HyGIeaCare Procedure for Chronic Constipation

This study has a single center, prospective, open label design. Patients will serve as their
own control.

The population will include patients with chronic constipation according to Rome III criteria
who failed to improve with currently available therapy (osmotic and stimulant laxatives, used
for at least one month at recommended dose).

Once patients are consented to participate in the study, they will complete the
Gastrointestinal Symptom Severity Index (GISSI) questionnaire. Patients will complete the 4
Week Bowel Movement Diary and 4 Week Medication Use Diary for the 4-weeks prior to their
HyGIeaCare procedure. The Medication Use Diary will include any rescue medications taken
above and beyond what patients are taking as part of their constipation regimen.

The patient will schedule their HyGIeaCare procedure directly with the HyGIeaCare Clinic. The
nurse manager can be reached at 480-750-2333. The clinic is located at 4001 E. Baseline Road,
Gilbert, AZ. The nurse manager will provide the patient with any instructions needed prior to
their HyGIeaCare procedure. HyGIeaCare will furnish the principle investigator with the
complete patient care records after the irrigation procedure has been completed.

Following the 4 weeks post the patient's HyGIeaCare procedure, the patient will complete a
new 4 Week Bowel Movement Diary and 4 Week Medication Use Diary for the 4-weeks post their
HyGIeaCare procedure. The patient will bring these documents to their clinic follow-up visit.
At this visit the patient will complete another GISSI questionnaire and will be evaluated for
possible adverse events.

Patient data will be collected on hard copy case report forms (CRFs) and then entered into an
electronic database.

Inclusion Criteria:

1. Patient has chronic constipation according to Rome III criteria

2. Patient has not experienced relief of symptoms following treatment with available
therapies (osmotic and stimulant laxatives) for at least one month at recommended
doses.

Exclusion Criteria:

1. Patient has functional bowel disorders characterized by alternating bowel habits
(diarrhea/constipation)

2. Patient has secondary constipation (colonic obstruction, medications, metabolic cause)

3. Patient has any other condition that, in the opinion of the investigator, may
adversely affect the compliance or safety of the patient or would limit the patient's
ability to complete the study.

4. Patient has any of the contraindications listed below:

1. Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%)

2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe
hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal
surgery

3. GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites

4. Abdominal surgery within the last 6 months

5. Pregnancy