Correlation Between Vaginal Laxity and Delivery Mode
Evaluation of pelvic floor using 2D and 3D Transperineal Ultrasound
parous women
pregnant women [+1]
Review clinical trials related to Vaginal Laxity. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.
Evaluation of pelvic floor using 2D and 3D Transperineal Ultrasound
parous women
pregnant women [+1]
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 [+4]
- Presence of sexually transmitted diseases or active genital lesions [+6]