The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms.
The main questions it aims to answer are:
Does the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months?
What other changes (pain during intercourse, Vaginal Health Index, urinary and sexual function, pelvic-floor strength, overall satisfaction) are seen in each group?
Researchers will compare six sessions of active RF with six sessions of sham (inactive) RF to see whether the active treatment works better.
Participants will:
Visit the hospital once a week for 6 weeks. Each visit includes about 20 minutes of intra-/extra-vaginal RF (or sham) and 20 minutes of guided pelvic-floor training whose content is adapted and progressed throughout the study.
Carry out a structured, progressive home-exercise programme, recording any discomfort in a diary.
Complete questionnaires and tests at baseline, after session 6, and 3 months later.
Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.
Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another clinical condition.
Negative urine culture at baseline.
Moderate to severe vaginal dryness, defined as a score > 4 on the Numeric Rating Scale (NRS 0-10)
Age over 75 years.
Current or past diagnosis of any cancer other than breast cancer.
Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.
Use of local estrogen therapy within the past month.
Parallel
Active Radiofrequency (Capenergy C500 UpGradeC200)
DeviceNon-ablative radiofrequency is applied using a Capenergy C500 device at a target tissue temperature of ≤ 45 °C, once a week for 6 consecutive weeks. Treatment is delivered through two channels simultaneously: a capacitive plate placed on the suprapubic area and an intracavitary vaginal probe. Each session lasts 20 minutes and is followed by 20 minutes of pelvic-floor muscle training guided by biofeedback. Participants will also follow a progressive home exercise programme and record adherence and events. In addition, all participants will receive education on pelvic-floor anatomy and function, underlying mechanisms of pain after breast cancer, bladder and bowel retraining, respiratory pattern re-education, and-if interested-information on sexual health.
Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)
DeviceParticipants will receive one session per week for 6 weeks of sham (placebo) radiofrequency using the Capenergy C500 in Placebo Mode (no temperature increase), designed to simulate active treatment. The screen will display a simulated "delivered energy" value; temperature and energy readings will be hidden; LED indicators will activate sequentially; and a suprapubic capacitive plate and intracavitary probe will be used with the same protocol as in the intervention group. This will be followed by 20 minutes of pelvic-floor muscle training guided by biofeedback, identical to the intervention group. Participants will also follow a progressive home exercise programme and record adherence and events. All participants will receive education on pelvic-floor function, pain mechanisms after breast cancer, bladder/bowel retraining, breathing pattern correction, and-if interested-sexual health.
Subjective sensation of vaginal dryness
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.
Subjective sensation of pain during sexual activity (NRS 0-10)
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.
Subjective sensation of vaginal itching (NRS 0-10)
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.
Vaginal Health Index Score
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).
Female Sexual Function Index total score
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.
Click on the lead sponsor to view all of their trials.
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead sponsor
Hospital Universitario Ramon y Cajal
Sponsor institution
Hospital Universitario Ramon y Cajal
Collaborator
