MedTrace Logo

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

NCT06925139 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-04-13

No results posted yet for this study

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 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. Participants will have six treatment sessions and will be checked at the start, end, and three months post-treatment.

Conditions

  • Genitourinary Syndrome of Menopause
  • Vaginal Health
  • Sexual 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.

Sponsors & Collaborators

  • University of Castilla-La Mancha

    lead OTHER

Principal Investigators

  • Claudia Quezada Bascuñán, Ms · University of Castilla-La Mancha

  • Asunción Ferri Morales, PhD · University of Castilla-La Mancha

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2024-12-30
Completion
2025-06-15

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06925139 on ClinicalTrials.gov