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Bipolar Radiofrequency for Genitourinary Syndrome of Menopause
Sponsor: University of Castilla-La Mancha
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.
Official title: Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical Trial
Key Details
Gender
FEMALE
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-15
Completion Date
2026-09-30
Last Updated
2026-02-18
Healthy Volunteers
No
Interventions
Active bipolar radiofrequency therapy
Bipolar radiofrequency will be delivered using a non-ablative medical device for vulvovaginal tissue remodeling. Participants will receive six weekly sessions lasting approximately 40 minutes each. Each session will include three phases: an initial 5-minute external application using a capacitive electrode applied to the perineal and vulvar areas with gradual thermal increase to a comfortable sensation (approximately 4-5/10); a 10-minute intracavitary phase using a bipolar electrode with controlled temperature maintained between 41-43°C and systematic rotation for uniform energy distribution; and a final 5-minute external capacitive application replicating the first phase.
Sham radiofrequency procedure
The sham procedure will replicate the structure, duration, electrode placement, and anatomical application sites of the active intervention. Participants will undergo six weekly sessions lasting approximately 40 minutes, including an initial 5-minute external application to the perineal and vulvar areas, a 10-minute intracavitary electrode placement, and a final 5-minute external application. However, no therapeutic radiofrequency energy or thermal increase will be delivered.
Locations (1)
University of Castilla-La Mancha
Toledo, Toledo, Spain