Solesta for Fecal Incontinence

Of the many ailments that plague the human body, fecal incontinence (FI) is one of the most challenging. The humiliating nature of such "accidents" has a profound negative effect on a person's quality of life and can contribute to social isolation. Up until now, treatment options have consisted of behavioral changes, biofeedback, and surgical procedures. Fortunately, Solesta, an injectable gel, has more recently come on the scene as a non-surgical treatment option for FI.

What Is Solesta?

Solesta is a gel made up of dextranomer and sodium hyaluronate. Solesta is injected into the tissue underneath the lining of the anus, through a series of four shots, without any need for anesthesia. The entire procedure takes only about 10 minutes and is performed by colorectal surgeons.

It is believed that the injection of Solesta builds up the tissue lining the anus, creating a narrower opening and therefore helping the muscles in the anus to retain fecal material. This then reduces the likelihood of involuntary passage of feces.

Solesta has been approved for use in Europe since 2006 and in the U.S. since 2011. The FDA has approved Solesta for use by individuals over the age of 18 whose symptoms have not been improved by dietary changes or diarrhea medications.

Does It Work?

The main research support for the use of Solesta comes from a study in which the gel was used on approximately 200 patients in both the U.S. and Europe. Patients were randomly assigned to receive injections of Solesta or a "sham" used to assess any placebo effect. Over a six-month period, just over half of the Solesta patients experienced a 50% or greater decrease in the frequency of incontinence experiences compared to approximately 30% of the patients who received the "sham" treatment.

It may be that Solesta, while not necessarily a "miracle cure," does have the potential to offer some symptom relief to some people. However, the study had certain limitations, and as a result its results are difficult to interpret. There is a need for a well-designed study of Solesta in fecal incontinence patients who are well-characterized clinically (passive vs. urge incontinence) with anorectal measurements and meaningful clinical endpoints.

Risks and Side Effects

Solesta is generally seen as safe and well-tolerated. The FDA reports the following possible side effects:

• Possible pain and/or discomfort in the rectum or anus
• Possible light bleeding from the rectum after the procedure
• Smaller risk of abdominal pain, constipation, diarrhea, and fever
• Rare risk of infection and/or inflammation in the anus

Who Can't Use Solesta?

According to the FDA, Solesta cannot be administered to individuals with the following health conditions:

• Allergy to the ingredients in Solesta
• Anal problems, including anal fissures, hemorrhoids, tumors, or structural abnormalities
• Current rectal bleeding
• Compromised immune systems
• Infection
• Inflammatory bowel disease