Surgery Section - Transanal Radiofrequency Treatment of Fecal Incontinence

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

Description

Radiofrequency energy is a common surgical tool that has been used for tissue ablation and more recently for tissue remodeling. For example, radiofrequency energy has been investigated as a treatment of gastroesophageal reflux disease, where radiofrequency lesions are designed to alter the biomechanics of the lower esophageal sphincter. Radiofrequency energy has also been used in orthopedic procedures to remodel the joint capsule or in the intradiscal electrothermal annuloplasty procedure where the treatment is intended in part to modify and strengthen the disc annulus. In all of these procedures, nonablative levels of radiofrequency thermal energy are used to alter collagen fibrils, which then result in a healing response characterized by fibrosis. All of these procedures are addressed in separate medical policies (see Cross References). Recently, radiofrequency energy has also been explored as a minimally invasive treatment option for fecal incontinence.

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. There are a variety of etiologies, including injury from vaginal delivery, anal surgery, neurologic disease, and the normal aging process. 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 patients with spinal cord injuries, may also be effective in patients with fecal incontinence. Biofeedback has been investigated as well. Surgical approaches primarily include a sphincteroplasty, although more novel approaches may be attempted in those whose only other treatment option is the creation of a stoma. These novel approaches include an artificial anal sphincter or sacral neuromodulation.

Radiofrequency energy, referred to as the Secca procedure, has also been investigated as a minimally invasive treatment of fecal incontinence. 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 potentially leading to improved continence.

In 2002, the Secca™ System received U.S. Food and Drug Administration (FDA) clearance through the 510(k) process for the following labeled indication:

“ The Secca™ System is intended for general use in the electrosurgical coagulation of tissue and is intended for use specifically in the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.”

Policy/Criteria

Transanal radiofrequency therapy is considered investigational as a treatment of fecal incontinence.

Scientific Background

A search of the MEDLINE database through December 1, 2005 identified one published study of the Secca procedure, which appears  to be the clinical study that was submitted as part of the FDA approval process (2)  The study consisted of an open-label, single-arm, nonrandomized clinical study that included 50 subjects who were treated and followed for 6 months.  Patients served as their own control.  The study assessed changes in fecal incontinence symptom scores and quality of life between baseline and follow-up intervals.  Fecal incontinence was assessed with the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI), and quality of life was assessed with the Fecal Incontinence Quality of Life Score (FIQL).  Both the CCF-FI and FIQL scores improved in a steady, gradual manner over a 6-month period, from 14.6 to 11.1 for the CCF-FI and 2.5 to 3.1 for the FIQL.  Previous studies have suggested that a CCF-FI of greater than 9 indicates a significant impairment of quality of life. (3)  Of the 44 patients with an initial baseline CCF-FI score greater than 9, a total of 15 (34%) achieved a CCF-FI less than 10 at 6 months.  Improvement was also assessed using the Medical Outcomes Study Short Form-36 (SF-36), focusing on mental and social parameters.  The mean social function sub score improved from 64.3 to 34.4, while the mental health sub score improved from 65.8 to 73.8.  Fourteen-day diary data demonstrated significant improvement in all 9 parameters.  For example, the days with any fecal incontinence dropped from 10 in a 14-day period to 7.

In contrast to the above subjective data, there were no differences in objective measures of anal sphincter function. Specifically, there were no differences based on manometry measures, rectal sensation volumes, pudendal nerve motor latency, or internal or external sphincter defects as noted on endoanal ultrasound. The authors noted that determining the mechanism of action for the procedure was not an objective of the study. Three significant procedure-related complications occurred during the trial. Two patients developed an ulceration, and one developed bleeding from a hemorrhoid vein. Twenty-six minor adverse events occurred, including minor bleeding in 5 patients, transient worsening of incontinence in 4 patients, and anal pain in 5 patients.

One uncontrolled study on the Secca procedure reported results of eleven women with fecal incontinence who underwent baseline and post-treatment testing. Six (55%) patients reported improvement; Vaisey scores decreased 13%, and no changes in anal manometry, rectal compliance measurement, or three-dimensional anal ultrasound were observed. (4) Postoperative pain was reported to be slight in eight (73%), moderate in two, and severe in one patient. The investigators suggest that this procedure merits further testing, and note that a randomized, controlled trial is underway.  A second small case series reported five-year outcomes of 19 patients who received the Secca procedure for fecal incontinence. (5) 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 patients (84.2 percent) demonstrating >50 percent improvement.  Kim and colleagues report no improvement in fecal incontinence scores and considerable complications in another small case series.(6)

In summary, the published data are inadequate to permit scientific conclusions due to the small size of the trial and the lack of a control group.  Results from larger randomized controlled trials are needed to determine the long-term safety and effectiveness of this procedure.

References

1. BlueCross BlueShield Medical Policy Reference Manual, Policy No. 2.01.58
2. Efron JE, Corman ML, Fleshman J et al. Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence. Dis Colon Rectum 2003;46(12):1606-18
3. Rothbarth J, Bemelman WA, Meijerick WJ et al.  What is the impact of fecal incontinence on the quality of life?  Dis Colon Rectum  2001;44(1):67-71
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):575-80
5. 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):355-9
6. 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 Jan;197(1):14-8

Cross References

Thermal Capsulorrhaphy as a Treatment of Joint Instability, Regence Medical Policy Manual, Surgery, No. 100

Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease, Regence Medical Policy Manual, Surgery, No. 110

Percutaneous Intradiscal Electrothermal Annuloplasty (IDET) and Percutaneous Intradiscal Radiofrequency Thermocoagulation, Regence Medical Policy Manual, Surgery, No. 118

Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence, Regence Medical Policy Manual, Surgery, No. 130

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