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

What this trial studies

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 double-blind, randomized clinical trial. 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.

Conditions in scope

• Genitourinary Syndrome of Menopause
• Vaginal Health
• Sexual Dysfunction

Interventions

• Non-ablative monopolar radiofrequency treatment (Device) — 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…

Who can join

Women only · Ages 40 Years to 65 Years

Inclusion criteria

• Age between 40 and 65 years.
• Postmenopausal women (defined as no menstrual period for at least 12 months).
• Experiencing symptoms of Genitourinary Syndrome of Menopause (GSM), such as vaginal dryness, irritation, or discomfort.
• Experiencing discomfort or complaints during vaginal penetration. Engaging in sexual activity (at least once a month).
• Willing to participate in the study and sign the informed consent form.

Exclusion criteria

• Presenting with active vaginal infections.
• Presence of neurological, neoplastic, or sexually transmitted diseases.
• Presenting with vulvodynia or vaginismus.
• Prolapse grade 2 or higher.
• Presenting with altered sensitivity in the pelvic area.
• Being a pacemaker carrier or having any device that contains batteries.
• Hormonal treatment with estrogens in the last 3 months.
• History of radiotherapy in the pelvic area.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-04-15
• Primary completion: 2024-12-30
• Last update posted: 2025-04-13
• First posted: 2025-04-13

Sponsor & contact

Lead sponsor: University of Castilla-La Mancha (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in Female Sexual Function Index (FSFI) (Baseline, end of treatment period (6 weeks), and three months post-treatment.)
  Multidimensional questionnaire evaluates sexual function over the past 4 weeks. The total score ranges from 2.0 (severe dysfunction) to 36.0 (no dysfunction). Sexual dysfunction was defined as a score equal to or below 26.55
• Change in Vaginal Health Index (VHI) (Baseline, end of treatment period (6 weeks), and three months post-treatment.)
  A tool that evaluates five parameters: vaginal elasticity, vaginal secretion (type and consistency), pH, mucosal epithelial integrity, and vaginal moisture. Each parameter was scored on a scale from 1 (most unfavorable condition) to 5 (optimal condition), with a maximum possible score of 25 points. In cases where the score was below 15, the vagina was considered atrophic.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.