Fecal incontinence

Fecal incontinence, or accidental stool leakage, affects some 8 to 10 % of the 325 million people in the United States. In up to half of patients, there is both fecal and urinary incontinence. “Not all patients with incontinence are the same. There are some with muscle injuries, some with nerve injuries, some with more diarrheal illness; some with a combination of diarrhea and nerve injury.
Consequently, one type of treatment may not work for all. the researchers want to know what is the right thing to do for our patients. Rao is helping lead a federally initiative that will provide the first head-to-head comparison of the benefits; side effects, and costs. The $18.8 million.

Awareness and Control

The three treatment options under study include biofeedback therapy to enhance awareness and control; inert injectable compounds that bulk up the anus so it can fully close and a pacemaker that stimulates and strengthens muscles; the key to keeping urine and feces where they belong. The study is comparing their efficacy and impact on quality of life and measuring issues like patients’ anxiety and depression before and after their treatment.
The study is also comparing the safety, by looking at adverse events, as well as costs. “All three options are FDA-approved and commonly used in practice today; but they really do not know which is good, which is better and if it works, why it works. The investigators hope to enroll about 600 male and female adults with two or more episodes of solid or liquid fecal incontinence weekly; which is considered moderate to severe fecal incontinence.

Four-Week Medical Management

Participants will first keep daily stool diaries for two weeks; they will enroll in a four-week medical management program that provides support like learning pelvic floor exercises and how to use nonprescription drugs to normalize stool consistency. They will also learn relatively easy lifestyle changes.
“A simple example is someone who is used to having a good breakfast; including a large cup of coffee, then taking a morning walk,” Rao says. “Breakfast stimulates the colon; coffee stimulates the colon and walking stimulates the colon so you are setting yourself up for increased colonic activity.” A simple change would walk before breakfast and coffee.
The final option uses a pacemaker to stimulate the sacral nerve; an important nerve in controlling muscles involved in both pooping and peeing. Constant stimulation of the nerve and so the muscles works much like regularly pumping iron to increase muscle size and strength. The battery will periodically need replacing and the pacemaker can remove, but like working out; the pacemaker likely will be needed for the rest of the patient’s life to continue to provide benefit.
When a treatment results in a 75%  reduction within three months; those patients will be followed for two years to look at the longer-term impact. Those who do not respond that well will offer one of the two treatments they did not initially receive. Investigators anticipate it will take about five years to get all participants enrolled, treated and followed for the two-year timeframe.
Outside the study, Rao and his co-investigator MCG gastroenterologist Dr. Amol Sharma, typically start with the medical treatment; then move to biofeedback as a next step if needed before moving to the more invasive anus bulking or nerve-stimulating procedures.