the completion of the bowel care, as well as stool incontinence. A water-miscible, bisacodyl-containing suppository compounded with a polyethylene glycol base (PGB) that has recently become available has been anecdotally reported to decrease overall bowel care time. Previously, a single subject study completed at this institution and an unblinded trial at the Tampa (FL) Veteran's Medical Center suggested a clinically significant decrease in bowel care time using the PGB suppository.                                                    Mini-enemas are an increasingly popular method of administration of stimulant laxatives for the initiation of bowel care. The Theravac SB mini-enenma (TVC) is a small soft plastic ampule with a 3cm extended tip that is inserted into the rectum after its distal end is cut off or puntured; the bulb is squeezed and its contents enter the rectum, acting on the mucosa as a surface stimulant within minutes. TVC contains a 4ml liquid combination of glycerine (275mg) and docusate sodium (283mg) in a polyethylene base.                                                                This randomized, prospective, double-blind study was designed to compare the effectiveness of bowel care using bisacodyl suppositories compounded with HVB and PGB. Additionally, the PGB suppository and the TVC mini-enema were compared independently.

Method

The study design and objectives were approved by the Intradepartmental Scientific Merit Review and University Human Subjects Committees. Subjects were recruited from an inpatient SCI unit at a VA Health Care System Division, and participated after signed concent. Inclusion criteria included: 3 months or longer since the SCI, spinal cord lesions above the 12th thoracic neurological level, lack of anal sensation, lack of voluntary anal sphincter contraction, a stable bowel program with pharmacologically-triggered bowel care, and the absence of known gastrointestinal disease. Subject history was reviewed for consistency in bowel care. Chart review identified lesion level, sensory and motor performance, anal cutaneous reflex, bulbocavernousos relex and lower extremity phasic stretch reflexes.                                   The two types of bisacodyl suppositories used in the study differ only in the base used for dispersion of the active ingredient. The HVB suppositories^a contained 10mg bisacodyl USPin a hydrogenated vegetable- oil base. The PGB suppositories^b contained 10mg bisacodyl dissolved in a mixed polyethylene glycol polymer base of two molecular weights: E1450 and E400             A randomized, prospective, double-blind study was implemented. Each subject was designated a previously determined ramdomized sequence of six suppositories to study three HVB and three PGB suppositories known only to the pharmacy. Time events and data were collected for three bowel care sessions in 10 subjects, who normally use Theravac SB mini-enema^c after completing the suppository study.         The investigators, nurses, and subjects were unaware of each individual's randomized sequence. Pharmacy personnel possessed the only suppository sequence and dispensed the subjects predetermined suppository blindly to the nursing staff. The nurses then administered the suppository to the subject and recorded timed bowel care events.                                                           Bowel care was performed using a consistent protocol. Subjects were either seated upright or lying on their side (left or right specified) during bowel program. This position remained unchanged for each subject throughtout the study and was consistent with usual bowel care session , either a 10mg HVB or 10mg PGB

suppository was inserted half a finger's lenght through the anal sphincter and placed against the mucosal surface of the rectal wall. Theravac SB mini-enema tips were cut off and 3cm extension was inserted into the rectum with bulb remaining outside. The bulb was then squeezed by the patient or the nurse if the patient did not have the required dexterity. The time of insertion of the suppository or squeeze of the Theravac SB contents into the rectum was considered 0 time and progress of bowel care was documented with time parameters. Digital stimulation and/or manual evacuation was not performed during suppository insertion, but was allowed only after either first flatus or first stool flow. The bowel care period was divided into intervals by discrete events. First Flatus marks the end of the interval from insertion of suppository until the first gas is passed, Begin Stool Flow marks the beginning of the defecation interval, End Stool Flow marks the end of the defecation interval, Time Off Toilet marks the interval from last stool flow to transfer off toilet or completion of clean-up if in bed, Total Time marks the time from insertion of the suppository to the last stool flow. Both duration and frequency of digital stimulation and manual evacuation were recorded. Stool results were recorded as: 0, none; 1, minimal; 2,small; 3, moderate; 4, large; 5, very large. All episodes of incontinence were recorded and defined as any passage of substance through the anus (include stool, mucus, liquid, etc.) at ant time outside the designated bowel care proceedure.                      Statistical analysis. Continuous mean interval data were compared using paired t tests. Ordinary data were compared with Wilcoxon rank sum tests. Probability (p) values were derived taking .05 as the level of significance.

Results

The subject demographics include nine cervical and six thoracic level injuries. Of the 15 subjects, 11 were complete and 4 were incomplete spinal cord lesions. All patients had a positive anal cutaneous reflex and bulbocavenousus relex and normal to hyperreflexic lower extremity phasic stretch reflexes to tendon percussion.                                        The 15 subjects had a mean age of 45 years (range, 26 to 61), were between 3 months and 45 years postinjury, and had been admitted to a VA Medical Center SCI unit for reasons unrelated to gastrointestinal pathology.                                    One hundred fourteen bowel care sessions were studied from the 15 subjects:43 using PGB suppositories, 43 using HVB suppositories and 28 using TVC. No subjects reported gastrointestinal symptoms or autonomic dysreflexia during or around the time of the bowel care. There were 10 incontinence episodes reported. Ten occurred within 1 hour of the end of the bowel care, 3 after PGB, 5 after HVB and 2 after TVC. Two of the 5 HVB incontinence episodes occurred on the same day in one subject, separated by a 2-hour period.

Therefore, to prevent gastrointestinal complications  that can occur due to fecal distention of the colon, a bisacodyl