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

NCT07034976 | Recruiting

• 2 other identifiers: 069/25IMP24_B01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genitourinary Syndrome of Menopause (GSM); Breast Cancer

Keywords

genitourinary syndrome of menopause; vaginal atrophy; vaginal dryness; breast cancer survivors; non-ablative radiofrequency; pelvic floor muscle training; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)

Secondary Outcomes (15)

• Subjective sensation of pain during sexual activity (NRS 0-10)

  T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)

• Subjective sensation of vaginal itching (NRS 0-10)

  T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)

• Vaginal Health Index Score

  T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)

• Female Sexual Function Index total score

  T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)

• Vaginal pH level

  T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)

Study Arms (2)

Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training

EXPERIMENTAL

Participants in this group will receive non-ablative monopolar capacitive radiofrequency therapy combined with pelvic-floor muscle training guided by biofeedback.

Device: Active Radiofrequency (Capenergy C500 UpGradeC200)

Sham Radiofrequency + Pelvic-Floor Muscle Training

SHAM COMPARATOR

Participants in this group will receive sham radiofrequency treatment combined with pelvic-floor muscle training guided by biofeedback.

Device: Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)

Interventions

Active Radiofrequency (Capenergy C500 UpGradeC200) DEVICE

Non-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.

Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training

Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode) DEVICE

Participants 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.

Sham Radiofrequency + Pelvic-Floor Muscle Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Active genital infections.
• Diagnosis of HIV infection or severe immunosuppression.
• Presence of pacemakers, metallic implants, or electromagnetic devices.
• Coagulation disorders or current use of anticoagulants.
• Pelvic organ prolapse stage \> III (POP-Q classification).
• Unexplained abnormal vaginal bleeding.
• History of pelvic anti-incontinence surgery, with or without mesh.
• Inflammatory dermatoses of the vulva.
• Pelvic-floor muscle strength score of 0/5 on the Modified Oxford Scale.
• Nickel allergy.
• Previous treatment with radiofrequency in the pelvic or genital area.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Hospital Universitario Ramon y Cajal: collaborator

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Irene Lázaro Navas, PhD, MSc, PT

CONTACT

+34 91 336 83 22; ilazaro@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. In addition, the independent statistician responsible for data analysis will remain blinded until the database is locked. Only the treating physiotherapists and the study coordinator will have access to the randomization list
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Physiotherapist, Department of Rehabilitation Medicine, Hospital Universitario Ramón y Cajal

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-07

Locations

ES (1)