Randomized, Controlled Trial to Evaluate the Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training on Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Survivors

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Spain
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Contact Information
Primary
Irene Lázaro Navas, PhD, MSc, PT
ilazaro@salud.madrid.org
+34 91 336 83 22
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training
Participants in this group will receive non-ablative monopolar capacitive radiofrequency therapy combined with pelvic-floor muscle training guided by biofeedback.
Sham_comparator: Sham Radiofrequency + Pelvic-Floor Muscle Training
Participants in this group will receive sham radiofrequency treatment combined with pelvic-floor muscle training guided by biofeedback.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Universitario Ramon y Cajal
Leads: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

This content was sourced from clinicaltrials.gov