The role of bipolar radiofrequency in the treatment of vaginal laxity: a single-center cohort study in premenopausal women.

Vaginal laxity is a prevalent condition that can impair sexual function. Bipolar radiofrequency (RF) is a minimally invasive treatment; however, prospective evidence remains limited. This study aimed to evaluate changes in both subjective and objective measures of vaginal laxity following bipolar RF. This prospective observational study enrolled premenopausal women with symptomatic vaginal laxity who received four intravaginal bipolar RF sessions. The primary outcome was the change from baseline to 6 months in the Vaginal Laxity Questionnaire score. The secondary outcomes included change in genital hiatus area assessed by transperineal ultrasound, vaginal flatus frequency, vaginal laxity bother, sexual function, sexual distress, and patient-reported global improvement. Analyses were performed using paired Student t tests for genital hiatus and Friedman tests for repeated measures for patient-reported outcomes, with corresponding effect sizes reported. Thirty-two women completed follow-up. VLQ scores increased from a median of 2.0 at baseline to 4.0 at 6 months (p < 0.001). Regarding the secondary objective outcome, mean GH area decreased from 21.4 cm2 to 18.3 cm2 (p < 0.001; Cohen's d = 0.89). FSFI scores increased, and FSDS-R scores decreased over time (both p < 0.001). LVB scores also decreased significantly (p < 0.001). At 6 months, 87.5% of participants reported global improvement, and no adverse events were observed. In this uncontrolled observational cohort, changes over time were observed in both subjective and objective measures of vaginal laxity in premenopausal women following bipolar RF; however, given the absence of a control or sham group, a contribution of placebo effect or expectation bias to the observed outcomes cannot be excluded.