Radiofrequency Energy Transanal Treatment of Fecal Incontinence
DESCRIPTION
Fecal incontinence is the involuntary leakage of stool from the rectum and anal canal. It is estimated that the disorder affects some 8% of the adult population. Medical management includes dietary measures, such as the addition of bulk producing agents to the diet and elimination of foods associated with diarrhea. Antidiarrheal drugs can be used for mild degrees of incontinence. Bowel management programs, commonly used in individuals with spinal cord injuries, may be effective in treating fecal incontinence.
Radiofrequency energy is being investigated as a treatment of fecal incontinence. Radiofrequency energy is delivered to the sphincteric complex by an anoscopic device. The device (e.g., the Secca™ System) has multiple needle electrodes that create thermal lesions deep into the mucosa of the anal canal. Over several months these lesions heal and the tissue contracts, which may change the tone of the tissue and improve continence. This outpatient procedure utilizes conscious sedation and a local anesthetic.
POLICY
Radiofrequency energy transanal treatment of fecal incontinence is considered investigational.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
Published data is inadequate to permit scientific conclusions regarding the utilization of radiofrequency energy transanal treatment of fecal incontinence. The available published studies have small trial sizes and lack a control group.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2011). Transanal radiofrequency treatment of fecal incontinence (2.01.58). Retrieved November 18, 2011 from BlueWeb. (8 articles and/or guidelines reviewed)
Brown, S. R. & Nelson, R. L. Surgery for faecal incontinence in adults. (Cochrane Review). In The Cochrane Library, Issue 1, 2008. Oxford: Update Software. (52 articles and/or guidelines reviewed)
Felt-Bersma, R. J., Szojda, M. M., & Mulder, C. J. (2007). Temperature-controlled radiofrequency energy (SECCA) to the anal canal for the treatment of faecal incontinence offers moderate improvement. The European Journal of Gastroenterology & Hepatology, 19 (7), 575-580. Abstract retrieved March 14, 2008 from PubMed database.
Kim, D. W., Yoon, H. M., Park, J. S., et al. (2009). Radiofrequency energy delivery to the anal canal: is it a promising new approach to the treatment of fecal incontinence? American Journal of Surgery, 197(1), 14-8. Abstract retrieved December 2, 2009 from PubMed database.
National Institute for Health and Clinical Excellence. (2011). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence. Retrieved November 18, 2011 from http://www.nice.org.uk/nicemedia/live/13047/54501/54501.pdf.
Person, B., Kaidar-Person, O., & Wexner, S. D. (2006). Novel approaches in the treatment of fecal incontinence. Surgical Clinics of North America, 86 (2006) 969-986. (54 articles and/or guidelines reviewed)
U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. 510(k) summary K014216. Retrieved August 10, 2004 from http://www.fda.gov/cdrh/pdf/k014216.pdf.
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 1/12/2012
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