It’s a hard subject to broach, but if you know anyone dealing with fecal incontinence, you might want to let them know about two new treatments recently approved by the U.S. Food and Drug Administration.
The first is Solesta, a sterile gel that is injected beneath the anus lining to help build tissue in that area and narrow the opening of the anus, thus giving patients greater control over muscles used for bowel movements. Solesta, manufactured by Oceana Therapeutics out of Edison, N.J., is recommended for use in patients for whom diet changes, fiber therapy and anti-diarrhea medications are not working.
The FDA based its approval of Solesta on results from a clinical study in which 136 patients received eight injections of the gel. After six months, more than half experienced a 50 percent reduction in the number of fecal incontinence episodes.
A few caveats, though: Solesta is not recommended for those who have active inflammatory bowel disease, immunodeficiency disorders or rectal prolapse, or for those who have had radiation therapy in the pelvic area, among other considerations.
The second new treatment is called InterStim Therapy, in which electrical impulses stimulate the sacral nerve and improve muscle function. The minimally invasive procedure has been used in other countries but had long been awaiting FDA approval for use in bowel incontinence. It’s already in use here for overactive bladder.
According to Northwestern Memorial Hospital in Chicago, which for several years has followed studies into InterStim’s effectiveness, the therapy helps reduce or eliminate bowel incontinence in about 80 percent of patients. It is said to be similar to using a pacemaker. First, doctors implant a thin wire near the sacral nerve to test the effectiveness of electrical impulses. If it works, doctors implant the neurostimulator device in the buttock. Over time, patients learn how to program the device to suit their needs using a small controller.
“Bowel control problems can have a significant, detrimental effect on a person’s emotional well-being,” said colorectal surgeon Anne-Marie Boller in a Northwestern Memorial press release. “Patients often struggle with everyday activities and withdraw from social interactions due to embarrassment or fear, causing them to suffer in silence. This treatment is a tremendous advancement that has the potential to improve patients’ bowel control and their quality of life.”
The National Institutes of Health estimates that 5.5 million Americans have fecal incontinence, although the number could be higher when you consider how many people are reluctant to seek medical advice for the problem. It tends to affect post-menopausal women and the elderly, although Northwestern says it is not necessarily an age-related condition.
The FDA approved InterStim as of April 2011 and is now available for use.
Sources:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257112.htm
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm259255.htm
http://www.nmh.org/nm/new-therapy-for-fecal-incontinence
Reviewed July 21, 2011
by Michele Blacksberg R.N.
Edited by Jody Smith