Not Yet RecruitingNot Applicable

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

Thailand56 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range

20 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Vaginal Laxity Questionnaire (VLQ)

Timeframe: From enrollment to the end of treatment at 12 weeks

Trial details

NCT IDNCT06872281

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31

Contact for this trial

Suthanud Premchit, MD

(66)+954575848 dai_suthanud@hotmail.com

View on ClinicalTrials.gov More Vaginal Laxity trials