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I want you to please notice the results of this brief Clinical Study that was done through the Veterans Administration and if you send e-mail to the VA Hospitals please be sure and send the e-mail to the Prosthetic Department and notify them of this important clinical study.

It is extremely important for you to notice all of the Safety discussion; however, the bottom of this article completely supports our experience of producing a complete bowel program with a lot less time. Your life is more important than spending time on a bowel program that really does not work good for you.

PIE* Bowel Program Clinical Study

Rondinelli R; Denver VAMC and the University of Colorado Medical Center (study accepted for publication in Journal of Neurorehabilitation 1989).

Seven (7) male patients with a history of neurogenic bowel disorders secondary to MS, who were on chronic manual and oral bowel care programs were qualified for the study. These patients' current manual bowel programs were replaced by a pulsed irrigation enhanced evacuation (PIE*) procedure using the PIE* device (the previous name for the PIE* device) for 90 days with PIE* procedures daily for the first 30 days, alternate days for 60 days and as needed for the last 30 days.

The results of the study measured the safety and efficacy of the PIE* procedure and device compared to baseline measurements.

Safety:

1.No significant changes in individual blood electrolyte profiles (Na, K, Ca, Cl, Phos) or absolute values were noted using the PIE* device
2.No significant changes in the blood elements of hemoglobin, hematocrit, and WBC were noted by long term use of the PIE* procedure using the PIE* device.
3.Comparisons to baselines revealed no significant changes in systolic/diastolic blood pressures and heart rate measured before/during and after the PIE* procedure using the PIE* device.
4.There were no incidences of autonomic dysreflexia (as commonly seen in these patients on standard bowel care programs) with long term use of the PIE* procedure using the PIE* device.
5.There were no instances in which speculum insertion problems were felt to require medical attention.
6.Flexible sigmoidoscopy (performed at baseline, 30 and 90 days) revealed no change from baseline except for development of anal fissure in one patient and minor abrasions in the rectosigmoid region in another.

Efficacy: TIME SAVINGS
I. The mean time spent on bowel programs per month was decreased by 75% from 38 hours per patient to 10 hours per month per patient.
2.The patients overall subjective responses to the use of the PIE* procedure and device versus their previous bowel care programs showed that 100% felt the PIE* procedure was better and all wanted to continue with the PIE* procedure
3.There was an 82% reduction (from 1.38 per procedure to .3 per procedure) in unexpected and/or uncontrolled bowel movements from the baseline to the last 10 days of the study. This supports our claim that... “once you become accustomed to the therapy... your procedure time will become less and less.”

The following studies were also done on the Safety and Efficacy of my product.

Published Medical Studies on the PIE* Abstracts:

(This abstract is probably the most valuable as it was created by the Cleveland Clinic for Dealing with long-term patients with the PIE* Bowel Prosthetic Device for almost seven years. Not only were the colon tissue samples very healthy, all four patients had no admissions for Fecal Impaction or UTI.)

Long Term Safety of Pulsed Irrigation Evacuation (PIE) Used with Chronic Bowel Conditions. Digestive Diseases and Sciences, August 1998. Gramlich (Cleveland Clinic) and Puet (Medical Director of Hillside Rehabilitation Hospital).

In order to determine the long-term effects of Pulsed Irrigation Evacuation on the colon, sigmoid/colonoscopy was performed on four patients with spinal cord injuries who have used this procedure an average of 3.5 times weekly, for an average of 6.7 years. No gross or microscopic abnormalities were identified in any of these individuals. Impactions as well as other complaints were markedly diminished or absent following the initiation of PIE* Bowel Therapy. Pulsed Irrigation Evacuation is a safe and effective method for long-term treatment of chronic neurogenic bowel.

The Use of Pulsed Irrigation Evacuation in the Management of the Neuropathic Bowel. International Sciences of Paraplegia, 1997. Puet, Jackson and Amy.

Management of the neuropathic bowel is one of the major issues in the treatment of patients with severe spinal cord injury (SCI). Pulsed Irrigation Evacuation (PIE) has been evaluated in several small studies for the clearing of fecal impactions in patients with a neuropathic bowel. Three Hundred, ninety-eight PIE procedures performed on inpatients and outpatients at Hillside Rehabilitation Hospital were evaluated. PIE* Bowel Therapy has proven to be both safe and effective in a wide variety of patients with neuropathic bowel, and is a valuable addition to traditional methods of bowel management.

Treatment of Fecal Impaction with Pulsed Irrigation Enhanced Evacuation. 

Dis Colon Rectum, February 1994. Kokoszka, Nelson, Falconio and Abcarian.

