Clinical Policy: Fecal Incontinence Treatments Form

# Clinical Policy: Fecal Incontinence Treatments
Reference Number: CP.MP.137  
Date of Last Revision: 06/24  

[See Important Reminder](#) at the end of this policy for important regulatory and legal information.  

## Description  
Fecal incontinence is generally defined as the uncontrolled passage of feces over at least three month’s duration in an individual who had previously achieved control.¹ It has substantial social and economic impact and significantly impairs quality of life.² The choice of therapy depends upon the etiology of incontinence, the anatomy of the sphincters, and the effect incontinence has on quality of life.  

*Note: For biofeedback treatment for fecal incontinence, please refer to CP.MP.168 Biofeedback.*  

  

## Background  
Treatment of fecal incontinence is challenging. The goal of treatment is to restore continence and to improve the quality of life. Dietary and medical management are initially recommended for patients with fecal incontinence. If fecal incontinence is a result of or in conjunction with anatomic defects (e.g., rectovaginal fistula, rectal or hemorrhoidal prolapse etc.), the defects should be corrected first as this often improves or eliminates the incontinence.¹ Although most current interventions show modest improvements, there is limited evidence to support any treatments for fecal incontinence past three to six months.³,⁴  

Sacral neuromodulation is thought to modulate rectal sensation by activating or deactivating chemical mediating receptors, stimulating the afferent pathway, and changing brain activity relevant to the continence. Sacral neuromodulation has consistently resulted in a reduction in frequency of fecal incontinence episodes and may be considered for incontinent patients with and without sphincter defects. Sphincter repair (sphincteroplasty) can be a treatment option for symptomatic patients with a defined defect of the external anal sphincter. Implantation of an artificial bowel sphincter remains an effective tool for select patients with severe fecal incontinence; however, its use is limited by complications including explantation in up to one-third of patients.¹,²,⁵  

Injectable bulking agents [e.g., dextranomer/hyaluronic acid (Solesta)] have been investigated for the treatment of fecal incontinence. However, evidence in the peer reviewed literature evaluating this treatment is limited. There is a paucity of randomized, controlled trials, and studies are limited by their small study sizes.² A prospective multicenter trial of 136 patients with fecal incontinence who received non-animal stabilized hyaluronic acid/dextranom (NASHA Dx) bulking agent reported it provided a significant improvement of fecal incontinence symptoms in a majority of patients, and this effect was stable during the course of the follow-up and was maintained for three years.³ Long-term data is lacking, however, regarding the durability of this treatment.⁶  

Transanal radiofrequency therapy (e.g., Secca procedure) is another procedure proposed for the treatment of fecal incontinence). This procedure uses thermo-controlled delivery of  

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# Clinical Policy  
Fecal Incontinence Treatments  

radiofrequency energy to the anal canal. The reported evidence is relatively sparse and has relevant limitations. Most studies have been small single-center series with short to mid-term follow-up.⁷,⁸  

The Eclipse System (Pelvalon Inc) is a nonsurgical vaginal bowel-control system for the treatment of fecal incontinence in women 18 to 75 years old who have had four or more fecal incontinence episodes in a two-week period. The device includes an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of fecal incontinence episodes. The device is initially fitted and inflated by a clinician with the use of a pump, and after proper fitting, the patient can inflate and deflate the device at home as needed. The device was granted FDA approval through the de novo classification process based on non-clinical testing as well as a clinical trial of 61 women with fecal incontinence treated with the device. The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of fecal incontinence episodes while using the device, as compared to baseline. Studies to date are limited by size and lack of long term evidence.⁹,¹⁰  

### American Society of Colon and Rectal Surgeons (ASCRS)  
In their most recent 2023 guidelines on the treatment of fecal incontinence, the ASCRS assigns conditional recommendations for sacral neuromodulation and sphincteroplasty based upon low quality of evidence. The ASCRS reports that injection of biocompatible bulking agents into the anal canal may help to decrease episodes of passive fecal incontinence. However, the ASCRS notes that “given the limited improvement over placebo, diminishing long-term results, and cost, injectable bulking agents are not considered first-line treatment for fecal incontinence.”¹  

The ASCRS guideline states the application of temperature-controlled radiofrequency energy to the sphincter complex is not recommended for the treatment of fecal incontinence. Per the ASCRS, “the evidence supporting this approach is relatively sparse and has relevant limitations, additionally, no new studies evaluating this modality have been published since 2014.”¹  

### American College of Gastroenterology (ACG)  
Regarding minimally invasive procedures for the treatment of fecal incontinence, the ACG concluded that minimally invasive procedures such as injectable anal bulking agents may have a role in patients with fecal incontinence who do not respond to conservative therapy. However, they note this is a weak recommendation based on moderate quality of evidence. The ACG reported that there is insufficient evidence to recommend radiofrequency ablation treatment to the anal sphincter (SECCA) at this time.⁷  

### National Institute for Health and Clinical Excellence  
An interventional procedure guidance on injectable bulking agents for fecal incontinence concluded that current evidence on the safety and efficacy of injectable bulking agents for fecal incontinence does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research, which should take place in the context of a clinical trial or formal audit protocol that includes information on well-defined patient groups.⁶  

### American College of Obstetricians and Gynecologists (ACOG)  

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# Clinical Policy  
Fecal Incontinence Treatments  

A practice bulletin on fecal incontinence concluded that anal sphincter bulking agents may be effective in decreasing fecal incontinence episodes up to six months and can be considered as a short-term treatment option for fecal incontinence in women who have failed more conservative treatments. However, this was based on limited or inconsistent scientific evidence (Level B).³  

## Coding Implications