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Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women
Sponsor: Mahidol University
Summary
Knowledge gap: Lack of randomized controlled trials evaluating the efficacy of fractional bipolar radiofrequency therapy compared to a sham treatment for vaginal laxity in premenopausal women. Primary outcomes * Subjective outcomes: The Vaginal Laxity Questionnaire (VLQ) Secondary outcomes * Subjective outcomes * The Thai version of the Female Sexual Function Index (FSFI) will be administered to evaluate sexual function. * The Thai version of the Female Genital Self-Image Scale (FGSIS) * The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), validated in Thai * The Patient Global Impression of Improvement (PGI-I) * Patients will report any side effects or adverse events experienced during the study. * Objective outcomes - Vaginal wall thickness will be assessed using 3D transvaginal ultrasound imaging, following the standardized protocol established in previous studies. PICO: P (Population): Premenopausal women with clinically diagnosed vaginal laxity who are sexually active. I (Intervention): Fractional bipolar radiofrequency therapy (single treatment) C (Comparison): Sham treatment (placebo). O (Outcomes): * Primary Outcome: Improvement in vaginal laxity as assessed by the Vaginal Laxity Questionnaire (VLQ). * Secondary Outcomes: Patient satisfaction with treatment (measured by the Patient Global Impression of Improvement - PGI-I)., Changes in sexual function (assessed using the Thai version of the Female Sexual Function Index - FSFI). Perception of genital self-image (evaluated using the Thai version of the Female Genital Self-Image Scale - FGSIS)., Evaluation of vaginal symptoms (using the International Consultation on Incontinence Questionnaire-Vaginal Symptoms - ICIQ-VS), Objective assessment of vaginal wall thickness through 3D transvaginal ultrasound, Recording of any side effects or adverse events associated with the treatment. Study Design: A double-blind, randomized controlled trial (RCT) conducted at the Female Pelvic Medicine and Reconstructive Surgery clinic in Ramathibodi Hospital.
Official title: A Randomized Controlled Trial Comparing Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women
Key Details
Gender
FEMALE
Age Range
20 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-04-01
Completion Date
2025-11-30
Last Updated
2025-03-17
Healthy Volunteers
No
Conditions
Interventions
Fractional bipolar radiofrequency
The treatment group will receive a single treatment of intravaginal fractional bipolar radiofrequency therapy.
Sham device
The sham group will receive treatment with a specialized sham device that mimics the treatment group's equipment. There are no differences in the design of the tip device, the auditory signal (beeping), or the pulse count display.
Locations (1)
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, Thailand