Digestive Health Diarrhea Solesta for Fecal Incontinence By Barbara Bolen, PhD Barbara Bolen, PhD Twitter Barbara Bolen, PhD, is a licensed clinical psychologist and health coach. She has written multiple books focused on living with irritable bowel syndrome. Learn about our editorial process Updated on March 14, 2022 Medically reviewed by Doru Paul, MD Medically reviewed by Doru Paul, MD Doru Paul, MD, is triple board-certified in medical oncology, hematology, and internal medicine. He is an associate professor of clinical medicine at Weill Cornell Medical College and attending physician in the Department of Hematology and Oncology at the New York Presbyterian Weill Cornell Medical Center. Learn about our Medical Expert Board Print 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. Jose Luis Pelaez Inc / Blend Images / Getty Images 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 anusPossible light bleeding from the rectum after the procedureSmaller risk of abdominal pain, constipation, diarrhea, and feverRare 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 Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. "Solesta® - P100014" U.S. Food and Drug Administration Graf, W., et.al. "Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial" Lancet 2011 377:997-1003. By Barbara Bolen, PhD Barbara Bolen, PhD, is a licensed clinical psychologist and health coach. She has written multiple books focused on living with irritable bowel syndrome. See Our Editorial Process Meet Our Medical Expert Board Share Feedback Was this page helpful? Thanks for your feedback! What is your feedback? Other Helpful Report an Error Submit