A new method of treating fecal impaction, Pulsed Irrigation Evacuation, is described. Individuals were selected for treatment based on evidence of massive fecal impaction on physical examination or abdominal x-ray and would otherwise have required operative disimpaction. Fourteen individuals were treated for fecal impaction. The patients ranged in age from 13 to 86 years. Only one patient required intravenous sedation, an elderly patient with Alzheimer’s disease. The treatment was successful in each case, although repeated treatment was often necessary. No morbidity arose from the treatment. By the midpoint of the study PIE* Bowel Therapy was so effective no patient required hospitalization for impaction. These PIE* Procedures demonstrate that Pulsed Irrigation Evacuation, PIE* Bowel Therapy is a simple, quick and effective treatment for severe fecal impaction.

New Treatment for Rectal Impaction in Children: An Efficacy, Comfort and Safety Trial of the Pulsed Irrigation Enhanced Evacuation Procedure. Journal of Pediatric Gastroenterology and Nutrition, 1994. Gilger, Wagner, Barrish, McCarroll and Healy.

To determine the efficacy, comfort and safety of the pulsed irrigation enhanced evacuation (PIEE) procedure in children, 27 procedures performed on 24 consecutive children were evaluated. Sixteen boys and 8 girls, 4-15 years old (mean 8.7) with chronic constipation, encopresis and rectal impaction made up the test group. Children with known heart, lung or neurological diseases were excluded. Temperature, pulse, respiratory rate and blood pressure were obtained prior to, during and immediately after the procedure. Abdominal radiographs were obtained before and after the procedure and a single radiologist estimated the degree of disimpaction. Patients graded the discomfort of the procedure at the time of speculum insertion and every 15 minutes. Serum sodium, potassium, chloride and bicarbonate values were obtained before and immediately after and 90 minutes after the procedure and compared by paired Student analysis. In conclusion, the PIE* Bowel Therapy procedure successfully disimpacted all patients either immediately or within hours of completion. Patients accepted the procedure well and no clinically significant electrolyte changes were noted. This new method of rectal disimpaction appears to be safe, effective and acceptable to children.

Pulsed Irrigation Enhanced Evacuation: New Method for Treating Fecal Impaction. Arch Phys Med Rehabil, October 1991. Puet, Phen and Hurst.

Fecal impaction is a common problem in patients with neurological impairment. The Pulsed Irrigation Evacuation (PIE) procedure is a new method of clearing fecal impactions using pulses of warm water in controlled amounts to hydrate stool and improve peristalsis. Thirty-seven PIE* Bowel Therapy procedures were preformed on 28 patients with a variety of neurological problems. The PIE* procedure was observed to be effective and safe. It should be used primarily as a proper bowel management program.

Per-rectal Pulsed Irrigation Versus Per-oral Colonic Lavage for Colonoscopy Preparation: A Randomized, Controlled Trial. Gastrointestinal Endoscopy, 1991. Chang, Erickson, Schandler, Coye, and Moody.

The aim of this study was to compare the efficacy and patient tolerance of a new Pulsed Irrigation Evacuation system to colonic lavage for colonoscopy preparation. Thirty-four prospective patients scheduled for routine colonoscopy were randomized to one of two preparations: a per-rectal Pulsed Irrigation Evacuation, PIE* Bowel Therapy device (18 patients) versus per-oral colonic prep (15 patients). Colonoscopy preparation was assessed on a 0 to 4 scale by region and overall. This was done live and by videotape by two independent endoscopists who were blinded to the patient’s preparation. There was no significant difference with respect to cleanliness of the colon with Pulsed Irrigation Evacuation patients having an average of overall preparation score of 3.0 ± 0.19 (SEM) versus colonic prep patients with a score of 3.14 ± 0.19. There was also no statistically significant difference between the two groups with respect to demographics, time to reach the cecum, time for entire procedure, volume of aspiration or wash or sedation given. The new Bowel Prosthetic Device (PIE*), provides an alternative to the standard per-oral lavage solution for colonoscopy preparation.

Dissolution of a Barium Impaction in a Child with the PIEE Procedure. Journal of Pediatric Gastroenterology and Nutrition, 1995. Gilger, Wagner and Kelley.

Barium contrast examinations, utilizing either barium meal or enema, are still a common choice for visualization of the gastrointestinal tract in children. After completion of these x-ray procedures the contrast material should be thoroughly evacuated from the bowel. Residual barium sulfate remaining in the gastrointestinal tract has the potential to harden, forming true “concretions” that can become impacted. Purgatives or enemas are often given after barium studies to insure complete evacuation of the contrast material. However, once the barium impaction has formed in the colon, routine enema preparations such as Phosphosoda, oil retention, tap water and soapsuds are frequently ineffective. Recently, the Pulsed Irrigation Evacuation (PIE) (Avatar 2000 Bowel Evacuation System, Aegis Medical, Denver, CO, U.S.A.) procedure was introduced as a simple, effective method for removal of rectal impaction in adults and children. PIE is an automated enema in which controlled pulses of warm water are delivered into the rectum, serving to hydrate feces and promote peristalsis. We report the successful evacuation of a severe barium impaction in a child with total colonic Hirschsprung’s disease using the PIE Bowel Therapy Procedure.

IMPORTANT: Over 500,000 PIE* Procedures have been performed with no reports of injury!