FDA Approves New Treatment for Incontinence

Fecal or double incontinence can have a profoundly debilitating effect on one's daily life, self-esteem and social interactions. Even something as routine as a trip to the market becomes an event fraught with insecurity. Millions of Americans suffer from fecal or double incontinence on a daily basis, and for many, traditional treatments like changes in diet and oral medications aren't effective means of controlling the problem. Are ongoing fecal or double incontinence problems a cause of suffering in your life, or in the life of a loved one? If other therapies, treatments and approaches to managing fecal or double incontinence haven't worked, don't despair: the US Food and Drug Administration has approved Solesta, an injectable gel which may be effective for those for whom other therapies like changes in diet and anti-motility medications have failed.

The gel is injected into the layer of tissue beneath the lining of the anus, and works by promoting the growth of new tissue in that area. The growth of this new tissue has the effect of narrowing the anus, which in many cases may help those with fecal or double incontinence gain better control over the muscles of the sphincter. This increased control has been shown to help many people reduce the number of incontinence episodes experienced.

According to the FDA, the new medication's approval was based on a thorough review of data from a clinical study involving 206 participants with ongoing fecal or double incontinence. The FDA reported that after six months, more than half of the participants who received Solesta injections experienced half as many fecal or double incontinence episodes as they did before receiving the treatments. A greater proportion of patients treated with Solesta experienced improvements, which according to the FDA indicates the gel provides benefit.

The FDA's Gastroenterology and Urology Devices Advisory Committee voted 5-0, with one abstention, that Solesta's benefits outweighed its risks. The most commonly reported side effects associated with Solesta include pain and bleeding at the injection site. Infection and inflammation of the anal tissue are more serious complications, but are reportedly less common.

The FDA cautioned that Solesta "should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products."