Cath Lab Digest

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The National Association For Continence is a national, private, non-profit organization dedicated to improving the quality of life of people with incontinence. The NAFC’s purpose is to be the leading source for public education and advocacy about the causes, prevention, diagnosis, treatments, and management alternatives for incontinence. This article was not subject to the Ostomy Wound Management peer-review process.

  Life just got a whole lot brighter for the 18 million adult Americans who experience fecal incontinence (FI),¹ commonly referred to as bowel control problems. FI encompasses the inability to hold a bowel movement until reaching a toilet to defecate, as well as the accidental leakage of gas or stool, whether liquid or solid.²

Prevalence of Fecal Incontinence

  Recently, National Institutes of Health-funded researchers gathered data from a questionnaire submitted to more than 4,000 men and women, ages 20 and older, who participated in the Centers for Disease Control and Prevention’s 2005–2006 Annual National Health and Nutrition Examination Survey (NHANES).³ NHANES researchers went directly to private homes to conduct extensive interviews, and health measurements including physical examinations and laboratory tests were performed in specially designed mobile centers that traveled to locations throughout the country. The bowel health questionnaire included items about accidental bowel leakage and stool consistency. From these data, one in 12 Americans (18 million) was estimated to have FI, ranging from 3% in adults 20 to 29 years old to 15% among adults 70 years and older (others4 estimate an FI prevalence of closer to one in 10 adult Americans). NHANES researchers found a variety of factors associated with an increased risk of FI, including advancing age, urinary incontinence, the inability to engage in physical activity, chronic illness, and diarrhea; FI prevalence did not differ significantly between genders. Until the publication of these data, efforts at both diagnosis and treatment have been minimal because prevalence was not documented and etiology was not well understood.

  Women with stress urinary incontinence severe enough to warrant surgical intervention have been found to be more than twice as likely to have symptoms of FI.⁵ Half of the women presenting with FI symptoms also exhibit moderate to severe stress urinary incontinence because of the underlying pelvic floor disorder that contributes to both.⁶ Although FI may stem largely from obstetrical trauma, the problem is not limited to women — men who have undergone radiation treatment for prostate cancer may experience symptoms of FI many years later.⁷

  Recent manufacturing and regulatory initiatives are promising for providers and patients seeking treatment for FI.

New Products

  Injectible bulking agent approval imminent. In April, the US Food and Drug Administration (FDA) issued an Approvable Letter for Oceana Therapeutics’ (Edison, NJ) product Solesta® as a treatment for FI. The FI product is a biocompatible bulking agent, injected as a gel in the deep submucosal layer in the proximal part of the anal canal. Although the exact mechanism of action has not been identified, it is hypothesized that the product injections may narrow the anal canal and allow for better sphincter control. This approach represents a one-of-a-kind treatment option for FI and addresses the large treatment gap between conservative therapies for FI such as dietary control and more complicated, invasive treatments such as surgery. In its considerations, the FDA determined the new treatment is safe and effective and that its benefits outweigh its risks. The product offers the advantage of relatively quick outpatient administration without the need for anesthesia.