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Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women
Sponsor: University of Castilla-La Mancha
Summary
This study will test if non-ablative monopolar radiofrequency can help improve vaginal tissue and reduce symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. The study is a randomized, sham-controlled clinical trial in which participants and outcome assessors were masked to treatment allocation. The study will examine the impact of the treatment on sexual function, vaginal health, and quality of life over an extended period. There will be two groups in the study: one will receive the non-ablative monopolar radiofrequency treatment, and the other will receive the placebo treatment. Participants will have six treatment sessions and will be checked at the start, end, and three months post-treatment.
Official title: Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women: a Randomized Clinical Trial
Key Details
Gender
FEMALE
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2024-06-15
Completion Date
2024-12-30
Last Updated
2026-08-17
Healthy Volunteers
No
Interventions
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 intravaginal temperature was maintained at 41-43°C throughout the 10-minute intracavitary application. 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. Participants in this group will receive the same treatment protocol, but with radiofrequency energy disabled.
Locations (1)
University of Castilla-La Mancha
Toledo, Toledo, Spain