Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women

Launched by MAHIDOL UNIVERSITY · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a treatment called fractional bipolar radiofrequency therapy is for women experiencing vaginal laxity, which means a feeling of looseness in the vaginal area. The study will compare this treatment to a sham (placebo) treatment to see if it really helps improve symptoms. They will ask participants to fill out questionnaires to share their experiences and measure changes in sexual function and overall satisfaction after the treatment. The trial will also use ultrasound to objectively assess the thickness of the vaginal wall.

To be eligible for this study, participants need to be premenopausal women aged between 20 and 55, sexually active, and experiencing some symptoms of vaginal looseness. They should be willing to undergo the treatment and attend follow-up visits three months later. However, certain conditions, like having active infections or previous treatments for vaginal laxity, may exclude them from participating. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the treatment or the placebo, which helps ensure fair results.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Premenopausal women
• • Age 20-55 years
• • Reported symptoms of vaginal looseness with a score of at least 1 on The Vaginal Laxity Questionnaire (VLQ)
• • Sexually active (≥1 time/month)
• • Willing to undergo vaginal energy-based treatment and attend follow-up visits 3 months after treatment
• Exclusion Criteria:
• • - Presence of sexually transmitted diseases or active genital lesions
• • Currently pregnant or planning for conception during study period
• • Pelvic organ prolapse (POP ≥ Stage II)
• • Previous treatment for vaginal laxity with modalities other than pelvic floor muscle training
• • Currently using intrauterine devices for contraception
• • Presence of any active electrical implant such as pacemaker, internal defibrillator
• • Current condition of genital cancer