Radiofrequency Energy Transanal Treatment of Fecal Incontinence
DESCRIPTION
Radiofrequency energy is being investigated as a minimally invasive treatment of fecal incontinence. This outpatient procedure utilizes conscious sedation and a local anesthetic. Radiofrequency energy is delivered to the sphincteric complex by an anoscopic device (Secca® System) with multiple needle electrodes that create thermal lesions deep into the mucosa of the anal canal. Over several months the lesions heal and the tissue contracts which is proposed to improve continence. Studies to date have shown only a moderate effect that declines over time.
POLICY
Radiofrequency energy transanal treatment of fecal incontinence is considered investigational.
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ADDITIONAL INFORMATION
Published data are inadequate to permit conclusions regarding the utilization of radiofrequency energy transanal treatment of fecal incontinence.
SOURCES
American College of Gastroenterology. (2014, July). ACG Clinical guideline: management of benign anorectal disorders. Retrieved March 23, 2018 from https://gi.org/guidelines/.
BlueCross BlueShield Association. Evidence Positioning System. (12:2020). Transanal radiofrequency treatment of fecal incontinence (2.01.58). Retrieved December 17, 2020 from http://www.evidencepositioningsystem.com. (15 articles and/or guidelines reviewed)
Felt-Bersma, R. (2014). Temperature-controlled radiofrequency energy in patients with anal incontinence: an interim analysis of worldwide data. Gastroenterology Report, 2, 121-125. (Level 2 evidence)
Frascio, M., Manolfino, F., Imperatore, M., Stabilini, C., Fornaro, R., Gianetta, E., et al. (2014). The SECCA procedure for faecal incontinence: a review. Colorectal Disease, 16 (3), 167-172. Abstract retrieved February 19, 2020 from PubMed database.
Lam, T.J., Visscher, A.P., Meurs-Szojda, M.M., & Felt-Bersma, R.J.F. (2014). Clinical response and sustainability of treatment with temperature-controlled radiofrequency energy (Secca) in patients with faecal incontinence: 3 years follow-up. International Journal if Colorectal Disease, 29 (6), 755-761. Abstract retrieved February 19, 2020 from PubMed database.
National Institute for Health and Clinical Excellence. (2011). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence. Retrieved February 19, 2020 from http://www.nice.org.uk.
Rosenblatt, P. (2015). New developments in therapies for fecal incontinence. Current Opinion in Obstetrics and Gynecology, 27 (5), 3453-358. Abstract retrieved March 24, 2017 from PubMed database.
U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K014216. Retrieved July 30, 2013 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 11/11/2021
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