Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

BACKGROUND: Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. OBJECTIVE: The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. DESIGN: This was a randomized sham-controlled clinical trial from 2008 to 2015. SETTING: This study was conducted in an outpatient clinic. PATIENTS AND METHODS: Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. MAIN OUTCOME MEASURES: Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-oflife score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. RESULTS: At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-oflife score at t = 6 months was not statistically different. Anorectal function did not show any alteration. LIMITATIONS: Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. CONCLUSIONS: Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known.