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Microablative Radiofrequency Versus Sham for Overactive Bladder: A Randomized Controlled Trial With 6 Months Follow
Constanza Alvear1, Cássia Raquel Teatin Juliato2, Anna Lygia B Lunardi1
1Department of Surgery, School of Medical Sciences, Postgraduate Program in Surgery Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.
Introduction And Objectives:
Overactive bladder (OAB) is highly prevalent among women. Energy-based treatments, such as radiofrequency (RF), have shown promising results in urinary incontinence, but evidence for OAB remains limited. This study evaluated the efficacy of microablative RF compared with sham in women with OAB over 6 months of follow-up.
Methods:
Bicenter, randomized, double-blind, parallel-group trial was conducted between March 2023 and July 2025 at two public hospitals in Brazil (UNICAMP and UFPR), following CONSORT guidelines. Women aged 45-65 years with OAB or mixed urinary incontinence with urgency predominance were randomized (1:1) to RF or sham treatment, both combined with behavioral therapy (BT). Participants underwent 3 monthly sessions. Assessments included validated questionnaires (ICIQ-OAB, ICIQ-OAB QoOL, ICIQ-UI SF, ICIQ-VS, FSFI), bladder diaries, pelvic floor evaluation (PERFECT and manometry), VHI, and vaginal cytology. The primary outcome was changes in ICIQ-OAB score at 6 months. Analyses followed the intention-to-treat principle.
Results:
140 women were randomized (RF = 72; sham = 68). Both groups showed significant improvement in OAB symptoms, with effects maintained at follow-up. ICIQ-OAB QoL, ICIQ UI-SF and ICIQ-VS improved in both groups. In the RF group, pelvic floor tone normalized and pain on palpation decreased (p = 0.026 and p = 0.035), repetitions of sustained and rapid contractions improved (p = 0.039, p = 0.015), with more adverse events than sham (44.2% vs. 22.9%; p = 0.025).
Conclusion:
RF combined with BT improved OAB symptoms with effects sustained at 6 months. However, no superiority over sham treatment was observed, reinforcing the value of BT as the, current first-line treatment recommendation for patients with OAB.
Clinical Trial Registration:
Registered in REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials) under number RBR-7xqzb9h (http://www.ensaiosclinicos.gov.br/rg/RBR-7xqzb9h/).
