Fecal incontinence is the involuntary leakage of stool from the rectum and anal canal.  Fecal continence depends on a complex interplay of anal sphincter function, pelvic floor function, stool transit time, rectal capacity and sensation. Radiofrequency energy has been investigated as a minimally invasive treatment of fecal incontinence, referred to as the Secca procedure. In this outpatient procedure using conscious sedation, radiofrequency energy is delivered to the sphincteric complex of the anal canal to create discrete thermal lesions.  Over several months, these lesions heal and the tissue contracts, changing the tone of the tissue and improving continence.  This procedure is very similar in concept to the Stretta procedure for treatment of gastroesophageal reflux disease.

Investigational and Not Medically Necessary:

Transanal radiofrequency therapy for the treatment of fecal incontinence is considered investigational and not medically necessary.

Ruiz and colleagues (2010) reported the one year outcomes of individuals who underwent the Secca procedure as a treatment for fecal incontinence at a single institution between March 2003 and June 2004.  Twenty-four individuals were enrolled in the study, but only 16 were available at the 12-month follow-up visit.  The main causes of fecal incontinence were due to obstetric injury, aging, trauma from previous anorectal surgeries or idiopathic.  The mean Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI) improved from a mean of 15.6 (+/- 3.2) at baseline to 12.9 (+/- 4.6) at 12 months (P = .035).  The CCF-FI score also indicated that four participants (25%) experienced a worsening of their fecal incontinence and two individuals (12.5%) showed no improvement.  Of the 10 participants (62.5%) with improvement, two (12.5%) had at least a 50% improvement in the CCF-FI score at the 12-month follow-up and seven participants (43.8%) demonstrated a 20% or more improvements.  Overall, 10 of the 16 subjects had a score less than 15, indicating moderate fecal incontinence.  After one year of radiofrequency treatment, the mean CCF-FI score was reduced from severe to moderate incontinence.  The mean Fecal Incontinence Quality of Life Questionnaire score improved in all subsets except for the depression subscore which did not reach significance (P = .58).  The authors acknowledged that some of the limitations of this study include the small sample size, the lack of physiologic study data and the loss of follow-up of 33% of the participants. 

Kim and colleagues (2009) evaluated the safety and effectiveness of radiofrequency energy to the anal canal (the Secca procedure) as a treatment of fecal incontinence in eight (8) individuals.  Measurements at baseline and after the procedure were assessed using the Fecal Incontinence Severity Index (FISI) score and the Fecal Incontinence-related Quality of Life (FIQL) scale.  Anorectal manometry and endoanal ultrasound also were used.  The median age of the individuals was 59 years (range, 28-73 years) and seven of the eight were women.  At six months after the procedure, the mean FISI score and all of the parameters in the FIQL scale with the exception of the embarrassment scale did not improve significantly.  Researchers did not observe any changes in the anal manometry and endoanal ultrasound parameters.  Seven of the eight individuals experienced complications including anal bleeding, anal pain, and anal mucosal discharge after the procedure.

Lefebure and colleagues (2008) reported the results of a nonrandomized, prospective study of 15 individuals who underwent the Secca procedure at a single institution between March 2005 and March 2006.  All had experienced fecal incontinence for at least 3 months and had attempted, but were unsatisfied with the results of, surgical and/or medical interventions.  The goal of the study was to evaluate changes in FI symptom scores and quality of life between the baseline and follow-up intervals.  Twelve months after the procedure, all 15 individuals were alive and in contact with the investigational site.  Investigators reported no long term complications.  The mean Wexner score improved from 14.07 (+/-4.5) at baseline to 12.33 (+/-4.6) at 1 year (p=0.02).  The mean fecal incontinence quality of life score improved only in the depression subscore.  There were no changes in endoanal ultrasound and anorectal manometry.  Researchers concluded that while the study confirmed the safety of the Secca procedure, most individuals remained in the moderate incontinence category as defined by the scoring system and did not improve their quality of life except in the depression subscore.

Takahashi-Monroy and colleagues (2008) evaluated the long term (5 years) durability of radiofrequency energy delivery for fecal incontinence in nineteen (eighteen females and one male) individuals.  This study was an extension of the follow-up from an earlier prospective study in which individuals who suffered from fecal incontinence were treated with the SECCA procedure.  The Cleveland Clinic Florida Fecal Incontinence Scale (0-20), fecal incontinence-related quality of life score, and Medical Outcomes Study Short-Form 36 were administered to all subjects up to 5 years after the procedure.  Differences between baseline and follow-up were analyzed by using paired t-test:  the mean duration for fecal incontinence was 7.1 (range, 1-21) years.  At five-year follow-up, the mean fecal incontinence score had improved from 14.37 to 8.26 (P< 0.00025) with 16 individuals (84.2 percent) demonstrating a greater than 50 percent improvement.  All fecal incontinence-related quality of life scores (coping, depression, embarrassment) improved.  The social function component of the Short-Form 36 improved from 38.3 to 60 (P< 0.05).  There was a pattern of improvement in the mental component summary of the Short-Form 36 from 38.1 to 48.14.  No long-term complications were reported.  The researchers concluded that significant and sustained improvements in fecal incontinence symptoms and quality of life are seen at five years after treatment with the Secca system.

