Abstract:

The SECCATM (Curon Medical, Freemont, CA USA) device delivers temperature-controlled radiofrequency (RF) energy to the anorectal junction to treat fecal incontinence. The procedure is performed as an outpatient either in the endoscopy suite or ambulatory surgery center. After appropriate local block, the SECCATM device is then inserted into the anal canal and submucosal RF energy is delivered circumferentially to the anorectal junction. A pilot trial in Mexico on 10 patients demonstrated a significant improvement in Cleveland Clinic Florida Fecal Incontinence Scores (CCF-FIS) from a pre-treatment score of 13.5 to 12-month post-treatment score of 3.8. These patients continued to have significantly improved continence with an average CCF-FIS of 7.3 at 24-month follow up. A multi-center, institutional review board-approved, open label, prospective trial that evaluates the efficacy and safety of the SECCATM procedure has been completed in the United States (U.S.). Five centers prospectively enrolled 50 patients with greater than or equal to 3 months of weekly fecal incontinence who also had failed either medical or surgical interventions. Patients underwent anoscopy, anorectal manometry (ARM), endoanal ultrasound (EAUS), and pudendal nerve terminal motor latency (PNTML) at 0 and 6 months. The CCF-FIS scale, fecal incontinence-related quality of life score (FIQL), and SF-36 were administered at 0, 3, and 6 months. After conscious sedation and local perianal block, RF energy was delivered by way of the SECCATM device. At 6 months, the mean CCF-FI score improved significantly (14.5 to 11.1, p<0.0001). All FIQL parameters improved: lifestyle (2.5 to 3.1; p=0.0001), coping (1.9 to 2.3; p=0.005), depression (2.8 to 3.1; p=0.0008), embarrassment (1.9 to 2.5; p<0.0001). Sixty-percent (n=30) of the patients improved after therapy, with 70% resolution of their symptoms. The SF-36 mental composite score (45.3 to 48.3; p=0.06) and social function sub-score (64.0 to 77.3; p=0.003) improved. No changes occurred in ARM, EAUS, or PNTML. Two major complications included two mucosal ulcerations. From these data, the authors concluded that RF energy delivered for treatment of FI safely improves CCF-FIS, FIQL, and quality of life.

Authors:

Jonathan E. Efron, M.D., F.A.C.S., F.A.S.C.R.S.

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