Novel Nonablative Radiofrequency Approach for the Treatment of Anal Incontinence: A Phase 1 Clinical Trial

Objective: We aimed to describe the action, impact on quality of life, and side effects of perianal nonablative radiofrequency (RF) application in the treatment of anal incontinence (AI) in women. Methods: This was a pilot, randomized clinical trial conducted between January and October 2016. We enrolled women who consecutively attended the Attention Center of the Pelvic Floor (CAAP) with complaints of AI for more than six months. Nonablative RF was applied to the perianal region of the participants using Spectra G2 (Tonederm®, Rio Grande do Sul, Brazil). The reduced or complete elimination of the need for protective undergarments (diapers and absorbents) was considered a partial therapeutic response. Results: Nine participants reported treatment satisfaction, while one reported dissatisfaction with the nonablative RF treatment of AI based on the Likert scale. No patient interrupted treatment sessions because of adverse effects, although adverse effects occurred in six participants. However, the clinical and physical examination of the participants with burning sensations showed no hyperemia or mucosal lesions. Conclusions: This study showed a promising reduction of fecal loss, participant satisfaction with treatment, and improved lifestyle, behavior, and depression symptoms with minimal adverse effects.