecological position and using a speculum. The following parameters will be recorded: genital hiatus (GH), perineal body (PB), total vaginal length (TVL), and reference points Aa, Ba, C, D, Ap, and Bp.

The ICIQ-SF is a self-reported questionnaire assessing the frequency, severity, and impact of urinary incontinence. Scores range from 0 to 21, with higher scores indicating greater severity.

The ICIQ-FLUTS (International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms) is a self-administered questionnaire designed to evaluate female lower urinary tract symptoms (LUTS) and their impact on quality of life. It consists of 12 items grouped into three independent domains: storage symptoms, voiding symptoms, and incontinence symptoms. Each item assesses the presence and perceived severity of the symptom

Assessed by vaginal palpation using the Modified Oxford Scale, which rates voluntary pelvic-floor muscle contraction from 0 (no contraction) to 5 (strong contraction). This is a validated, clinician-administered tool.

Pelvic-floor muscle activation is measured using surface electromyography (sEMG) with an intracavitary Periform® vaginal probe. The outcome is expressed in microvolts (μV) and reflects the neuromuscular response of the pelvic floor during both contraction and resting phases. For each participant, the final value will be calculated as the mean of three voluntary contractions, with 10-second rest intervals between contractions

Participants will be asked to rate their overall perception of improvement in symptoms after the intervention using a 7-point Likert scale, specifically designed for this study and based on the Patient Global Impression of Change (PGIC). The scale ranges from 1 ("very much improved") to 7 ("very much worse"), reflecting the participant's subjective global impression of improvement compared to their baseline condition.

Any unexpected or undesired sign, symptom, or condition temporally associated with the intervention will be recorded

Measured through a self-reported diary where participants record the frequency and completion of home-based pelvic-floor exercises. Adherence is expressed as a percentage of the total prescribed sessions completed.

Oncological follow-up will document any confirmed local breast cancer recurrence occurring within 12 months of completing the intervention.

At the end of the intervention, participants will be asked whether they believe they received the active treatment or the placebo treatment.