This policy was originally created in 2011 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period of September 2011 through September 2012. Following is the summary of the key literature to date.
As of September 2012, no trials allowing comparison of outcomes of transanal radiofrequency (RF) treatment of fecal incontinence to available alternative treatments have been identified. The literature search to date has identified 8 nonrandomized studies on this procedure; 7 studies published between 2003 and 2010, and 1 study published in 2012 identified in the updated literature search.
Abbas et al. (2012) published results of their retrospective review of 27 patients who underwent the Secca™ procedure over a 6-year period (2004-2010) at Kaiser Permanente Los Angeles Medical Center. (2) Thirty-one procedures were performed for moderate to severe fecal incontinence. The majority of study patients were women with a mean age of 64 years, and the most common cause of the incontinence was obstetrical injury. Median length of symptoms was 3 years. Biofeedback had failed in more than half of patients, and more than 20% of patients had previous surgical intervention to treat the incontinence. No major complications occurred following the Secca™ procedure, and minor complications were observed in 5 patients (19%; anal bleeding in 4 and swelling of the vulva in 1). A treatment response was noted in 21 patients (78%) (mean Cleveland Clinic Florida Fecal Incontinence [CCF-FI] Score: 16 [baseline] and 10.9 [3 months postoperatively]). Previous studies have suggested that a CCF-FI of greater than 9 indicates a significant impairment of quality of life. (3) However in the study by Abbas et al. only 6 patients (22%) had a sustained long-term response without any additional intervention, and 14 patients (52%) underwent or are awaiting additional intervention for persistent or recurrent incontinence over a mean follow-up period of 40 months.
A published study of the Secca procedure by Efron et al. in 2003 (4) consists of an open-label, single-arm, nonrandomized clinical study that included 50 subjects who were treated and followed up for 6 months. Patients served as their own controls. The study assessed changes in fecal incontinence symptom scores and quality of life between the baseline and follow-up intervals. Fecal incontinence was assessed with the CCF-FI score, and quality of life was assessed with the Fecal Incontinence Quality of Life (FIQL) score. 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. 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 subscore improved from 64.3 to 34.4, while the mental health subscore 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, there were no differences in objective measures of anal sphincter, i.e., 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 anal ulceration, and 1 developed bleeding from a hemorrhoidal 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.
Felt-Bersma et al. (2007) published the results of an uncontrolled study on the Secca procedure in 11 women with fecal incontinence who underwent baseline and post-treatment testing. (5) Six (55%) patients reported improvement; Vaizey scores decreased 13%, and no changes were observed in anal manometry, rectal compliance measurement, or 3-dimensional anal ultrasound. Postoperative pain was reported to be slight in 8 (73%), moderate in 2, and severe in 1 patient. The investigators suggested that this procedure merited further testing and noted that a randomized, controlled trial was underway.
Ruiz et al. (2010) published a paper reporting on 1-year quality-of-life and continence outcomes for a series of 24 patients treated with RF energy for fecal incontinence in 2003 to 2004. (6)Twelve-month results were available for 16 of the 24 patients (67%). The mean CCF-FI score improved from 15.6 at baseline to 12.9 at 12 months (p=0.035). The mean FIQL Questionnaire score improved in all subsets except for the depression subscore. The authors comment that the actual clinical significance of this improvement needs to be determined.
Three additional very small case series (n=15, 19, 8) were performed outside the U.S. (7-9) In 2 of these small trials, no clear benefit was noted for the procedure. Given the small number of studies that have been conducted and the limitations of those trials (i.e., small number of patients, lack of control arm and randomization, inconsistencies with inclusion and exclusion criteria, and short-term follow-up, the efficacy of RF therapy for fecal incontinence is not supported in the literature.
A search of online site ClinicalTrials.gov in October 2012 did not identify any clinical trials of RF treatment of fecal incontinence.
The trials described in this policy include a small number of patients, and the estimates of treatment differences are very imprecise. The study follow-up periods are variable and need to be considerably longer for a proper evaluation of long-term success. Only one new retrospective study on this procedure has been published since the last update. Multicenter randomized controlled trials with sufficient power are required to evaluate the continuing use of this procedure as an alternative to other surgical interventions or physical therapies or as an adjunct treatment option for fecal incontinence. Given the insufficient evidence available to evaluate the impact of the technology on net health outcome, this surgical procedure is considered experimental, investigational and unproven.
Practice Guidelines and Position Statements
The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) issued guidance on radiofrequency treatment for fecal incontinence in 2011. (10) NICE concluded that “evidence on endoscopic radiofrequency therapy of the anal sphincter for [fecal] incontinence raises no major safety concerns. There is evidence of efficacy in the short term, but in a limited number of patients. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.” (10)
The American Society of Colon and Rectal Surgeons, in their 2007 practice parameters for the treatment of fecal incontinence, classified the Secca™ procedure as a potentially useful treatment intervention for selected patients with moderate fecal incontinence. (11) This statement was based on level IV evidence (grade of recommendation C) because of the limited data available on this treatment modality.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
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