At this time, there is a lack of strong evidence in the published peer-reviewed literature to demonstrate additional or increased benefit from the use of transanal radiofrequency to treat fecal incontinence when compared to other therapies.  There are no randomized controlled trials to compare the efficacy of this treatment to other treatment modalities and further investigation is needed.

Fecal incontinence is the inability to control the bowels, which results in leakage of stool or gas.  There are many causes of fecal incontinence, including injury from childbirth, injury from a previous surgery, nerve-related diseases, and age-related changes in muscle tone.  Fecal incontinence affects between 2-8% of the U.S. adult population.  Seven percent of the otherwise healthy individuals over age 65 who are living at home experience fecal incontinence at least once per week or need to use a pad.  Females are affected more frequently than males.

Management of fecal incontinence is provided in a tiered approach, beginning with lifestyle modification or harmacologic therapy followed by selectively offering various modalities and surgery to eligible individuals. Selection of which treatment modality to be employed depends on a number of aspects, such as severity of symptoms, availability of methods and the individual's adherence to treatment.  Moreover, concomitant use of different methods can improve results and is usually applied.

The Secca procedure is a minimally invasive, outpatient procedure that represents a less-invasive option for treatment of fecal incontinence, as compared to surgery.  The Secca™ System, which received U.S. Food and Drug Administration (FDA) approval in March 2002, consists of the Curon Control Module, a four-channel radiofrequency generator, and the Secca Handpiece, which is a single use device used to deliver energy to the muscles of the anal canal.  The physician places the device into the anal canal, deploys the electrodes into the tissue, and initiates radiofrequency energy delivery.  Discrete thermal lesions are created in the tissue surrounding each electrode.  Over time, the treated areas resorb and the tissue contracts, changing the tone of the tissue and improving continence in most individuals.  Potential complications include stricture, pain, and constipation.  Additional studies are needed to examine the long-term outcomes of results and development of complications.

Fecal incontinence: The inability to control the bowels, which results in leakage of stool or gas.

Radiofrequency: Relating to, using, or induced by using heat produced by high-frequency radiowaves.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When Services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Bachoo P, Brazzelli M, Grant A. Surgery for faecal incontinence in adults. Cochrane Database Syst Rev. 1999; (3):CD001757.
2. Cooper ZR, Rose S. Fecal incontinence: a clinical approach. Mt Sinai J Med. 2000; 67(2):96-105.
3. Efron JE. The SECCA procedure: a new therapy for treatment of fecal incontinence. Surg Technol Int. 2004; 13:107-110.
4. Felt-Bersma RJ, Szojda MM, Mulder CJ. Temperature-controlled radiofrequency energy (SECCA) to the anal canal for the treatment of faecal incontinence offers moderate improvement. Eur J Gastroenterol Hepatol. 2007; 19(7):575-580.
5. Kim DW, Yoon HM, Park JS, et al. Radiofrequency energy delivery to the anal canal: Is it a promising new approach to the treatment of fecal incontinence? Am J Surg. 2009; 197(1):14-18.
6. Lefebure B, Tuech JJ, Bridoux V, et al. Temperature-controlled radio frequency energy delivery (Secca procedure) for the treatment of fecal incontinence: results of a prospective study. Int J Colorectal Dis. 2008; 23(10):993-997.
7. Person B, Kaidar-Person O, Wexner SD. New approaches in the treatment of fecal incontinence. Surg Clin North Am. 2006; 86(4):969-986.
8. Rudolph W, Galandiuk S. A practical guide to the diagnosis and management of fecal incontinence. Mayo Clin Proc. 2002; 77(3):271-275.
9. Ruiz D, Pinto RA, Hull TL, et al. Does the radiofrequency procedure for fecal incontinence improve quality of life and incontinence at 1-year follow-up? Dis Colon Rectum. 2010; 53(7):1041-1046.
10. Takahashi T, Garcia-Osogobio S, Valdovinos MA, et al. Extended two-year results of radio-frequency energy delivery for the treatment of fecal incontinence (the Secca procedure).  Dis Colon Rectum. 2003; 46(6):711-715.
11. Takahashi T, Garcia-Osogobio S, Valdovinos MA, et al. Radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence. Dis Colon Rectum. 2002; 45(7):915-922.
12. Takahashi-Monroy T, Morales M, Garcia-Osogobio S, et al. SECCA procedure for the treatment of fecal incontinence: results of five-year follow-up. Dis Colon Rectum. 2008;51(3):355-359.

Government Agency, Medical Society, and Other Authoritative Publications:

1. National Institute for Health and Clinical Excellence (NICE). Faecal incontinence. The management of faecal incontinence in adults. Sep 3, 2007. Available at: http://www.nice.org.uk/nicemedia/pdf/CG49FullGuideline.pdf. Accessed on February 11, 2011.
2. Tjandra JJ, Dykes SL, Kumar RR, et al. Standards Practice Task Force of The American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of fecal incontinence. Dis Colon Rectum. 2007; 50(10):1497-1507.

1. International Foundation for Functional Gastrointestinal Disorders. Available at:  http://www.iffgd.org. Accessed on February 11, 2011.
2. National Association for Continence. Available at: http://www.nafc.org.  Accessed on February 11, 2011.
3. National Digestive Diseases Information Clearinghouse. Available at: http://digestive.niddk.nih.gov/. Accessed on February 11, 2011.

Fecal Incontinence
Radiofrequency Therapy
Secca^® Procedure
Transanal Radiofrequency

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