Aetna considers pulsed irrigation evacuation (PIE), a device used for bowel management, experimental and investigational because its clinical value for persons with chronic constipation has not been established.

Generally accepted standard treatments for chronic constipation include: minimization of use of any medications known to cause constipation; correction of metabolic abnormalities (e.g., hypothyroidism) that may contribute to constipation; exercise; increased fluid intake; increase dietary fiber; and bulk (fiber) forming laxatives.  In addition, hyper-osmotic laxatives (e.g., lactulose, magnesium hydroxide, and sorbitol), enemas, and emollient laxatives (docusate sodium) are used in selected cases.

Pulsed irrigation evacuation (PIE) (Innovatec Medical Corporation, Oakwood, GA) has been used for bowel management of chronic constipation patients without voluntary bowel control (e.g., paraplegics, quadriplegics, and spina bifida, etc.).  Pulsed irrigation evacuation has been described as an automated enema in which small pulses of warm tap water are delivered into the rectum, serving to rehydrate feces and promote peristalsis.  The system consists of a speculum, tubing, a disposable collection container, and an electrical unit that delivers positive and negative air pressure through the tubing.  The device was cleared by the Food and Drug Administration (FDA) based on a 510(k) application due to its substantial equivalence to pre-amendment devices.   Hence, the manufacturer was not required to present clinical efficacy data to the FDA.

The published evidence of efficacy of PIE in patients with conditions predisposing them to chronic constipation is limited to several uncontrolled case series.  Most of the published studies are from the experience of a single investigator.

However, the only comparative study of PIE compared the device to a standard per-oral colonic lavage in patients undergoing colonoscopy preparation.  The study found PIE equivalent to, but not superior to, standard per-oral lavage.

There are no comparative studies of PIE in patients with conditions predisposing them to fecal impaction.  Hence, the value of PIE in place of or in addition to a standard bowel regimen in these patients has not been demonstrated.  Reviews on chronic constipation by Lembo and Camilleri (2003) as well as by Talley (2004) did not include PIE as a tool for managing patients with this condition.

Guidelines from the Paralyzed Veterans of America (1998) concluded that "the research is insufficient to support recommendations" for PIE.  "Randomized controlled trials involving people with varying levels of SCI should be conducted to determine the efficacy and safety of this treatment.  Such studies will provide data on risk of autonomic dysreflexia and indications of when and when not to use this technique."