Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women

NAActive, not recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

December 30, 2024

Study Completion Date

June 15, 2025

Conditions
Genitourinary Syndrome of MenopauseVaginal HealthSexual Dysfunction
Interventions
DEVICE

Non-ablative monopolar radiofrequency treatment

"Protocol for the experimental group:~Tissue preparation phase: 5 minutes with the circular resistive monopolar electrode, applying slow circular or semicircular movements in the perineal area. The temperature will be gradually increased based on the patient's temperature perception, ensuring it remains comfortable (approximately 5 out of 10).~Main phase: 10 minutes using the intracavitary capacitive electrode connected to the PLUMA handle, lightly resting it on the tissues and continuously moving the electrode. The temperature should reach 40-42°C in the tissue and be maintained for at least 10 minutes.~Final phase: 5 minutes with the circular resistive monopolar electrode, applying it similarly to the preparatory phase, with a subthermal effect, reaching a self-reported thermal sensation of 3 to 4 out of 10.~Protocol for the sham group: this group will receive the same treatment protocol that treatment group, but without the application of heat."

Trial Locations (1)

45000

University of Castilla-La Mancha, Toledo

All Listed Sponsors
lead

University of Castilla-La Mancha

OTHER