Time Comparison of Interventions on Bowel Programs in Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCasa Colina Hospital and Centers for Healthcare
About this trial
The goal of the study is to find out which of three different options (a suppository, a mini enema, or a transanal irrigation device) takes the least amount of time for completing bowel program amongst those who have spinal cord injuries with a neurogenic bowel. The main questions this study aims to answer are:
* Does one of these tools meaningfully reduce the amount of time people with spinal cord injury need to complete their bowel programs? * Does one of these tools meaningfully reduce the number of times someone might experience incontinence or constipation? * Are participants satisfied in using these devices, and would they prefer to use the same tool at home? Researchers will compare the answers to these questions between the three different tools to improve quality of life for patients while improving the efficiency of the care provided.
Participants in this study will:
* Be enrolled in one of these options depending on when they are admitted to Casa Colina Hospital * Will receive the same tool for their bowel program for the majority or entirety of their stay * Will have a tracking sheet placed in their rooms for nursing to record when bowel program started and when it was completed * Will receive questionnaires when they enroll and when they finish the study on their experience with the tool and how likely they would be to use it at home
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
admission to acute rehab inpatient unit
diagnosis of spinal cord injury
reflexive type neurogenic bowel requiring bowel program with suppository and digital stimulation
Disqualifiers
anal or rectal stenosis
active inflammatory bowel disease
acute diverticulitis
colorectal cancer
Trial design
Design model
Parallel
Treatments tested in this trial
Suppository
DeviceThe patient will receive a suppository 15-20 minutes prior to being transferred to toilet. Then while on the toilet patient will receive multiple digital stimulations 5-10 minutes apart to trigger the bowel reflex until bowel program is completed.
Enemeez
DeviceThe patient will receive the 5mL enema then be transferred onto the toilet. If no evacuation occurs within 15 minutes, then while on the toilet patient will receive multiple digital stimulations 5-10 minutes apart to trigger the bowel reflex until bowel program is completed.
Peristeen
DeviceThe Peristeen device will be prepared prior to sitting the participant on the toilet. The lubricated rectal catheter will be inserted, and the retention balloon will be gently inflated to ensure a rectal seal. The irrigation pump will then pump water into the rectum. The balloon will be deflated and the catheter removed to allow for emptying of the water and stool. The catheter will be discarded.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: SuppositoryActive comparator 1 intervention
Group B: EnemeezActive comparator 1 intervention
Group C: PeristeenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time required to complete bowel program
During the bowel program nursing staff will document time suppository or Enemeez is given. In the case of Pertisteen, the nurse will document the time out of bed instead. This will be done manually via a paper chart that is placed in the patient's room. The staff will also document the time bowel evacuation is complete and if there has been any need for intervention to treat constipation in the last 24 hours.
Time frame
Every morning for approximately two hours, from enrollment and lasting 21 daysSecondary outcomes
1
Effectiveness of treatment intervention
Assessed by episodes of bowel incontinence and constipation. This will be evaluated by a chart review. We will note episodes of bowel incontinence and episodes of additional orders to address constipation (e.g. abdominal xray with indication of constipation, Relistor, additional oral medications, etc.)
Time frame
Assessed every morning via chart review from enrollment and lasting 21 daysOther outcomes
1
Patient satisfaction and anticipated feasibility for home use
Assessed via questionnaire made for this study utilizing the Theoretical Domain Framework and Consolidated Framework for Implementation Research. The questionnaire will assess domains of patient satisfaction and feasibility for home use utilizing a 5-point Likert Scale from "Strongly Disagree" to "Strongly Agree." Higher scores will indicate higher satisfaction and feasibility.
Time frame
Upon enrollment and again at 3 weeksSponsors and contacts
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Source ClinicalTrials.gov