Clinical Trial

Bipolar Radiofrequency for Genitourinary Syndrome of Menopause

Study acronym: BRF-GSM
Not Yet Recruiting
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Summary
This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of bipolar radiofrequency in the treatment of genitourinary syndrome of menopause (GSM) in postmenopausal women. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure. The primary objective is to determine whether bipolar radiofrequency improves vaginal and sexual function. Secondary objectives include assessment of pain with vaginal penetration, vaginal lubrication and tissue distensibility, patient-reported vulvovaginal symptom severity, and treatment safety and tolerability.
Trial Details
NCT Number NCT07419035
Lead Sponsor University of Castilla-La Mancha
Conditions Genitourinary Syndrome of Menopause (GSM)
Enrollment 40 participants
Start Date 2026-03-15
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-18