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.
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)
- 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
Mahidol University
Lead sponsor
InMode MD Ltd.
Collaborator