Microablative radiofrequency versus sham for overactive bladder: a randomized controlled trial.

Objective: Energy therapies have been suggested as potential treatments for overactive bladder (OAB), yet there are few studies examining their efficacy. This study aimed to compare the effects of fractional microablative radiofrequency (RF) to sham treatment.

Methods: A pilot clinical trial was conducted with 77 women diagnosed with OAB, randomized into two groups: one receiving three monthly sessions of fractional microablative RF and the other receiving sham treatment, both combined with behavioral therapy. Assessments were conducted at baseline and 30 days after therapy using validated questionnaires for urinary symptoms (International Consultation on Incontinence Questionnaire-Short Form, Overactive Bladder, and Quality of Life), as well as vaginal and sexual function, and pelvic floor muscle functionality.

Results: Both treatment groups demonstrated significant improvements in all validated questionnaires assessing urinary and vaginal symptoms (P < 0.001), with no significant differences between them. The International Consultation on Incontinence Questionnaire-Overactive Bladder scores improved significantly in both the RF group (-4.5 points; P < 0.001) and the sham group (-4.5 points; P < 0.001), with no significant differences between the groups (P = 0.812). Additionally, there were no improvements noted in sexual function or vaginal trophism in the RF group. However, assessments of endurance, resistance, and fast contractions of the pelvic floor muscles showed improvement only in the RF group, with no changes observed in power or perineometer measurements.

Conclusions: Microablative RF treatment combined with behavioral therapy did not show benefits over sham treatment with behavioral therapy for addressing OAB symptoms.