Use of a Squatting Assist Device in Patients With Constipation

Inclusion criteria:

- Able to communicate adequately with the investigator and to comply with the
requirements for the entire study

- Meet Rome III criteria for functional constipation as assessed by questionnaires in
period 1, i.e., report at least 2 of the following symptoms for last 3 months or more
with symptom onset at least 6 months prior to diagnosis: a) <3 SBMs/week b) hard or
lumpy stools ≥ 25% of time c) straining ≥ 25% of time d) sense of incomplete
evacuation ≥ 25% of time e) feeling of anorectal blockage ≥ 25% of time or f) manual
maneuvers to facilitate defecation ≥ 25% of time. Patients who meet Rome III criteria
for irritable bowel syndrome will also be eligible provided they also meet above
criteria.

Exclusion criteria:

- Current use of opioid analgesics. Patients on opioids will be allowed to participate
if they have discontinued them for at least 3 days (72 hrs.) before date of screening
and are willing to stay off them for the duration of the study.

- Current use of anticholinergics (e.g. nortriptyline, amitriptyline, hyoscyamine).
Patients who use low dose tricyclic antidepressants (nortriptyline upto 50 mg/day or
amitriptyline upto 25 mg/day ) will be eligible provided they do not increase the dose
during the study period. Patients on higher doses or on other anticholinergics are
eligible to participate if they can discontinue their medication at least 3 days (72
hrs) before the date of screening and are willing to stay off them till the study is
complete.

- Current use of laxatives (MiraLax, Ex-lax, senna, herbal supplements), linaclotide,
lubiprostone, and prucalopride to treat constipation- patients using these medications
will be eligible to participate if they can discontinue the medication at least 3 days
(72 hrs.) before the date of screening and are willing to stay off them till the study
is complete.