Clinical Review

Fecal incontinence: New therapies, age-old problem

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References

The major barrier to utilization of the artificial bowel sphincter is infection. In a series of 112 patients who were implanted with the sphincter, 384 device-related adverse events occurred in 99 patients.14 A total of 73 revision operations were required in 51 patients (46%). Twenty-five percent of patients developed infection that required surgical revision, and 37% had the device explanted. Eighty-five percent of patients with a functional device had a successful outcome.14

Given the device-related challenges and infectious complications, patients should be considered for less invasive treatments before being offered an artificial bowel
sphincter.

Radiofrequency current
The Secca procedure (Curon Medical, Fremont, California) involves the application of radiofrequency current to the anal canal to generate thermal energy. This procedure causes contraction of collagen fibers, which are permanently shortened, and leads to tightening of the muscle. It is performed under intravenous sedation on an outpatient basis.

This approach is indicated for patients with mild to moderate fecal incontinence who have not responded to conservative management. An external sphincter defect is a contraindication.

Small, nonrandomized studies have found improvement in the CCF-FIS score in patients treated with this approach.15 The major limitation of this treatment is the lack of high-level clinical evidence demonstrating its efficacy and safety.

Antegrade continence enema
This approach, also known as the Malone procedure, is usually reserved for debilitating incontinence or constipation in the pediatric population. An appendicostomy is constructed at the navel, allowing daily introduction of a catheter and antegrade enema. The purpose is to perform rapid, controlled emptying of the colon at times chosen by the patient. It is also reserved as a last resort for patients considering an ostomy.

Adult patients with neurologic problems, such as spina bifida, may be candidates for this procedure, provided they are highly motivated.

Fecal diversion
Creation of a colostomy or ileostomy is usually the last resort for a patient with fecal incontinence. We are fortunate that there are an increasing number of options that may improve the patient’s condition before colostomy is required.

If fecal diversion is chosen by the patient, it is important to involve an enterostomal therapist for site marking and patient education. A well-constructed ostomy is essential, as this option often is permanent.

Up and coming options
A novel treatment approach for fecal incontinence is the magnetic anal sphincter. The device, marketed as the FENIX Continence Restoration System (Torax Medical, Shoreview, Minnesota) consists of a series of titanium beads with magnetic cores that are interlinked with titanium wires. The device is designed to encircle the external anal sphincter muscle, reinforce the sphincter, and expand to allow passage of stool at a socially appropriate time.

Preliminary data from 16 patients indicate a mean decrease in the number of episodes of incontinence from 7.2/week to 0.7/week, as well as a mean reduction in the CCF-FIS score from 17.2 to 8.7.16 Two de­vices were removed due to infection, and one device passed spontaneously after disconnection of the suture.16

This device is not approved by the FDA, but it may become a promising treatment if its safety and efficacy can be established in larger clinical trials.

The TOPAS sling (American Medical Systems) is currently being studied in a Phase 3, multicenter, nonrandomized, clinical trial (NCT01090739) for the treatment of fecal incontinence.17 The sling is implanted using a minimally invasive transobturator approach; two needle-passers deliver the sling ­assembly. Two small posterior incisions facilitate the postanal placement of the mesh.

This procedure replicates the anorectal angle created by the puborectalis muscle. Although it may become a minimally invasive treatment in the future, final results of the Phase 3 trial are not expected until 2016.

Tibial nerve stimulation is commonly used for urinary urge incontinence. Several small series have documented modest success with its application to fecal incontinence.18

The outpatient procedure involves the insertion of a needle electrode three fingerbreadths above the medial malleolus, followed by electrical stimulation. The current is slowly increased until a sensory or motor response (tingling under the sole of the foot or great toe plantar flexion) is elicited. Treatment necessitates several outpatient sessions.

In a recent series, the mean CCF-FIS decreased from 12.2/20 at baseline to 9.1/20 ­after treatment (P <.0001).18

The role of this procedure in the treatment algorithm for fecal incontinence remains to be determined.

What we offer patients
Fecal incontinence is a debilitating condition with an increasing number of potential therapeutic options. It clearly is under-recognized by patients and physicians alike.

After a thorough work-up, conservative treatment options should be offered first. When those fail, we generally recommend a trial of sacral neuromodulation for patients with no sphincter defect. When a sphincter defect is present, we counsel the patient about the merits of sphincter repair versus a trial of neuromodulation. These options have the most robust data supporting their clinical use, and have been used successfully in our own practices.

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